Highlights from the CMO Summit 2025 (Boston, MA): Insights for Pharma and Biotech Leaders

Our team attended the 13^th annual Chief Medical Officer (CMO) Summit in Boston, MA held on April 7-8, convening Chief Medical Officers and Medical leaders across pharma, biotech, and medical devices. The event provided a platform for CMOs and Medical therapeutic area (TA) leaders to connect and share guidance for the community. Several key themes emerged, highlighting common challenges and opportunities that CMOs at companies of varying sizes and stages—particularly pre-commercial companies—are navigating today.

There was a clear concern about uncertainty regarding the near-term future due to multiple macro-level events causing disruption but also presenting opportunities for CMOs to elevate their role and shape their company’s development and strategy. One prominent theme was the expansion of the CMO’s responsibilities into areas such as strategy, finance, business development, and policy. Additionally, discussions included classic considerations regarding the central role of Medical Affairs early in the product lifecycle – echoing conversations from MAPS earlier this year – and continued innovation in the clinical trial process to enhance efficiency and impact.

The Elevation of the CMO

New uncertainties emerging over the past year have made the role of the CMO increasingly critical, necessitating CMOs to assume broader leadership responsibilities. These uncertainties include unknown policy changes, potential tariffs on pharmaceutical products, cuts in federal funding, increasing difficulty in raising capital, and reluctance for potential partners to complete deals. While it may require stepping outside of traditional boundaries of the role, there is an opportunity for CMOs to have more impact and to help guide their organization in an unknown environment.

• Given changes in policy and uncertain regulatory environment, including the potential near-term impacts of the IRA, CMOs are well positioned to navigate and influence company strategy for therapeutic development.
• Given funding challenges, CMOs’ role of articulating the value of their company and assets will continue to be critical in telling their asset story to fully unlock value for their company.
• CMOs must also be more engaged in the M&A/diligence process and be able to develop protocols that unlock the highest commercial potential for their company. There needs to be a thoughtful strategic consideration of looking beyond the traditional norm of thinking about just regulatory approval but also thinking about commercial viability when designing trials.
• To that point, CMOs need to think about their role not just as getting a therapeutic through regulatory approval but to the investor mindset and deal thesis for partnering and M&A.

Indeed, there were several announcements post-conference that reinforce changes coming that the CMO would need to help navigate. This includes the current administration potentially ending the IRA “pill penalty” by conceding the IRA provision that gives small-molecule drugs just nine years before Medicare price negotiations can set in, versus thirteen for biologics. Additionally, the FDA announced that they were phasing out animal testing requirements for antibody therapies and other drugs and moving toward AI-based models and other tools it deems “human-relevant.”

The Central Role of Medical Affairs

Similar to the MAPS conference, there was further emphasis on the strategic importance of Medical Affairs and the role the CMO needs to play in bringing in Medical Affairs early in the development pathway. It was highlighted that the more successful biotechs commercially begin building out and leveraging Medical Affairs activities earlier in the development lifecycle than less successful biotechs. Many CMOs at the conference admitted that their sole focus has been on clinical development and designing trials for regulatory approval and not leveraging the full potential of Medical Affairs in developing a differentiated therapeutic and corresponding supporting evidence.

Key themes included:

• How to bring Medical Affairs earlier and more creatively into the development lifecycle.
• Building a robust Medical Affairs team even in resource-constrained environments will unlock the full value of therapeutics to patients.
• Deploying Medical Affairs to bridge the gap between clinical development and commercial teams.

It was evident that many CMOs at smaller pre-commercial biotechs have not fully harnessed the power of Medical Affairs but are increasingly and strategically understanding the need and the value of doing so. This includes the development of the scientific narrative, real-world evidence generation, building trusted KOL/PI relationships for insight generation which can all increase the market potential of the asset. This strategic integration is particularly relevant given the evolving pipeline landscape highlighted in the keynote:

38% of drugs in R&D are personalized therapies and 41% targeting rare diseases; both of which increase the complexity for the CMO.

While the importance of Medical Affairs was clearer at MAPS, there is an opportunity for smaller companies and their CMO to further elevate.

Clinical Trial Innovation

There was a rather large focus on clinical trial innovation and how to make trials more efficient and impactful. Key themes included:

• Leveraging tools such as AI and machine learning (ML) to increase efficiency, learnings, and to increase the technical success of trials. The keynote speaker highlighted that 29.2% have partially or fully implemented AI/ML for planning and design, 32% for clinical trial execution, and 27.1% for regulatory submissions highlighting the value of these tools for CMOs to deploy.
• Leveraging PROs across primary and secondary endpoints to maximize the value of the patient experience and perspective.
• Leveraging real-time data for medical monitoring to identify potential concerns about efficacy and safety and be able to proactively manage.

These themes collectively underscore the evolving landscape for CMOs and medical leaders, highlighting opportunities to strategically elevate their roles, more effectively integrate Medical Affairs, and embrace innovation in clinical trial design and execution.

To learn more from our experts about optimizing your Medical Affairs strategy, [contact us].