Got a Date with the FDA? Conducting Successful Meetings
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:
- How to effectively write and present you background materials including questions to the Agency
- How to effectively respond to Agency comments
After attending this interactive live session you will be able to:
- Apply regulatory strategy to streamline your questions and background material
- Prioritize items to discuss during the 60 minute
- Conduct a successful meeting with the FDA
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.
Heather Tokatlyan, MS, is a Senior Consultant at Halloran Consulting Group, Inc. Heather has more than 12 years of experience in the healthcare and life sciences industry. Her most recent roles have focused on Regulatory Affairs, where she has more than 7 years of experience in regulatory strategy. Heather has worked across all stages of drug development, ranging from early stage IND/CTA planning and readiness to NDA/MAA negotiations and submission of global marketing applications
At Halloran, Heather provides overall management and strategic regulatory planning for our emerging clients’ product development programs ranging primarily from preclinical stages through Phase 2. She collaborates directly with the product sponsor, their affiliates, and the relevant regulatory agencies to effectively support and advise her clients. Since joining Halloran over a year ago, she has worked with a number of clients in both the drug and device space though her expertise is around the development of drug products.
Prior to joining Halloran, Heather worked at Vertex Pharmaceuticals as a Manager of Regulatory Affairs in the Global Clinical Regulatory Strategy group. In this role, she was the Regulatory lead primarily focused on Cystic Fibrosis early to mid-stage development programs where she provided strategic regulatory support for upcoming nonclinical and clinical studies and planning for registration. Heather has experience in both orphan drug and pediatric development. Prior to her work at Vertex, Heather was the global lead for three development programs of Renal and Endocrine products at Genzyme Corporation. In this role, she led multiple global marketing applications and label expansion planning for commercial products. Prior to Genzyme, Heather worked in the Cancer Center Protocol Office at Massachusetts General Hospital providing regulatory support for investigator sponsored clinical studies.
Heather earned a Master of Science in Regulatory Affairs for Drugs, Biologics, and Devices from Northeastern University and a Bachelor of Science in Biology from University of Massachusetts-Boston. She was also a graduate lecturer for a ‘New Drug Development’ course in the Northeastern Master of Science in Regulatory Affairs program.
Samantha Zappia, MS, is a Consultant for Halloran Consulting Group, Inc. Samantha has more than 12 years of experience in biologic and pharmaceutical development, with an emphasis in oncology product development. She 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.
Samantha serves as a Regulatory Lead, providing strategic regulatory support for Halloran’s Emerging Group clients. Since joining Halloran, she has provided on-demand tactical and strategic regulatory support to a variety of clients in the pharmaceutical and biotechnology development space, who are preparing for INDs and product development through Phase 2.
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 Regulagory 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.