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

Time: 9:00 am
day: Pre-Conference Workshop Day

Details:

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 these impact development timelines
  • Strategic considerations for clinical trial design, patient access, and commercialization in ex-FDA countries
  • Collaborative pathways, regional trends, and the future of regulatory convergence for advanced therapies

Speakers:

Allen Callaway
Allen Callaway 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 Read more
Rajesh Thangapazham
Rajesh Thangapazham 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 Read more
Omar Tounekti
Omar Tounekti