Roshan Ramanathan | Founder & Executive Director
Bridges Initiative for Vaccine Regulatory Science and Practice
Dr. Roshan Ramanathan is a physician–scientist specializing in vaccine and biologics development. Her career spans leadership roles at the National Institutes of Health, the U.S. Food and Drug Administration, and the biopharmaceutical industry. As Branch Chief at FDA’s Center for Biologics Evaluation and Research, she oversaw regulatory review across more than 400 INDs and 21 BLAs. In industry she led the clinical development of VIMKUNYA and directed development strategy for mRNA COVID-19 and combination COVID-19/influenza vaccine programs at GSK. She now leads the Bridges Initiative, advising biotechnology companies and global health organizations on regulatory strategy and vaccine development.
Appearances:
Festival of Biologics Day 1 @ 17:10
Misaligned Decisions in Vaccine Regulation: A Hidden Driver of Delay and What Sponsors Can Do About It
- Regulatory decisions follow a structured logic - but this logic is often implicit and not clearly articulated.
- Through case studies, this talk illustrates how this "hidden gap" in understanding by sponsors can lead to misalignment, rework and delay - slowing vaccine development.
- Practical strategies are derived to help sponsors navigate regulatory interactions more effectively. By clarifying regulatory assumptions, constraints and framing risk effectively, sponsors can navigate regulatory uncertainty more effectively and reduce risk to vaccine development program
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