This big-picture session featuring Lowenstein's James C. Shehan 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
Speakers:
- James C. Shehan, Senior Counsel; Chair, FDA Regulatory, Lowenstein Sandler LLP
- Kyle Faget, Partner, Foley & Lardner LLP
Time: 8:30 a.m. ET
*This event is open to the public but requires a registration fee. To register, please email Jack Ploscowe at jploscowe@lowenstein.com.
