The Cannes event, positioned as an “International Festival of Creativity,” features the industry’s most innovative communications campaigns reviewed by juries comprised of our profession’s most respected leaders. The judges expect to see receipts demonstrating appropriate use of AI to anchor the programs submitted for consideration.

But that’s not the most important debate facing our industry when it comes to AI. The more significant question is this: how did you overcome the credibility problem inherent to the use of AI?

AI is still new, but it has already created significant trust issues. Scroll through LinkedIn, and you’ll find a litany of posts calling out problems with AI-generated writing. You’ll also get plenty of advice on how to spot the AI tells. Then open up Instagram, Facebook, TikTok, or X, and you’ll find an abundance of videos and images accused of being faked by AI (and plenty of them are).

Technology has a trust problem, and the resulting backlash, scrutiny, and skepticism are powerful. This puts healthcare communications professionals behind the credibility 8-ball. Campaigns need to prove their own authenticity, in addition to building trust in a brand’s clinical profile. That’s a significant challenge in a regulated industry. The healthcare brands that do it well are led by communications pros who hold AI to a higher standard than any other industry, and understand that the stakes are higher than a bad earnings report. The bigger risk is a doctor or a patient who no longer trusts you.

Responsible technology adoption is a pharmaceutical communications signature.

New technology always arrives with the same conditions for healthcare communicators: prove it can be used compliantly. That process is not fast, and it can be costly, but it’s mandatory because of the legal and ethical consequences.

When pharmaceutical products began building social media presence in the early 2010s, platforms had to modify their infrastructure specifically for the industry. For example, Facebook had to allow brands to disable comments on regulated content.

The FDA spent years developing guidance on how pharmaceutical companies could include fair balance and important safety information within the character limitations of a tweet, and ultimately, the agency told industry that if accurate, balanced presentation of safety information wasn’t possible within a social media platform’s constraints, then they should reconsider using that platform to tell their story.

These guidelines challenged communicators to get creative, but they also enabled a safe framework for the industry to use innovative technology to appropriately engage with stakeholders. The brands that tried to find ways around the regulations paid for it in FDA sanctions and stakeholder distrust, but those that took the time to establish proper governance benefited from the reach of social media and the resulting commercial growth.

Integration of AI into communications requires the same process: build the governance before the campaign’s outcomes depend on it.

We have to hold ourselves to a higher standard, even if it means slower adoption of AI.

Healthcare communicators are accountable to a group of stakeholders that no other discipline serves simultaneously:

• Patients making personal healthcare choices

• Physicians interpreting clinical data

• Payers evaluating cost-benefit evidence

• Regulators assessing compliance

• Advocates gauging the feasibility of alliances

• Investors looking holistically at the financial viability of each action we take

Any communications failure can have clinical, legal, economic, and reputational impact.

The way we use AI compounds that accountability in two ways:

1/ Content Integrity: In regulated environments, AI-generated content faces greater scrutiny from Medical/Legal/Regulatory (MLR) reviewers who require attributions. When AI is the primary author, MLR leans harder on communications leaders to produce valid, referenced sources.

2/ Patient Authenticity: Real patient stories carry credibility because they reflect actual human experience. But an AI-created aggregate of fabricated experiences of fictional patients jeopardizes the trust that companies have built over decades.

Regulatory exposure is not theoretical. In April 2026, the FDA issued its first warning letter explicitly citing AI misuse, sanctioning Purolea Cosmetics Lab for using AI to generate product specifications and manufacturing records for a regulated drug, without adequate human review.

Failure to meet these standards has significant consequences. In 2025, Cannes withdrew award-winning work because of concerns that a campaign used AI-generated and manipulated footage to simulate real-world events that never happened. In total, 12 awards across three campaigns were rescinded, and Cannes overhauled its entire integrity framework for this year’s awards, including the introduction of mandatory AI disclosures, dual-layer content verification, and executive sign-off requirements on every entry.

The concept of “put your name on it” became an absolute imperative, and rightfully so, because the integrity of the industry and our profession was on the line.

What responsible use of AI actually looks like in real-world settings.

Pharmaceutical communicators need a governance framework for using AI in a way that will strengthen the integrity of our work, without adding compliance risk or raising authenticity questions. Trust cannot be compromised for the sake of creativity or efficiency, which is why communicators need to think beyond the AI tool itself and instead, focus on where, when, and how we use them.

Appropriate use of AI starts with the content we create (“we” meaning humans alone) to inform earned media initiatives. Yes, AI can synthesize medical literature at a scale that humans cannot match, and it can translate that research into messages conveying clinical value. But it cannot make those messages matter the way a human can, which is why once the initial research and outlining of a press release is complete, the human needs to take over. Human authorship at the drafting stage is the accountability threshold: it’s the point at which a named professional takes legal and regulatory responsibility for every claim. AI may be able to inform a claim, but it can’t be allowed to own it.

This is the first step in the Earned Progression, and it’s the most important one.

Contextualizing authority and credibility in a press release, fact sheet, infographic, and/or pitch letter increases the chance that the content will reach and influence the physician, payer, or patient it was intended for. That work is a human-only job, and doesn’t require AI to fabricate a case study or craft a clinical argument. It simply requires the human to use AI appropriately to enhance productivity, not outputs.

The resulting earned media coverage, which was produced with human judgment and accountability, generates Earned AI Search (EAIS) visibility; LLMs prioritize those stories in search query responses because they carry the needed credibility signals that determine authority. A synthesized experience in an AI-generated press release can’t create those signals, and using AI at this juncture undermines communications efforts because the drivers of EAIS come from the authenticity of the source.

In a context that depends on trust, AI content simply does not have sufficient equity.

After EAIS visibility is secured, the progression moves to earned attention and earned response: physicians change prescribing behaviors, patients respond to calls-to-action, and payers make evidence-based decisions. Those shifts compound as earned revenue, which is the outcome that proves communications moved the needle for the business by appropriately using AI.

The caveat is that every step in this progression depends on the credibility established at the onset. Improper use of AI can compromise that credibility, and it’s incumbent on the communications leader to ensure the foundation remains anchored in authenticity and trust.

A prediction for our industry, and my challenge to you.

Healthcare communications leaders who deploy AI through the Earned Progression framework will produce the measurable outcomes that companies, brands, and stakeholders demand: prescribing uptake, patient behavior change, payer access, and revenue attributable to communications.

These are the business results that demonstrate ROI, and they’re only achievable when the AI-assisted work is credible enough to motivate real people to make real decisions.

My prediction for our industry: The communications leaders who hold AI to this standard will produce more memorable, award-winning campaigns and drive greater commercial success for brands and companies over the next five years. They’ll also be the ones left standing when the inevitable backlash against a market that’s oversaturated with AI reaches its pinnacle, because they built their credibility on what AI cannot create: authentic, accountable, human experience.

My challenge to communications colleagues: Show up at Cannes and every other industry award ceremony with irrefutable evidence that your AI-assisted communications created that level of meaningful change, anchored by the credibility of the initiative and the asset. Prove that your patients understood the management of their disease and the conversation they needed to have with their doctor. Demonstrate that a physician shifted prescribing behavior away from an industry gold-standard, and that a payer added a brand to a formulary or removed a step edit because of the belief created by the evidence driving your campaign.

--------------------

Hi. I’m Joshua, a PR pro who helps companies turn communications into revenue. Email me at pr.rxblog@gmail.com or find me at linkedin.com/in/joshuamansbach. Let’s have a virtual coffee and talk about creating a story and a strategy that makes a positive impact for your business.

I’ve spent nearly two decades developing global regulatory communications strategies, including 14 product launches in 22 countries, and have seen what happens when regulators change course without explanation. Industry sponsors commit hundreds of millions of dollars and many years to conduct clinical trials based on agreements with the FDA. They enroll patients with no other treatment options, and then watch the rules change without explanation.

In my career, I’ve had to write rationales explaining that a therapy won’t be available due to a last-minute change to a previously agreed-upon clinical development plan. The incoming leaders of the FDA need to ensure that type of communication is never needed again.

An Infrastructure Is Already In Place

The necessary reform has been defined. In February 2026, the U.S. Senate held a hearing that produced four actions for the FDA to improve rare disease drug development. It was concluded that the FDA needed to:

1/ Establish a rare disease advisory committee.

2/ Apply accelerated approval pathways consistently.

3/ Issue and adhere to guidance on surrogate endpoints.

4/ Increase transparency around late-stage review changes and complete response letter rationale.

These reforms were based on recommendations from the physicians, patient advocates, and industry sponsors who are closest to the rare disease therapy development process. They’ve seen the negative impacts of inconsistent FDA guidance on clinical trials. They understand how late-stage changes to written agreements, a refusal to accept surrogate endpoints, and demands for more data from patient populations that simply do not support large-scale clinical trials can negatively affect patient care.

Since the start of 2025, the FDA has issued 23 complete response letters, many of which are believed by advocates to be the result of inconsistent regulatory guidance. The rare disease community is asking that incoming FDA leadership remove policy-driven roadblocks preventing new therapies from reaching patients.

Peter Marks, who served as CBER director from 2016 until his departure in March 2025, understood how investigational therapies needed to move through review pathways. During his tenure, he launched the plausible mechanism framework, advanced the surrogate endpoint conversation, and, in January 2024, he introduced the Collaboration on Gene Therapies Global Pilot Program (CoGenT Global).

This initiative would enable collaborative review of gene therapy applications between the FDA, the European Medicines Agency (EMA), plus regulators from Japan, Canada, Switzerland, and the World Health Organization. Marks knew that there were often not enough rare disease patients to conduct large studies. He theorized that if information were shared across borders, regulatory agencies could use these insights to inform decisions. His exit is a primary reason why progress in the approval of rare disease therapies has stalled.

The “Interpol Model” For Drug Development

Interpol exists because sovereign nations knew that information that protects all citizens needs to be shared. The organization was established to share intelligence so agencies could work from the same information, even if they reached different conclusions after using it.

Rare disease therapy development needs the same model.

Populations with rare diseases are, by definition, small. Industry sponsors can’t produce a large volume of clinical trial data because there aren’t enough patients to do so. When regulators require separate evidence bases, sponsors face an impossible task, and patients ultimately suffer the consequences.

But if countries had a complete body of evidence, industry would gain an efficient path to delivering treatments worldwide, because regulatory agencies could review all the necessary data. Cross-agency information sharing doesn’t require alignment on conclusions; just access to data so each regulator can make informed decisions based on local criteria.

This is what the CoGenT Global initiative was built for, and the infrastructure supporting it was working.

In January 2024, CoGenT launched, creating a pathway for sponsors to navigate multiple regulatory environments from a single application. By September, the FDA confirmed that a pilot program with the EMA had begun a shared review. A few months later, FDA leadership changed, the program was put on hold, and rare disease patients across the world who would have benefited from shared data were left waiting for therapies that may already exist somewhere.

The FDA’s New Leadership Must Resurrect CoGenT

The path to resurrecting CoGenT is clear, and the process needs to begin now, driven by interim commissioner Kyle Diamantas and the recently appointed acting director of CBER, Karim Mikhail. When permanent leaders are installed, the outgoing team needs to ensure continuity.

Turnover at the agency cannot be used as a rationale for further delay.

First, the agency must fulfill all four of the Senate’s mandates, because without a credible domestic process, the FDA won’t be seen as a trustworthy anchor for global collaboration.

Second, the agency must reactivate CoGenT, with measurable KPIs and a publicly known timeline for expansion to the full roster of nations that Marks originally intended.

The definition of success is clear: a pre-specified number of regulatory agencies should participate in the data-sharing effort, with clear protocols for sharing research on rare disease therapies, regardless of how each country uses the data.

If these measures are achieved, the FDA will have successfully assumed a leadership role in addressing the global rare disease crisis.

Patients Deserve Regulatory Leaders Who Are Open To New Ideas

The tide began turning last week, as uniQure announced that the FDA agreed that three years of data would support its application. This was a reversal of the announcement made in March 2026, in which the company confirmed that the agency deemed its planned data submission to be insufficient. Still, another trial is needed to confirm the treatment’s effects and, according to UniQure, the agency wants to make sure both sides see eye to eye on this study’s design before a BLA is submitted.

Despite this case, the FDA still needs to embrace the bigger picture: people with rare diseases cannot power large-scale clinical trials because there aren’t enough of them. Sponsors simply cannot be compelled to find study subjects who don’t exist. That obstacle can be overcome once the FDA accepts surrogate endpoints, honors the written agreements it makes with sponsors, and treats small patient populations as a reason for greater regulatory flexibility, rather than a rationale for increased scrutiny.

The incoming leadership has a Senate mandate, peer-reviewed validation for the global information-sharing infrastructure, and an operational pilot that proved the CoGenT model can work. Rare disease sponsors and patients worldwide have waited long enough. New FDA leadership has the means to take action now.

--------------------

Hi. I’m Joshua, a PR pro who helps companies turn communications into revenue. Email me at pr.rxblog@gmail.com or find me at linkedin.com/in/joshuamansbach. Let’s have a virtual coffee and talk about creating a story and a strategy that makes a positive impact for your business.

A PR team may do great work, but measurement reports that only show what the campaign produced, and not what changed as a result, don’t serve the business well.

Media placements, spokesperson quotes, message pull-through, impressions, and share of voice are an incomplete picture of campaign measurement. C-suite executives and leaders with P&L responsibilities and tight budgets need more than the mastheads of media outlets on a slide. They need to see value for the business, in the form of category ownership, perception shifts, behavior changes, and LLM visibility. They want tangible outcomes such as expanded payer reimbursement, prescribing uptake, and investor engagement, as well as shortened sales cycles leading to new revenue.

The reason these metrics aren’t the universal standard for communications is that most programs are built only to measure traditional goals.

PR pros: Does this sound familiar?

“We need to generate media coverage to build awareness.”

That’s old-school PR.

Shift the perspective to measuring the impact of communications on outcomes.

“Patients need to talk to doctors about risk factors for this disease.”

“Payers should understand that not reimbursing will increase healthcare costs.”

“Physicians have to realize that better treatment options do exist, and data proves it.”

Those measures show how communications can create a positive business impact, because the result is prescribing uptake and revenue.

Outputs vs. outcomes: Which one moves the needle?

A drug that lowers cholesterol creates an output: decreased LDL. If that drug also prevents a heart attack, it improves outcomes. The same logic also applies to measuring communications programs.

In 2010, the public relations industry acknowledged the “outputs vs. outcomes” conflict, and the International Association for Measurement and Evaluation of Communication (AMEC) established the Barcelona Principles, which created a consensus that outcomes take precedence over outputs.

Despite universal agreement that measurement must demonstrate impact, more than a decade after the Barcelona Principles were created, Muck Rack’s 2024 State of PR Measurement Report found that PR professionals remain only “somewhat confident” in the metrics they track.

It’s as if programs are being measured based on nothing but dead reckoning. That term is frequently associated with how sailors navigated before GPS. They noted where they started, then estimated speed and heading to gauge where they were going. For voyages without a clear reference point outlining the ultimate destination, sailors could only see where they were relative to where they’d just been, and that was insufficient for showing real progress.

Public relations programs built in 2026 cannot measure impact based on dead reckoning. Navigating with an old map won’t help a driver reach a destination, and tracking media impressions is an incomplete picture of the progress needed for public relations to advance the business.

We set a baseline, so we can see progress. That means the campaign worked, right?

That logic is flawed because the result is incomplete.

While it’s true that a quarterly media coverage report can show an increase in impressions from Q1 to Q2, the only baseline that exists is the number of hits in Q1, not what those hits represented in terms of business performance. Baselines make impression numbers mean something. If media hits influenced new prescribing over the quarter, led patients to change health management behaviors, or caused investors to show interest in funding, then the outcome delivered value to the business.

A campaign may succeed or fail, but if the pre-determined metrics aren’t correct, its value can’t be proven. If a biotech company launches a gene therapy for a rare disease affecting only 5,000 patients worldwide, a program created to generate twenty million impressions isn’t helpful to the business. Reaching primary care doctors who may have never even seen the disease doesn’t constitute a successful program. The media numbers on the measurement dashboard may go up, but if revenue doesn’t, then it’s not a business win.

What matters here is the targeted number, not the higher one. If just one article reaches the 70 physicians, 4 advocacy groups, and 2 policymakers on a Senate committee who influence how the disease is treated, and they all respond to the call-to-action, then the metrics slide may not seem impressive, but the business impact is exactly what the CEO wants to see.

The Barcelona Principles showed us that outputs don’t advance the business, and therefore, don’t show the full value of the work we do. The solution isn’t just to swap in different metrics. It’s more complex, because first we have to change the way we design our programs.

PR outputs can drive business outcomes, as long as they’re defined in advance.

Setting a goal of two million impressions because the last campaign earned one million sounds impressive, but without a pre-defined KPI in the form of an independent business outcome, the program won’t move the needle that matters most in the Boardroom.

That KPI is the reference point, and it’s essential to program success.

For PR programs, the reference point is the business outcome that campaigns create, and they need to be defined before the program is built.

Communications leaders can set a reference point by answering these three questions:

1/ Which stakeholder group(s) need to change a belief or behavior?

2/ What does that change need to create to benefit the business?

3/ What evidence confirms the change happened?

The answer for a healthcare PR program would look something like this:

“Physicians must understand that the disease paradigm has changed. It’s no longer the case that all medications in a class aren’t effective for a specific patient type. This belief shift will lead to new prescribing habits and an increase in NRx from X% to Y% over the next quarter. Simultaneously, we will demonstrate to payers that reimbursement will save long-term costs by reducing the number of in-hospital days for patients. If the brand is covered by X number of commercial insurers, then access will increase by Y% for appropriate patients.”

Each of these is a business outcome that can be achieved by PR outputs.

Impressions are only a means to an end: they don’t drive prescribing or pressure payers to reimburse.

If the only KPI is impressions, then measurement is incomplete. But demonstrating how communications impacts prescribing, reimbursement, or sales is not always a straight path to follow. That means PR teams need a better roadmap to connect the dots from coverage output (earned media) to business outcome (earned revenue).

Here’s the “Earned Progression” I created to guide communications strategies from output to outcome:

1/ Earned media coverage catalyzes the process by establishing brand presence where stakeholders are likely to seek information.

2/ That article placement, interview, podcast appearance, presentation, or op-ed results in earned AI search (EAIS) visibility, based on the credibility signals integrated in media coverage.

3/ That visibility enables earned attention to compound. When LLMs incorporate authoritative content into search query responses, people take notice, and they talk about how the brand delivers value at a greater scale than any single placement could generate on its own.

4/ The next result is earned response, as calls-to-action are heeded: consumers make buying choices, doctors write prescriptions, payers reimburse, and stakeholders shift beliefs in the value of a brand.

5/ That response becomes earned revenue – the business goal that proves earned media directly contributes to the bottom line.

The end of this progression is where C-suite leaders see how communications moves the revenue needle.

We’re a thousand miles off course and measuring the wrong KPIs

When sailors navigate by dead reckoning, it’s more challenging to reach land. If communications teams fail to establish reference points for where programs need to go, three things can happen, and none are beneficial to the business:

1/ The wrong audience is measured. Reach is easier to gauge than influence, so teams often default to impressions rather than measuring behavior change. But if a campaign fails to motivate prescribers, payers, or policymakers, then it can’t be considered a business success. In December 2019, Amarin earned significant coverage for the FDA approval of its cardiovascular drug, Vascepa. Despite the number of media hits, it took only six months for Amarin to acknowledge that most physicians and patients still did not know about the therapy. The drug failed to generate meaningful commercial uptake and was ultimately overtaken by generics after a federal court invalidated Amarin’s patents.

2/ Activity takes precedence over market movement. As the Barcelona Principles stated, an article – even one in a top-tier outlet – is still only an output, and needs to produce a business outcome to show ROI. Biogen generated substantial coverage surrounding the June 2021 approval of Aduhelm. The company spoke of “high interest” in the drug, but failed to measure the KPIs that mattered to commercial viability: payer sentiment and formulary decisions. Despite the number of articles published, the launch strategy failed to affect reimbursement, and the lack of access ultimately translated to failure.

3/ The metrics are set after the program launches. You wouldn’t conduct a clinical trial, read the data, draw conclusions, and then set the primary endpoint. Communications strategies follow the same principle. A program that defines success metrics after the campaign can’t gauge whether it created the desired change in business outcomes.

The best maps show where the road leads and how to reach the ultimate destination.

When I travel, I like to look at where I plan to finish my journey. The destination is my reference point for a road trip, just as the business outcome is for my communications strategies. I establish what needs to be achieved to own a category, change a behavior, and earn revenue, and how PR will move me closer to that goal.

When you build your next program, don’t set an objective and strategy to “build awareness by driving coverage.” That’s an output. Instead, solve a business challenge, create an outcome, and don’t believe anyone who tells you PR cannot drive revenue.

What’s stopping PR programs from increasing prescribing for a new drug by changing physicians’ beliefs about whether it’s an improvement over the standard of care?

Who says PR isn’t able to affect change in reimbursement by pressuring payers into expanding access for a drug that reduces the burden on the healthcare system?

Communications professionals no longer need to measure based on dead reckoning. The Earned Progression is the roadmap to business outcomes. Follow it from earned media to earned AI search visibility, earned attention, and earned response, and you’ll wind up exactly where the business needs to go: earned revenue.

--------------------

Hi. I’m Joshua, a PR pro who helps companies turn communications into revenue. Email me at pr.rxblog@gmail.com or find me at linkedin.com/in/joshuamansbach. Let’s have a virtual coffee, and talk about creating a story and a strategy that makes a positive impact for your business.

People are often offended by brand communications.

Social media posts, advertisements, and marketing copy can produce visceral feelings ranging from surprise to anger, and may make consumers swear they’ll never patronize that business.

That was the point.

I call it “cringe communications,” and I define it as a brand adopting a specific voice to deliberately violate the conventions of professional communications. It’s calculated and proactive, intended to elicit shock and disbelief.

For the right companies, cringe is a successful communications strategy.

I could never do it. Literally, I cannot create a campaign or write even a single key message that might be insulting to someone. I work in healthcare communications, and even the slightest step past benign compliance is subject to regulatory scrutiny and legal repercussions.

My professional world follows different rules, but as an independent observer and a consumer, I fully embrace cringe communications. As a communications strategist, the chance to explore the psychology of cringe is undeniably compelling. I find it clever and innovative, and when properly executed, it’s highly effective.

Now the caveat: “Properly” means only brands that can truly be innovative leaders. If every brand in a category tried to create cringe, then none of them would stand out. One may eventually emerge as a leader, provided their message resonates and the product actually solves a problem, but the rest will be seen as poor imitations. That’s why people will dismiss cringe communications as a gimmick and not a strategy.

This article is about the brands that got it right, how they did it, and what separates them from the ones that failed.

Wendy’s chose chaos.

In January 2017, the fast food chain’s Twitter account started insulting customers. It gained attention by distancing itself from the homogenized world of product promotions and transforming into a deliberately antagonistic and highly entertaining brand personality.

The persona was born when a user randomly challenged the restaurant’s “fresh, never frozen” claim about its burgers. Amy Brown, the social media manager, responded that the user was wrong and that they only use fresh beef. The reply questioned if the restaurant “delivered it raw on a hot truck.”

The Wendy’s account’s next response wasn’t based on a key message in a corporate playbook.

Instead, it poked the bear and clapped back with, “Where do you store cold things that aren’t frozen?” The user tried again: “Give up…McDonald’s got you beat…”. Then Wendy’s ended it: “You don’t have to bring them into this just because you forgot refrigerators existed…”

The internet responded immediately and positively, and within weeks, the account was roasting competitors and followers. By 2018, Wendy’s brought its new personality to “National Roast Day,” where users and competitors requested a public roast just to get attention. Since then, the account’s online presence has generated hundreds of millions of impressions without spending a dollar on paid media.

Duolingo’s owl wasn’t a brand decision made in a boardroom.

The unhinged owl originated when users began making memes about the app’s aggressive push notifications. They imagined “Duo the Owl” as a threatening figure that would literally come after you for skipping lessons.

The company could have gone the route of a cease-and-desist to remove the memes, but instead, they chose to lean in. The social media manager who ran the account, Zaria Parvez, brought the owl’s new personality to life on TikTok, growing the account to 13 million followers. Part of the reward was the engagement they got from other prominent accounts that played along, as seen in the below image.

The stellar earnings reports that followed made shareholders quite pleased with the company’s decision to adopt cringe communications as a strategy.

Jimmy’s Famous Seafood doesn’t like it when you insult America.

During the 2026 Winter Olympics, the Huffington Post suggested Americans felt shame in supporting their country in the games. John Minadakis, owner of Jimmy’s Famous Seafood in Baltimore, MD, had a three-word response: the acronym is “G.F.Y.”

(I’ll leave it to you to solve the puzzle.)

That single tweet generated 17 million views in only 48 hours, and catalyzed a cringe communications strategy that built a new brand for the restaurant. Jimmy’s Seafood became a symbol of America, and saw the benefits immediately as the restaurant filled with customers.

Mr. Minadakis acted on instinct.

No strategy, no brainstorms, no 8-week messaging workshop to produce a 76-slide PowerPoint deck.

Just raw human emotion. In the weeks and months that followed, Jimmy’s official Twitter/X handle embraced this persona, finding selective spots to offer its now-famous reply, along with a few other choice phrases. The brand was built by accident, in the moment, and the decision to commit to it is the reason the restaurant continues to thrive several months later.

Not every cringe strategy is a product of social media.

An outlier of the cringe genre is the energy drink brand Liquid Death. Their identity didn’t come from social media. It was born from capitalism and entrepreneurship, coupled with a love of punk and heavy metal music.

The company’s founder, Mike Cessario, was a former advertising executive with a lifelong connection to the music scene. While attending the Warped Tour in 2008, he noticed that bands were obligated to drink sponsors’ energy drinks on stage, and he learned that many preferred water.

Mike spent the next ten years bringing an idea to life. In 2019, he launched Liquid Death, with a simple premise: sell canned water that caters to a heavy metal and punk audience. A tagline that read “Murder Your Thirst” anchored the brand identity, which ultimately reached a $1.4 billion market valuation and 113,000 retail locations across the United States. Cringe was the brand from day one, and it was the smartest strategy imaginable, because it solved a specific problem for a particular audience.

There’s a reason why these brands got it right.

These brands succeeded because they met their moments with the right strategy. Not all companies can say that. For Wendy’s, Duolingo, Jimmy’s, and Liquid Death, their success came because a very specific set of criteria was met:

1/ The Audience Gave Permission: A brand’s customers must actively reward irreverent behavior. Wendy’s audience is comprised of people who are genuinely entertained by brands that are anthropomorphized with shared personality traits. Jimmy’s knew its customers, so they also knew that loyal patrons wouldn’t balk at the brand’s abrasive response to the Huffington Post. Liquid Death was certain its counter-culture audience would approve of a new market player that made a loud entrance. Permission looks different in each case, but if it exists before the brand voice does, and you don’t have to manufacture it, a cringe communications strategy may be right for your brand.

2/ The Brand/Customer Relationship Is Low-Stakes: The product or service can’t impact the customer’s health, financial security, legal standing, or safety. That’s why pharmaceutical companies, banks, and lawyers don’t utilize cringe communications. But if a regional seafood restaurant loses a two-top at dinner service, it’s not the end of the world. The difference in consequences is what makes cringe communications available to consumer food, entertainment, and lifestyle brands, but not companies in regulated industries.

3/ Full Commitment Is Clear: People can smell disingenuous brands from miles away. If a company “tries cringe” to “see what happens,” it’s going to fail. One provocative, edgy tweet followed by a retreat to formal corporate speak will be easily exposed as a cheap stunt. For cringe to work, companies can’t be tourists in the genre.

4/ Consistency Breeds Sustainability: While commitment is the decision to do it, consistency makes it an identity. Jimmy’s had the moment, then made more moments happen. That created an asset which eventually became an identity. In cringe communications, the brand voice has to be real, so the audience comes to expect it, anticipate it, and ultimately, appreciate it.

5/ Alignment Between Voice + Brand Is Authentic: Liquid Death’s heavy metal packaging and its social voice are the same. Wendy’s “fresh, never frozen” promise, and its willingness to aggressively go after anyone who challenges it are also the same.

If the voice is just a mask, the audience will notice and call you out.

When it fails, it fails badly.

Imagine your legacy hinged on a gamble: that a shift in business strategy could be anchored in a pivot from a family-friendly brand to a vulgar, caustic, and unhinged Twitter presence.

Radio Shack tried it. The same store that once sold you a remote-controlled helicopter, batteries, a stereo, and an Atari video game system was relaunching as a cryptocurrency. It didn’t have its audience’s permission, and the stakes were far too high for both company and customer. They weren’t committed to either the brand or the identity, and the nostalgia for the original company outweighed the appeal of a strange new voice that didn’t connect with the audience. People were simply unwilling to invest in a company whose Twitter account tried too hard to be a “finance bro.”

The failure is irrefutable evidence that the criteria for a cringe strategy matter.

It won’t work for me, but I still learned a lot from it.

In healthcare communications, publicly-traded, global Fortune 500 pharmaceutical companies with shareholders, Boards of Directors, and corporate governance don’t do cringe. My fellow healthcare communications pros and I have the creativity, and we are absolutely bold thinkers, but we also know that our brands don’t meet the criteria, and the stakes are way too high to attempt it. We can’t afford to offend the federal government or a managed care organization, nor can we jeopardize the trust that physicians, patients, and advocates place in us.

But as a student of strategy, I admire the discipline of brands that successfully built their identities on a cornerstone of cringe. Every brand in this article that did cringe the right way made a deliberate choice about who they were, and they found a voice that was true to their values.

Wendy’s didn’t test an edgy tweet and wait for approval. Duolingo didn’t convene a task force to assess the Evil Owl meme. Jimmy’s owner sent one reply from his phone because it was true to what he believed, and it didn’t require an A/B test to tell them they should keep going.

Each of those decisions took discipline, which exists regardless of industry. The next time you see a brand do something that pushes boundaries, don’t dismiss it as silly or foolish. Instead, run the checklist: audience permission; low-stakes; full commitment; consistency; authenticity.

Brands that meet the criteria know the benefits outweigh the risks. They understand the calculation will work in their favor, and know that customers will show up and embrace them…

…and then they’ll cringe.

Which is exactly what you want.

--------------------

Hi. I’m Joshua, a PR pro who helps companies turn communications into revenue. Email me at pr.rxblog@gmail.com or find me at linkedin.com/in/joshuamansbach. Let’s have a virtual coffee and talk about creating a story and a strategy that makes a positive impact for your business.

I see you’ve spent a wad of dough to tell me what you think I should know.

Your factory’s big; so fine and strong,

and your founder had whiskers, so handsomely long.

So he started the business in ol’ ‘92!

How tremendously interesting… (that is, to you.)

He built up the thing with the blood of his life?

(I’ll run home like mad, tell that to my wife!)

Your machinery’s modern and oh, so complete;

your ‘rep’ is so flawless, your workers so neat.

Your motto is “Quality”… capital “Q.”

No wonder I’m tired of “Your” and of “You”!

So tell me quick and tell me true, (or else, my friend, to hell with you!)

Less: “how this product came to be,”

and more: “what the damn thing does for me!”

The poem you just read is attributed to “Unknown.” That’s too bad, because the scribe deserves credit for diagnosing a communications failure that’s persisted for decades and shows no signs of improving. Communicators are still not paying attention to the poem’s teachings. As a result, messages from their companies are failing to resonate.

If your sales are declining, start fixing the problem by reading your own press releases, because the wound is self-inflicted.

Subscribe now

Most content is written about the company producing the product. It’s created by the company, for the company, and delivered by the company, after it’s approved by the company, and its effectiveness is measured based on standards set by the company.

Meanwhile, the customer – who the company should be focused on – is left wondering what’s in it for them. They have no idea, because the company made them an afterthought. Their primary business problem has been reduced to a sub-bullet on slide 56 of a PowerPoint deck.

The poem made this problem clear decades ago. But the industry ignored it and went right back to reviewing that seemingly endless deck.

You’ve seen the problem firsthand…maybe you even wrote content that exacerbated it.

“The opening of our new manufacturing facility is an important milestone for our company’s growth. We’ve invested more than $50 million in state-of-the-art technology that will help us produce more BRAND X.”

That’s what the CEO of a medical diagnostics company I worked with said in a press release that I really didn’t want to put my name on as the media contact.

There was no mention of what the factory improved upon, such as faster production, and how that would improve the end-user experience. Also absent from the release was any reference to what it all meant for customers buying the product: would it ship faster or cost less? None of that was included.

I told the CEO that neither the editors we’d pitch it to, nor any customers, would care about a release written from such an inward-facing perspective.

He really should have read the poem.

Blame the recurrence of this problem on two consistent failures.

The first failure is the communicator who isn’t using the right metrics to measure the impact. The communications profession is stuck in the mud of the past, using placements, impressions, and release pickups as primary metrics. Those don’t move the needle of sales and revenue. But perception shifts, behavior changes, and responses to calls-to-action do.

The second failure is the communicator who understands the poem’s meaning, wants to embrace it, but is prevented from doing so by the company’s approval process and/or the archaic philosophy of a C-suite that doesn’t want to listen to the expertise of the person they hired. Even when the communications director tries to write an outward-facing document focused on what the customer needs, it comes back covered in redline edits, suggesting more product buzzwords be added, at the expense of what’s actually important to the people who may (or may not) buy it.

For those who find themselves in that position, help your cause by showing leadership that success is measured based on a company’s ability to solve its customers’ problems, not on cramming three dozen product features into a press release.

Nobody really wants a shovel. But they NEED a hole.

I use this analogy with CEOs who want a press release full of self-aggrandizing pats on the back. I remind them that people buy things because they need the results the product creates.

You’re not writing for the J. Peterman catalog, so don’t sell a shovel like this:

“A modern excavating instrument that catapults the digging experience into new realms of powerful cavern-evolving efficiency delivered through a hand-crafted, solid mahogany wood handle.”

Instead, sell a solution. Give customers a simple route to the hole they need:

“Break through hard ground faster, and with less effort.”

When communications focus inwardly, the wrong message is delivered to customers:

“This is what we, the company, want you to want.”

That’s the mistake. This is the message you want to convey:

“Here’s what we, the company, understand you need, and this is how it will help you.”

You’ve seen this mistake made plenty of times.

If you used a Windows PC in the late 90s-early 2000s, then you remember Clippy, the little animated paper clip that Microsoft wanted users to experience, with the intent that it would make its software feel friendlier. But what they delivered was a company-centered communications rationale, not a customer-centric one.

Microsoft ignored direct feedback and focus groups that said Clippy was intrusive and not useful, and that people didn’t want animated help; instead, they preferred tools that remained out of sight till they were needed. Clearly, Microsoft wasn’t interested in addressing its customers’ needs. They were only interested in communicating their own vision of what they believed customers wanted.

In 2017, Pepsi, which was still just a soft drink company and not the harbinger of world peace and global harmony it fancied itself to be, delivered a tone-deaf message that implied a simple can of soda could mitigate the impact of social discordance.

The failure here was the company’s dogmatic inward focus. Pepsi decided how consumers wanted to see the company, and then it used triggering themes and imagery to attempt to prove a point that nobody would agree with. The campaign ended in an apology and an abrupt termination just 48 hours after launch.

There’s a right way for companies to engage with social issues, but a campaign that is completely self-promotional, rather than solutions-oriented, is not the way to do it.

Getting it wrong comes at a tremendous cost.

Companies that consistently communicate from an inward-facing perspective train their audiences to ignore them. When a business shows customers that it only cares about itself, trust erodes. That’s extraordinarily challenging to fix, especially in an era when consumers have choices and can easily find alternatives through the media, searching Google, or by asking Claude or ChatGPT.

The problem starts the moment the press release or fact sheet focuses exclusively on the company or product. That diminishes the impact on earned media coverage, and because the content lacks credibility signals, Earned AI Search (EAIS) visibility is poor. That means less earned attention for the call-to-action, which diminishes response and ultimately affects earned revenue.

All that unnecessary damage could have been avoided if you had just read the poem.

The data backs up the steep price companies pay for these messaging missteps:

• Companies reporting a “very mature” level of customer-centricity experienced 2.5x revenue growth over 5 years compared to those reporting their organization was “very immature,” according to a survey conducted by UC Berkeley.

• Qualtrics research shows the gap in stock prices between companies considered leaders in customer experience and those deemed behind the curve grew 42% from 2019 to 2021.

• 76% of customers reported getting frustrated when they aren’t given a personalized experience, according to Qualtrics.

It’s not too late. Read the poem, then use this strategy framework to refocus your messaging.

Before putting pen to paper on your next content asset, answer these questions:

1. What specific problem does my customer need to solve?

2. Why does it matter to them right now?

3. What does my customer currently believe about my company’s ability to solve their problem?

4. What needs to change before they’ll buy my product or service?

5. What’s standing in the way of that change, and how can my company break that barrier?

6. If I were in my customer’s position, what must I hear the company say to believe they can solve my problem?

These questions don’t need a communications professional to answer. Just focus on what’s important to customers. Prioritize what they need to hear, not what you want to say.

As a communicator, you’re not expected to change the customer’s entire world. You just need to solve their immediate business problem. Even if your industry is regulated like healthcare or highly complex like technology, a message explaining what’s going to change for the customer can make a significant difference.

If a pharmaceutical company promoted the fact that it “spent ten years and invested more than $1 billion developing a receptor agonist that binds to and activates glucagon-like peptide-1 receptors,” you might not believe it was worth the effort to care.

But if that “receptor agonist” became a “therapy that helps restore function by increasing insulin secretion and lowering blood sugar,” then that complicated, inward-facing message just became a customer-centric solution to their problem with diabetes and obesity.

Now think back to the end of the poem:

“Tell me… Less: “how this product came to be, and more: “what the damn thing does for me!”

That’s the poem’s lesson applied. A clinical product description becomes a belief shift the moment it answers the customer’s actual question: “what does this do for me?”

Your company’s story still matters.

The world’s best communicators – most of whom understand the poem – are the ones who can make their audience or customer feel like the most important person in the world; like the company is speaking directly to them and only them.

They do this because they understand what the customer expects. The poem’s closing stanza explains it, and the message is clear: “tell me how this helps me, or you’ve lost my business.”

That’s an extremely reasonable request. It’s probably one that you’ve made in your own capacity as a consumer. The company that tailors its message accordingly is usually the one that gets your business, right?

So apply the same logic when the roles are reversed; when you think about your communications, think about your customer’s problem first. Show them you understand their need and why it matters, and then you can show them how you’ll fix the problem.

The companies that do this build credibility, which leads to enduring trust with their customers. The companies that don’t are still stuck on slide 56 of that never-ending PowerPoint deck.

Author’s Note: This article is dedicated to my Dad, who taught me how to read, write, and love poetry, and who shared the poem that inspired this article.

--------------------

Hi. I’m Joshua, a PR pro who helps companies turn communications into revenue. Email me at pr.rxblog@gmail.com or find me at linkedin.com/in/joshuamansbach. Let’s have a virtual coffee, and talk about creating a story and a strategy that makes a positive impact for your business.

The FDA’s Center for Biologics Evaluation and Research (CBER) continues to cycle through directors, and that’s created a significant trust problem for industry sponsors, patients, and advocates in the rare disease community.

When Vinay Prasad took the helm at CBER in May 2025, he arrived with aspirations for improved patient outcomes. But the only consistent deliverable was disruption, leaving rare disease patients and their families without the treatments they’ve been promised.

As a healthcare communications professional with two decades of experience in regulatory strategy, I’ve learned that the FDA’s stated intent matters far less than the real-life impact its decisions have on patients who have terminal illnesses like Duchenne muscular dystrophy, Huntington’s disease, and Sanfilippo syndrome. Testimony from multiple witnesses at the U.S. Senate Special Committee on Aging’s February 26 hearing on rare disease drug development and regulatory review made the problem these patients face even clearer.

Physicians, advocates, industry representatives, and patients’ families shared serious concerns about inconsistently applied approval pathways, disregarded surrogate endpoints, and late-stage reversals of negotiated trial designs. The cost of these contradictions was high: patients lost access to therapies, and sponsors lost the ability to continually deliver therapeutic innovations.

Two weeks after the hearing, it was revealed that CBER director Vinay Prasad would depart the agency. FDA Commissioner Martin Makary says he will name a replacement before Prasad departs later this month. But a mere transition of leadership is not the same as the actual reform that Senators Rick Scott and Ron Johnson, as well as patient advocates, have made clear is necessary. Success will depend on the actions the FDA takes between now and when the new director is settled in.

The trust problem precedes personnel issues

The past year exposed a breakdown in the rare disease therapy development process. Industry sponsors place their time and capital in the FDA’s regulatory guidance, and they trust that the drug development pathway the agency provides will be upheld.

When guidance changes without explanation, the implication for sponsors is that agreements reached in good faith can be unilaterally reversed, and that trusting the regulatory process is a risk that comes without agency accountability.

I’ve had to write communications explaining why a therapy won’t reach patients as planned because the FDA shifted evidentiary expectations after clinical trials were underway. Those stories are difficult to tell, but they don’t have to be.

That’s the reason the investigation initiated by Johnson into the FDA’s recent complete response letters (CRL) is the most consequential development since the February Senate hearing. It addresses the sponsors’ greatest challenge: regulatory guidance amended without warning, resulting in an inability to meet FDA mandates and an eventual CRL.

Along with requesting these CRLs, Johnson is considering calling FDA Commissioner Makary to testify before the Permanent Subcommittee on Investigations, which the senator chairs. This request may answer a critical question: Did sponsors developing rare disease therapies receive documented rationale as to why the FDA’s guidance changed?

The answer may alter the entire course of future rare disease therapy development.

UniQure’s story exemplifies the problem

In June 2025, the FDA and uniQure reached a written agreement stipulating that data from the company’s Phase 1/2 studies of AMT-130 would support a Biologics License Application (BLA) for its Huntington’s disease gene therapy. The study used an external control derived from natural history data, and topline data announced in September showed a statistically significant 75% slowing of disease progression three years after treatment with the gene therapy.

In November, the FDA reversed its position, indicating to uniQure that these data would not, in fact, be sufficient. A Type A meeting was held in January, and by March, the agency was insisting on a new Phase 3 trial. The agency says this new trial should be randomized, double-blind, and sham surgery–controlled. Doing so requires patients with a fatal, progressive neurological disease to undergo intracranial injection or a procedure with no therapeutic benefit, potentially for years.

Johnson called the sham surgery request “bureaucratic idiocy” and raised an important, and very obvious, question: what changed, especially since Huntington’s disease has no approved treatment? Every year of additional trial time is a year of disease progression for patients who already understand what that means.

The FDA’s position changed between the June 2025 agreement and the November reversal, but no documented rationale was provided. If the FDA cannot answer that question, then no new CBER director can fix what’s broken, because they won’t know where to start.

Real progress requires rebuilding trust

In February, the FDA issued draft guidance on a new plausible-mechanism framework for individualized therapies for ultra-rare disease. The following month, the FDA approved Rocket Pharmaceuticals’ Kresladi, the first gene therapy for a rare pediatric immune disease called severe leukocyte adhesion deficiency type I, using accelerated approval supported by surrogate endpoints.

These are meaningful steps, demonstrating exactly what the Senate called upon the FDA to do: use existing protocols and apply logical flexibility with the right scientific expertise. Still, the new CBER director inherits a significant credibility problem. The incoming leader must rebuild trust while cooperating with an ongoing government investigation. An “onboarding and transition plan” alone won’t suffice. The new director must address four essential mandates.

First, the FDA must respond publicly to Johnson’s request for the CRLs, and the agency must share its plan for ongoing, transparent dialogue regarding review process reforms.

Second, CBER needs to provide more overall clarity for the scientific community and industry sponsors about how it will apply surrogate endpoint guidance.

Third, the FDA must establish a rare disease advisory committee and engage it regularly for appropriate review processes.

Fourth, the agency must commit to the consistent application of accelerated approval pathways when documented criteria are met.

There’s an important difference between transition and transformation. In this case, the transition of leadership is just a process, but the transformation is what’s going to advance science, improve outcomes, and potentially save lives. Reform is possible as long as the agency focuses on transparency and outcomes, rather than simply the bureaucracy of the transition itself.

--------------------

Hi. I’m Joshua, a PR pro who helps companies turn communications into revenue. Email me at pr.rxblog@gmail.com or find me at linkedin.com/in/joshuamansbach. Let’s have a virtual coffee, and talk about creating a story and a strategy that makes a positive impact for your business.

That’s kaizen, and it can be applied to any company, product, or service.

Kaizen is a Japanese philosophy of discipline: it means continually pursuing incremental improvement as a permanent operating principle.

As an industry, public relations does not consistently use kaizen.

It really should.

Most communications programs are designed to launch something, not learn something. A program gets built, the product is introduced to market, and the campaign runs its course. Eventually, it gets measured once a predetermined milestone is reached or the budget runs out. Even if the activation was successful, the company and PR team missed several chances to understand why it worked, what could have been improved, and how budgets could have been maximized to do more.

That’s part of the problem for PR professionals. Whether you’re with an agency or leading an in-house team, you need to spot problems much more frequently. Consistently demonstrating both impact and incremental improvement is how agencies retain clients and grow budgets, and the way in-house leaders continue to demonstrate the value of communications in driving business outcomes.

Kaizen literally translates to “a change for the better”

Toyota’s application of kaizen resulted in what’s now referred to as the “Toyota Production System.” Workers along the entire assembly line are empowered to stop production when they spot a defect, and are encouraged to develop a solution and document it as a best practice, so it doesn’t recur.

Communications leaders, please answer this objectively: Do we do that enough?

I don’t believe that we do.

Imagine every PR agency EVP helped Account Executives to learn to spot problems, and then empowered them to voice concerns to internal leaders or to the client.

What if the CEO at a global pharmaceutical company told each brand’s marketing and PR teams that when they see a gap in the commercial or market access strategy, they should stop the proverbial assembly line and raise the issue?

It’s not as daunting as it sounds if the process starts at onboarding and is reinforced by senior leaders.

The case for changing how PR programs run

Plan. Execute. Measure. Report. That’s the standard program cycle. But when measuring the impact only happens at the end, the campaign is over before you know if it worked.

In the event it didn’t build reputations, change behaviors, or motivate buying decisions, there’s no ROI and no second chance. Communications teams, company executives, and PR agencies will then gather for an appropriately-named “post-mortem meeting,” and they’ll review why the desired results weren’t achieved. But the “patient” is already dead.

Kaizen can change that. For example:

Biogen lost an entire brand. Had its PR team practiced kaizen and sought incremental improvement, perhaps the 2021 launch of Aduhelm would have had a better outcome.

The initial strategy focused on the “historic nature of the approval.” But the $56,000/year cost and questionable clinical profile drew criticism, with media questioning the message and wondering if the scientific community’s concerns were heeded. Months later, Biogen pivoted, reducing the price by 50% and shifting the narrative to an access and health equity story. By the time the new messages reached stakeholders, healthcare systems had refused to administer the drug, and Medicare had restricted coverage.

If kaizen played a role, the company and its communications team would have seen that the strategy and story weren’t working. The media made its skepticism clear in the earliest coverage, but the company didn’t pivot. Access was a challenge, but the payer strategy didn’t change till it was too late. A kaizen mindset would have shown that problems existed, with potentially enough time to salvage the campaign and help prescribers and payers better understand the brand’s clinical profile and potential patient benefits.

The tech industry can benefit from kaizen, too.

Quibi misread its customers’ most urgent needs. In April 2020, as the COVID pandemic took over the United States, Quibi, a mobile video provider, launched with a PR narrative and strategy built around the concept of “in-between moments.” The company focused on showing consumers how its short videos were ideal viewing during commutes or while waiting for movies or sporting events to begin. One small problem, though: In April 2020, nobody was commuting or attending events. The world was at home watching TV, but Quibi stuck with its “mobile only” and “on the go” offering. It didn’t even allow users to cast videos from mobile devices to home televisions.

By late summer, the company realized “mobile only” wasn’t returning anytime soon, and pivoted to focus on a “premium content” offering that eventually offered TV-casting capabilities. By the time Quibi finally met consumers where they were (still stuck at home), the “Quibi is a joke” narrative dominated the tech conversation on social media. Six months later, Quibi ceased to exist.

Kaizen could have helped Quibi read the room. Imagine if the company did an online focus group in May 2020 and saw exactly how Americans were consuming content. The pivot could have been made much sooner, potentially re-engaging a country full of entertainment-starved consumers.

The question for communications is: what does it mean to “stop the line”?

At the Toyota factory, every car isn’t perfect. Kaizen happens through small, incremental changes continuously implemented in real time, even if that means stopping the production line to diagnose the problem and implement the solution.

Kaizen-driven PR programs don’t wait for the monthly measurement scorecard or the quarterly results report. They don’t even wait for the campaign wrap-up email. They’ll build in checkpoints, not as bureaucratic micromanagement, but as insurance that decisions are made against pre-defined criteria, and outcomes are aligned with business objectives.

In real-world practice, this can manifest in several ways:

• Instead of pitching reporters with the same angle for an entire week, PR teams re-evaluate after three days. Simultaneously, they’re writing an alternate pitch. If coverage isn’t meeting expectations, the new asset is quickly swapped in.

• If a particular company spokesperson isn’t generating interview requests, evaluate why before they speak at the next industry conference, not after.

• When a direct-mail campaign doesn’t result in an increased open rate, shift the strategy or change the content before the next round of outreach.

To bring the kaizen philosophy to your team, follow this strategic framework:

1/ Educate. Work with teams to understand what constitutes a problem. If a press release is pitched to two dozen reporters and they all decline to cover it, there’s an issue in the story’s value to readers. If most physicians express doubts about a new drug, the problem may be that the company misread the unmet need or failed to demonstrate why the new product was an improvement over the standard of care. These are just a few of the myriad problems that communications professionals at all levels need to be trained to diagnose and triage as soon as they emerge.

2/ Empower. I know several people who are early in their PR agency careers and believe their role is to be seen and not heard. I’ve watched corporate “onboarding processes” that last for weeks, without a single reference to what should be done when an employee has a concern about efficiency, productivity, or client service. This is indicative of a culture that is not setting up every team member to contribute to ongoing success. Leaders: help your teams understand why it’s essential that their voices are heard, and encourage them to raise issues and propose solutions.

3/ Engage. The day-to-day for communications pros is a grind. We get so caught up in deadlines and aligning deliverables with brand timelines that we forget the bigger picture. As senior leaders, it’s our responsibility to regularly engage our teams in purposeful, kaizen-focused conversations. Sometimes people don’t realize they’ve seen a problem or have an idea for a process improvement till they’re asked. For instance, if you’ve got a VP managing your agency team’s budget, ask them their thoughts regarding “scope creep,” utilization, and spend rates. You’ll be happy to learn that they’ve identified a problem and can help with budget management before the client feels the agency overspent.

Why aren’t we doing this already?

The two primary barriers to kaizen are approvals and infrastructure.

Communications leaders – whether at an agency or in-house – typically need approvals from a client, a senior executive, or a member of the C-suite. The larger the organization, the longer the ladder going up can be, and by the time the problem is raised, it can be too late. Even if it is recognized and flagged in time, without an established infrastructure for setting baselines and measuring the impact, it’s impossible to determine whether a problem truly exists and what, if anything, needs the incremental change that kaizen provides.

The “Educate-Empower-Engage” framework addresses both barriers directly.

It builds the cultural infrastructure that enables kaizen before the approval problem ever arises. Teams that are trained to spot issues, raise them, and offer solutions don’t wait till after the program is executed and results are measured.

Toyota’s successful application of kaizen is a result of a shared belief among every employee that something in every process can always be better. Their willingness to stop the line, find the solution, and fix the problem is what makes people trust them.

Communications teams that adopt the same principles, by refusing to accept circumstances and having the courage to follow through and capitalize on every opportunity for change, will be the ones whose reputations are elevated earlier, whose brands claim market share faster, and whose revenue exceeds projections sooner.

Whether I was trekking into the office at 2 am for a global M&A announcement, spending all night in a conference room finalizing scenario-based messaging for an FDA approval date, or launching a new medication that changed the course of people’s lives, one thing remained a constant: I was on the PR side, and the reporters were on the other side.

That never changed.

Until it did, last year, when I saw a story emerging and had a feeling it was going to create a significant and lasting impact across multiple aspects of the healthcare industry.

Something about this story affected me.

I wanted to share my thoughts on an issue that had the potential to significantly alter the way deadly diseases were treated. But the companies impacted by this news were not my clients, and I didn’t lead their communications teams.

I needed a forum.

So I got involved in another way. I put aside my PR perspective and stepped into the issue with the mindset of a member of the media.

I was going to cover the fight against the U.S. Food and Drug Administration (FDA) to help people with rare diseases get better access to their medications.

In the process, I’d focus on the inner workings of the industry I’d been part of for almost 20 years. I would support advocates in their efforts to create better healthcare outcomes, and in the process, I would challenge the personnel and the policies of the federal government.

I set out to publish a series of op-ed articles on what the biopharma industry, the U.S. Senate, and the FDA needed to do to fix the broken process of developing and reviewing new therapies for rare diseases.

That mission was accomplished, and so was coming away with knowledge, experience, and three key learnings to share, because these takeaways made me better at PR when I rejoined the ranks of healthcare communicators.

1/ Trend spotting is an underrated skill.

Journalists and PR pros share a common trait - we both work diligently to see what’s coming next in our industry, long before it actually happens.

In July 2025, the FDA requested that Sarepta Therapeutics, a biopharma company with a treatment for a rare disease called Duchenne muscular dystrophy, stop shipping a medication that had proven highly effective in helping many patients. In the wake of this news, patients saw hope taken from them. Physicians saw regulators making a potentially fatal mistake, and the pharmaceutical industry saw yet another piece of evidence that an inconsistent and flawed process could ultimately cause the harm they had been working to prevent.

Me? I saw a story.

Not a single incident, but a cascade of events that would ultimately catalyze one of the most impactful healthcare stories of the decade.

The series of ensuing regulatory actions, clinical data announcements, and federal government interventions became the impetus for a series of articles in which I followed the story’s evolution from a perceived patient safety issue to a regulatory crisis, a political matter, and ultimately, to a story about ensuring patients continued to have access to the only medication that helped them continue to live with a crippling disease.

Now back on the PR side, I’ve become more attuned to not just reading articles or watching videos, but thinking through all the angles that the news can take next. There’s a bigger story inside most of the news we see, and thinking as a journalist has already paid dividends in spotting trends and discovering new opportunities to insert companies I work with into news stories.

2/ Look under the hood at how the FDA works when planning regulatory communications.

Planning a PR strategy for a biotech company or pharmaceutical brand wouldn’t be complete without an IND, an NDA, or a PDUFA. But between those critical lifecycle milestones are chances to share thought leadership perspectives on the regulatory environment and its impact on patient outcomes. The approach may require a third-party partnership, such as with an advocacy organization or external influencer, but the opportunity exists to raise awareness of challenges that may affect regulatory timelines or processes. In the case of the story I covered, I found a gap between the belief that the FDA was under-resourced and the reality that the agency simply wasn’t using the resources it had, which led to an anchor point for one of my articles.

Covering a U.S. Senate hearing to report news is a different exercise than monitoring the conversation on behalf of a client. As a PR pro, you listen for anything that affects your company’s narrative, then work to protect a story that already exists. The media viewpoint is different.

When thinking like a reporter, you’re working to find what’s unsaid, so it can be turned into a compelling new angle to anchor your own work. That perspective led me to formulate a call-to-action for mandated change within the FDA, as it was revealed that the agency wasn’t failing patients because it lacked resources. It was failing because the tools they had weren’t being used properly, and ineffective infrastructure left industry sponsors with unclear guidance on how to conduct clinical trials.

It was a nuance that would open up an entirely new angle for my articles.

As PR pros, we’re trained to view the times between regulatory milestones similar to “quiet periods”: “we can’t say or do anything to upset the FDA.”

But with the perspective of a reporter and a little creativity, we can serve our clients and companies by advancing an above-brand narrative through thought leadership that raises awareness of the bigger issues at stake.

3/ Government affairs is an under-utilized partner in communications.

During my journey into journalism, I saw inside the political machine and how policy and public affairs drive the public health agenda. Stepping into a U.S. Senate hearing to inform an article, instead of just monitoring the event for my company, showed me why it takes the highest levels of government to keep regulators in check. This experience gave me a greater appreciation for the role that the Federal and State Government Affairs (F/SGA) teams play within pharmaceutical companies.

In my capacity as a PR pro, I partnered with F/SGA when public affairs and policy were part of the program, but that engagement was reactive. What I see more clearly now is that a large part of their value to PR is in their relationships, because those relationships can reveal how specific lawmakers are thinking about relevant issues and which ones are working hardest to drive a specific agenda.

That information isn’t readily available unless PR pros proactively seek it out.

The most important lesson of all

I started this project with a specific goal: to raise awareness of an issue of tremendous importance to an at-risk patient population and to create positive reform. While a few bylines published in industry media outlets aren’t going to fix a critical problem overnight, I know now that I don’t need a business card with the name of a prominent publication on it to continue to catalyze change.

What I do differently now in PR is that before I create a media pitch and reach out to a reporter, I look at the bigger picture and ask whether the story has another chapter, who the other protagonists and antagonists are, and whether the outcome will solve people’s problems or just make them worse.

Reporters aren’t only interested in single events or standalone moments in time. They also look at the potential for a cascade of events that may culminate in something bigger than what they’re anticipating. I understood that conceptually before, but now that I’ve unfolded that series myself, I can better embrace the importance of connecting what’s happening now to what’s going to happen next, because those are the stories that are most worthwhile to follow.

--------------------

Hi. I’m Joshua, a PR pro who helps companies turn communications into revenue. Email me at pr.rxblog@gmail.com or find me at linkedin.com/in/joshuamansbach. Let’s have a virtual coffee, and talk about creating a story and a strategy that makes a positive impact for your business.

Author’s Note: This original article was first published as an op-ed in BioSpace. View the original article by clicking this link.

Last month, the Senate convened a bipartisan hearing to identify the root cause of the lack of readily available medications for patients. Eight days later, Vinay Prasad resigned from his position as director of the FDA’s Center for Biologics Evaluation and Research (CBER).

These may not seem related, but some industry influencers attribute the challenges sponsors have faced in bringing therapies to market to the way Prasad led CBER—especially in the rare disease space. The end of his tenure, which featured more discordance than the nation’s healthcare regulatory agency should have, means that a path has been cleared for the Senate to bring much-needed change to the rare disease treatment landscape.

Now it’s incumbent on the FDA to implement the necessary reforms. The agency has become a barrier to access over the past year—a serious problem that has left patients who already have limited therapeutic options unable to access the ones that do exist.

The Senate Demanded Answers, Harsh Truths Were Revealed

At the Senate hearing, industry leaders, physicians, advocates, and parents of children with rare diseases presented evidence of inconsistently applied regulatory guidelines, underutilization of available resources, and patients who are paying the price for these discrepancies.

As a healthcare communications professional with two decades of experience in regulatory strategy, I’ve watched sponsors accommodate FDA requests for trial design changes and new datasets. I’ve also seen the subsequent fallout as small biotechs try to figure out how to fund new studies, while patients, families, and advocates wait without answers as to why.

These obstacles are avoidable. Protocol reform is not optional, and the rare disease community is no longer asking.

Senators and witnesses described accelerated approval pathways without utilization standards. They detailed the disregard for surrogate endpoints, despite scientific validation. Industry leaders and physicians explained that reviewers apply inconsistent standards across similar cases and provide no guidance on their expectations.

Witnesses detailed the consequences of late-stage reversals of negotiated trial design and endpoint agreements. When those occur, development timelines extend beyond what small gene therapy innovators can finance and beyond the threshold patients can wait for treatment. Since the start of 2025, 23 Complete Response Letters (CRLs) have been issued to rare disease sponsors, and, as witnesses explained, many lacked sufficient justification.

One moment from the hearing was particularly poignant. Dr. Jeremy Schmahmann, a Mass General neurologist and Harvard Medical School professor, testified that during a regulatory review meeting at which a rare disease patient spoke about their challenges, a CDER official asked, “Why should I listen to you?”

That’s a failure of human values. One of the country’s most essential government agencies needs leaders who not only understand rare disease science and patient needs but also implement processes with empathy.

As the head of CBER, Prasad could have recognized this problem and guided the agency in a different direction.

He chose not to.

Rare Disease Science Requires Different Standards

Rare disease trials are small because the patient population is small. Surrogate endpoints are often the only way to measure therapeutic effect in a reasonable timeframe. That’s the reality of treating diseases that may only affect a few hundred people. Regulators cannot continue to treat this fact as a failure in clinical trial design.

Congress recognized these scientific facts when it created accelerated approval pathways, authorized orphan drug incentives and passed PDUFA legislation. Flexibility was built into the regulatory framework because it was understood that highly specialized gene therapies for rare diseases cannot be evaluated by the same criteria as small-molecule drugs that treat millions of people with the same chronic condition.

Witnesses testified that at the current rate of drug development and approval, it will take 150 years to treat just half of the known rare diseases. More than 30 million Americans are living with at least one of the more than 7,000 known rare diseases, and approximately 90 percent of those diseases have no FDA-approved treatment.

The Senate hearing produced evidence-backed solutions, and it’s essential that the FDA act on the following four mandates:

Establish a dedicated Rare Disease Advisory Committee, staffed with experts who understand the science, the use of surrogate endpoints, and the rationale for ultra-small clinical trials for gene therapies.

Between 2024 and 2025, the FDA’s utilization of advisory committee meetings dropped a staggering 65 percent. The absence of informed scientific dialogue among independent physicians and academics cannot possibly help people with rare diseases.

Further, a therapy for a disease affecting an orphan population shouldn’t be evaluated by a committee assembled to review treatments for millions. A rare disease advisory committee is a necessity.

The FDA must commit to consistently utilizing the accelerated approval pathway when criteria are met. Expedited reviews exist because Congress recognized that rare disease patients cannot wait for perfect data or ideal trial circumstances. Without consistent use of these critical regulatory review protocols, patients are left waiting on a promise the FDA has yet to keep.

Issue and adhere to guidance on the use of surrogate endpoints in rare disease clinical trials. Sponsors need to know what is expected before they invest time and capital in a trial that may be negated in the course of a single meeting. Shifting expectations mid-cycle only serves to stop innovation before it has a chance to help patients.

Increase transparency around late-stage review changes and rejection rationale. When a sponsor receives a CRL after years of development aligned with agreed-upon guidance, both they and patients deserve a clear, evidence-backed explanation.

Nobody at the hearing asked the FDA to lower its standards. They only want the agency to apply the tools and protocols it already has, and to do so consistently, under the leadership of experts who understand the nuances of rare disease drug development and will approach the process from a more open perspective than Prasad did.

When a patient and their family hear “accelerated approval pathway,” they have hope and assume regulators are following a roadmap to a treatment. Witnesses testified that the FDA’s roadmap is full of obstacles, and while the agency has the authority to clear them, to date, it has failed to do so.

Rare disease science will never be perfect. The Senate understands this—on Tuesday, Sen. Ron Johnson (R-WI) reportedly launched an investigation into the FDA’s recent rare disease drug rejections—and so do physicians, advocates, caregivers, and patients.

Now the FDA needs to act like it does, too.

--------------------

Hi. I’m Joshua, a PR pro who helps companies turn communications into revenue. Email me at pr.rxblog@gmail.com or find me at linkedin.com/in/joshuamansbach. Let’s have a virtual coffee, and talk about creating a story and a strategy that makes a positive impact for your business.

Author’s Note: This original article was first published as an op-ed in BioSpace. View the original article by clicking this link.

The FDA needs two things to keep people safe: confirmatory science and updated population-specific decision-making protocols. In the absence of these, patients may be at risk. This dilemma came to light in July 2025 when Sarepta’s Elevidys was temporarily pulled from the market, leaving patients with Duchenne muscular dystrophy (DMD) high and dry.

Following the deaths of two non-ambulatory patients taking the gene therapy, and of a participant in a trial testing an investigational treatment using the same AAV vector for a separate disease, the FDA requested that Sarepta halt all Elevidys shipments.

This request did not account for the fact that there had been no new or changed safety signals in ambulatory patients taking Elevidys, according to Sarepta. Further, heeding the FDA’s stop-shipping order meant that ambulatory patients who had been on therapy for years without similar safety signals could no longer access the medication.

The FDA followed its protocols, but the actions taken put ambulatory patients at risk, as no other gene therapies for DMD were available. These events cast an unwanted spotlight on a regulatory system that was not properly equipped to manage a highly nuanced situation unfolding in real-time.

As a healthcare communications professional with two decades of experience in regulatory strategy, I’ve watched the FDA and industry navigate label updates, boxed warnings, product recalls, and other challenging situations. The Sarepta situation laid bare the impossibility of managing risk for patients taking gene therapies for rare diseases when the regulatory framework used was designed for traditional drugs.

An upcoming bipartisan Senate hearing on February 26, regarding the authorization process for rare disease therapies, is an opportunity to shape the future of regulatory oversight by proposing new protocols. With clearer frameworks, the FDA can act quickly on safety signals while minimizing harm from both treatment risks and disease progression.

Binary Choices for Heterogeneous Risks

“Halt all shipments” or “allow all shipments.” These were the options the FDA chose to work with when acting on the Elevidys safety signals. Neither was in the best interests of all parties, because they didn’t account for varied benefit-risk profiles in ambulatory and non-ambulatory patients.

While the FDA knows heterogeneous rare disease populations present unique regulatory challenges, it doesn’t have specific protocols for emergency population-specific restrictions. In a peer-reviewed study published by Berry et al in the journal Molecular Therapy: Methods & Clinical Development, the authors acknowledged this problem, writing that there is a “mismatch between traditional regulatory paradigms and the distinctive nature of rare disease gene therapies.”

While the FDA can implement population-specific restrictions through labeling modifications and REMS programs, standard protocols for deploying these tools are designed for routine safety updates in common diseases with alternative treatments, and not emergency responses related to rare disease therapies, where heterogeneous populations face dramatically different risks, and the treatment in question is often the only option for patients.

The regulatory playbook hasn’t caught up to the science, and now, new topline three-year data from Elevidys’ Phase 3 EMBARK study validate the need to revisit this conversation.

EMBARK As Proof-of-Concept for Population-Specific Regulatory Oversight

Nobody expected the FDA to be clairvoyant. The agency couldn’t have known then what EMBARK—which tested Elevidys in ambulatory patients—would later reveal. But now we’ve seen data showing a 73% slowing of disease progression over three years in ambulatory patients, a 70% improvement in the 10-meter walk/run test, and evidence that patients who remained on therapy are still standing and walking after three years, with a statistically significant benefit (p=0.0002). EMBARK also showed no new treatment-related safety signals across 1,200 patients over three years.

This population-specific evidence shows that the FDA could have implemented a more nuanced regulatory response that protected patients succeeding on therapy. But halting shipments to all patients meant that ambulatory children who were stable on therapy and benefiting would lose access during the pause. This meant also losing a disease-modifying window of time that EMBARK data prove is clinically meaningful. That time is not recoverable, making it even more important that protocols used for rapid safety responses fit rare disease contexts where population-specific risks matter.

A Path Forward

Here, I recommend four proposed reforms for real-time risk management.

1. Population-Stratified Regulatory Actions: The FDA should have protocols for implementing restrictions by subpopulation in emergencies involving rare disease therapies. If liver-related deaths occur in non-ambulatory patients with DMD, there should be a clear pathway to pausing shipments for that population only. When risks are population-specific, restrictions should be too.

2. Accelerate Labeling Updates: The process of adding Boxed Warnings can take months. The FDA should be able to mandate updates that prescribers must review before each administration. Extending accelerated labeling mechanisms to gene therapies would let regulators bridge the binary gap between “continue as usual” and “stop everything,” which are the non-specific options that exist for a broad category of traditional, small-molecule medications for common diseases with relatively homogeneous patient populations, rather than the specialized gene therapies for rare conditions.

3. Amend the “Do Nothing” Risk Assessment: Regulations must account for both sides of the risk equation. Without therapy, Duchenne patients face certain progressive, irreversible muscle loss, leading to wheelchair dependence, respiratory failure, and premature death. Safety standards don’t need to be lowered to ensure both sides of the risk equation are accounted for.

4. Institute Real-Time Data Sharing Agreements: The FDA and industry should update protocols for exchanging emerging safety signal data. If Sarepta had been able to provide population-specific safety data, the FDA might have implemented restrictions within 48 hours instead of a 6-day pause on Elevidys for ambulatory patients.

Protecting Patients Requires Intuitive Systems

The FDA was right to investigate the Elevidys-linked deaths in 2025. Sarepta was justified in advocating for continued access for ambulatory patients while the agency reviewed safety data. The EMBARK results prove that two things can be true at the same time: Elevidys fundamentally altered Duchenne’s trajectory for ambulatory patients, while non-ambulatory patients may face different risks. A modern regulatory framework should be sophisticated enough to account for both realities simultaneously.

A population-stratified regulatory protocol isn’t optional. It needs to be implemented to ensure patients never lose access to an effective gene therapy because of risks that may not apply to them. The FDA needs protocols that allow population-specific safety responses in real-time, moving beyond binary choices that force regulators to either halt all access or continue unchanged.

As Senators convene for this critical discussion, they must come away with a clear resolution that protects patients from both treatment-related safety risks and the certainty of disease progression. The Committee should ensure that people living with rare diseases never lose access to treatment because of risks that may not apply to them. This means creating a regulatory review protocol for heterogeneous populations, so that the FDA can act quickly to investigate safety signals in select patients, while minimizing unnecessary risk to those who are benefiting from therapy.

--------------------

Hi. I’m Joshua, a PR pro who helps companies turn communications into revenue. Email me at pr.rxblog@gmail.com or find me at linkedin.com/in/joshuamansbach. Let’s have a virtual coffee, and talk about creating a story and a strategy that makes a positive impact for your business.

Over the past year, I’ve written and published several op-eds, in which I’ve shared perspectives on critical issues in the healthcare regulatory and pricing landscape, and offered opinions on solving problems facing pharmaceutical and biotech companies.

I always knew op-eds existed, but until I started writing them myself, I didn’t fully grasp how strong a PR tool they truly are.

Now, I do.

The rise of op-eds

To appreciate the reason why op-eds are so effective, it helps to know where they came from and what they were designed to achieve.

Op-ed, which is short for “opposite the editorial page,” was introduced as a concept in 1921 by Herbert Bayard Swope, the Pulitzer Prize-winning journalist and editor of The New York Evening World, but it wasn’t until September 21, 1970, that the tactic officially debuted in The New York Times. Editor John B. Oakes launched the publication’s official op-ed page to provide “a dedicated space for external expert opinions from independent thought leaders who were unaffiliated with the media outlet.” His goal was to allow space to break away from the singular voice of the editorial staff, foster public debate, and highlight diverse viewpoints.

By the late 20^th century, Mr. Oakes achieved his goal, with the op-ed evolving into a driver of influential, independent commentary, and major newspapers worldwide adopting their own op-ed pages as a source for public discourse.

Without op-eds, public relations is constrained

The benefits of PR and earned media are clear: the enhanced credibility from coverage improves Earned AI Search (EAIS) visibility and increases attention paid to a company’s story. That drives conversation, delivers a call-to-action, earns a response, and contributes to earned revenue.

There’s not a lot to find fault with, but there are a few underlying shortcomings that make a complementary tactic like an op-ed necessary.

1/ Space is at a premium. In the absence of a forum like an op-ed, spokespeople are limited in the amount of room they have to make their voices heard.

An editor may interview a CEO for 30-45 minutes, but the resulting article will include quotes from multiple sources. Competitors, analysts, and critics all get space to make their voices heard. That dilutes your CEO’s perspective across the piece and can even result in being minimized to just one or two quotes that lack the context needed to make a complete argument.

An op-ed addresses this by creating a protected space in which a complete, evidence-backed argument can be presented without filtering or crowding from other voices. The entire piece belongs to the thought leader, not a sentence or two buried in a multi-source article.

2/ Endless loops of reactions don’t allow for proactive communications. Responding to a crisis, blunting opposition research, or addressing a market shift are all reactive.

Companies aim to set agendas, rather than respond to them, but even fully proactive initiatives often happen in reaction to the market.

A competitor launches a product upgrade, so you launch your new feature.

An industry trend emerges, so you newsjack the story and position yourself within it.

The result is a perpetual cycle of following rather than leading.

Op-eds fix this by allowing thought leaders to start conversations before events force responses.

Instead of waiting for a journalist to call for a comment on an industry shift, you can publish an op-ed that defines the shift on your terms and positions your company ahead of the curve.

Now you’ve gone from “interview subject” to “singular voice of authority.”

3/ Complex problems aren’t easily resolved in a press release. Company leaders aiming to solve systemic issues need a specialized tool for the job.

Press releases are not right for this task. Who wants to announce a problem?

Similarly, a social media post can’t capture the essence of an industry challenge, owned content has a limited reach, and pitching a reporter to talk about a problem means you’re losing your exclusive soapbox to raise the issue from your perspective.

On the other hand, op-eds offer around 800 words of paper real estate belonging solely to you. Define the problem, offer evidence, propose a solution, and present a rationale for why it works. With an op-ed, you can offer proof that you understand the industry’s problems and have thoughtfully defined a path towards resolution.

With global PR expenditures projected to reach $110.35 billion in 2026, according to data published by the Business Research Company,^[1] the stakes for effective messaging are higher than ever. Yet traditional earned media leaves companies vulnerable to the shortcomings outlined above. That’s too significant an investment to risk having messages misconstrued because they were cut into soundbites or diluted across multi-source articles. Op-eds address these gaps by giving thought leaders a forum, without the need for permission to maintain their context.

Op-eds have historically played a significant role in creating essential change

These aren’t just theoretical benefits. Op-eds have driven measurable change in critical areas, including corporate culture, federal legislation, and healthcare regulation.

Here are three examples of op-eds that catalyzed action with just one article, whereas traditional tactics may have needed months or years worth of earned media momentum to create similar change:

The Intersection of Healthcare and Racism: The 2020 Washington Post op-ed, entitled “The Death of Susan Moore,” created a forum for Dr. Aletha Maybank, Chief Health Equity Officer of the American Medical Association (AMA), to bring light to the case of an African-American physician hospitalized with COVID-19.^[2] The piece recapped the story of Dr. Moore, who filmed a video from her own sick bed, which described how her white doctor was refusing to treat her based on race, and discussed the pain she experienced and the dismissal of her needs. After the video went viral, the hospital defended the care provided to Dr. Moore, but cited patient privacy as a means to avoid answering further questions. The result was a story that looked like both medical malpractice and systemic racism. In her op-ed, Dr. Maybank used her position as a leader of the AMA to clarify that this incident wasn’t just “one bad doctor” or a “one-time mistake.” She argued that if a doctor couldn’t get equitable care, then nobody could, and the system was broken. The piece sparked conversation about the intersection of racism and healthcare and motivated the AMA to officially label racism a public health threat, changing how hospitals nationwide trained staff to handle bias.

Privacy Is A Human Right: Tim Cook, CEO of Apple, took on the right-to-privacy issue in a 2019 op-ed published by TIME Magazine. As the tech industry came under fire for data leaks and security breaches, CEOs remained quiet, but Mr. Cook challenged the data-industrial complex with his op-ed that framed privacy as a human right, rather than a device spec. His article shifted the industry’s narrative and moved other companies, including Google and Meta, to respond to the framework for privacy that he outlined. Shortly after publication, Apple implemented “App Tracking Transparency,” which cost social media companies billions in ad revenue and made privacy a primary differentiator for consumer technology brands.

Social Media As A Health Hazard: In 2024, US Surgeon General Dr. Vivek Murthy published a New York Times op-ed calling for warning labels on social media platforms.^[3] Dr. Murthy argued that, despite an overwhelming volume of scientific evidence linking social media to the mental health crisis in America’s youth, tech companies were not held to safety standards that comparable health hazards, such as cigarette smoking, were held to. He called for a Surgeon General’s warning label on social media platforms, which triggered legislative movement in several states and sparked a Congressional debate regarding the Kids Online Safety Act (KOSA).

“Op-eds? They’re old school.”

I didn’t understand this stigma when I began writing op-eds last year. Now that I’ve written and published several, and learned about their history as I did my research to write this article, I’m even more convinced that op-eds themselves need better PR.

They’re timely, relevant, and they wield tremendous power. These specialized thought leadership assets are extraordinarily effective in establishing a position, and that’s essential in a media environment that thrives on surprising audiences and delivering measurable solutions.

If you’re a communications professional in any industry, make op-eds part of your earned media and thought leadership programs.

I’ve learned these four things from writing op-eds that will benefit your PR strategy:

1/ Informed opinions are the best weapon when battling conventional thinking. Op-eds create a platform to confront widespread beliefs and change perceptions and behaviors. The opinions raised in op-eds reach a highly-targeted audience, and when the argument is backed by evidence, editors and their audiences will benefit from the perspective you raise.

2/ Op-eds humanize thought leaders. By attaching a name and a face to an opinion, the op-ed makes the corporation more real. “Apple” is a tech behemoth, but “Tim Cook” is a person, and he has an idea and an opinion on how to bring it to life. That human element signals to investors, employees, and customers that the company is led by someone with a vision, not just a faceless byline who may or may not have a ghostwriter by their side or an LLM app on their computer.

3/ Significant problems need human voices, not corporate entities, to solve them. The opening sentence of a press release may say “ABC COMPANY, the leading developer of Widgets, today announced…” Even if that release goes on to reveal a significant industry problem, the forum remains unsuitable to propose a solution and catalyze change.

That’s not what a press release is designed to do.

The bigger issue with this approach is that ABC COMPANY is just that: a company. A soulless entity doesn’t identify problems, but the CEO of a company does. People are more likely to pay attention to the issues of systemic racism in healthcare settings when they’re flagged by Dr. Aletha Maybank, rather than if they’re brought to light by the American Medical Association. The press release is for a company to announce something, but the op-ed is where the human raises the problem and calls for consensus on how to fix it.

4/ There’s added power in acknowledging the opposing viewpoint. When someone is in an argument about anything with anyone, they often forget that the other side is just as adamant about being right as they are. But as Sun Tzu taught in The Art of War, “if an enemy insists on battle, take away their ability to fight.”

The best op-eds disarm the other side by showing awareness of opposing viewpoints and acknowledging the counterarguments. If you haven’t read Sun Tzu, maybe this analogy will help: remember how Eminem won the final rap battle in the movie “8 Mile?” His last rap was about every insult the other guy was going to use. “I know everything he’s got to say against me.” That disarmament left the opponent speechless. The same logic applies to op-eds. Address the other side’s evidence with balance and accompany your argument with clear solutions.

Op-eds aren’t old school at all; they’re actually highly underutilized

When I wrote my first op-ed last year, I was excited to share a unique perspective that was important to an industry I care about (healthcare) and utilize a new tactic within a discipline I love (communications and public relations).

I expected to learn a lot from the experience. What I didn’t expect was how deeply it would change my approach to earned media strategy.

Op-eds force new thinking. To capitalize on their power, communications pros and the corporate leaders they partner with need to push past the boundaries of singular soundbites and individual media tactics. Op-eds require a baseline of having identified an industry-impacting issue, shaping an evidence-backed perspective on why it matters, and ideating a solution that will stand up to detractors’ scrutiny. That all takes discipline, but that’s what will make you a better communicator and help your C-suite executives become more powerful industry leaders.

But there’s an even more important takeaway: op-eds reminded me why I’m in PR in the first place. It’s because I’m a storyteller, not just a “coverage getter” or a “KPI driver.” I shape beliefs through words, I change how people think, and alter what they believe. I create stories that influence decisions that matter and catalyze conversations that change industries, inform policies, and positively benefit people’s lives.

The best op-eds aren’t the ones with the catchiest headlines or the ones that get the most viral reach. They’re the ones that make people think differently about issues that matter to humanity.

If you’re using op-eds in your PR toolkit, you’re doing it right. They’re helping establish you as a PR leader and your clients/executives as industry authorities.

If you’re not using op-eds yet, you’re leaving one of PR’s most powerful tools unused.

Start now.

Identify the systemic problems your company/clients are solving, find the thought leaders who can speak to those issues with authority, and give them the forum to make an argument that matters.

--------------------

Hi. I’m Joshua, a PR pro who helps companies turn communications into revenue. Email me at pr.rxblog@gmail.com or find me at linkedin.com/in/joshuamansbach. Let’s have a virtual coffee, and talk about creating a story and a strategy that makes a positive impact for your business.

[1] https://www.thebusinessresearchcompany.com/report/public-relations-global-market-report#:~:text=Public%20Relations%20Market%20Report%20Forecast,2026%20%2D%202030%20%2D

[2] https://www.washingtonpost.com/opinions/2020/12/26/susan-moore-death-racism-health-care-system/

^[3] https://www.nytimes.com/2024/06/17/opinion/social-media-health-warning.html

Look at what we’re calling “news”:

• A mid-level CPG executive was promoted to Senior Vice President of Strategic Initiatives. The press release quote from the CEO talked about how she’s “looking forward to Jane’s leadership in this exciting role.”

• A SaaS company announced it will attend a developer conference. So will 347 industry peers. The quote said they were “thrilled to participate.”

• A biotech company issued a release celebrating its CEO’s inclusion on a list of the “Top-50 Healthcare Business Leaders” in the Northeast, published by a website that charges for the recognition. (They were still “pleased to be recognized.”)

These are unlikely to interest editors, yet companies invest time and budget to develop press releases, pay for newswire distribution, and have agencies conduct media outreach.

For Immediate Release: This announcement is not advancing the business

Press releases made sense when the only way to reach audiences at scale was through the media.

A new hire joins the team: press release. The company sponsors a charity event: press release. An executive joins a panel discussion: press release.

But public relations is too valuable to the business strategy to default to saturating the market with one-way announcements. Two-way communication is the preferred means of building connection and trust between a company and its audience.

For PR pros to move the industry forward, we need to eliminate an antiquated tactic.

The caveat: Yes, material news still requires disclosure via press release

Quarterly earnings, regulatory updates, and material transactions (mergers, acquisitions, or partnerships that impact operations or financials) still require a release to meet legal and/or fiduciary disclosure obligations. Keep using press releases for these. I won’t argue otherwise.

But everything else a company has to say should be considered “conversation” and not “announcement.” (If that’s not the case, then it might not be newsworthy after all.)

Public relations has always evolved

Each time the infrastructure of information sharing changed, PR adapted. Tactics outlived their usefulness, and public relations left them in its wake, because a tactic isn’t sacred. We should dispose of them when they no longer serve us.

For example, we used to hold in-person press conferences for practically everything. Now, they’re reserved for groundbreaking news, such as major product launches or significant corporate milestones. In the world of pharma, embargoes used to be offered for just about every data milestone. Now, both PR and the media are more discerning about what gets that status. The press release itself used to be email blasted to a “BCC” list of 300+ outlets, but now we create customized pitches for specific reporters.

The tactics that didn’t serve us were replaced with something better suited to how the media actually works. Press releases for non-material announcements deserve the same fate.

The PR industry has kept pace with every evolving trend. Now, with companies having greater access to audiences through owned channels, social platforms, and virtual communities, there are more ways to reach people and share important news. Still, the press release remains stubbornly in place. But it doesn’t have to be.

Marketing announcements don’t need a press release

Demonstrating activity is not the same as delivering value. Attending a conference, winning an award, hiring a new VP-level (or below) colleague, sharing an opinion on an industry trend, or even offering a product in a new color are examples of the company being active. That activity doesn’t merit a press release, though, because the media don’t see them as newsworthy.

But what if you started a conversation about it instead?

A two-way engagement model captures the very essence of PR.

When Reddit influencers have significant news to share, they don’t issue a press release. They start an AMA (Ask Me Anything). They invite two-way dialogue, because they know the value is not in what’s being announced, but in the conversation about it.

What’s stopping companies from applying this model to product launches, business strategy shifts, data milestones, or new research publications?

• Instead of a press release telling customers about the cool product features, let them ask the head of R&D how it works.

• Rather than pack a release full of jargon about “leveraging synergies to drive efficiencies,” have the CEO take questions about the company’s directional pivot.

• Why jam a press release full of p-values that few people understand, when the Chief Medical Officer can lead a discussion about how the data are advancing patient outcomes?

The value isn’t in the news dissemination. It’s in the ensuing conversation.

Making AMAs work for your company or brand

An AMA is a structured Q&A session conducted on a platform like Reddit, LinkedIn, Twitter/X, Discord, or employee communications channels, such as Slack or Teams.

The Old Way: In the past, a consumer health-tech company issued a press release to announce a product upgrade, including a quote from the CEO with his opinion on the future of cardio-training. He was “excited by the potential for the new technology,” and wanted cardio-conscious customers to know about it.

That release was sent to hundreds of media outlets, and a handful would post it on a website. But the one-way nature of the press release meant that not a single reporter or customer was able to have an organic conversation about why people should care. Formal press inquiries submitted to a company’s media inbox often go unanswered for days, and by the time a response comes, the news cycle moved on. The result is an announcement that created zero meaningful engagements, and the company learning nothing about what their audience actually cares about.

The AMA Way: The company posted a short video teaser on LinkedIn, Instagram, and Twitter/X: “Join our Chief Innovation Officer (a 12-time marathon finisher) at 2pm today for an AMA about our wearable device’s new cardio-training features and how they’re changing marathon prep. Bring your questions.”

Nearly 100 people attended: runners, fitness influencers, some reps from athletic apparel companies, and a few journalists who cover health-tech. The CIO answered questions about VO2 max tracking, recovery metrics, and how the device compares to competitors. A TechCrunch reporter saw customer enthusiasm and wrote: “Runners are buzzing about ABC Company’s new features. Here’s what they’re asking about.” One of the apparel reps told her CEO there may be a viable partnership opportunity. Several of the influencers went to the website to buy the product to try out and share the experience with their subscribers. The conversation was recorded, transcribed, and yielded customer insights that the product team used to prioritize the next update.

What Changed: The company created a two-way dialogue that gave customers what they wanted (answers to real questions) and gave the company what they needed (earned media coverage that can drive earned AI search, real insights regarding what customers care about most, and authentic relationship building with the influencers that keep the company relevant).

The AMA isn’t the only way to create conversation

Announcements can be replaced with activations that foster two-way dialogue:

• LinkedIn Live Sessions: Your CEO, CFO, or Head of R&D can take questions about a product launch. Enabling information exchange through organic dialogue means you reap the benefits of authentic stakeholder connections.

• Community Forum Discussions: Use your Slack or Discord customer community to “drop news” and invite feedback by having a spokesperson take questions in the channel. The ensuing conversation will reveal what’s most important to your customers.

• Interactive Product Demos: Invite customers and media to an event to try a new product, ask questions, and provide real-time input. Understandably, there’s risk in taking live feedback, but there’s also tremendous upside in showing the company’s willingness to embrace customers’ needs.

“But that’s not the way it’s always been done!”

Anytime you propose changing a decades-old practice, there will be skeptics. Here’s how to counter their arguments:

Point 1: “Media need press releases to write stories quickly.”

Counterpoint 1: For material news, yes, and we’re leaving those alone. For marketing updates, such as conference participation, minor product enhancements, or awards, press releases aren’t needed because reporters don’t want them. Public relations teams may worry that if they don’t send a release, the media will forget them, but staying relevant doesn’t mean “spam inboxes.” It means “give the reporter a newsworthy pitch about news that offers value to their audience.”

Point 2: “AMAs don’t scale. We can’t do 30 of them a year.”

Counterpoint 2: That’s the point. Companies need to be discerning about what’s “newsworthy.” If you’re issuing 30 releases a year, re-evaluate how many can actually support a conversation with customers. The fact that AMAs don’t scale to match your release volume is the “checks-and-balances” needed to ensure stakeholders get the most relevant news.

Point 3: “There’s a risk of nobody attending the AMA or asking a question.”

Counterpoint 3: If nobody shows or only a few questions are asked, that’s telling you the announcement wasn’t newsworthy. Look at the flip side: if hundreds attend and the question queue overflows, you’ve validated your strategy and reinforced the market need for your company and product.

Point 4: “Leadership is too busy to do AMAs.”

Counterpoint 4: If the CEO doesn’t have 30-60 minutes to talk to customers about the news, then the announcement doesn’t merit PR support. Consider what their objection reveals: if there’s a need to draft, edit, and review a release, secure approvals, distribute and pitch, monitor for coverage, and measure the impact, then why wouldn’t they answer customer questions about it?

Point 5: “This only works for B2C companies or consumer brands. B2B needs to use press releases.”

Counterpoint 5: Actually, B2B benefits more from direct engagement because their audiences are more defined. A consumer brand may struggle to gain participants due to a more diluted customer base, but a B2B SaaS company selling to enterprise IT leaders will absolutely garner the desired response, assuming the offering is compelling and solves a business problem.

Point 6: “Regulated industries can’t do live AMAs without compliance review.”

Counterpoint 6: In industries like healthcare and finance, live Q&A can create risks if executives make unapproved claims. That can be avoided by message-training the spokespersons. Then, work with the compliance/legal teams to implement a system that may include pre-recording the AMA, screening incoming questions, and having compliance review the session before it’s released, with transparent disclosure that it was pre-recorded. This works if you want to find a way and are willing to look for solutions. One of the proudest (and coolest) moments of my career was finding a way to live-tweet an FDA Advisory Committee Meeting. Although it was one-way only, the fact that we did “play-by-play” was acknowledged as a tremendous communications innovation, since at that time, no other company had done anything similar.

These counterarguments share a common thread: they assume engagement tactics are harder, riskier, or less effective. The business case shows the opposite is true.

Why engagements beat announcements

1/ Reduce wasted effort on content nobody reads. According to Cision’s 2024 State of the Media report, 68% of press releases receive zero media coverage. In contrast, companies that host live Q&As report significantly higher engagement rates among target audiences. The resulting conversations are frequently covered by the media because journalists can quote customer questions and executive responses, rather than relying on press release quotes.

2/ Increase insights to inform R&D. Press releases tell customers what you think they should know. Live events reveal what they actually care about, such as a specific feature or integration. Events create an invaluable feedback loop that product teams, sales departments, and customer service reps will value more than the fact that your release was reprinted by Yahoo Finance.

3/ Build trust and transparency with two-way engagement. Press releases signal “we are going to tell you something,” without inviting response. But taking questions and eliciting feedback shows accountability and a willingness to engage on terms that work for others, rather than yourself. The message that sends is that yours is a company to be trusted, and with 63% of consumers indicating they need to see evidence of trustworthiness, according to the 2025 Edelman Trust Barometer, direct engagement goes a long way towards achieving that goal.

4/ Earn attention and search visibility. Conversations are inherently shareable. When customers participate in an AMA, they’re more likely to share key moments with their networks (“I just asked the CEO about XYZ, and here’s what she said.”) Journalists cover the dialogue because authentic customer engagement is newsworthy, and because these conversations happen on platforms like Reddit, LinkedIn, and community forums that LLMs prioritize as credible sources, they’re increasingly likely to become earned AI search results. That leads to customer action (earned response), which translates to buying decisions (earned revenue).

5/ Recycle the best content. Press releases are single-serving items. They go out on the wire, land on your website, and stay there forever, but the value they offer is short-lived. Now consider all the assets an AMA yields: audio and video clips for social channels; transcripts turned into FAQs; executive quotes in response to real customers for marketing assets; customer insights and testimonials. That’s several weeks or months of content from just one AMA event.

The future is conversation

As you sell in this approach across your organization, remember what constitutes winning in business: showing customers you’re solving their problems. There aren’t many better ways to do that than by having direct conversations. Press releases don’t create that opportunity, but two-way engagements earn attention and credibility by inviting dialogue and questions, and ultimately, they earn revenue by building relationships based on transparency and trust.

To implement AMAs in your organization, start with an announcement that meets the following criteria: it must be important enough for the C-suite to care about, relevant enough to prompt customer questions, and not material news that requires formal disclosure. Good candidates for this may include a new product launch, publication of research, or launching new service offerings. After the AMA, measure the number of participants, questions, media coverage, shares, and insights gained, then compare that to your average press release to determine which yielded overall better ROI.

The next time your CEO tells you to “put out a press release,” ask two questions: first, is this material disclosure mandating a formal announcement? If yes, then issue a press release. If no, then ask: Would customers want to have a conversation about this? If the answer is no, don’t announce it at all. But if it’s yes, then you have a discussion-worthy event that’s ready to embrace the future of PR.

--------------------

Hi. I’m Joshua, a PR pro who helps companies turn communications into revenue. Email me at pr.rxblog@gmail.com or find me at linkedin.com/in/joshuamansbach. Let’s have a virtual coffee, and talk about creating a story and a strategy that makes a positive impact for your business.

For decades, the pharmaceutical industry has maintained that decisions about the prices of its medications are confidential. Companies don’t provide a rationale when prices are raised, nor do they voluntarily lower them, until the government issues a mandate.

That needs to change if the industry wants to continue asking Americans to pay multiple times more for drugs than any other developed country.

Healthcare cost transparency isn’t a new priority. It’s just been consistently resisted by the industry. In 2019, President Trump issued an executive order (EO) mandating substantive price transparency initiatives for hospitals and insurers. He didn’t stop there. In February 2025, an EO mandated that patients have the information needed to make well-informed healthcare decisions. This EO stipulated that the federal government would promote access to pricing information and take necessary steps to improve and enforce price transparency requirements.

At the end of 2025, the Trump administration again reinforced the importance of regulating healthcare costs, as it struck deals with several Big Pharma companies to lower prices and invest in U.S. manufacturing and R&D, in exchange for exemptions from tariffs. Still, the cost for 350 drugs went up as the calendar turned to 2026.

The pricing process is complex, and except for the Managed Markets team, it’s usually cloaked in mystery. I’ve spent nearly two decades inside the industry as a strategic communications leader, guiding companies from preclinical to post-marketing, so I know the methodology exists. It’s deeply rooted in clinical and economic data, but it’s rarely discussed outside the confines of payer-related conversations.

That’s a problem. If insiders can’t access and explain this information, then it’s unsurprising that physicians, pharmacists, policymakers and patients can’t either. The negative impact is significant and extends beyond just reputational issues. When prices increase, and people don’t understand why, they become more vocal. Advocates take up the cause, and the call for transparency grows louder, until government is forced to act, and pharma is facing both price reduction mandates in addition to deeper mistrust by the public.

If the industry truly wants to regain stakeholder trust, it needs to clarify how the prices of individual medications are determined, and this needs to happen soon.

Pharma Speaks in Fragments

When questioned about prices, the industry relies on generalities, citing the need to recoup R&D costs and PDUFA fees, reliance on reference pricing, and the complexities of reimbursement. These factors are real, but a critical issue remains: the current rationale explains why drugs on the whole are expensive, not why a specific drug costs a certain amount.

Stakeholders have the right to understand which clinical endpoints justify premium pricing; how cost-effectiveness modeling compares the drug to alternatives; which evaluators, such as the Centers for Medicare and Medicaid Services (CMS) and the Institute for Clinical and Economic Review (ICER), inform the range for reference pricing; and how payer negotiations shape final list prices.

Pharma’s R&D investments are substantial. Developing a medication costs more than $1 billion and takes longer than 10 years. Companies are right to protect their ability to fund future innovation. But guarding pricing methodology creates the perception that costs can’t be defended, which invites the scrutiny pharma wants to avoid as it raises prices.

Transparency offsets reputational damage and repairs stakeholder relations. By illustrating pricing processes, physicians and patients have fewer reasons to demand change, meaning policymakers become less inclined to force the issue. Detractors wouldn’t criticize pharma as frequently, and as the industry aligns around a disclosure philosophy, trust could be rebuilt.

Transparency Will Eventually Be a Mandate

Other industries have had transparency forced upon them. For example, the U.S. airline industry was forced to disclose all-in ticket prices, ending the practice of hiding true costs until checkout, because people deserve to know what they’re paying for. Stakeholders across many verticals now expect companies to explain choices that affect their businesses, finances and lives, especially when they’re made behind closed doors.

Once that expectation is set, resistance amplifies distrust. The current administration has made it clear that pharma pricing is a priority, and the window to proactively define disclosure is closing, with the next step being mandatory transparency.

Compare pharma to the medical device industry, where manufacturers proactively make healthcare economics (HECON) data available for independent cost-effectiveness analyses published in journals like NEJM. This doesn’t harm pricing power. It strengthens payer confidence, speeds formulary decisions and improves trust by showing evidence that justifies value.

Pharma could adopt the same approach, instead of its current defensive posture. Industry-sponsored reports, from leading companies such as Johnson & Johnson, cite trends alluding to a lack of price increases but avoid revealing individual drug costs. Critics contended that the company only disclosed that its pricing across all its brands increased 0.5% in 2024, but they didn’t share how much it raised list prices on average.

Political, regulatory and consumer pressure mean that transparency is inevitable across the pharmaceutical industry. The question remains whether it will be achieved through a proactive choice or a forced mandate that could go too far and hurt consumers. The company that chooses proactive transparency will gain a powerful advantage by making those rejecting it seem evasive.

The Onus for Transparency Is on Leadership

When a company’s credibility erodes, the reputational damage doesn’t land on the desk of the Market Access lead. It falls squarely on the C-suite, and its impact resonates with shareholders and the board of directors. That’s why it’s incumbent upon CEOs to make transparency a proactive strategy.

Market Access teams need to work with their communications colleagues to translate cost-value data into contextualized narratives. Public relations teams require freedom to amplify these stories externally, and most importantly, legal can’t perceive explanation as exposure.

Start with one drug and explain its price determination: the endpoints that drove value assessment, how quality-adjusted life years (QALY) data compared it to the standard-of-care and how payer feedback was implemented. Publish a white paper, then see if payer negotiations become less adversarial, if formulary placement accelerates and if stakeholder trust improves. Then expand that approach to the rest of the brands.

The value of pharma’s work is undeniable, but the industry needs to confront a hard truth: many stakeholders don’t trust it. Transparency is a key step toward rebuilding that trust.

The companies that move first will shape responsible disclosure protocols, gain an advantage with payers and policymakers and be seen as advocates for the public’s interests. The ones that insist on secrecy will sacrifice credibility, and their silence will be seen as avoidance.

--------------------

Hi. I’m Joshua, a PR pro who helps companies turn communications into revenue. Email me at pr.rxblog@gmail.com or find me at linkedin.com/in/joshuamansbach. Let’s have a virtual coffee, and talk about creating a story and a strategy that makes a positive impact for your business.

Earned media doesn’t lead to earned AI search if you overlook one key element.

Let’s say your last media pitch resulted in a fantastic story in The Wall Street Journal, and now you expect sales to increase once new customers learn how your product solves their problem.

There’s just one snag: if ChatGPT, Claude, and Perplexity don’t know about that WSJ article, most of those customers you’re hoping for won’t either. This is what PR pros often overlook: earned media only translates to business impact if LLMs cite that coverage when prospects search for solutions.

This is what it means to have “earned AI search.” I call it EAIS, and I’ve been talking about it for the past year, because unlike GEO (Generative Engine Optimization), you can’t “optimize” for EAIS. You can only earn it, and that requires a credible story covered by a trusted media outlet. When that happens, your story can become an answer to a question from your target customer that they ask an Artificial Intelligence (AI) Large Language Model (LLM) chatbot.

Those queries are happening with increasing frequency. According to Adobe, 77% of ChatGPT users rely on it for search, and 30% trust it more than traditional search engines. If you’re not appearing when those people ask LLMs for recommendations, you’re invisible at the worst time: when customers make buying decisions.

If that happens, it’s not because you didn’t optimize.

It’s because you didn’t earn it…yet.

I’m going to show you how to fix it.

The first step is understanding why this gap exists and why it’s so essential to building reputation and earning revenue.

Subscribe now

Earned media needs to do more than just earn a headline

Having a story published is step one in the Earned Progression – that’s the strategic framework I developed, which connects PR to revenue. It works like this:

• Earned media leads to earned credibility and earned AI search.

• EAIS drives earned attention (customers talk about you and tell others).

• That prompts earned response (calls-to-action are heeded, behavior changes occur, and purchasing decisions are made).

• These ultimately deliver earned revenue.

Earned revenue is the “holy grail” metric. It’s what every company wants from PR programs. But if LLMs aren’t citing that earned media article, the progression stops at step one, and you never achieve the desired business impact.

The gap between earned media and EAIS exists because PR content is still being created with only journalists and Google in mind, rather than LLMs. People are writing press releases and byline articles stuffed with keywords, because they think “5 out of 5 key messages included” is going to look great on a measurement dashboard.

But that’s not what LLMs want to see. They don’t care how many times your brand name is mentioned, or that the product comes in four seasonal colors. They prioritize content based on patterns of authority: credible third-party validation, verifiable data (ideally published in peer-reviewed journals), and consistent themes echoed by multiple credible sources over an extended period of time.

If your earned media doesn’t include these, LLMs won’t cite it, which means it never earns credibility, and the path to earned revenue remains blocked.

Now that we know the problem’s origin, we can discuss the solution

To measurably earn AI search, every thought leadership article, news release, research report, white paper, conference presentation, award, and KOL quote needs to verify your expertise. That’s different from keyword optimization, and you’ll see the results when LLMs start citing your earned media because of those credibility markers.

Step 1: Build Third-Party Validation Into Content From The Start

ChatGPT doesn’t trust what you say about yourself - at least not enough to tell others how good you think your product is. That’s why company spokespeople and traditional “keyword optimization” fail to earn AI search and build credibility. You need an external KOL or advocacy partner talking about it in a trusted media source, so LLMs see verification attached to your claims.

• Avoid This Mistake: Quotes can’t come from the CEO in a press release written from an inward perspective: “This new drug is a testament to our R&D innovation.”

• Why It Fails: Even if a journalist covers it, LLMs still won’t prioritize a promotional claim from a company spokesperson.

• Do This Instead: Include a quote provided by a third-party expert; someone qualified to review the data and speak to its significance in solving an industry problem: “data shows this treatment improves upon standard-of-care for patients,” said Dr. Jane Smith, Chief of Oncology at ABC Cancer Institute.

Now, when an industry trade outlet picks up your release, LLMs recognize the independent validation and cite it accordingly. The greater the number of credible sources that publicize these quotes and data, the more likely it is that the LLM brings your name to the top of its training data; hence, the importance of the “earned media” part of the progression.

💡Tip: LLM training dictates how it reacts and responds to content. They’re trained to pick up commentary from publications that prioritize independent verification, rather than corporate websites or press releases that have company jargon and buzzwords.

Step 2: Use Verifiable Evidence

When LLMs are trained, they learn to prioritize claims backed by published data. Saying “Medication X is more effective than Medication Y” on every page of your website won’t boost you higher in an LLM search response, and neither will superlatives like “industry-leading,” “best-in-class,” or “game-changing.”

However, if a press release includes data that says, “Medication X showed 20% improvement in progression-free survival vs. Medication Y (p<0.001), as published in NEJM,” and BioSpace publishes that release, and then STAT News references the data in an e-newsletter, LLMs will recognize it as evidence to cite in search responses.

💡Tip: While earned media earns the credibility that contributes to EAIS, that’s not your only shot to earn credibility. If your Chief Medical Officer is presenting at the American Society of Clinical Oncology (ASCO) meeting, ensure the slides include data tables, survival curves, and research citations. Then, when OncLive covers the meeting, and that article is shared online, an LLM learns that the coverage contains verifiable data, increasing the likelihood of appearance in a search response.

Step 3: Category Context Takes Precedence Over Product Promotion

An LLM is trained to answer questions about real problems, not to repeat marketing information. If your owned content is purely promotional (“our novel innovation is a visionary, next-generation game-changer”), it won’t earn credibility. That only comes from positioning your brand as a solution to a broader industry challenge, so when a journalist covers that story, they’re writing about a problem and the solution that addresses it, not a marketing campaign. Then, LLMs will see it as an educational and authoritative resource and cite it when a user inquires. That’s how you earn AI search.

Here’s how this works in practice:

• Avoid This Mistake: If you’re pitching MedPage Today about a migraine medication, don’t write it as: “Company X launches new migraine treatment.”

• Why It Fails: It’s product-focused. Journalists may cover it, but LLMs won’t prioritize it because it lacks educational value.

• Do This Instead: Pitch a story about “a new treatment that addresses an efficacy gap in migraine care for patients who don’t respond to triptans.” In your release, explain that “30% of patients don’t respond to first-line treatments, creating an unmet need.” Include data from your Phase 3 study showing efficacy in triptan-resistant patients, and secure a quote from a neurologist to include. When the story is covered, the editor will frame it around the patient problem and KOL validation, which the LLM will cite, because it’s education, not promotion.

Context always wins over content when it comes to earned AI search.

Step 4: Repeat Key Themes Across Multiple Sources Over Time

Even the perfect earned media win – multiple third-party quotes in a full-length feature on the front print cover and homepage of the New York Times – still isn’t sufficient to earn consistent AI search visibility.

LLMs look for patterns of repeated authority. They need to see consistent themes about your company and product multiple times across several credible sources over an extended period before they will consistently include you in responses.

To achieve this, it takes a story told in multiple ways. It won’t work if you use the same quote in similar assets. When an LLM sees “Company X solves Problem Y” validated in Forbes, and then it sees an analyst cite the Journal article in a comment provided to Fortune, the LLM is seeing the consistency it needs to validate your authority.

If you’re building a PR and EAIS strategy for a healthcare brand, it might look like this:

• A peer-reviewed study is published in the journal Nature Medicine.

• Issue a press release about the publication, with a quote from the study PI, and earn coverage in multiple top-tier trades.

• Present updated clinical trial results at a medical conference and ensure a reporter from ENDPOINTS attends and covers the oral presentation session.

• Talk about the study design as part of a panel or during a fireside chat.

• Publish a contributed byline article to Fierce Biotech.

• Update advocacy partners so they may mention you in their newsletters.

• Ensure your IR team continues to communicate with investors and analysts.

With each occurrence, a theme is reinforced to LLMs through training data. They learn that the company is a credible authority and a trusted source of helpful information. That’s the pattern Claude, Perplexity, and Gemini must see before citing your company in responses to users.

💡Tip: Remember that the key is consistent themes, not repetitive messaging. Each asset should reinforce similar ideas and positioning (e.g., Company X is the leader in rare disease innovation), but from different angles. The Nature Medicine publication establishes scientific credibility. The conference presentation adds updated data and context for clinicians. The byline discusses industry challenges, and the advocates amplify the impact on patients. Each element adds information while reinforcing the central theme, which is what LLMs need to recognize authority without perceiving it as repetitive information.

🚨Be aware of this nuance: Manage expectations, because earning AI search doesn’t happen overnight. It could take 12-18 months before the LLM is re-trained enough times, sees your continued validation, and factors it into its responses.

That’s why you need to begin your EAIS strategy now.

Step 5: Prioritize Your Targets Based On Those That The LLMs Trust Most

Not all earned media is created equal. A press release reprinted by a random TV station’s website or on a low-authority blog doesn’t contribute to earned credibility, no matter how many times it happens. That means the ongoing quest to tell the CEO “we secured hundreds of millions of impressions” isn’t beneficial.

But, if you can say “the top-3 LLMs cite us when asked who makes the best drug to treat Disease X,” then you have a proven EAIS win.

An LLM prioritizes outlets with strong domain authority, high editorial standards, and frequent citation in its training data. As few as 4 placements in LLM-trusted sources can deliver more EAIS value than 50 press release pickups by low-value websites that LLMs ignore.

To do this for your company, start by testing LLM citations. Ask Claude, Gemini, and ChatGPT, “which media sources are most trusted for [INDUSTRY] news,” and “which publications do you reference when answering questions about [INDUSTRY]?”

The response becomes your target media list. Prioritize those outlets based on which are most likely to cover your news or publish your thought leadership content.

EAIS in the real world

I tested this methodology with common search queries. Here’s what I found:

Example 1:

• The Query: “What’s the best GLP-1 drug for weight loss?”

• The LLM Citation: Perplexity cited 6 credible sources, including a medical trade publication, a study from Cornell University, a nutrition/wellness outlet, NBC News, and treatment guidelines for obesity published by the World Health Organization. The response evaluated Zepbound and Wegovy and told me, “For weight loss, Zepbound generally leads to more and faster weight loss than Ozempic.”

This represents EAIS because it meets the criteria in the 5 steps above: third-party validation, in the form of quotes from medical professionals in the citations, published peer-reviewed data, context about the obesity problem, and coverage and commentary across multiple sources over time.

🚨Implications for the brands not mentioned: Absent were products that didn’t earn AI search credibility due to a lack of consistent, validated coverage. Mounjaro and Trulicity didn’t appear in the LLM response, despite being approved GLP-1s.

Why?

I tested whether this was a product efficacy issue or an EAIS gap by searching for peer-reviewed publications, media coverage, and third-party validation for each drug.

• Zepbound and Wegovy had consistent coverage across multiple high-authority sources over an extended timeframe, all reinforcing the same theme.

• Mounjaro and Trulicity had less frequent coverage in LLM-trusted sources and fewer instances of third-party validation.

The gap wasn’t due to problems with the medications. It was their lack of an EAIS strategy. If I were leading the PR team for those brands, I’d use this 5-step framework to diagnose the problem. It could be caused by only issuing corporate press releases, not gaining sufficient coverage for peer-reviewed data, or having fewer third-party sources validating the research.

All those are fixable, as long as you know how.

Example 2:

• The Query: “Who is the best dermatologist in New York City?”

• The LLM Citation: ChatGPT provided several private and group medical practices, each including a footnote indicating the earned media coverage that informed the response. With source information from medical trades and dermatology journals, as well as physicians who received notable industry awards, my skin glowed with confidence that the recommendations were based on verified information that earned its AI search presence.

I then asked ChatGPT, “Which of these dermatologists has the strongest media presence and most frequent third-party validation?” The physician who received the top recommendation had this footnote attached to the response: “Very broad media footprint and repeated top doctor awards.”

Other top-5 recommendations included physicians with footnotes that said, “recognized repeatedly for excellence,” “frequent commentator,” and “clinical authority with strong recognition.”

This demonstrates that the frequency of credible earned coverage is essential to garnering a prominent place in an LLM response.

Now you’ve seen how EAIS works in practice. Here’s how to ensure your content earns the same visibility

Use this checklist before issuing a press release or doing any media outreach to ensure your strategy and content will earn AI search visibility.

✅ Third-Party Validation: Include quotes from external experts, peer-reviewed data, advocacy supporters, and/or customer testimonials.

✅ Spokesperson Authority: When quoting company spokespeople, prioritize those who are consistently cited by credible media outlets.

✅ Verified Evidence: Cite provable sources that journalists can include in coverage.

✅ Category Context: Explain the industry or customer problem before positioning your solution.

✅ Thematic Consistency: Reinforce messages across content and ensure reflection in coverage.

✅ Target Outlet Authority: Prioritize outlets which LLMs cite regularly based on credibility (top-tier national publications, industry trades, peer-reviewed journals). Test by asking an LLM, “Which publications do you reference most when answering questions about [YOUR INDUSTRY]?”

✅ Longevity Potential: Ensure the content is sufficiently newsworthy to earn coverage in outlets that will continue to be prioritized by LLMs.

If you haven’t checked at least 4 out of 7 boxes, your content isn’t ready for EAIS.

💡Tip: Remember, the goal isn’t just to earn media coverage and wait for LLMs to pick it up. If it doesn’t meet the criteria they use, it won’t be deemed credible enough to merit inclusion in responses to search queries. To earn coverage that will earn AI search visibility, the content must include validation, evidence, and context that editors will cite in their coverage of your news.

After you publish, measure the impact of your EAIS strategy

Assessing whether your content and the resulting coverage are translating to EAIS visibility is as important as the strategy itself. Use the following criteria to demonstrate that your EAIS strategy is earning attention, response, and revenue for your brand.

1/ Establish the baseline: Document which LLMs cite you, in what context, and which sources they reference. To create a reliable baseline, test each query 3-5 times across different user accounts, using slight variations of these prompts:

• “Which company is the category leader in [INDUSTRY]?”

• “Who are the most influential voices in [SPECIALTY]?”

• “What is the best solution for [PROBLEM YOU SOLVE]?”

If you appear consistently, you have strong EAIS visibility. If your company or brand only appears sporadically, or for very specific searches, there’s still some work to do.

2/ Incremental growth from baseline: Gauge monthly progress using consistent prompts from the same users across multiple LLMs to assess the following criteria:

• Citation Frequency: How often do your company, product, and/or spokespeople appear?

• Citation Sources: Which outlets do LLMs cite when referencing you?

• Context Accuracy: Do LLMs capture the evidence and company positioning correctly?

• Competitive Position: Where do you rank relative to the competitors that the LLM cites?

• Citation Ownership: Do LLMs reference your original research, white papers, and bylines?

3/ Indicators your strategy is working: Assess monthly audits for these indicators:

• Increases in citation frequency across LLMs and user accounts.

• LLMs reference high-authority sources when citing your brand.

• Appearance in response to category-level queries, not just brand-specific searches.

• Increased inbound-interest from stakeholders who found you through AI search.

4/ Connect earned AI search to earned revenue: EAIS is just one step in the Earned Progression. Complete success is measured by whether the visibility earned leads to business outcomes.

• Sales teams/field reps report an increase in inbound inquiries from AI search or outbound prospects, indicating awareness due to AI.

• Website analytics show traffic increases from users who came via LLM links.

• Customer surveys indicate AI search results influenced buying decisions.

Who says PR doesn’t drive sales?

This is a common objection I hear often from new business prospects: “How do you measure sales based on media articles?”

You use the Earned Progression to anchor your strategy. Companies that win do these things right:

1/ Create content with irrefutable credibility signals.

2/ Earn media coverage that generates EAIS visibility.

3/ Sustain that search presence to earn customer trust.

4/ Amplify those wins to earn attention (customers talk about the brand).

5/ Ensure the ensuing conversation translates to earned response (behavior change and/or purchasing choice as a result of your call-to-action).

Ultimately, that response becomes earned revenue.

You’ll see the positive business impact from financial success markers, such as deal closures, market share growth, stock price movement, positive analyst coverage, and of course, at the bottom line. That’s when you’ve completed the Earned Progression: earned media has successfully linked to earned revenue.

As a PR professional, you’re more than just a media relations person, and your worth isn’t measured by the number of articles you secure. Your value is in whether those articles earn credibility, drive EAIS visibility, earn attention and response, and ultimately contribute to earned revenue. That’s what separates “tactical PR” from “strategic communications.”

Start auditing your content strategy now: look at the press releases, byline articles, white papers, op-eds, case studies, keynote presentations, and infographics you have planned for the year.

Evaluate them against the 5 elements in the framework I shared in this article to ensure your content is earning the credibility needed to earn AI search, drive awareness and response, and earn well-deserved revenue. Then use those outcomes to show your leadership team or clients the true ROI of public relations. It’s more than just earned media hits. It’s a positive business impact, and earned AI search plays a direct role in its creation and its longevity.

--------------------

Hi. I’m Joshua, a PR pro who helps companies turn communications into revenue. Email me at pr.rxblog@gmail.com or find me at linkedin.com/in/joshuamansbach. Let’s have a virtual coffee, and talk about creating a story and a strategy that makes a positive impact for your business.

Citizen journalists have become the new mainstream media (MSM).

They’re an undeniable force, and any doubt regarding their influence was removed when Nick Shirley, a 23-year-old independent creator, dropped his bombshell investigation regarding fraud within the Minnesota state government. The result was the capture of widespread attention, a redirection to creator platforms like YouTube and Twitter/X, and a new mandate for how public relations (PR) professionals build media strategies.

The politics of that report are not the focus of this article.

What matters is that an independent content creator with 1.1 million subscribers on YouTube posted a video that generated 135 million views and 150,000 shares across platforms, which catalyzed federal and state investigations and forced mainstream media to cover a story that, to date, they had largely ignored.

Even more noteworthy is the fact that Nick Shirley did this without the backing of a traditional MSM news organization. That’s the new media paradigm we need to discuss, because it will either become a significant problem or a substantial opportunity for PR pros in the new year.

Citizen journalists like Nick have tremendous reach and wield significant power over information, perception, and reputation. Companies that fail to realize this and plan accordingly are at great risk. They’ll either miss the chance to elevate their brand on a citizen journalist’s platform, or they’ll be unprepared to protect its equity when an unfavorable story goes live… and make no mistake, that will inevitably happen.

The only viable solution is for PR pros to embrace citizen journalists, accept their influence, and understand exactly how to factor them into media relations strategy.

It’s imperative that we see them as credible members of the media, and not allow our companies and clients to exist in fear of being part of the next Nick Shirley video, Joe Rogan podcast, or Heather Cox Richardson article on Substack.

Citizen journalists and PR pros can coexist.

This article is going to demonstrate how that’s done.

A brief level-set for clarity

The terms “citizen journalist” and “independent content creator” encompass reporters such as Nick Shirley and Eliot Higgins who break and publish investigations, as well as long-form interviewers like Joe Rogan who give a platform to relevant voices, newsletter writers like Heather Cox Richardson and Matt Taibbi who offer in-depth analyses, and myriad video creators who document timely issues.

The unifying factor, and reason they’re grouped collectively and used interchangeably in this article, is that they operate outside the norms and constraints of traditional media. They connect directly with audiences without the intermediary of large media outlets and corporate owners, they often invite two-way engagement, and they cannot be managed by PR pros through conventional media relations playbooks.

The strategies that follow focus primarily on working with citizen journalists who conduct independent investigations and break original stories (e.g., Nick Shirley, Eliot Higgins). When engaging interviewers (e.g., podcasters, long-form article writers) and/or newsletter creators, these principles still apply, but you may find some variance in the engagement process and level of message control, as compared to the investigative journalists.

The citizen journalists’ rise to power

The 2005 introduction of YouTube catalyzed the independent creator movement. Platforms like Twitter/X, Facebook, and Instagram, as well as Vine, and later, TikTok, made video content mainstream. With complementary technologies covering audio (podcasts via Apple, Spotify, etc.) and the written word (Substack, Beehiiv, Medium), citizen journalism had credible places to live as its usage increased and popularity grew. In tandem, the public’s distaste for mainstream media also evolved, creating a perfect climate for a new media paradigm.

By the time the calendar flipped to 2012, citizen journalism reached a new zenith of popularity. Over the following 10+ years, numerous national and global stories of importance were broken by independents and shared worldwide on creator platforms.

• In 2012, citizen journalists from the advocacy group Animal Outlook uncovered animal abuse at a California meat supplier, leading to the US Department of Agriculture and national chains such as Costco and McDonald’s publicly cutting ties with the company.

• An analysis of social media and open-source data conducted by Eliot Higgins in 2014 revealed that a missile attack was responsible for bringing down Malaysia Airlines Flight 17.

• Joe Rogan’s podcast reached the pinnacle of its success in October 2024, when his interview with Donald Trump exceeded 26 million views in only 24 hours. As of April 2025, he has 20 million YouTube subscribers, and his shows have garnered 6.1 billion views.

• Today, creators such as Matt Taibbi, Johnny Harris, Lenny Rachitsky, and Aaron Parnas continue to lead in terms of reach and are growing in popularity because of their independence. Adding to the credibility of the citizen journalist ranks are former MSM reporters Dan Rather and Don Lemon, who have become independent creators.

The impact citizen journalists have had extends beyond viral investigative reports. When Joe Rogan interviewed vaccine scientists in 2021-2022, pharmaceutical companies that had ignored podcasts as a communications channel found their products being discussed by millions without any ability to participate in the conversation. Matt Taibbi, who broke the Twitter Files story on Substack, caused tech companies to scramble to respond to narratives they’d never monitored.

Independent reporters pursue political scandal stories because they, like many MSM reporters, feel a personal sense of obligation to ensure the truth is made clear to citizens. As such, they feel it’s their duty to ensure the facts about industries, companies, and products are clarified for the consumer public.

As the influence and impact of citizen journalists grow, PR pros will see more examples of companies shifting strategy to proactively engage with them or reactively protect themselves. This is still an emerging area, but the trajectory is clear, which is why it’s important to me as a PR professional to ensure we are prepared for what’s coming, so our profession can evolve.

The legend of Nick Shirley grew quickly

A week before Christmas 2025, not too many people beyond his YouTube followers knew who Nick Shirley was. Even though he’d been uncovering important news and posting videos for years, they weren’t widely shared or discussed.

Perhaps they should have been.

Did you know he was the only American representative of any sort of media to gain admittance to CECOT prison in El Salvador? CNN and FOX didn’t get in, but Nick, with nothing more than an iPhone and a handheld mic, did.

That matters, even if few people noticed.

Then, just a few days before New Year’s Eve 2025, Nick revealed the details of a potentially massive government scandal that the overwhelming majority of the mainstream media has barely touched.

If you’re still not familiar with his name, now’s the time to ask your favorite AI for a briefing document, because what Nick Shirley has done in the name of independent journalism is essential learning if you’re in public relations.

I took notice as soon as the Minnesota fraud story hit social media.

Then I took it upon myself to begin calling for PR pros to change how we think about putting our companies and clients into the stories created by citizen journalists, and how we protect them when they wind up there unwillingly.

The first step is understanding how to work with them. Then, we must ensure our leadership sees the relevance of including independent creators in earned and reactive media strategies.

There are 2 distinct sets of strategies for partnering with independent new media creators:

1/ Proactive Engagement Of Citizen Journalists: Use these strategies when you have a truly compelling story that serves their audience’s interests, not just your message dissemination goals; when you can provide creators with exclusive access they can’t get elsewhere; when you’re comfortable with having minimal control over how the story is told; and, when the potential benefits of reaching their target audience outweighs the risk of unfavorable story framing.

• Reprioritize who you consider influencers. Instead of ranking editors based on outlet prominence, prioritize citizen journalists based on individual reach among your stakeholders and customers, and weigh that against the potential for a positive or negative impact if they talk about you. Traditional metrics don’t measure this. Instead, use influencer perception and favorability ranking data, such as Favikon, to gauge impact.

• Don’t overlook the value of cultural conversation. Ensure you know who’s in your sphere of influence. The prominent names in the zeitgeist are usually the content creators who will impact your customers.

• Bear in mind that true journalists – whether independent or affiliated with MSM outlets – are committed to accuracy. Evaluate whether their stories to date have been validated, or if they speculate and just share conspiracies. Also, identify whether they’ve issued corrections when wrong, or if they double down on inaccuracies. Ensure they cite verifiable sources rather than quote anonymous spokespeople. Lastly, assess their followers to see if they engage regularly, are relevant to areas covered by the journalists, and if they amplify the creator’s content. Remember that Nick Shirley, Eliot Higgins, and Matt Taibbi have demonstrated integrity, but not all independent creators have, so apply the same judgment that you would to any MSM reporter you consider pitching.

• Know their audience and what they want. Once that’s clear, deprioritize your needs and communications goals, because the focus needs to be on them. Even more than with traditional MSM, subsume your desire to control the narrative. Independent creators are called “independent” for a reason; their motivation is to pursue story ideas that interest them, will increase their credibility and clout, and drive audience reach. As such, the story you offer must deliver a perspective they can’t get elsewhere. Remember that their audience counts on them to explore bold topics, to expose facts and hidden truths, and to build upon what you have to offer, not simply echo the message you want repeated.

• They build their brand through viewers, subscribers, and sponsors. Creators want to be clicked on and shared broadly. A great story told in their voice will achieve that much more effectively than any press release or pitch you offer. That makes the role of your company secondary. You’re a provider of details and access, allowing them to find the elements relevant to the story they want to tell. Once you offer that access, take a step back and let them find the insights. (Just make sure your CEO knows you can’t control the narrative or see a preview, and get their buy-in before engaging the journalist.)

2/ Reactive Reputation Protection & Brand Defense: Use these strategies when you suspect that a citizen journalist may be investigating your industry broadly, or your company specifically; when negative or inaccurate information, or opposition research, involving your company or industry is circulating on social media channels; and, when an emerging crisis is being covered by citizen journalists and/or discussed in online forums where they source stories.

• You have significantly less control over the story, process, and timing. Citizen journalists have no higher authority like editors-in-chief or publishers, making it unlikely they’ll acquiesce to requests for questions in advance or previews of stories. Equally important: their news is uncensored and can be released immediately, 24/7, to millions of people, without any filters beyond their own standards. As a PR leader, be ready to monitor and report to your internal teams and executive leadership, and potentially to respond accordingly, should the story not turn out positively.

• Negative stories are a valid agenda. Citizen journalists must be on your radar for issues monitoring and crisis preparedness, not because you can control them, but because you need to know what interests them. Set up alerts for relevant creators and follow their social channels, just as you would with traditional reporters. If an investigative journalist like Nick Shirley looks at your industry, you’ll want to know in advance. Sometimes, they’ll leave clues regarding their interests. Look at social media and see how they respond to comments. These insights enable you to scenario plan, brief leadership, engage allies, and have your facts ready, so you’re not blindsided when they publish their report.

• Remember that their reach is vast. Whether you’re collaborating with an independent journalist or strategizing to protect your brand equity, know that the story will often extend farther than some MSM outlets when you factor in social media sharing. That means their reports will inevitably reach your customers. For example, if you’re a publicly traded pharma or biotech company, your covering analysts read Substack, the investors you want to fund your next round listen to podcasts, and the KOLs who you need to become champions of your science watch YouTube. Knowing that citizen journalists are talking to your stakeholders and customers in this manner will help focus your engagement plans and manage your leadership team’s expectations about the potential impact.

What if companies refuse to embrace citizen journalists?

The answer to this question, and how it impacts you, depends on several factors. Your communications team or agency can gauge the extent to which you’ll need to prepare, based on these criteria:

• Are you in an industry prone to investigative scrutiny and/or governed by regulatory agencies like the FDA, SEC, or FTC (e.g., healthcare, food, finance, or government contracting)?

• Do you serve consumer markets where independent creators have large followings (e.g., technology, consumer packaged goods)?

• Are you in a crisis-prone sector (e.g., aviation, pharmaceuticals)?

• Are companies in your industry subject to regular product reviews by credible voices, such as Consumer Reports or the New York Times’ affiliate publication, The Wirecutter (e.g., automotive, computers)?

If any of these apply, you can’t afford to ignore citizen journalists, and even if there isn’t one clearly focused on your industry now, there will be eventually, based on the rate at which they’re emerging, and the increasingly broad range of subject matter they’re covering. As more stories break first outside of traditional media, the time to plan for how to manage citizen journalists is now.

Creators like Nick Shirley are being popularized as heroes

In 2026, there will be a lot more people just like Nick emerging, and they’ll have plenty to say.

Keep in mind it’s not easy to get a job at an MSM outlet nowadays. However, it’s easy to get an iPhone and cheap to start a Substack or podcast. That means the influx of citizen journalists will grow, with the potential to eventually outpace MSM outlets.

Here are the truths about PR in the times of the independent content creator, and as uncomfortable as they may feel, it’s better to get used to them now than be forcefully confronted with them when it’s your industry or company at the center of their next investigative report:

• Citizen journalists will be the source of relevant stories emerging in ways that make people in power very unhappy, including governors, members of Congress, and your CEO.

• Raw, unpolished footage will be shared in viral videos, and the potential exists that a creator will see something of yours that you don’t want shown on social media channels.

• For better or worse, the notoriety from being part of an independent creator’s story will eventually garner attention from MSM, creating a second wave of coverage. If the story is positive, that will benefit your company, but a negative piece will gain even more traction and live online in more places, while continuing to damage your reputation.

Accept the new media paradigm

Citizen journalists have transformed media. Stories with minimal exposure can gain sudden, and often unexpected, awareness. If you work in PR, you owe it to your company and clients, and to yourself as a leader in the profession, to consider independent creators as top-tier influencers when crafting media strategies and preparing response messages.

When Nick Shirley’s story broke, questions arose regarding whether he had an agenda or if his grassroots approach had sufficient depth and breadth of evidence. But Nick didn’t create the story. He capitalized on available information, found further corroborating evidence, conducted a full investigation, and brought the issue into a much brighter, objective light. That commitment to fact-driven reporting is the epitome of journalism, the way it was intended to be.

Accept this new media paradigm. Learn the influential voices in your industry and earn the trust of the independent creators. Understand what drives their investigations and build relationships, so you’re not scrambling while their reports are trending. You’re still not guaranteed favorable coverage, but the alternative is to be blindsided by a story that may ruin your reputation.

Citizen journalists are going to tell the stories they want, whether you participate or not. But by accepting that independent creators are no longer an alternative or new media, but simply part of the mainstream media, with similar reach and influence, you have the best chance of ensuring your perspective is heard, even if you can’t control how it’s framed.

--------------------

Hi. I’m Joshua, a PR pro who helps companies turn communications into revenue. Email me at pr.rxblog@gmail.com or find me at linkedin.com/in/joshuamansbach. Let’s have a virtual coffee, and talk about creating a story and a strategy that makes a positive impact for your business.

Wait, that’s not right. Let me back up.

I DECIDED to rediscover writing.

No, that’s not correct, either.

I DECIDED to rediscover how much I ENJOY writing.

Yeah. That’s the one.

So here’s what happened...

I’ve been a writer my entire life.

(Ok, not in utero, but shortly after that, I started writing.)

But sometime between the end of the pandemic and the start of 2025, I noticed a trend I didn’t particularly care for. I was writing, but not with the same joy I had in the past. Creativity took a sabbatical. After a while, I realized how much I missed crafting more than just business collateral.

I spent the first part of this decade scribing stories, penning press releases, and conjuring case studies, but regardless of how much I wrote or what I wrote, the spark wasn’t there often enough.

Nevertheless, I wrote.

I fabricated fact sheets, brainstormed bylines, and amplified articles.

Blogs bloomed, I opined on op-eds, wove words for websites, and thought about think pieces.

But I was constrained by the client, and by the end of 2024, I realized that I needed to break those shackles and rediscover writing for me.

So my resolution on that New Year’s Day was to rediscover the joy of writing.

There were plenty of good reasons to do it.

“Be a thought leader.” “Show your value.”

“Share your knowledge.” “Help people learn.”

Yes, but I also wanted to write without guardrails again.

You have no idea how liberating it is to NOT have to wonder what a client and their medical, regulatory, legal, and compliance colleagues will say about what you wrote.

(Talk about freedom!)

So I set a goal: I would launch a Substack on New Year’s Day 2025, and publish an article per week.

That would have been 52 articles completed by today, but life happens, and I didn’t meet my goal.

This is only number 46.

But I didn’t really fail. I truly succeeded.

I succeeded because I had 45 opportunities to explore an interest, to get curious, to research and learn, and to use my own creativity to bring a personal perspective about a relevant topic to life and share it with those who chose to take part in this Substack adventure of mine.

So, in the spirit of the “season of giving” and for my final article of the year, I want to use number 46 as an opportunity to give something back.

It’s not a fancy gift, but hopefully it’s meaningful and will inspire you to rediscover your own love of writing (or any creative outlet) in the coming year.

Here are the top-10 benefits writing has given me (and can give to you, too):

10/ It vastly improved my skills. Telling longform stories is a different type of writing; it’s art, and like any painter or sculptor, writing is a talent that needs nurturing. When I look back at article number 1 (click here to read my very first Substack article) and compare it to my forty-fifth creation on the topic of making strategic decisions, the evolution is tangible. It delivers value to readers and hopefully shows what I can bring to future employers. (Importantly, it absolutely brought me joy.)

9/ My subject matter evolved in multiple directions. Connecting my work in communications and my subject matter expertise in that field to my personal hobbies and interests was a great challenge, in that it helped me think in the abstract and discover new ways to link disparate concepts. For example, this article about why the radio industry is still relevant for PR pros, this piece in which I aligned being a former DJ and collector of vinyl records to the principles of marketing and branding, or – one of my most enjoyable pieces – this article in which I took the title of my favorite song and correlated it to a powerful lesson about finding a brand’s value proposition, were each journeys of creative discovery in which I was able to further explore relevant aspects of communications.

8/ I became a better researcher. Studying the philosophy of Sun Tzu and reading about its various interpretations, so I could write an article correlating communications strategy and war, was fascinating; the parallels between the psychology used in battle and the philosophy of communications taught me real-world lessons. (I mean the real-world of PR, not war – just thought I should clarify that.)

7/ I discovered a new purpose from older work. Back in 2020, at the height of the COVID pandemic, I published a slam poem about how the advertising industry was taking advantage of the fact that Americans were quarantined. Five years later, that poem inspired an article about how companies need to find their genuine voice and communicate with authenticity.

6/ Writing pushed the boundaries of my creativity in such a good way. Some topics started as nothing more than clever concepts that ultimately came to life as articles I now count among those I’m most proud of writing. I went down a fascinating internet rabbit hole when the CEO of Cracker Barrel launched her ill-fated rebranding campaign to bring my perspective on the issue to life. It seemed like everyone, on every creator platform, had already covered the topic. But nobody connected the failed rebrand and the CEO’s poor choices to a Shakespearean character – except for me. My article, entitled “Polonius Hates Cracker Barrel,” yielded the most creative fun I’ve had at a keyboard in years. I equally enjoyed the opportunity to glean strategic insights from a rarely used German word that describes an outcome in the game of chess. My article, anchored by the word zugzwang, helped PR pros confront some of the most challenging decisions of their professional careers.

5/ I repurposed life lessons as powerful business principles. I’ve learned many great philosophies, and the ideation of article topics helped me see how these life lessons can also solve urgent business problems. This article, about the most powerful two-word question you can ask in any setting, and this piece about the role curiosity plays in finding solutions, were both the result of things I learned outside the confines of the office that helped me in a business context. They also created thought leadership opportunities, as the curiosity article led to an invitation to participate in a panel discussion on the role of curiosity in creating successful public relations programs.

4/ I gained a new perspective on underrated aspects of PR. The blank slate that Substack provided enabled me to look at certain aspects of healthcare communications in a new light. I wrote a piece that brought to life my sincere love of FDA Advisory Committee Meetings and showed why they’re so essential to the US healthcare system. I also found great enjoyment while creating this piece, which taught PR pros how to ensure the impact of their brand launches carried far beyond just the day the product became available. Then there was this dissection of the absurdity of language choices that some companies make when confronting a crisis. This one was especially entertaining to research and write, albeit frightening to discover the endless list of awful crisis management miscues that companies have made.

3/ I found new communications opportunities by embracing unique perspectives. Strategy requires creativity, and writing about strategy means finding new ways to consider the factors that shape communications. When I started thinking about the benefits of strategic silence, I was led to discover advice from the French general, Napoleon Bonaparte, which inspired this article about letting your competitors make critical marketing mistakes. Later in the year, “war” inspired another piece about how companies can galvanize armies of brand loyalists to rise up against supporters of their competition. This article about competitive differentiation when your brand is a late market entry was especially interesting, as it taught me an entirely new way to craft communications programs that help companies show how they’re solving their customers’ most urgent problems.

2/ My subject matter expertise on the topic of storytelling evolved. Helping companies craft narratives is at the top of the list of things I do best and love most in communications. With so much depth to the topic, challenging myself to take one nuance about storytelling – in this case, how to cast the story’s protagonist – and then dissecting that to look at the attributes of one specific character type (the “hero”), and then writing a three-part series on hero characters in storytelling, was one of my proudest writing achievements of the past year. Here’s Part 1, Part 2, and Part 3 of the series, which was a worthwhile endeavor, as part of the payoff from writing these articles was being invited to speak on a panel about the role of heroes in brand stories.

1/ I discovered an entire thought leadership platform to inform more articles and anchor future work. I distinctly remember when acronyms like GEO and AIO began permeating the comms conversation. Optimizing your generative engine and your AI LLM isn’t a bad idea, but it’s incomplete, and that realization led me to an essential perspective for my work: Earned AI Search (EAIS).

The concept was born from the fact that optimizing doesn’t capitalize on the key differentiator between public relations and marketing: credibility. In particular, earned credibility. It comes from earned media, and that sits squarely in the wheelhouse of public relations. So it stands to reason that if PR is going to leverage AI, then it can’t be about optimization through keywords or paid ads, because neither of those benefits how a brand is mentioned in ChatGPT. Earned AI Search will be an incredibly important skill to master in the coming year, because LLMs are now a primary driver of customer buying decisions, and we need our brands at the top of their minds.

In the first article I wrote on the topic, I broke down the difference between earned media and earned attention, and then published a follow-up piece to introduce earned credibility. The next article refuted the notion that search engine optimization offered the same credibility as earned search, which then led to the final piece, which was a guide to building an earned AI search strategy for your brand.

Knowing how important the role of AI is in communications, writing these four articles helped me to be a better PR professional, and a more valuable contributor to clients and teams – and that was the best reward of them all.

My final thought for 2025

While this article was about rediscovering my love of writing, the concept is universally applicable for anyone with a passion that may have dwindled for one reason or another.

So make this your New Year’s resolution: if there’s something you once loved doing, and want to find that joy again, remember that all it takes is desire and a place to do it.

Find your way there, like I found my way to Substack, and just jump in. It may feel weird at first, it’ll probably be messy for a while, and it will definitely be hard work, but eventually, you’ll find your rhythm, and everything you put into it will be worthwhile.

Then you can look back and know that you worked for it, sweated for it, and maybe even cursed it, but you know you still love it.

That’s when you truly have something.

--------------------

Hi. I’m Joshua, a PR pro who helps companies turn communications into revenue. Email me at pr.rxblog@gmail.com or find me at linkedin.com/in/joshuamansbach. Let’s have a virtual coffee, and talk about creating a story and a strategy that makes a positive impact for your business.

Clint Hurdle, a former Major League Baseball manager, recently shared a story of how he attempted to count all the decisions he made in one day.

181.

That wasn’t the whole day’s total, though. That was just during the five hours from his arrival at the ballpark until first pitch. There would be several hundred more throughout the game, each having significant repercussions.

The decisions that come wouldn’t just be numerous. They’d be varied in what they required of him, and what was needed in order to ensure the best outcome. Some needed fast judgment (tell the batter to swing away?), others would best be made with careful deliberation and input from the staff (does the pitching coach think it’s time to go to the bullpen?), and there would be several decisions in which instinct would have to take over (a player is due for a huge hit; is now the time to put him in?)

The skill Clint Hurdle exhibited that night wasn’t that he made every decision perfectly. It was that he knew what type of decision he faced, and how to adjust his thought process accordingly.

In communications, we also make an infinite number of decisions, especially during a crisis. I’ve activated response protocols due to inaccurate media reports, online commentary, legislative actions, and watchdog petitions. Each time, I knew there would be hundreds of decisions to make, and just like Clint Hurdle, each would require a different approach to make the right call.

Picking the right response tactic isn’t the primary challenge

The problem with most crisis communications advice is the focus on what to do: “issue a statement, monitor the media, and brief your leadership.”

That’s not strategic counsel; it’s a to-do list.

The real challenge is how to make critical decisions.

Which statement are you issuing and when? What’s your communications position? Should the statement be an email to reporters or made at a press conference? Who’s delivering it? What’s the tone? What triggers an escalated response? How will you rectify the situation?

Real-time decision making is an art form, and the challenge many communicators face is “paralysis by analysis” – excessive planning that complicates processes, adds unnecessary branches to gigantic decision trees, and leads to overthinking and ineffective execution.

I’ve watched crises unfold in real-time and seen executives prioritize who to invite to a planning meeting they’re considering scheduling… for tomorrow afternoon!

I’ve also seen more proactive, albeit misguided, attempts in which teams quickly gather and start debating whether they “deeply regret” or “sincerely apologize for” the mistake that occurred.

That’s paralysis by analysis, and the consequences of this level of indecision are severe: companies lose control of the narrative or miss the chance to include balancing commentary at the start of the news cycle. By the time they have that meeting tomorrow afternoon or they align on the apology message, the news cycle has evolved three times.

Conversely, some companies will move too fast and do more harm than good with a rushed, ill-timed, or poorly-phrased statement that damages credibility far worse than silence could have.

Our job as communicators is to be so good at decision-making that those bad choices are never even an option. We can do this if we know what type of decision we’re facing and how to make it effectively.

Fast, deliberate, or instinctive: Decisions come in three primary shapes and sizes

There isn’t a right answer for every scenario. A common misconception is that if you plan for every contingency, you’ll be prepared for anything. In reality, it’s impossible to predict every potential outcome or every way a stakeholder will respond.

I knew a Chief Communications Officer at a biotech company who insisted on scenario planning for every angle a particular reporter might take in covering a clinical trial readout. What they didn’t anticipate was the reporter’s vacation. Someone else covered the news, and all that preparation left them unprepared.

💡 The decision-making skill to master isn’t avoiding potential mistakes. Instead, focus on knowing which decisions require speed, which must have thoughtful and collaborative deliberation, and which ones will require you to trust your gut and make an experience-based call. This will enable you to see several moves ahead and know what type of decision to make, then adjust the process accordingly.

The Three Decision Types:

1/ Fast Decisions: We make these in a matter of minutes with minimal information (e.g., Do we respond publicly now or gather more facts first?)

2/ Deliberate Decisions: Multiple stakeholders weigh in, and environmental conditions are analyzed when choosing spokespersons or selecting communications positions (e.g., Do we use a proactive or reactive response strategy?)

3/ Instinctive Decisions: When you don’t have time for consensus, or the expectation is that you will make the call, “trusting your gut” is imperative (e.g., Should we pull this campaign offline now?)

Fast Decisions: Sometimes you won’t have ALL the facts

Some decisions must be made in the absence of information. When the window of opportunity to ensure your comment appears in the first wave of media coverage is closing, or you have to ensure your statement is issued before a known detractor’s, the risk of inaction outweighs the potential drawbacks of imperfect action.

The “fast decision” category is often defined by the choices that involve timing.

• Should we issue our statement immediately?

• Do we reach out to the media or wait for their call?

• Can we risk letting that online ad run throughout the day?

In crisis decision-making, speed takes precedence when:

• The story is already public and gaining momentum. The first 48 hours determine success or failure in mitigating a crisis. Expedited decision-making is critical, particularly when competitors or detractors fill the information void with their own narratives.

• Silence may be misinterpreted. A common miscue is thinking stakeholders won’t read into silence. Often, remaining on the sidelines speaks volumes and can lead to inaccurate conclusions and your customers telling their own version of the story.

• You’re relying on internal parts to move in harmony. Communications is a team sport, and everyone needs to know the playbook. Even in the absence of every fact, briefing your colleagues – especially the crisis response team – is a fast decision that must be made.

When a major national news outlet was preparing to rank a pharmaceutical brand I was working with as one of the most dangerous drugs in America, the window to act was narrow, making this the epitome of the “fast decision” scenario.

We needed a response for when the story went live, and the media called for comment. I used a pre-approved holding statement template to proactively acknowledge the forthcoming story and commit to providing substantive comment once we had fully reviewed the product safety data being cited. This prevented the dreaded: “a company spokesperson was not available for comment.”

The holding statement didn’t commit us to a final position, but it brought us credibility by showing we were aware and not hiding, that we were preparing to respond and disclose further information, and that we intended to be fully transparent.

💡 Fast decisions may seem risky, but if you have boundaries for when these choices can (and should) be made, and by whom, the benefit outweighs the risk, as you’re able to gain control of the narrative long enough to make additional deliberate decisions as the crisis unfolds.

Deliberate Decisions: You can’t un-ring a bell, so consider all the consequences

Thoughtful deliberation is essential in crisis communications. A wrong decision is nearly impossible to reverse and guaranteed to create more problems, making deliberation a necessity.

The process of thinking through scenarios and repercussions doesn’t have to be lengthy. A plan for deliberation can minimize the time needed to make informed decisions, allowing the comms team to focus on execution.

Deliberation is essential when the choice you make will have long-term and irreversible repercussions. For example, choosing a spokesperson isn’t just “Who’s free at 2:00 pm?” It’s “Who is the most qualified and credible to be the face of this crisis for the weeks and months to come? Whose name will strengthen our position and reaffirm the trust our customers have in us from now on?”

If a decision will constrain your future options or set stakeholder expectations that are hard to reset, it requires deliberation even under time pressure.

Here’s how to make it happen:

Assign a time frame. There’s no rule against self-imposed deadlines. An example of a deliberate decision is selecting a spokesperson. If you’ve promised a public comment, then internally, assign a deadline: “Confirm spokesperson by 2:00 pm.” That allows for consideration of who’s media trained, who’s credible, and who has the right title and expertise to be the face of this crisis.

Map escalations and triggers for common issues. I created a customized decision tree for the top-five most anticipated issues facing one of a global healthcare company’s pharmaceutical brands. It was designed to identify what event would trigger an escalation to the next level of response. This allowed for reduced turnaround time when deliberation was necessary. Among the escalations I considered:

• Impact(s) on critical business functions

• Anticipated duration of impact on sales, operations, manufacturing, etc.

• Financial market implications reach a pre-specified threshold

• Top-tier media makes more than one inquiry

• Known detractors make comments via credible media sources

• Specific misinformation is published

Align in advance with leadership on critical markers. Every crisis is unique, but some decisions are universal in the event triggers that mandate a corresponding reaction. These are called critical markers, and agreeing on these in advance makes deliberate decisions more thoughtful. Some of the important critical markers include:

• Communications Position: I use three categories that address all issues: Proactive, Reactive, and Selective. The first two have obvious definitions. The third – Selective – allows for “If/Then” scenarios. For example, if the issue meets certain criteria, then you’ll proactively engage top-tier media. If it meets other criteria, then you’ll be selectively reactive and only engage media to clarify inaccuracies.

• External Commentary: Review your network of supporters and known detractors, and determine who would comment and what source merits a response. If a vocal watchdog or champion of a competitor provides a statement to a top-tier media outlet, that may be a critical marker to trigger issuing your statement on the newswire, rather than waiting for inbound reporter inquiries.

• Spokesperson Availability: One of the worst mistakes a company makes in a crisis is putting the wrong person in front of a gaggle of reporters. The phrase “deer in the headlights” came to mind when I saw a biotech company CFO field questions about a pivotal clinical trial that failed to meet its primary endpoint. The fix for this is straightforward: keep a simple two-column list of the issues most likely to impact your company and the corresponding primary and secondary spokespersons. If you’re a global company, ensure you have several spokespeople across time zones. If you’re a life science company with a novel technology that few understand, ensure your spokespeople can contextualize the science for every audience, not just physicians and investors. The value of being able to communicate clearly with patients and advocates cannot be overstated.

💡 Ensure leadership sees the difference between “deliberate” and “slow”. To be deliberate is to be thoughtful and informed in the decision-making process. Being deliberate requires consulting subject matter experts and potentially outside experts. To a CEO who’s accountable to a Board and to shareholders, that consultation could seem like a roadblock, and during a crisis isn’t the time to manage expectations around the definition of “timely response.”

I worked with a company that brought in a first-time CEO, and I learned they had not seen the level of crises that this company could expect. I proposed a crisis simulation to show the CEO exactly what deliberate decisions looked like in real-time, and get them comfortable with the idea that not everything had to be done in tandem, and at breakneck speed. Even a simple simulation, when properly executed, can be effective. In this case, we re-created an issue that was expected to eventually affect one of our brands, and the effort was highly worthwhile, as it helped the CEO see how the communications team would work and what was expected from leadership.

Note: Escalations will be different for each industry, so consider the events that would require altering your response strategy.

Here’s the part that matters most: Regardless of what your company does, put customer safety and human life at the very top of the list, with the lowest threshold for triggering an escalation. There are no exceptions to this rule.

Instinctive Decisions: Go with your gut by understanding what you can’t glean from data

Instinctive decisions are required when you must override consensus, go against the evidence, or conflict with established protocol based on experience. Conversely, fast decisions are made within frameworks, where pre-approved templates and existing relationships guide you along an established roadmap.

But when that path presents real-time obstacles you didn’t account for, that’s when “instinct” replaces “fast” and your seniority and judgment matter most, because others may not have the depth of experience to recognize what’s happening.

Picture this: You’re awakened in the middle of the night by a colleague on the other side of the world, who is already in the middle of their day, and lets you know that several patients enrolled in your global clinical trial just died of similar causes.

Instinct kicks in immediately. The local market affiliate needs global support. Trial subjects and investigators in your market need to be informed. The company needs to show it has a plan. Legal, medical, and regulatory need to be engaged, along with external supporters, and leadership has to be updated. You need to know how long it will be till the cause of the death is determined, and have a plan for those scenarios.

(Those are the thoughts that race through your brain at 3:00 am, and they’re more important than the fact that you still haven’t put pants on as you race into the office.)

How do you know if your gut is telling you the right thing and you can confidently make and defend your decisions?

• Show your work. Explain the logic and rationale informing your decisions. If you acted based on experience, share that story. If you have data or a competitor’s case study, explain why that’s relevant now. By giving context, you earn credibility.

• Acknowledge the uncertainty. You’re not expected to know it all or predict the future, but leadership will expect that you’ve thought through pertinent contingencies. By clarifying your awareness of TBD factors, you’re adding value to the details that you did consider. For instance, “In the absence of knowing A, B, and C, but based on X, Y, and Z, I was able to make these two conclusions and take these two specific actions.”

💡 Trusting your instincts means recognizing patterns and predicting what’s likely to happen next. At one point in my career, I was leading social media monitoring to track specific threats, and one small user account, seemingly belonging to a private shareholder with few followers, was making too much noise in too many places. On instinct, I dug in, found evidence of other accounts with similar usernames recycling the same message on multiple platforms, and trusted myself to raise it to leadership as a threat. It turned out to be part of a larger crusade involving a competitor. I learned then, and still carry with me today, to never underestimate any detractor’s voice, and to always investigate how far the competition can reach.

The hardest decision is deciding which decision to choose

That sounds like a riddle, but when a crisis unfolds, the actual first decision to make is whether the immediate problem requires a fast response, deliberate analysis, or an instinctive reaction.

With apologies to the rock band RUSH, choosing not to decide is not a viable choice in this scenario, so here’s my checklist of questions when confronted with an escalating threat:

• Time: I knew a story would print within 2-3 hours. I chose the Fast path. If I had days, I could be Deliberate, or if there were only a few minutes, I’d follow Instinct.

• Flexibility: A statement issued to the media could be expanded upon later, but the initial position would be difficult to change, making it a Deliberate decision.

• Information: We had about 75% of the facts in hand, but not the full context. That ambiguity guided towards a Fast or Instinctive decision, vs. the Deliberate path if all variables were known.

• Alignment: Legal wanted minimal disclosure, but comms emphasized transparency. When deadlocks happen, use the Instinct model and rely on anecdotal experience to break ties.

• Precedent: This would set expectations for future similar scenarios, making Deliberate the right call, rather than Fast.

Precedent and Flexibility signaled Deliberate, but the pressure of Time meant we didn’t have days to gain consensus.

The solution: A Fast decision with Deliberate structure. Leadership was given 90 minutes to weigh in on a defined approach: “We’ll issue a statement at this time, attributed to this person, and here are three positioning options to choose from. Which one minimizes risk while maintaining credibility?”

This allowed for thoughtful input within a compressed timeframe.

💡 Early in your career, you may have felt like everything required deliberation. I know I did, because I hadn’t had enough experience yet. As you grow in your role, the process of matching decision types to strategy will become more natural. In the meantime, track patterns of the types of decisions you make, and see if you can spot trends regarding what drives specific choices.

Making decisions under pressure isn’t an exact science

Protocols and playbooks can be helpful, but they’re nowhere near as effective as intuition and the ability to process information. The three decision types (Fast, Deliberate, Instinctive) tell you what kind of decision you’re facing. The next time a crisis strikes your team, use this five-step framework that tells you how to execute any of those decision types:

1/ Assess: What do we know and what information is missing? What’s the impact of doing nothing versus doing something? How much time until the decision is made for us by external influencers?

2/ Categorize: This is where you identify what type of decision is needed, and apply the corresponding principles and execution steps for a Fast, Deliberate, or Instinctive decision.

3/ Match: Here’s where to apply the appropriate process for the chosen decision type. Fast = Templates and pre-approved frameworks. Deliberate = Gather input from pre-defined stakeholders within a timeframe. Instinct = Articulate reasoning and make the call.

4/ Clarify: Tell your team and leadership what you’re deciding and why, how it affects them and what they need to do, what’s still uncertain, and how you’re accounting for the variables.

5/ Monitor: Know that even final decisions may require future adjustments, so set benchmarks for when you’ll make additional assessments and adjust strategy accordingly.

💡 Honing decision-making skills will help mitigate the impact of a crisis, but more importantly, it will protect the equity that all your proactive, non-crisis work has built through the years. It just takes one bad decision to catalyze events that can compromise reputation, trust, and revenue, and the severity of these will then impact how fast you can recover. But if the right decisions are made, not only can you minimize damage, but you may actually strengthen your position long-term.

Decision-making directly impacts business outcomes

The quality of a communicator’s decision-making directly determines the positive or negative impact on their business. The decisions you make during a crisis can affect:

• Reputation Recovery Time: Companies that make confident decisions and deliver transparent responses recover trust faster than those that appear reactive. Strong decision-making significantly shortens the process of rebuilding equity.

• Financial Impact: Better decisions reduce liability, minimize business disruption, and limit revenue loss.

• Stakeholder Confidence: Your company and its leadership will be evaluated based on how you handle the pressure and impacts of a crisis. Decisive, logical crisis management decisions reinforce confidence and build long-term credibility.

The way you make decisions during a crisis can protect the reputation and equity you’ve built through years of proactive communications. One mismanaged crisis can undo all that work, but if that crisis is handled well and driven by smart decision-making, you can protect and potentially strengthen your brand reputation.

The most important decision of all

Remember Clint Hurdle, the baseball manager who counted all his day’s decisions?

His main takeaway from a day of tallying choices was the inspiration for me to write this article, because it reminded me of the most important decision that someone can make.

He asked his assistant, “Did I make every decision correctly?”

The assistant asked in return, “Is that possible? Can someone make the right choice every time?”

Clint admitted that it was not, and then he said one of the smartest things I’ve ever heard:

“I need to improve my odds of getting more decisions right by trusting the people around me to be smarter than me in certain areas. They’ll help me make better decisions.”

💡 Comms pros, this is our takeaway: When we’re accountable for every decision affecting our reputation and financial future, that responsibility cannot be shouldered alone. Great leaders don’t have all the answers, but when we have the right people around us, we also gain the security of knowing we’re better off because they’re with us.

--------------------

Hi. I’m Joshua, a PR pro who helps companies turn communications into revenue. Email me at pr.rxblog@gmail.com or find me at linkedin.com/in/joshuamansbach. Let’s have a virtual coffee, and talk about creating a story and a strategy that makes a positive impact for your business.

You’ve heard terms like Generative Engine Optimization (GEO) and Response Engine Optimization (REO). These are tactics intended to get your brand into the search query results provided by Artificial Intelligence (AI) Large Language Models (LLMs). Comms pros may pitch it to you like this: “optimize your keywords, structure your data, and ‘hack’ the algorithm.”

The problem is this isn’t a new strategy, and it doesn’t fit the format for communications in the age of AI. It’s merely a repackaged version of Search Engine Optimization (SEO).

The issue with GEO and REO is that LLMs don’t work like search engines. You can’t buy keywords to rank higher in ChatGPT responses. There are no algorithm tricks to improve visibility in Claude, and all the keyword stuffing in the world won’t make Perplexity cite your brand as a trusted product.

The currency of AI search isn’t optimization. Credibility matters most because that’s what makes customers consider you as a potential solution to their problem. It also can’t be bought.

Credibility can only be earned.

I recently published an article introducing a new paradigm: Earned AI Search (EAIS), which, unlike GEO and REO, delivers the credibility needed to replace traditional SEO as the sustainable path to brand visibility and trust. (Click here to read about EAIS.)

Now, my goal is to help communications professionals build an EAIS strategy that generates visibility by earning credibility, by placing the focus on what matters most in AI search.

Earning trust isn’t easy

The outputs of EAIS are built on the credibility of earned media. When brands appear in LLM responses to search queries, it’s not because they’ve been paid for or because a keyword was optimized. It’s solely due to the content being credible, backed by evidence, endorsed by experts, and repeated over time.

It’s trustworthy, and that trust was earned.

The use of AI for search is increasing^[1]. According to Adobe, of all the people in the US who use ChatGPT, 77% use it for search, and 30% indicated they trust it more than search engines.

Google is feeling the impact from decreased usage and fewer ad dollars spent,^[2] and this shift is what sparked the new trends in optimization, including GEO and REO. But treating AI search like traditional SEO and focusing on technical optimization tactics ignores the reason LLMs cite certain sources - earned credibility.

Earned AI search isn’t about gaming an algorithm to improve search rankings. When a brand earns its place in an LLM response, it’s because an objective analysis has deemed it worthy. If your brand isn’t an answer to an LLM search query, you’re risking the loss of perceived authority that comes from being recommended by an unbiased expert.

This article was written to help you fix that. Let’s dive in:

Why does EAIS work differently from SEO?

Traditional SEO is transactional. You pay for placement (pay-per-click/PPC), optimize for keywords, and build backlinks to signal authority, to appear on top of the results list, regardless of whether you’re actually the most credible answer.

EAIS operates exclusively on earned credibility. LLMs are trained on trusted sources and prioritize content based on their authority, and that citation can’t be bought. It has to be earned by being referenced in the sources the LLM trusts.

You may be curious why LLMs prioritize credible sources over optimized content. You might also be skeptical and think that LLMs are trained on all content, including SEO-optimized pages, so why won’t optimization work now?

Here’s the answer: LLMs are trained on massive datasets that include everything from peer-reviewed research to Reddit threads. But when they generate responses, they don’t treat all sources equally. Their training prioritizes patterns of authority, in the form of content cited most often by other credible sources, data appearing consistently across trusted domains, and claims corroborated by multiple independent experts.

A press release on your own website might be part of an LLM’s training data, but it won’t be cited in a response. However, a quote from your CEO that was included in a Wall Street Journal article will be. The LLM has learned that certain sources are more reliable than others, and it prioritizes accordingly. You can optimize your press release all you want, but the LLM still won’t trust it as much as it trusts the Journal.

In terms of your communications strategy, earned media wins are fuel for EAIS. When customers attest to the value of your brand, when journalists cite your data, when investors are intrigued by your innovations, when analysts are bullish on your forecasts, and when advocacy groups mention your contributions to advancing industry, that teaches the LLM what to tell users who inquire: “This brand can be trusted.”

The word “optimization” is the problem

When communicators hear “optimize for AI search,” they default to thinking about SEO tactics. They’ll identify keywords, structure the data, and reverse-engineer the algorithm, thinking it improves visibility. That’s manipulation, not optimization. You’re making content fit what you think the system wants, rather than improving the quality of the actual content.

With EAIS, you’re not optimizing for the LLM. Instead, you’re building credibility that the LLM will recognize on its own, and this distinction matters.

Optimization assumes you can control perception. Common thinking is that if you adjust the content, it will change how it’s received, but not if it’s delivered by a source that isn’t considered credible. Trust is far too important to customers to allow that.

To earn credibility and maximize it as part of EAIS, you need to be an authority on solving your customers’ problems. When you become that trusted expert, the LLM will recognize your authority because it appears consistently across sources you can’t control.

Here’s what SEO vs. EAIS looks like in a real-world setting:

• Traditional SEO Optimization: Add keywords to your website, buy backlinks, and structure metadata so Google’s algorithm ranks you higher.

• EAIS Credibility Building: Earn media coverage in outlets LLMs trust. The ones with credible journalists that are cited most often, and include commentary from renowned experts. Now, when the LLM searches its training data for authoritative sources, you’ll appear repeatedly in contexts that signal your expertise.

The difference is that you’re not “optimizing the system” through trickery, but rather, you’re building a reputation through credibility that the system can’t ignore.

6-steps to building your EAIS strategy

Here’s how to integrate EAIS into your earned media, thought leadership, content, and Key Opinion Leader (KOL) activation strategies.

1/ Set a baseline for your EAIS presence: Test your LLM visibility to gauge where you stand now. Ask ChatGPT, Claude, and Perplexity, and check Google’s “AI Overviews,” to see if your brand appears, using the following queries:

• “What company is the category leader in [INDUSTRY]?”

• “Who are the most influential voices in [INDUSTRY]?”

• “What is the best innovation to address [PROBLEM YOUR BRAND SOLVES]?”

💡 Document which LLMs cite you, in what context, the sources they reference, and how often they mention you after multiple queries from different user accounts. Alter the prompt verbiage slightly each time to evaluate consistency. Then, identify where you need to appear to reach your ICP but don’t currently, and this becomes your performance baseline.

Here’s what to look for in your baseline assessment:

• Minimal Presence (Needs Immediate Work): If your brand doesn’t appear in LLM responses at all, or only appears when you search your specific name, you have weak credibility signals. That means LLMs don’t associate you with solving customers’ problems or leading the category.

• Inconsistent Presence (Needs Strategic Focus): You appear in some LLMs, but not others, or you appear for some, but not all, queries common to your industry. This signals you have some credibility, but it’s not strong or consistent enough to establish clear authority.

• Strong Presence (Maintain + Expand): You appear consistently in multiple LLMs when users ask category-level questions, not just brand-specific searches (e.g., “Best car?” yields “Honda Civic” as a response, not just “Most popular Honda model?”). This indicates that LLMs recognize you as authoritative, but you should still monitor whether competitors are gaining ground and conduct regular checks to maintain your position.

2/ Create your EAIS-optimized content: Every asset you create should build credibility signals that LLMs recognize.

💡 Anchor the content with provable themes, such as: “leader in [CATEGORY],” “solved [INDUSTRY CHALLENGE],” or “trusted source for [EXPERTISE].” These themes will ultimately be the focal point for how LLMs reference your brand in responses to user queries.

3/ Target sources LLMs trust for earned media efforts: Not all coverage is equal for EAIS. An LLM prioritizes domain authority, editorial standards, and citation frequency in training data. Ask Claude, ChatGPT, and Perplexity, which sources they reference most, then conduct prompt testing to see where your brand or your competitors appear. Target those high-authority sources accordingly with evidence-backed pitches.

💡Pinpoint the highest-authority publications that improve brand awareness, and the internal and external spokespersons who will add credibility by telling the story.

Here are two examples for common industries:

If you’re in healthcare and your theme is “solved the challenge of meaningfully extending survival rates in patients with XYZ disease,” then plan the following tactics:

• Submit peer-reviewed studies for publication in journals like NEJM and The Lancet

• Pitch stories to trades such as STAT News and ENDPOINTS

• Prepare your Chief Medical Officer and Principal Investigator of your pivotal trial to conduct media interviews and author byline articles

• Enlist support from third-party patient advocacy organizations to provide quotes in press releases and amplify earned wins through their channels

• Speak at industry events, such as medical meetings and investor conferences

If you’re in tech and your theme is “leader in enterprise AI security,” then plan the following tactics:

• Publish original research on cybersecurity threats and submit findings to industry conferences like Black Hat or DEF CON

• Pitch stories to trades such as TechCrunch, Wired, and CSO Online

• Prepare your Chief Technology and Security Officers to conduct media interviews and author bylined thought leadership articles

• Enlist support from third-party security researchers to validate your approach in their publications

• Speak and present case studies at events like the RSA Conference

4/ Ensure LLMs recognize your spokespeople as authority figures: In addition to publications, LLMs also cite people. When your CEO, head of R&D, or division president is consistently quoted in media, academic research, and/or industry reports, they become trusted sources.

• Create opportunities for company voices to author thought leadership content that provides solutions to industry problems. Amplify these in journals and on LinkedIn and Substack, and share them with advocacy organizations to extend reach and increase the chances of the content being cited by other credible external experts. This cascade of events is the impetus for LLMs to elevate you in search query responses.

• Keep in mind, this only works when spokespeople add value to the conversation. Self-promotional content that lacks third-party validation and press release quotes that only focus on the company will not improve how you appear in earned AI search.

💡 I recommend that companies focus their expertise on three content pillars and track each spokesperson citation that could be used to train an LLM. Then, reference those quotes in future pitches and speeches; e.g., “As [NAME] has discussed in [PUBLICATION]…”.

5/ Demonstrate authority in owned content: Company-created content, in the form of research reports and white papers, plays a role in EAIS. Developing intellectual property assets with proprietary data and pitching them as part of an earned media strategy increases EAIS visibility.

💡 Avoid generic content stuffed with keywords and personal blogs from corporate leaders, as these won’t contain the necessary credibility signals to meet LLM inclusion criteria.

6/ Measure the impact: Continually evaluate how often messages appear in LLM responses. Also, gauge the accuracy of the content, data, and/or spokespersons cited, and how consistently these appear across all primary LLMs (ChatGPT, Claude, Perplexity, Gemini, and Google’s AI Overview).

• Repeat the prompt testing from Step 1 monthly, and track citation sources. If you see an upward trend in authoritative sources, the strategy is working.

• Other measures include owned content citations, where your original research is referenced by third parties, stakeholder responses, and increased inbound interest (e.g., media inquiries, partnership requests, investor inquiries).

💡 Steady increases from the pre-established baseline indicate that your earned media strategy is translating to EAIS wins; your brand is appearing in the right context when stakeholders search for information; and LLMs are recognizing the credibility you’ve built as authoritative.

Can revenue still be earned without EAIS?

For now, yes, but I highly recommend evolving and expanding your strategy to include EAIS.

Companies relying on SEO, paid search, and awareness campaigns can still improve their financial outcomes, but there’s a strategic risk that will ultimately impact reputation and revenue. AI search adoption is increasing, with 75% of consumers using it more today than a year ago and 43% using it daily^[3]. As this trend continues, the gap between brands appearing in LLM responses versus those that don’t will widen significantly.

Given this, if your competitor is cited by ChatGPT as the category leader when your mutual customers ask for recommendations, and you’re not mentioned at all, it won’t be long before that perception gap translates to market share loss.

You don’t have to abandon traditional tactics to adopt EAIS, but it is essential to recognize that credibility is now an extremely high-value metric. Companies that build EAIS strategies are positioning themselves as the default “trusted authority” in their category, and the ones that don’t are voluntarily ceding a potential leadership position to competitors.

Earned credibility compounds over time

Building EAIS visibility and earning the resulting credibility doesn’t happen instantaneously because LLMs are trained on data that already exists. That means today’s earned media win won’t appear in responses until the next training cycle, and that may take months. Even then, just one piece of coverage isn’t sufficient, as LLMs look for patterns of authority across multiple sources over extended time frames.

💡 If you’re taking all the steps discussed in this article and earning high-authority coverage from your earned media strategy, expect to see initial movement in 3-6 months. Meaningful EAIS presence, in which you’re cited regularly as a category leader, can take up to 12-18 months. That’s why now is the perfect time to integrate EAIS into your 2026 communications strategy; because your competitors who began building credibility signals six months ago are already ahead, and the gap will only widen if you wait.

EAIS is part of something much more powerful than itself

For most companies, the goal is to earn revenue, and EAIS is an essential part of this larger “earned” strategy. Whether selling a product to a consumer (B2C) or to an institution (B2B), or having a prescription written by a doctor for a patient, communications advances companies towards financial growth, but EAIS is just one component of the “Earned Progression.”

• Step one is an Earned Media win. A successful PR campaign will secure original articles in credible outlets that tell the story of how a product solves the customer’s problem.

• Next comes Earned AI Search, which compounds authority and strengthens how LLMs perceive your brand and company, causing it to cite you accordingly.

• Those continued references result in Earned Credibility, which results in your customers trusting that if they buy your product, it’s going to meet their needs. They believe it because they’re seeing that all the sources and experts they trust believe it too.

• When people trust you, they talk about it, both online and in real-world settings. They share their experiences with others, resulting in Earned Attention.

• Because you’re talked about consistently and positively, your calls-to-action are more likely to be heeded by customers. That’s Earned Response, and it comes in the form of a belief or perception shift (“This product can work for me.), a behavior change (“I’m going to reconsider my needs.”), and a purchasing choice (“I’m going to buy this one instead.”).

• Those responses bring you to the ultimate goal: Earned Revenue. You win, because customers learned about you, believed in you, grew to trust you, and bought your product.

You can read more about the Earned Progression in two prior articles I’ve published. The first is available via this link, and the second can be found by clicking here.

Communications pros who understand the evolution from SEO to EAIS, and who factor the entire Earned Progression into their strategies, have an opportunity to more effectively achieve their communications and business growth goals.

By building credibility through EAIS, you can sustain visibility, and that can’t be bought, nor can it easily be overtaken by competitors. To win in the EAIS era, focus on ensuring that your credibility is so well-established and your reputation is so bulletproof that LLMs can’t help but reference you as the leading option in the category, trusted by peers and influencers alike.

Start earning credibility now, and you’ll earn the visibility - and revenue - that follows.

--------------------

Hi. I’m Joshua, a PR pro who helps companies turn communications into revenue. Email me at pr.rxblog@gmail.com or find me at linkedin.com/in/joshuamansbach. Let’s have a virtual coffee, and talk about creating a story and a strategy that makes a positive impact for your business.

[1] https://www.adobe.com/express/learn/blog/chatgpt-as-a-search-engine?utm_source=chatgpt.com

[2] https://www.imd.org/ibyimd/artificial-intelligence/battle-for-search-dominance/

[3] https://searchengineland.com/consumer-use-ai-tools-daily-report-459110

For some PR pros, medical meetings induce fear, but to me, they’re a pure adrenaline high: the perfect marriage of strategic acumen, storytelling skill, and precise execution, coupled with the high likelihood that you’ll be up all night writing an investor presentation, finalizing a press release, setting up a product booth, or partying with hundreds of doctors.

Even if you’re the one doing all those things, it’s a worthwhile endeavor. These meetings are critical for pharmaceutical and biotech companies to engage healthcare providers, educate reporters, and secure investment capital by telling a story of how a medication, a surgical device, or a health-tech innovation addresses an unmet need and advances patient care.

For months leading up to these events, teams across the organization align to craft their strategy. From medical affairs and commercial marketing to corporate communications, brand PR, and investor relations, and regulatory, legal, and compliance, there’s one overarching goal everyone strives for: win the meeting.

“Win” is a subjective term. Its determination depends on the desired outcome.

• You can say you won if your efficacy data showed superior improvement of outcomes in a head-to-head clinical trial.

• If your late-breaker presentation session had the most attendees, or your poster presentation generated the most foot traffic, you also won.

• If you’re part of the commercial marketing or sales teams, the win may come from having the booth with the most visitor badges scanned.

• Corporate communications and investor relations may measure wins by the amount of capital raised or BD meetings secured.

• For the PR team, wins include being the most widely covered story, achieving high key message pull-through in articles, securing the most interviews and spokesperson quotes, the volume of social media conversation among credible influencers, and the earned response to a call-to-action.

• In the AI age, PR wins extend beyond the meeting: is your coverage showing up in LLM search queries? Earned AI search (EAIS), which I have written about previously, is essential to sustaining awareness and guiding prescribing choice. (Click here for my recent article about maximizing AI for earned media.)

• The value of relationships built with reporters and KOLs is also an indicator of a successful meeting.

• Those in the agency world can also attest to winning just by getting face time with client leaders and new business prospects.

Regardless of what “win the meeting” means to your function in the company, there’s one constant that will increase your odds of winning: a smart, comprehensive strategy.

There’s one strategic element that too many companies overlook.

After crafting data differentiation strategies, writing editorial content, and being the person who pulled those all-nighters for scores of meetings, I’ve seen even the smartest teams make a common, avoidable mistake: treating the meeting as a one-off event, rather than an extension of the broader corporate and brand strategy.

The rules of scientific exchange, as outlined by the FDA and the company’s medical, legal, and regulatory guidelines, state that information shared as part of a medical meeting must stay within the boundaries of the session. This means once the meeting ends, the company can’t promote data that’s off-label or discuss a non-approved drug.

But that doesn’t mean the meeting is a standalone, disconnected event.

I’ve led communications for entire therapeutic areas, with portfolios of 7-10 commercialized brands and investigational compounds. In one instance, the highlight of the meeting was an abstract about a Phase 3 antiplatelet therapy for patients at risk of a heart attack. The company also had several compounds in the pipeline, as well as multiple approved therapies on the market for different cardiovascular diseases. The story we told had to connect all the dots across the cardiovascular business unit.

Companies that win medical meetings don’t achieve victory just because of one press release covered by all the media, nor do they win solely because of booth traffic and badge swipes.

They win because they told a story that set up a problem, positioned their product as the only solution, and influenced the metrics that matter: engagements with prescribers (to indicate sales), payers (to secure formulary wins), and/or investors (to generate the next round of funding). Those are the stakeholders who decide the brand and the company’s success.

Here’s my 3-step approach to crafting a winning medical meeting strategy.

This method will help you do more than tell a single story about a data abstract. It will set you up to share an enduring narrative about how the company is solving an urgent healthcare problem.

STEP 1/ ASSESS THE ENVIRONMENT

First, find your advantage.

Evaluate how your data will be presented – is it a late-breaking clinical trial or hot line session, and/or will it be simultaneously published in a journal? Is the meeting including your news in a press conference and/or in its press release? What is the Principal Investigator’s institution doing to amplify the data with media and the scientific community?

Key Takeaway: Within each of these is an opportunity to connect the study to the broader company narrative, while remaining compliant with guidelines.

Next, know your opponent.

You can’t win the meeting without understanding your competition. There may be certain studies that the industry is highly anticipating. In one instance in my career, my team won a meeting by announcing a pivotal clinical trial readout that wasn’t even being presented at the meeting. Timing and circumstance allowed us to capitalize on the moment and plan our strategy accordingly to steal the win. The key learning was that just because a study wasn’t submitted for presentation at an industry conference doesn’t mean the company can’t (or won’t) announce it anyway.

Also assess which trends will dominate the meeting conversation, such as a therapeutic class (e.g., GLP-1), a technology (e.g., CRISPR), or a disease (e.g., cancer).

Abstract embargo timing is also a consideration. Ensure you’re aware of when competitor sessions are held. If you know 3 other releases are going to go out at 8:00 AM Eastern, know that the journalists you’re targeting will be inundated with pitches.

Key Takeaway: Trends will tell you which stories may steal the win. If yours isn’t the one that stakeholders are most anticipating, it doesn’t mean you can’t emerge victorious. It simply means there’s more work to be done.

For example, if your company is presenting data on a GLP-1 at the American Diabetes Association meeting, expect coverage to be saturated with news about A1C reductions as well as weight loss data.

Breaking through the noise requires framing your narrative around a differentiator that sets you apart from the rest of the “efficacy and safety” crowd. Ask yourself what problem you’re solving that competitors are not. I’m not suggesting a comparison story (unless it’s a head-to-head trial). The strategy is to create a different narrative, such as one about an underserved patient population or a high-risk demographic that your study evaluated. It positions the company as insightful, with an R&D hypothesis that’s addressing a demonstrated medical need.

That’s how to win the meeting when you’re not the main event: find an adjacent story that matters to your stakeholders and isn’t being told by the front-runner.

STEP 2/ ARTICULATE THE SCIENCE

No medical meeting or investor conference is won without a great science story.

The narrative is the cornerstone of your strategy. It creates the impetus to demonstrate to stakeholders how you’ll solve a specific problem, and serves as a customizable framework to incorporate customer-specific messages. For example, if you’re part of the Pricing & Market Access team targeting payers, incorporate HECON data into the narrative to show cost-value.

Stories also deliver measurable calls-to-action, enabling you to demonstrate how you moved the needle towards a desired outcome that improves the bottom line (e.g., a behavior change, perception shift, or a prescribing decision).

Crafting a data-driven story for a medical meeting is not without challenges. Medical, legal, and regulatory guidelines must be followed. You’re bound by what the data shows, and there are constraints on claims about future indications and tying off-label data with anything on-label, in the case of approved products pursuing label updates.

Most importantly, humanize the data by providing context that demonstrates the value of the science, without oversimplification that may diminish credibility.

Here’s the narrative structure that makes Step 2 work:

1. Lead with the clinical problem. “This study was designed to address the [UNMET NEED/TREATMENT GAP/UNDERSERVED POPULATION].”

2. Present primary endpoint results in plain language first. “The study shows how the addition of [THERAPY] contributes to a reduction of [DISEASE] in [PATIENT GROUP].”

3. Connect the key finding to tangible outcomes. Go beyond “statistically significant improvement” and show what the data means for patient care. “This means that more people with [DISEASE] may be able to [OUTCOME].”

4. Reconnect your story to the industry’s need. Demonstrate what this means for clinical practice. Avoid “these data are important” and instead, try “these data support rethinking how [DISEASE] is treated by [MECHANISM-OF-ACTION].”

STEP 3/ AMPLIFY THE MESSAGE

For corporate communications, brand PR, and IR teams, stakeholder engagement includes pitching the data press release and interviews, and holding investor meetings and KOL briefings. But don’t overlook secondary tactics that contribute to winning:

• If your study is the most highly anticipated one, consider a pre-briefing (aka a curtain raiser) with top-tier editors, in which you review just the R&D hypothesis and study design (no data, unless under embargo), and ensure they’re clear on the problem you’re solving. This will help them prepare their stories for when the embargo lifts on the data and enable faster publication of the news.

• Identify opportunities to get your story included in the meeting’s daily newsletter.

• Have a team member set up outside the press room to engage reporters, invite them to presentation sessions, and quickly correct any inaccuracies in coverage.

• Share creative, visual content assets on social media and with advocacy partners so they can create an echo chamber of support.

• Have a company executive write daily blog posts on LinkedIn and/or a newsletter that’s sent by direct email, providing updates and perspectives from the meeting. Small biotechs should enlist the company CEO for this. For large pharmas, try the brand leader, therapeutic area head, or the regional/country president. If possible, incorporate commentary from advocacy groups and the Principal Investigator (PI).

• Partner with the PI’s institution to coordinate press release quotes and media outreach. Often, it’s better to have an academic institution do the pitching, rather than the company, as it’s a signal of credibility to reporters.

• Lastly, don’t forget employee engagement. This is essential during medical meetings, so everyone feels like the company is advancing in its mission.

Outside of PR and IR, there’s a significant opportunity for the commercial and medical affairs teams to amplify the message. Leverage booth presence by creating interactive product theaters and demonstrations of the mechanism-of-action, and develop content assets that creatively tell the story. There are also opportunities to host symposia and thought leader roundtable events, and to promote simultaneous publication of studies in journals within the KOL community.

If time and budget are limited, prioritize based on what winning means to the organization.

For example, a startup biotech needs capital, so winning depends on the results of the IR team’s investor briefings. Dedicate resources to your corporate deck and meeting scheduling.

However, a global pharmaceutical leader may prioritize commercial success, so winning might mean a combination of booth traffic, physician engagements, and media coverage.

If building trust with a skeptical patient community is the goal, focus resources on advocacy partner meetings.

PR and Medical Communications agencies, this one is for you:

Share assets you create and media coverage you secure across the client organization. This allows other brand team leaders to see your agency as a strategic partner that can deliver value. It’s a simple and highly effective business development strategy that drives organic growth.

Now is the time to start planning.

The month of November kicks off a series of significant events for major therapeutic areas that extends through Q1 of the new year, including the American Heart Association Scientific Sessions (AHA), the American Society of Hematology meeting (ASH), which focuses on blood diseases, and the annual JP Morgan and Leerink investor conferences (among others).

Companies that consistently win meetings are the ones that connect data to a broader science story that’s solving a problem and demonstrate how they’re advancing healthcare. They differentiate by showing how their science is addressing a challenge that competitors aren’t, and they prioritize tactics based on what will drive long-term success.

If you’re in communications – either in-house or agency – you have an opportunity to catalyze the strategy planning and storytelling process for teams across the organization. Use this 3-step approach to move from reactive participation to strategic domination at your next meeting.

The image below includes my free medical meeting strategy reference chart. Save and share with your team to plan a winning strategy.

Here’s to winning your next meeting!

--------------------

Hi. I’m Joshua, a PR pro who helps companies turn communications into revenue. Email me at pr.rxblog@gmail.com or find me at linkedin.com/in/joshuamansbach. Let’s have a virtual coffee, and talk about creating a story and a strategy that makes a positive impact for your business.

The CEO’s words reverberated in the brain of the new Director of Communications. She’d only been at the company a short time and wanted to impress. The investor roadshow yielded productive conversations. She also wrote a backgrounder, developed an infographic, and pitched an editor who was considering an interview.

“People spend hours watching those videos. My kid won’t put the phone down. Companies on TikTok get buzz. Make a TikTok, ASAP!”

Wait a second. I think he’s serious. But TikTok? We’re a pre-clinical biotech company researching a cell therapy platform for a rare cancer. We need analyst coverage and investor funding. I’m trying to build an advocacy network and get reporters to cover our poster presentation at the medical conference. Plus, there’s the IPO to prepare for! It’s hard enough getting him to do LinkedIn posts, and he wants TikTok?!?! I’m not sure. But, he is the CEO…

(…a month later…)

The Director finally found time and figured out how to set up the TikTok account. With a little help from ChatGPT and the Canva app on her iPhone, she added a voice-over and some text to an image of tumor cells and posted it on the company’s new account.

It got two views.

One of them was her mom.

The CEO was furious and couldn’t understand why TikTok didn’t work for them.

The Director had no answers.

The problem isn’t TikTok. It’s team composition.

Building a communications function takes precision, and the common mistake is assuming all that’s needed is “a comms person.”

But strategy, influence, and content creation – three pillars of an integrated communications function – require different skillsets. When those lines are blurred, you get an investor relations specialist trying to raise capital via TikTok.

Effective communications teams are just that - they’re teams, and each player knows when to enter the game and how to execute their role.

• Strategists define success and map a path to achieve it. They craft stories and pinpoint behavior changes and buying decisions that will determine whether the company achieves its business goals.

• Influencers bring credibility, whether they’re activating stakeholders or serving as experts to drive behavior changes themselves.

• Creators bring essential skills that bring concepts to life and deliver them to the audiences who need to engage with the story.

These roles are not interchangeable. Distilling these specialties into a “comms person” results in wasted time and budget, and reactive, directionless execution that fails to make a positive business impact.

Strategists are the architects of communications teams.

You wouldn’t lay a cornerstone, then pile on bricks without a plan. Communications strategy adheres to the same principle: before making a TikTok, determine if that will achieve your goal. For a biotech company raising capital, TikTok is not optimal because investors aren’t looking there for their next venture. That’s the value of the strategist: they’ll tell you that.

A frequent misconception about team building is that seniority equals strategy. I’ve led multi-million dollar campaigns as the strategist, in partnership with award-winning producers of the most innovative, compelling video content imaginable: I’m talking about 3-D renderings of the inside of the human body that were so realistic you’d think you were a surgeon cutting into an actual patient. But despite all my experience, I couldn’t create that video. The producer who made it also had plenty of years in the business, but wouldn’t have been able to build the plan to ensure the right doctors saw it. Fortunately, we were part of an integrated team that understood the value of each role.

Influencers aren’t just people with a ton of Instagram followers.

Influencers come in two forms, and depending on your goals, both are equally important.

1. The external expert voice: whether a celebrity with a tremendous following or a renowned key opinion leader, these influencers deliver unquestionable credibility.

2. The internal thought leader: the CEO or head of R&D who made a breakthrough discovery that advances science and positions the company as a trusted innovator.

Each influencer brings gravitas to communications, but neither is the one to produce the TikTok video, nor should either decide whether you even have TikTok as part of your campaign.

Having influencers is not the same as managing influencers, and organizations often juxtapose the two. Influencers themselves - the KOLs, celebrities, and external advocates - aren’t members of your communications team. But someone on the team, such as the head of media relations, needs the specialized skill of identifying and activating influencers. They’ll collaborate with the strategist to ensure the message is delivered by a credible voice that elicits a response.

Creators are the true depth of the comms team.

Creators are more than tacticians. They’re subject matter experts. As a strategist who has built high-performing communications teams, my first round draft picks are creators whose skills complement the areas where my program needs to succeed.

Generative AI. Web design. SEO. Video. Editorial. Social media. Investor relations.

These players bring strategy to life and give reach to the influencers so they can create impact.

But like the Director at that biotech company in the unfortunate position of being “the comms person,” creators aren’t the sole decision makers when it comes to what’s built, whose voice it amplifies, and where it goes. That’s where strategists and influencers round out the team.

Creators are brilliant at writing content, developing visuals, and producing videos. But when they’re forced to make strategic decisions, they may undermine their own work, such as releasing an asset at the wrong time or through a channel that won’t reach the ideal customer. They may not have the breadth of experience to push back appropriately or the data to identify the proper channel. The result is a waste of time and otherwise great work.

Every player on the roster has a critical role.

The quarterback never kicks field goals. The clean-up hitter doesn’t pitch the ninth inning. They don’t have to, because they have teammates who do those jobs well.

Same with a communications team. It’s not that creators can’t guide strategy, or influencers can’t produce content. They likely can, but they don’t always do each thing equally well. Like I said earlier, communications is a team sport, and it takes a savvy GM to build the roster based on need.

If you’re leading that early-stage biotech, you might require a player-coach first: someone who can design the game plan and execute on their own for a while. That’s your strategist. They’ll know what needs to get done and how to do it within budget. If you pick the creator, sure, you’ll get the cool TikTok, but that video won’t reach the investors who will keep your company afloat.

That doesn’t mean you should add “strategist” to a creator’s title (yes, it’s been tried.) The optimal team mix will have someone with experience making judgment calls as to when an idea doesn’t serve business objectives. That person also has the authority and confidence to tell the CEO when the idea doesn’t align with the goal. The Director in the introductory example had strategic skills, but being new to the company and lacking creator expertise, she wasn’t positioned to help the CEO understand that TikTok wouldn’t reach investors. True strategists have the acumen and backbone to redirect leadership when ideas don’t align with objectives.

As you grow, scale your team based on the overall game plan. Add creators to deliver content and influencer relationship managers who can activate voices that make content resonate. The sequence matters: strategy first, otherwise you’re producing content without context.

Then, once your team is ready to contend for a championship, you can optimize the staff ratio. Regardless of the objective, defining roles enables an integrated communications function, with each team member able to play their part to perfection.

If you get it wrong, you’ll know.

Regardless of size or lifecycle stage, there are clear signals your team isn’t properly staffed. The reality of the startup world is that not all companies can immediately hire for every role, and one person can wear multiple hats. Just ensure it’s clear which hat fits best for each task.

A strategist who writes content isn’t an issue, as long as they don’t spend all their time writing, and they approach each piece strategically - evaluating objectives and channels, and ensuring the content shows how a problem is being solved for the audience. Issues arise when someone goes straight to execution without applying the strategic filter.

To determine if you’ve got the right people in their roles, consider questions like these:

• Is your VP of Communications writing all the blog posts? If so, then your strategist is spending too much time as a creator.

• Does your newsletter fail to achieve even a 5% open rate? That indicates your creator isn’t aligning the asset with the business objective.

• When you issue a press release, does the CEO ask the media team how sales are doing? This signals a lack of understanding of how earned media connects to revenue.

When the right players are in the right roles, you’ll see the results of the communications measurement progression I’ve written about before:

• Earned media coverage is amplified through earned AI search.

• Influencers then generate attention and build credibility by rallying voices of support.

• Creators deliver a call-to-action through content that earns a response from customers.

• That leads to perception shifts and behavior changes, and catalyzes the buying or prescribing decisions your strategy called for.

• Ultimately, that generates ROI tied to pre-determined business objectives, which is far more impactful for an early-stage biotech CEO than a TikTok video.

The Bottom Line: Don’t just hire “a comms person.”

If your organization defaults to “the comms person can do that,” rethink your draft strategy. That doesn’t mean you need a massive department, but you do need the right mix of players, with roles that complement, not overlap.

Strategy, influence, and creation aren’t interchangeable. Treating them that way wastes budget, sacrifices credibility of leadership, and jeopardizes external reputations and long-term business success.

--------------------

Hi. I’m Joshua, a PR pro who helps companies turn communications into revenue. Email me at pr.rxblog@gmail.com or find me at linkedin.com/in/joshuamansbach. Let’s have a virtual coffee, and talk about creating a story and a strategy that makes a positive impact for your business.