Learning Tracks

This session will explore key scientific and regulatory issues affecting synthetic peptide development, approval, and lifecycle management. Panelists will discuss opportunities for greater harmonization of global regulatory frameworks for synthetic peptides, current considerations for nonclinical immunogenicity studies for peptides and biosimilars, and evolving expectations for peptide post-approval changes and requirements. The discussion will highlight practical challenges for developers and areas where greater regulatory clarity or alignment could support more efficient development and continued product availability.

Moderator: Houri Simonian-Houldsworth, PhD
Senior Director, Analytical and Development, Apotex

Darshan Aigal, M.S.
Director, Regulatory Affairs, Cipla

Lara Hansen
Director, U.S. Regulatory Affairs, Sandoz

Eric Pang, PhD
Acting Team Lead, DTP I, ORS, OGD, CDER, FDA

Cameron Smith, PhD
Supervisor, DPQA V, OPQA I, OPQ, CDER, FDA

Chaoju Xiao, PhD
Formulation Development, R&D, Fresenius Kabi USA