Regulatory Strategies to Employ When Your Study Doesn’t Qualify for Breakthrough/Prime

September 12, 2019 8:00 AM - 10:00 AM

MassBio, 300 Technology Square 8th Fl, Cambridge, MA 02139

Add to Calendar 9/12/2019 8:00:00 AM 9/12/2019 10:00:00 AM Regulatory Strategies to Employ When Your Study Doesn’t Qualify for Breakthrough/Prime It is well understood that achieving Breakthrough or Prime Designation status provides sponsors with significant advantages in the regulatory process to achieve approval. However – not every drug candidate will qualify. This Forum will showcase best practice and real world examples of regulatory success, even without achieving coveted breakthrough status.
  • Overview of Breakthrough vs Fast Track vs Accelerated Approval, etc.
  • FDA and EMA engagement techniques to keep momentum and enthusiasm even without Breakthrough
  • Panel will share success stories and real-world examples of their strategies and FDA / EMA interactions that allowed for regulatory success
  • Equally important – what NOT TO DO examples will be shared
MassBio, 300 Technology Square 8th Fl, Cambridge, MA 02139
Senior Vice President, Head of Regulatory
Dr. Jennings regulatory experience encompasses drug development across multiple therapeutic realms, including diabetes, cardiovascular disease, obesity, viral infections and hematology. Amy is currently SVP, Head of Regulatory Affairs at Casebia Therapeutics, a company looking to harness the power of gene editing to transform the lives of patients and families affected by a wide array of genetic diseases. Prior to Casebia, Amy was the SVP, Head of Regulatory at Achillion Pharmaceuticals, where she was responsible for global regulatory strategy, regulatory operations, quality assurance and medical writing. During her time at Achillion, Dr. Jennings led successful IND submissions for two rare disease indications for which phase 2 patient trials are ongoing. Earlier, Dr. Jennings served as Sanofi’s associate vice president for global regulatory affairs in the company’s North American diabetes program. At Sanofi she led a US and global regulatory affairs team and was also responsible for labeling and advertising/promotions. Before Sanofi, Dr. Jennings held positions of increasing responsibility at Bristol-Myers Squibb, including leadership of US regulatory affairs for its cardiovascular/metabolic programs. She was ultimately group director in global regulatory affairs for special products. During her tenure at BMS, Dr. Jennings headed regulatory efforts that led to the approval of two new diabetes drugs. Amy was a post-doctoral fellow at the Harvard-affiliated Joslin Diabetes Center. She received her Ph.D. in Biochemistry from The Ohio State University and her Bachelor of Science in Chemistry from the University of Wisconsin-Madison.