GLP-1 Law & Policy

Join the 2025 conference chairs as they kick off the summit with a look at the legal, regulatory, and business forces reshaping the GLP-1 market. Topics will include:

• Highlighting the critical intersections between development, compliance and litigation
• Framing the major risks and opportunities driving business and legal strategies
• Previewing what attendees will take away to stay ahead in this fast-evolving space

This big-picture session examines market trends, legal risks, and regulatory shifts shaping GLP-1 drugs, including the impact of evolving business models on pricing, access, and compliance. Topics of discussion include:

• Reviewing the history of the GLP-1 drug class
• Analyzing the $100 billion GLP-1 market with growth projections
• Exploring legal, regulatory, and business model shifts impacting pricing and access.
• Navigating FDA oversight, compounding restrictions, and compliance risks
• Assessing emerging competition and commercialization strategies.
• Examining how subscription pricing, employer coverage, and reimbursement dynamics are shifting the landscape
• Understanding PBM strategies and their role in access and pricing
• Forecasting changes in government payor reimbursement over time
• Evaluating how price negotiations and potential policy shifts could alter drug valuation and commercialization strategies
• Understanding how potential deregulation, Medicare pricing rollbacks, and industry-driven policy shifts could reshape GLP-1 drug development and commercialization

With GLP-1 market expansion accelerating, companies are facing an aggressive surge of patent disputes, compounder challenges, parallel import risks, and increased regulatory scrutiny. As competition intensifies and enforcement actions ramp up, protecting IP and navigating evolving regulatory frameworks has become mission-critical for manufacturers. Topics of discussion will include:

• Protecting exclusivity rights amid growing threats from biosimilars, compounding pharmacies, and workaround strategies
• Challenging unauthorized compounders through patent litigation, trade secret claims, and regulatory action
• Navigating global market access hurdles, including data exclusivity gaps and international enforcement risks
• Mitigating FDA, FTC, and regulatory risks around off-label marketing, compounding oversight, and parallel imports
• Addressing rising antitrust scrutiny and supply chain barriers that could impact GLP-1 commercialization and market dominance

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

With pricing pressures mounting, companies must navigate coverage barriers, government scrutiny, and shifting payer strategies to maintain access and profitability in the GLP-1 market. Topics of discussion will include:

• Managing DOJ and State investigations into payer fraud and contract practices
• Overcoming formulary placement hurdles
• Navigating PBM and insurance strategies for coverage
• Adapting business models using subscription pricing, employer coverage, and competitive pricing strategies
• Responding to IRA price negotiations and evolving reimbursement rules

As scientific breakthroughs accelerate, GLP-1 therapies are moving beyond diabetes and obesity toward broader applications – creating new regulatory, market access, and investment challenges. Topics of discussion will include:

• Supporting new indications and therapeutic applications with scientific evidence
• Advancing innovation in metabolic pathways and drug mechanisms
• Securing FDA and EMA approvals for expanded therapeutic uses
• Expanding access through virtual care & personalized medicine

As GLP-1 drug usage expands, so do safety concerns and litigation risks. This session explores the current and future landscape of pharmacovigilance and legal exposure tied to obesity drugs.

• Tracking mass tort filings and understanding the core allegations around gastroparesis, psychiatric effects, and off-label use
• Strengthening pharmacovigilance protocols to support safety monitoring, adverse event reporting, and litigation risk management
• Anticipating new waves of litigation driven by safety signals, label expansions, and evolving regulatory expectations

As competition intensifies, investors and dealmakers are navigating IP risks, regulatory hurdles, and shifting valuations to capitalize on the market boom. Topics of discussion will include:

• Tracking how M&A and licensing trends are shaping the market
• Managing IP and regulatory risks in deal structures
• Analyzing where key market players in private equity, hedge funds, and venture capital are placing their bets

In this closing session, leaders will explore how legal, regulatory and business strategies will need to evolve as the market matures and new challenges emerge. Topics of discussion will include:

• Forecasting legal and regulatory enforcement trends
• Adapting pricing, reimbursement, and compliance strategies
• Predicting market access and payer evolution
• Tracking investment, M&A and strategic positioning across the sector