Blank Rome partner Rachael G. Pontikes will serve as a panelist at American Conference Institute’s (“ACI”) Inaugural Summit on GLP‑1 Law & Policy, being held virtually on Thursday, July 24, 2025, from 8:15 a.m. to 5:15 p.m..
ABOUT THE SUMMIT
The GLP‑1 drug market, now exceeding $100 billion, is rapidly expanding. While the market boom in GLP‑1 drugs presents enormous financial opportunities for life sciences companies, it also carries substantial legal, regulatory, and reimbursement risks. Political shifts may potentially impacting Medicare/Medicaid, new leadership at the Food and Drug Administration is increasing compliance pressure, and new entrants to the market are compounding existing litigation and market share exclusivity risks. Industry leaders will discuss the opportunities and challenges of this booming industry.
Rachael’s session, “Protecting Exclusivity: Drug Classification, Compounding Risks, and Market Access Challenges,” will take place from 10:45 to 11:45 a.m. EDT
ABOUT THE SESSION
As the GLP‑1 market shifts, understanding the impact of drug classification on market access and pricing and the long-term commercial implications of regulatory decisions is critical. This session will focus on developing strategies for maintaining exclusivity and favorable categorization.
- Understanding how large molecule v. small molecule classification impacts regulatory approval and market exclusivity
- Responding to increased FDA scrutiny of compounding pharmacies and telehealth providers
- Managing business risks from compounded products
- Anticipating long-term market shifts
- Assessing the evolving exclusivity strategies to counter patent challenges
- Monitoring legal battles against compounders
Panelists:
- Edgar J. Asebey, Managing Partner, Asebey Life Science Law
- Julie Dohm, Partner, Covington & Burling LLP
- Guilherme Ferrari Faviero, Esq., MS, MPH, Director, AHF Global Public Health Institute at the University of Miami
- Rachael G. Pontikes, Partner, Blank Rome LLP
Other sessions include:
- The Future of GLP-1s: Market Trends, Business Models & Legal Hurdles
- Defending Market Position: IP, Regulatory & Enforcement Challenges in the GLP‑1 Market
- Market Access, Cost Containment & Compliance Challenges
- Expanding the Therapeutic Horizons of GLP‑1 Drugs: The Future of Incretin-Based Therapies
- Strategic Deals and Investment Moves Influencing the Marketplace
- The Next 5 Years: What to Expect for the Future of GLP‑1s
For more information and to register, please visit the event webpage.
