Allen Callaway

Company: Johnson & Johnson

Job title: Distinguished Scientist, CMC Regulatory Affairs

Bio:

In his current role, Allen drives innovative regulatory strategies for key modalities through internal influence and external advocacy. Allen has more than 20 years’ experience in the clinical development and commercialization of monoclonal antibodies, cell & gene therapies, and other advanced biologics.

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