GLP-1 Law & Policy

Overview of the summit’s key themes and objectives, emphasizing the cross-functional interplay in GLP-1 drug development, litigation, and market expansion.

• Discussion on the intersection of regulatory, legal, and commercial challenges
• What attendees can expect to gain from the event

This big-picture session examines market trends, legal risks, and regulatory shifts shaping weight-loss drugs, including the impact of evolving business models on pricing, access, and compliance.

• High-level analysis of the $100 billion weight loss drug market
• Legal, regulatory, and business model shifts impacting pricing and access
  • Regulatory Perspective: FDA oversight, compounding restrictions, and compliance risks
• Emerging competition and commercialization strategies.
  • Business Model Evolution: How subscription pricing, employer coverage, and reimbursement dynamics are shifting the landscape
  • PBM strategies
  • Forecast for government payor reimbursement over time
• IRA Pricing Impact: How price negotiations and potential policy shifts could alter drug valuation and commercialization strategies
• Second Trump Term Outlook: Potential deregulation, Medicare pricing rollbacks, and industry-driven policy shifts that could reshape GLP-1 drug development and commercialization

A comprehensive session covering how growing IP disputes, compliance with evolving regulatory requirements and risks, and enforcement actions intersect in the obesity drug space.

• Patent Litigation & Exclusivity: The rising threat of patent invalidations, biosimilar competition, and workaround strategies
• IP Actions Against Compounders: How branded manufacturers are leveraging patents and trade secret claims to challenge compounding pharmacies offering semaglutide-based formulations
• Navigating international market entry: Patent and regulatory considerations in cross-border launches, including data exclusivity and secondary patent strategies
• Securing IP Amid Legal Scrutiny: Best practices for securing patents amid legal disputes
• Regulatory Risks: FDA’s role in enforcement actions, off-label marketing concerns, and oversight of new therapies
• Compounding & Parallel Imports: The growing gray market for GLP-1 drugs, including challenges posed by unauthorized formulations and regulatory gaps
• Legal & Compliance Considerations: What life sciences companies must prepare for in the next 12 months
• Antitrust & Supply Chain Challenges: How competition law and logistical barriers are intersecting with IP and regulatory strategies in the GLP-1 space

In a shifting marketplace, 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.

• Biologic vs. Small Molecule: How the FDA classifies new therapies
  • Regulatory Scrutiny: How the FDA is targeting compounding pharmacies and telehealth GLP-1 providers
  • Interchangeability & Substitutions: Regulatory impacts on market share, competition, and pricing
  • Bulk drug lists for compounders: Impact on requests for inclusion on Difficulties for Compounding (DDC) lists
• Business Risks: How compounded products challenge market exclusivity and traditional pharma revenue models and impact market viability
• Long-Term Market Impact: Industry response to regulatory shifts
• Legal Perspective: How FDA exclusivity strategies are evolving amid patent challenges
• Litigation Watch: Legal challenges against compounders and their defense strategies

This practical session explores the financial, regulatory, and legal intersections in securing coverage for obesity drugs – from understanding payer access barriers and cost containment measures to examining fraud risks and reimbursement hurdles, to analyzing how government pricing policies will shape market conditions.

• Legal and Compliance Risks: DOJ and State investigations into payer contracts and what companies need to know about payer fraud risks
• Market Access: Overcoming formulary placement hurdles
• PBM and insurance strategies for coverage
• Cost Containment & Business Model Innovation: Subscription pricing, employer coverage, and competitive pricing strategies
• IRA & Government Pricing Controls: What price negotiation under the IRA means for GLP-1 manufacturers and the impact on reimbursement and pricing strategies

A discussion on current treatments, unmet needs, and breakthroughs in obesity care, and the role of digital health and remote prescribing in expanding access.

Explore the expanded applications of GLP-1 therapies beyond diabetes and obesity, including cardiovascular, renal, neurological, and hepatic health and understand the regulatory hurdles you’ll face.

• Clinical Research: Supporting new indications and therapeutic applications with scientific evidence
• Innovation: New pathways and drug mechanisms in metabolic disorders
  • Cutting-edge obesity treatment innovations
• Regulatory Approvals: FDA and EMA perspectives on label expansion
  • Regulatory & Market Access Challenges: Bringing new treatments to market
• Investment Trends: How pharma companies are positioning for broader applications and the next wave of industry developments
• Digital Health & Equity: 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

A critical look into the deal-making strategies shaping the future of obesity and metabolic drug development.

• M&A and Licensing Trends: Key partnerships and acquisitions in the space
• Legal Due Diligence: How IP and regulatory risks impact deal structures
• Investment Outlook: Where key market players in private equity, hedge funds, and venture capital are placing their bets

A forward-thinking session designed to address future policy, legal, and business developments shaping the industry.

• Legal/Regulatory Trends: Expected enforcement actions and compliance updates
• How regulatory and legal strategies will shift over the next five years
• Market Evolution: Predictions on payer trends, reimbursement, and regulatory oversight
• Expected challenges in pricing, reimbursement, and compliance
• Investment & M&A: Where and how major players are positioning themselves in the marketplace
• Key investment and strategic trends shaping the industry