Learning Tracks

This session will examine why large-scale adoption of U.S.-based generic drug manufacturing remains limited despite recent federal initiatives and growing policy interest in domestic manufacturing capacity. FDA and industry panelists will discuss structural barriers to onshoring, the role of existing underutilized U.S. manufacturing capacity, and what additional regulatory, commercial, or policy levers may be needed to meaningfully motivate domestic production. Topics may include FDA pilot programs, HHS-led initiatives, extended exclusivity, targeted subsidies, demand guarantees, and other incentives or operational considerations affecting practical adoption.

Moderator: Victoria Keck, MS, VMD
Associate Director for Generic Drug Stakeholder and Global Engagement (Acting), IO, OGD, CDER, FDA

Mukul Bajaj, M.S.
Senior Associate, Regulatory & Business Continuity, Sun Pharmaceuticals

Sharmista Chatterjee, PhD
Division Director, DPMA III, OPMA, OPQ, CDER, FDA

Gabriela Grasa Mannino, PhD
Senior Director, Advanced Supply Chain Solutions, USP

Mayank Nagar, MS, MBA
Vice President – Strategic Alliance & Tech Services,  Dr. Reddy’s Laboratories