Learning Tracks

This session will include discussion of how to better integrate the patient perspective in generic drug and biosimilars development, regulatory assessment, and in the policy environment. Panelists will discuss best practices for supporting patients and patient advocacy groups and the education of healthcare practitioners on biosimilars to help enact patient-forward changes in the context of access, human factors and product usability, and beyond.

Participants:

Galvin Clingham, JD
Director, Public Policy, Alliance for Patient Access

Sarah Ikenberry
Associate Director, Stakeholder Engagement and Education, OTBB, CDER, FDA

Sarah Ibrahim, PhD
Associate Director for Stakeholder and Global Engagement, OGD, CDER, FDA

Nimi Chhina, PhD, JD
Vice President, Global Regulatory Affairs Operations Policy and Intelligence, Teva Pharmaceuticals

Kimberly Maxfield, PhD
Lead of Regulatory Affairs, US, Biocon Biologics

Moderator:
Sarah Brown, PharmD
Associate Director, Reg Strategy & Science Biopharma, Sandoz