Leading the Way: Highlights from the 12th Annual ACI Women Leaders in Life Sciences Law Summit

Boston was once again the hub for female leadership in life sciences law this summer as attorneys, executives, and policymakers gathered for the 12th Annual American Conference Institute (“ACI”) Women Leaders in Life Sciences Law Summit on July 30–31, 2025. Hosted at the Seaport Hotel, the event brought together top women leaders from across the biotech, pharmaceutical, and medical device industries – including the authors of this blog – to discuss the pressing legal and regulatory issues shaping the sector (agenda).

The agenda featured timely discussions on several topics of interest including: recent Executive Orders and U.S. Department of Justice/Equal Employment Opportunity Commission guidance; new initiatives at the U.S. Food and Drug Administration (FDA), U.S. Department of Health and Human Services (HHS), and the National Institutes of Health (NIH); the use of artificial intelligence (AI) in drug discovery and evolving regulatory frameworks; patent reform and march-in rights; drug pricing under the Inflation Reduction Act; fraud and abuse enforcement trends; and European Union pharmaceutical legislation. One session also explored recent policy shifts and state laws and their impact on reproductive health, and any resulting implications on drug and device manufacturers including the potential for expanded liability. These sessions offered more than just policy updates—they highlighted the growing need for regulatory agility as life sciences companies navigate shifting federal priorities and court rulings. Speakers cautioned being reactionary in an ever-evolving U.S. regulatory atmosphere. Other panelists emphasized the complexity of cross-border compliance, particularly as global markets face diverging regulatory regimes. They also explored the opportunities and challenges of emerging technologies such as AI, stressing the importance of strong, proactive legal frameworks to foster innovation while protecting both patients and data integrity.

As the summit concluded, a key takeaway emerged: women leaders are driving change across every corner of life sciences law—from shaping policy to steering companies through regulatory complexity. The conversations underscored that success in this environment requires not just technical expertise, but adaptability, collaboration, and a willingness to share experiences and lessons learned within the broader legal community.

At Hyman, Phelps & McNamara, we are proud to partner with many clients whose organizations are driven by female leadership who work collaboratively to advance patient-focused solutions in this dynamic and evolving industry. We look forward to seeing how the ideas shared at this year’s summit will continue to inspire and empower women across the life sciences legal landscape.