Author: Tara Diflumeri

Disclaimer: These images are for illustrative purposes only.

If you read through each of those and noticed a glaring error, join the Green Room crowd! In the first instance, the word “cures” is used as an unsubstantiated, absolute claim. It implies FDA approval and guaranteed results, which is prohibited if the product is still investigational and the call-to-action suggests commercial availability where there may be none.

In the second example, the press release overstates results from an exploratory Phase 2 trial and in the third, the web copy suggests efficacy and safety are proven, even though the product is still in clinical trials.

What do they all have in common?
They are non-compliant, misleading, overly promotional or unbalanced.

In our industry, proactively communicating pipeline progress and new data is essential for attracting investors, enabling scientific collaboration, laying the groundwork for approval and reinforcing corporate credibility. But companies must do so while navigating strict regulatory guidance from the FDA. Getting it wrong can result in reputational damage, investor concern or even regulatory action.

However, the FDA’s guidance on investigational product communication can be complex and open to interpretation. Missteps like overstating efficacy, omitting risks or promoting unapproved drugs can lead to public-facing enforcement like warning or untitled letters.

Coloring Within the Lines
The FDA expects that external communications about investigational or approved products ensure:

• Accuracy: All claims must be scientifically valid and evidence-based
• Non-misleading language: Avoid overstating benefits or minimizing risks
• Balanced presentation: Benefits must be accompanied by risks
• Adherence to pre-market restrictions: No promotion of unapproved drugs

Seasoned healthcare PR practitioners can mitigate risk. At Green Room, we regularly work with clients to appropriately share phase 1/2 data at major medical meetings and highlight topline results into a press release. Our team is trained to ensure the release is compliant by clearly separating exploratory findings from statistically significant endpoints and avoiding promotional language about unapproved use.

Having an agency well versed in cross-functional Medical, Legal and Regulatory (MLR) collaboration is also key here. Regulatory, legal and PR and communications teams must work together with shared commitment to transparency and consistency.

Best Practices to Ensure Compliance at Every Turn
Our Green Room team can reduce regulatory risk by:

• Implementing robust internal review processes for all public-facing content
• Training employees on FDA standards across functions
• Engaging regulatory affairs early in content planning
• Monitoring enforcement trends and adapting accordingly

Proactive, transparent communication builds trust. But to protect reputation and ensure long-term success, companies must pair transparency with compliance. That means grounding communications in both science and regulatory strategy because compelling storytelling only works when it stays within the lines.

Imagine planning a surprise party but forgetting to send the invites until the night before. The cake’s perfect, the decorations are up…but the room’s still empty. 

That’s the trap too many early-stage companies fall into when they delay communications until top-line data is in hand. But in today’s crowded, noisy landscape, visibility can’t wait. Stakeholders from investors and media to future partners and trial participants need to know you exist before there’s data to talk about. 

So, what do you communicate before you have results? 

You communicate your vision. Your leadership. Your promise. 

At Green Room, here’s how we guide our clients to show up early and strategically. 

Start Early. Engage Often. 

For early-stage companies, engagement isn’t just possible pre-data, it’s essential. One privately held biopharma came to us while still shaping its identity. With a subcutaneous therapy platform and clinical milestones approaching, the company needed a cohesive story. 

We helped leadership align on messaging that articulated both corporate vision and scientific potential. From there, we brought the message to life across stakeholder segments: short-term (investors, talent, media) and long-term (patients, HCPs). Each group received a tailored version of the same core story delivered in language that spoke to their individualized needs.  

Just like in corporate America, journalists are being forced to do more with less. They need time to understand the science and the unmet needs of a potential drug in a therapeutic area before reporting on it. That education takes time. Reporters need to get up to speed on your science and your story well before the data is available.  Holding up your message and media strategy creates major blind spots in accurate reporting or can even turn a journalist off from covering your news. You don’t want to leave your audience scrambling for context. 

Offer a Point of View, Not Just Updates 

Being visible isn’t enough. You need to stand for something. 

Our Green Room team worked with a pre-commercial gene therapy company operating in a rare disease space. While waiting for data, we worked with their CEO to publish op-eds, appear at investor forums and partner with advocacy leaders to elevate the disease’s unmet need and spotlight their novel approach. Afterall, without a product, audiences look for “a reason to believe.” In many cases, that means looking at the company’s leadership and their track records to build credibility on past successes. Sharing that vision as well as unique perspectives give stakeholders a glimpse into where the company could go. It provides the roadmap and sets the stage for future data milestones.  

The result? Momentum. Media interest. Trial recruitment.  

Thought leadership, when done right, builds authority and community. 

Build a Digital Presence That Scales with You 

We get it. When you are pre-revenue, web traffic may not feel like a priority. But a neglected digital presence is a liability. Whether it’s attracting top talent, supporting trial recruitment or shaping how AI interprets your brand online, a polished, findable and future-proof website is non-negotiable. 

With 80% of consumers relying on AI tools for search, your site is either fueling credibility—or fading into digital irrelevance. 

The bottom line: If you’re not telling your story, someone else will and they won’t get it right. 

Start communicating before the data drops. Establish your voice, build the foundation, and send out those invitations well before the party starts. Letting people know what to expect is always a best practice and will be sure to optimize not only your attendance at the proverbial party but getting your story in front of the right people. 

The atmosphere in San Francisco was buzzing with healthcare’s brightest minds collaborating and striking deals to help usher in the next generation of innovative medicines and technologies. After attending Fierce Life Sciences JPM Week events, meeting with colleagues and soaking in the excitement of the biggest healthcare investor event of the year, I was left with a lot to think about. Here’s what I took away:

Mergers and Acquisition Have Rebounded to Historic Highs
Right out of the gate, Johnson & Johnson set the tone for this year’s dealmaking playoffs with its announcement of a $14.6 billion acquisition of Intra-Cellular Therapies, bringing Caplyta into its portfolio. PwC’s M&A Report predicts that 2025 is going to be the year of corporate courtships – lower interest rates and post-election clarity are setting the stage for some serious healthcare hookups. What I’m most interested in is a potential shift toward investment in earlier stage assets that may come with a lower price tag, but hold incredible promise to change the treatment paradigm in therapeutic areas of high unmet need like oncology and rare diseases. This trend signals an increased need for strategic healthcare communications that can effectively position early-stage assets, build investor confidence, and differentiate innovations in crowded markets. PR efforts will need to focus on storytelling that highlights the long-term value and patient impact of these emerging therapies.

AI Will Continue to Shape Healthcare Advancements
No surprises here — AI was everywhere at this year’s conference. Morgan Health’s CEO Dan Mendelson announced that the company wants to do more in AI, and several companies introduced new AI-based products and initiatives. Tempus AI unveiled new upgrades to Tempus One, its generative AI tool for clinical decision-making, while Nvidia announced partnerships with IQVIA, Illumina, Mayo Clinic and the Arc Institute to push digital pathology, drug discovery, and multiomics analysis forward. Talkspace is rolling out an AI-powered tool to help therapists with pre-session prep and post-session notes.

AI’s influence on healthcare is undeniable—however, speakers at JPM also emphasized that real-world impact depends on thoughtful implementation and ongoing technological refinement.

Health Insurers Remain Under Scrutiny
The tension between insurers and healthcare providers is reaching a boiling point and it was palpable at JPM. The recent assassination of UnitedHealthcare CEO Brian Thompson cast a sobering shadow over discussions and prompted some insurers like CVS Health and UnitedHealth Group to forgo the event entirely. Meanwhile, protesters outside the conference called for prioritizing patients over profits. The friction between payors and providers is only intensifying as costs rise and contract disputes escalate. How this dynamic plays out in the coming months will be critical.

Women’s Health Is in the Spotlight
Women’s health was a standout topic at the conference. At Fierce Life Sciences JPM Week, Dr. Jill Biden reaffirmed her commitment to push for more investment in women’s health research, calling it an area with too much potential to ignore. In a powerful visual statement, women from the Biotech CEO Sisterhood showed up in pink to call out the ongoing gender gap at the conference.

On the product front, Bayer announced that its new menopause drug, elinzanetant, is under FDA review. Meanwhile, Morgan Health is actively looking at startups like Kindbody, a fertility and family-building healthcare provider as potential investment opportunities. Conversations estimate the size of the women’s health market will grow from $9 billion to $29 billion in just eight years due to momentum from founders and funders.

The GLP-1 Market Will Evolve, But Where Is It Headed?
The GLP-1 obesity drug market is still booming, but Eli Lilly’s CEO David Ricks said the long-term trajectory is still uncertain. He emphasized that despite the hype, predicting consumer demand and sales patterns for obesity drugs remains tricky. Ricks also pointed to an overestimation of the market’s short-term growth, which has led to some financial setbacks.

GSK’s Chief Scientific Officer Tony Wood said the company is steering clear of the overcrowded obesity market for now and instead focusing on obesity-related conditions rather than diving directly into weight loss treatments.

The Takeaway
As healthcare stands at the intersection of technological innovation and human-centered care, the 43rd J.P. Morgan Healthcare Conference revealed a future where AI, strategic investments, and patient-focused solutions will redefine medical advancement. The industry is not just adapting to change but actively shaping a more precise, efficient, and inclusive healthcare ecosystem. These transformative trends signal a pivotal moment where technology and compassionate care converge to unlock unprecedented potential in medical science and patient outcomes. For communications professionals, this evolving landscape will require a shift toward corporate and investor relations communications to support investment narratives, while heightened M&A activity will demand a sharper focus on internal communications to ensure seamless integration of operations and corporate cultures.