You’ve sent in a request to the FDA for a meeting, just to find you only have 60 minutes to address your long list of questions. Budgets and timelines suggest your product’s development is both lengthy and costly. How do you know you’re on the right track? With few opportunities to obtain the Agency’s buy-in, you need to get the most you can out of each meeting with the Agency. Whether you are attending a Pre-IND Meeting, an End of Phase 1 Meeting, an End of Phase 2 Meeting or a Pre-BLA/Pre-NDA Meeting, this session will cover key strategies to help you streamline the development of your background materials and conduct an effective meeting with the Agency. It’s your meeting, make the most of it!
This detailed, 90-minute session will help you navigate complex relationship strategies and brainstorm ideas to set you up for success. Topics include:
After attending this interactive live session you will be able to:
This course will benefit anyone who plans to request or attend a meeting with the FDA Center for Drug Evaluation and Research (CEDR) or the Center for Biologics Evaluation and Research (CEBR). This session is specifically beneficial for sponsors with novel products in discovery and early stages of product development who are looking ahead to next steps.
Samantha Zappia serves as Regulatory Lead of Halloran Consulting Group, guiding strategic regulatory support for Emerging Group clients. She has more than 12 years of experience in biologic and pharmaceutical development, with an emphasis in oncology product development and has provided on-demand tactical and strategic regulatory support to clients in the pharma and biotech development space who are preparing for INDs and product development through Phase 2.
Samantha has worked across all stages of development from pre-IND R&D to market application planning and execution. She has focused on strategic planning, gap analysis, domestic and international applications, and process optimization.
Prior to joining Halloran, Samantha was Senior Manager of Regulatory Affairs with ZIOPHARM Oncology. In this role, she was the Regulatory lead for the company’s gene therapy oncology programs, providing strategic regulatory support and leading the cross-functional team through the National Institute of Health’s Recombinant DNA Committee protocol review process. In addition, she was the Regulatory lead for the study start-up and maintenance of a global Phase 3 small-cell lung cancer study for one of the company’s small molecule products. In addition to this, she designed and implemented many of the processes used within the Regulatory Department. Prior to ZIOPHARM Oncology, Samantha held Regulatory positions with Tolerx, Synta Pharmaceuticals and ImmunoGen, where she led regulatory efforts for multiple Phase 1 – 3 oncology, anti-inflammatory and autoimmune disease studies. Prior to working in Regulatory Affairs, Samantha worked in Biolevel 2 GLP and R&D laboratories at ImmunoGen and Genzyme, respectively.
Samantha earned a Master of Science in Regulatory Affairs from Northeastern University and a Bachelor of Arts and Sciences in Biology and United States History from Boston University. She also has her Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professional Society and is a graduate lecturer in Northeastern University’s Master of Science in Regulatory Affairs Program.