Combination Products Summit 2023
Presentations
Tue. November 28th, 2023 – Workshop
8:00 am – 1030 am
Notified Body Opinion Workshop – Experiences And Lessons For Combination Products In EU
Leading Facilitators: Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca; James Wabby, Global Head – Emerging Technologies, Combination Products, and Devices, Abbvie
Facilitators:
- Arabe Ahmed, Bsi Group;
- Timothy Chesworth, Senior Director Regulatory Affairs – Devices & Digital Therapeutic, AstraZeneca;
- Katie Chowdhury, Director, Global Regulatory Affair, Emerging Technologies, Digital Medical Devices, & Combination Products, AbbVie;
- Amanda Matthews, Senior Director, Regulatory CMC for Combination Products & Medical Devices, Pfizer
10:30 am – 10:50 am
BREAK
10:50 am – 2:20 pm
Combination Products Risk Management: Integration Of ICH Q9(R1) And ISO 14971:2019
Leading Facilitators: Tine Albeck, Senior Quality Assurance Professional, ALK A/S
Facilitators:
- View PDF Presentation – Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC;
- View PDF Presentation – Rick Wedge, Compliance Lead / Associate Research Fellow, Pfizer;
- View PDF Presentation – Milind Ganjawala, Division Director of Drug Quality II, Center for Drug Evaluation and Research (CDER), FDA
2:20 pm – 2:40 pm
BREAK
2:40 pm – 5:10 pm
Risk Management Application In Post-Market Safety & Other PMSR Hot Topics
Leading Facilitators: Khaudeja Bano, Vice President, Combination Product Quality, Amgen; Rich Wolf, Head of Pv Operations at CSL Behring
Facilitators:
- John “Barr” Weiner, Associate Director for Policy in FDA’s Office of Combination Products (OCP), FDA;
- Fubin Wu, Co-founder, GessNet Safety Engineering;
- Kate Gillespie, Sr. Director, Global Product Vigilance and Post Market Reporting, Johnson & Johnson
Wed. November 29th, 2023
8:00 am – 8:20 am
Let’s Make A Difference!
Moderator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
8:20 am – 9:05 am
The Solutions Exchange
Moderators:
- Fran DeGrazio, Executive Advisor, Kymanox
- Susan Neadle, Principal Consultant and President, Combination Products Consulting, LLC;
9:05 am – 10:05 am
From The Desk Of The Office Of Combination Products: Strategic Priorities & Action
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
10:05 am – 10:25 am
BREAK
10:25 am – 11:25 am
Global Harmonization Opportunities In Combination Products
Moderators: 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
11:25 am – 12:25 pm
Platform Drug-Delivery Devices: Regulatory And Technical Considerations
Moderator: 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
12:25 pm – 1:25 pm
LUNCH
1:25 pm – 2:25 pm
Evolution Of Essential Performance Requirements
Moderator: 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
2:25 pm – 3:25 pm
Use Of Non-Integral Medical Devices In Medicinal Product Clinical Studies
Moderator: Jason Lipman, Senior Director, Global Regulatory Affairs, Device and Combination Products, Sanofi
Speakers:
- View PDF Presentation – Jonathan Amaya-Hodges, Director, Technical Services, Sutton Creek;
- View PDF Presentation – Suzette Roan, Associate VP, Head of GRA Devices, Sanofi
3:25 pm – 3:45 pm
BREAK
3:45 pm – 4:45 pm
Use Of Emerging Digital Health Technologies For Combination Products
Moderators: Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca; Ryan Hoshi, Director, Regulatory Policy and Intelligence at AbbVie – View PDF Presentation
Speakers:
- No slides – Katie Chowdhury, Director, Global Regulatory Affair, Emerging Technologies, Digital Medical Devices, & Combination Products, AbbVie;
- View PDF Presentation – MiRa Jacobs, Acting Assistant Director, Digital Health Policy, Digital Health Center of Excellence at FDA;
- View PDF Presentation – Kristina Lauritsen, Combination Products Regulator, Center for Drug Evaluation and Research (CDER), FDA;
- No slides – Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca;
- No slides – Andrew Yeatts, Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA
4:45 pm – 5:30 pm
Next-Generation Combination Products
Moderators: 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;
Thu. November 30th, 2023
8:00 am – 8:15 am
Opening Day 2
Moderator: Timothy W. Hsu, Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
8:15 am – 9:15 am
Navigating Combination Product Pathways: Industry Experiences And FDA’s Role
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 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
9:15 am – 10:05 am
Building Clarity To Address Regulatory Challenges Of On-Body Delivery
Moderator: 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
10:05 am – 10:25 am
BREAK
10:25 am – 11:40 am
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
Moderator: Jiaying Shen, Distinguished 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
11:40 am – 12:40 pm
Navigating The New Frontier In Cybersecurity: Technical And Regulatory Considerations For Managing Cybersecurity Risks For Combination Products
Moderator: Ryan Hoshi, Director, Regulatory Policy and Intelligence at AbbVie
Speakers:
- No slides – Edison Alvarez, Sr. Director, Regulatory Strategic Planning for Cybersecurity, BD;
- View PDF Presentation – Aftin Ross, Acting Deputy Director – Division of All Hazards Response, Science & Strategic Partnerships, Center for Devices and Radiological Health (CDRH), FDA;
- View PDF Presentation – Fubin Wu, Co-founder and President, GessNet Safety Engineering;
12:40 pm – 1:40 pm
LUNCH
1:40 pm – 2:30 pm
FDA & Health Authority Fireside Chat
No slides were used during this discussion
Moderators: 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