Combination Products Summit Agenda
All sessions are in CST. If you missed the 2023 Combination Products Summit, the agenda included:
Workshop
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesBreakfast
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesJoin your colleagues from around the globe as we kick off the Combination Products Summit with a complimentary hot breakfast!
Let’s Make a Difference!
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
The Solutions Exchange
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerators:Fran DeGrazio, Executive Advisor, Kymanox
Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC;
From the Desk of the Office of Combination Products: Strategic Priorities & Action
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
Speakers: James Bertram, Director of the Office of Combination Products (OCP), FDA; John "Barr" Weiner, Associate Director for Policy in FDA’s Office of Combination Products (OCP), FDA
Break
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesGlobal Harmonization Opportunities in Combination Products
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerators: Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC; Khaudeja Bano, VP Combination Product Quality, Amgen
Speakers: Stiina Aarum, Scientific Officer, Scientific Advice and Protocol Assistance, European Medicines Academy(EMA); Theresa Jeary, Principal Technical Specialist, Medicinal & Biologics, BSI; Joo Hee Kim Professor, Regulatory Strategy center for Combination Products (RSCP), Ajou University; Mike Wallenstein, Global Head Regulatory Medical Devices, Combination Products & Precision Medicine, Novartis; John "Barr" Weiner, Associate Director for Policy in FDA’s Office of Combination Products (OCP), FDA
Platform Drug-Delivery Devices: Regulatory and Technical Considerations
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerator: Chin-Wei Soo, Global Regulatory Head - CMC/Devices and Combination Products, Genentech
Speakers: Jiaying Shen, Distinguished Scientist, Merck; Kent Abrahamson, Director, Combination Product and Device Development, Abbvie; James Bertram, Director of the Office of Combination Products (OCP), FDA; Patricia Love, Deputy Director, FDA’s Office of Combination Products (OCP), FDA (Invited)
Lunch
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesSit with FDA officials, speakers, industry experts, and your colleagues at tables dedicated to topics that are important to you! Enjoy the discussion while sharing a meal together!
Evolution of Essential Performance Requirements
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerator: Rumi Young, Director, Regulatory Policy, BD
Speakers: Matthew Ondeck, Senior Manager Regulatory Affairs, Regeneron Pharmaceuticals; Subhi Saadeh, Sr. Manager - Combination Products QA, Gilead Sciences; Ashley Boam, Director, Office of Policy, Center for Drug Evaluation and Research (CDER), FDA; Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA; Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems, RA CMC
Devices, AbbVie
Use of Non-integral Medical Devices in Medicinal Product Clinical Studies
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerator: Jason Lipman, Senior Director, Global Regulatory Affairs, Device and Combination Products, Sanofi
Speakers Jonathan Amaya-Hodges, Director, Technical Services, Sutton Creek; Suzette Roan, Associate VP, Head of GRA Devices, Sanofi
Break
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesUse of Emerging Digital Health Technologies for Combination Products
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerators: Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca; Ryan Hoshi, Director, Regulatory Policy and Intelligence at AbbVie
Speakers: Katie Chowdhury,Director, Global Regulatory Affair, Emerging Technologies, Digital Medical Devices, & Combination Products, AbbVie; MiRa Jacobs, Acting Assistant Director, Digital Health Policy, Digital Health Center of Excellence at FDA; Kristina Lauritsen, Combination Products Regulator, Center for Drug Evaluation and Research (CDER), FDA; Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca; Andrew Yeatts, Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA
Next-Generation Combination Products
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerators: Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC; Sandy Boyd, Independent Consultant
Speakers: Dan Groszmann, Director of Engineering, Amgen; Geoff Hamilton , Chief Executive Officer, Stemson Therapeutics; Steven Oh, Deputy Office Director, Office of Cellular Therapy and Human Tissue, Center for Biologics Evaluation and Research (CBER), FDA; James Wabby, Global Head, Regulatory Affairs (CoE) - Emerging Technologies, Devices, and Combination Products & Volwiler Senior Research Industry Fellow - Regulatory Science, Abbvie;
Networking Reception
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesBreakfast
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesJoin your colleagues from around the globe as we kick off the Combination Products Summit with a complimentary hot breakfast!
Opening Day 2
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesWelcome and Summary of Highlights of Day Before Moderator
Navigating Combination Product Pathways: Industry Experiences and FDA’s Role
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerators: Chin-Wei Soo, Global Regulatory Head - CMC/Devices and Combination Products, Genentech; Rumi Young, Director, Regulatory Policy, BD
Speakers: Chelsea O'Connell, Director, Global & Regulatory and R&D Policy at Amgen; Kristina Lauritsen, Combination Product Policy Advisor, Center for Drug Evaluation and Research (CDER) FDA; Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA; Winifred Wu, President and Principal Advisor, Strategic Regulatory Partners, LLC
Building Clarity to Address Regulatory Challenges of On-Body Delivery
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerator: Fran DeGrazio, Executive Advisor, Kymanox
Speakers: Carolyn Dorgan, Director, Technical Services, Suttons Creek; Sujith Kallur, Regulatory Affairs Lead, Wearable Injectors, BD Medical Pharmaceutical Systems; Juliane Lessard, Director, Division of Drug Delivery, General Hospital and Human Factors, Office of Gastro-Renal, ObGyn, General Hospital, and Urology Devices, Center for Devices and Radiological Health (CDRH), FDA; Krishna Venugopalan, Vice President - Combination Products, Drug Delivery and Sterile Packaging, AbbVie
Break
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United States.
Part 1 – Bridging and leveraging human factors data in drug-device combination products development. Part 2 – Q&A and Discussion of Final Guidance of Application of HF Engineering Principles for Combination Products
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerator: Jiaying Shen, Distinguised Scientist, Merk
Speakers: Irene Chan, Deputy Director, Division of Medication Error Prevention and Analysis, Center for Drug Evaluation and Research (CDER), FDA; Carrie O'Donel, Principal Device Engineer, Teva Pharmaceuticals; Jen Soosaar, Director of Human Factors, Core Human Factors, Inc; Colin Roscoe, Principal Human Factors Scientist, Teva Pharmaceuticals
Navigating the New Frontier in Cybersecurity: Technical and Regulatory Considerations for Managing Cybersecurity Risks for Combination Products
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerator: Ryan Hoshi, Director, Regulatory Policy and Intelligence at AbbVie
Speakers: Edison Alvarez, Sr. Director, Regulatory Strategic Planning for Cybersecurity, BD; Aftin Ross, Acting Deputy Director - Division of All Hazards Response, Science & Strategic Partnerships, Center for Devices and Radiological Health (CDRH), FDA; Fubin Wu, Co-founder and President, GessNet Safety Engineering;
Lunch
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesFDA & Health Authority Fireside Chat
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerators: Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC; Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca
Speakers: James Bertram, Director, Office of Combination Products;
John “Barr” Weiner, Associate Director for Policy, Office of Combination Products, FDA;
Ashley Boam, Director, Office of Policy, Center for Drug Evaluation and Research (CDER), FDA;
Kristina Lauritsen, Combination Products Regulator, Center for Drug Evaluation and Research (CDER), FDA;
Juliane Lessard, Director, Division of Drug Delivery, General Hospital and Human Factors, Office of Gastro-Renal, ObGyn, General Hospital, and Urology Devices, Center for Devices and Radiological Health (CDRH), FDA
Andrew Yeatts, Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA
Stephanie Shapley, Senior Advisor, Office of Combination Products, FDA
Sarah Mollo,Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA
Summit Close
Omni Fort Worth Hotel 1300 Houston Street, Fort Worth, Texas, United StatesModerator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative