Combination Products Summit Agenda

Moderator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative

Moderators:Fran DeGrazio, Executive Advisor, Kymanox
Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC;

Moderator: 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

Moderators: Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC; Khaudeja Bano, VP Combination Product Quality, Amgen
Speakers:
Theresa Jeary, Principal Technical Specialist, Medicinal & Biologics, BSI; Agnes Sitta Kijo,Technical Officer, Facilitated Products introduction Team, World Health Organization (WHO); Joo Hee Kim,Regulatory Strategy center for Combination Products (RSCP), Ajou University; Hemal Mehta, Associate Director, Global CMC Regulatory Affairs, Medical Devices & Combination Products, Janssen Pharmaceutical (J&J); Mike Wallenstein, Global Head Regulatory Medical Devices, Combination Products & Precision Medicine, Novartis;

Moderator: Chin-Wei Soo, Global Regulatory Head - CMC/Devices and Combination Products, Genentech
Speakers: Jiaying Shen, Distinguished Scientist, Merck; Kent Abrahamson, Director of Engineering - Combination Product Development, Abbvie; John "Barr" Weiner, Associate Director for Policy in FDA’s Office of Combination Products (OCP), FDA

Sit 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!

Moderator: Rumi Young, Director, Regulatory Policy, BD
Speakers: Matthew Ondeck, Senior Manager Regulatory Affairs, Regeneron Pharmaceuticals; Subhi Saadeh, Sr. Manager, Quality, 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, Assistant Director, Injections Team, Center for Devices and Radiological Health (CDRH), FDA

Moderator: 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

Moderators: Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca; Ryan Hoshi, Director, Regulatory Policy and Intelligence at AbbVie
Speakers: Katie Chowdhury, Director, Global Regulatory Affairs, Medical Device Team, Digital Health, Emerging Tech and Combination Products, AbbVie (Invited); MiRa Jacobs, Acting Assistant Director, Digital Health Policy, Digital Health Center of Excellence at FDA; Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca; Andrew Yeatts, Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA

Moderators: Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC; Sandy Boyd, Consultant
Speakers: Dan Groszman, Director of Engineering, Amgen; Geoff Hamilton , Co-founder and 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;

Welcome and Summary of Highlights of Day Before Moderator

Moderators: 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 Products Regulator, 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;

Moderator: Fran DeGrazio, Executive Advisor, Kymanox
Speakers: Krishna Venugopalan, Vice President, CPD & DD, BioCMC Development Sciences, AbbVie; Carolyn Dorgan, Combination Product Development, Regulatory and Quality Consulting, Suttons Creek; Sujith Kallur, Regulatory Affairs Manager, BD; Juliane Lessard, Director, Division of Drug Delivery, General Hospital Devices, and Human Factors, Center for Devices and Radiological Health (CDRH), FDA

Moderator: Jiaying Shen, Distinguised Scientist, Merk
Speakers:
Irene Chan, 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

Moderator: Ryan Hoshi, Director, Regulatory Policy and Intelligence at AbbVie
Speakers: Edison Alvarez, Sr. Director, Regulatory Strategic Planning for Cybersecurity, BD; Fubin Wu, Co-founder, GessNet Safety Engineering; Aftin Ross, Acting Deputy Director - Division of All Hazards Response, Science & Strategic Partnerships, Center for Devices and Radiological Health (CDRH), FDA

Moderators: Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC; Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca

Speakers: Thinh Nguyen, Director, Office of Clinical Policy & Programs; James Bertram, Director, Office of Combination Products; John “Barr” Weiner, Associate Director for Policy, Office of Combination Products

Moderator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative