Rajesh Thangapazham

Company: GSK

Job title: Director Regulatory Affairs, Specialty

Bio:

Dr. Rajesh Thangapazham is an experienced global regulatory affairs strategist specializing in regenerative medicine, cell and gene therapies, ATMPs, mRNA/LNP therapeutics, and emerging technologies such as iPSC and automated manufacturing systems. He has led regulatory strategies for in vivo and ex vivo gene therapies at GSK, Vertex, Aruvant, and Lonza, guiding products from early development through commercialization.

Seminars:

Global Regulatory Alignment for Cell & Gene Therapies: Opportunities & Obstacles Beyond the FDA 9:00 am

As advanced therapies progress toward global development and commercialization, regulatory divergence remains a major challenge. This session will explore how developers are navigating inconsistent expectations across regions, and where opportunities lie to optimize patient access and streamline approvals beyond the U.S. Key regulatory misalignments between major agencies (e.g., EMA, PMDA, MFDS, NMPA, Swissmedic) and how…Read more

day: Pre-Conference Workshop Day

Panel Discussion: Navigating Global Regulatory Expectations for Cell & Gene Therapy Development 9:00 am

As cell and gene therapy programs become increasingly global, developers must align with diverse regulatory frameworks across regions. This session explores what’s required to successfully advance programs through non-clinical, CMC, and clinical milestones in markets such as Europe, Asia-Pacific, and Latin America. Understanding regional differences in CTA requirements for advanced therapies Preparing CMC and comparability…Read more

day: Conference Day Two