Combination Products Summit 2025 has been announced!
November 13-14, 2025
Providence, RI
Presents
Combination Products Summit took place October 9th to 10th, 2024
Providence, RI
Agenda from 2024
If you missed the summit, here’s what we covered:
October 8, 2024 @ 9:00 am
–
5:15 pm
Other
Moderators
Chin-Wei Soo, Global Regulatory Head, Devices and Combination Products, Genentech/Roche
Jason Lipman, Senior Director, Global Regulatory Affairs, Devices and Combination Products, Sanofi
Hemal Mehta, Associate Director, Global CMC Regulatory Affairs, Medical Devices & Combination Products, Johnson & Johnson
Ryan McGowan, Director, Digital Devices and Combination Products, AstraZeneca
Ryan Hoshi, Director, Regulatory Policy and Intelligence, AbbVie, Inc.
October 8, 2024 @ 10:00 am
–
2:00 pm
Other
Speakers
James Bertram, Director, Office of Combination Products (OCP), U.S. Food and Drug Administration
Patricia Love, Deputy Director, Office of Combination Products, FDA
Annette Marthaler, Senior Regulatory Counsel, Office of Combination Products, FDA
Stephanie Shapley, Associate Director for Policy, Office of Combination Products, FDA
October 9, 2024 @ 8:00 am
–
8:30 am
General
Moderator
Kim Belsky, Strategic Facilitator, Combination Products Summit, AFDO/RAPS Healthcare Products Collaborative
October 9, 2024 @ 8:30 am
–
9:15 am
General
Moderators
Khaudeja Bano, Vice President Combination Product Quality, Ex Amgen
Fran DeGrazio, Principal Consultant, Strategic Parenteral Solutions LLC
James Wabby, Global Head – Emerging Technologies, Combination Products, and Devices, AbbVie Inc.
October 9, 2024 @ 9:15 am
–
10:00 am
General
Moderator
Kim Belsky, Strategic Facilitator, Combination Products Summit, AFDO/RAPS Healthcare Products Collaborative
Speakers
James Bertram, Director of the Office of Combination Products (OCP), FDA
Danita Dixon, Associate Director for Information Management, Office of Clinical Policy and Programs, Office of the Commissioner, FDA
October 9, 2024 @ 10:25 am
–
11:25 am
General
Moderators
Bonnie Odom, Partner in the Healthcare and Life Sciences Practice, Epstein Becker & Green
Chin-Wei Soo, Global Regulatory Head, Devices and Combination Products, Genentech/Roche
Speakers
October 9, 2024 @ 11:25 am
–
12:25 pm
General
Moderators
Speakers
October 9, 2024 @ 1:40 pm
–
2:25 pm
General
Moderator
Speakers
October 9, 2024 @ 2:25 pm
–
3:25 pm
General
Moderator
Ryan Hoshi, Director, Regulatory Policy & Intelligence, AbbVie, Inc.
Speakers
October 9, 2024 @ 3:50 pm
–
4:50 pm
General
Moderators
Bonnie Odom, Partner in the Healthcare and Life Sciences Practice, Epstein Becker & Green
Tine Albeck, Senior QA Professional, ALK A/S
Speakers
Khaudeja Bano, Past Amgen
Sara Coon, Director Regulatory Affairs, Halozyme, Inc
Nik Thakur, Senior Program Manager, Quality and Compliance, Center for Devices and Radiological Health (CDRH), FDA
October 9, 2024 @ 4:50 pm
–
5:00 pm
General
Moderator
Kim Belsky, Strategic Facilitator, Combination Products Summit, AFDO/RAPS Healthcare Products Collaborative
October 10, 2024 @ 8:00 am
–
8:10 am
General
Moderator
Kim Belsky, Strategic Facilitator/MedCon-Combination Products Summit, AFDO/RAPS Healthcare Products Collaborative
October 10, 2024 @ 8:10 am
–
9:10 am
General
Moderators
Rumi Young, Director, Regulatory Policy, Novo Nordisk
Andrea Redd, Associate Vice President, Global Regulatory Affairs, Drug Delivery & Combination Products, Eli Lilly
Speakers
October 10, 2024 @ 9:10 am
–
10:10 am
General
Moderator
Speakers
Isabelle Clamou, Policy Officer, European Commission
October 10, 2024 @ 10:35 am
–
11:20 am
General
Moderator
Shannon Hoste, Chief Scientific Officer for Pathway for Patient Health
Speakers
Natalie Abts, Head of Human Factors Engineering Device and Packaging Development, Genentech
Kristina Lauritsen, Combination Products Regulator, Center for Drug Evaluation and Research (CDER), FDA
Patricia Love, Deputy Director, Office of Combination Products, FDA
Jenny Wu, Associate Director, Human Factors, AstraZeneca
October 10, 2024 @ 11:20 am
–
12:20 pm
General
Moderator
Speakers
October 10, 2024 @ 1:20 pm
–
2:00 pm
General
Moderator
Ryan Hoshi, Director, Regulatory Policy & Intelligence, AbbVie, Inc.
Speakers
October 10, 2024 @ 2:00 pm
–
3:00 pm
General
Moderators
Jason Lipman, Senior Director, Global Regulatory Affairs, Devices and Combination Products, Sanofi
Rumi Young, Director, Regulatory Policy, Novo Nordisk
Speakers
October 10, 2024 @ 3:00 pm
–
3:10 pm
General
Moderator
Kim Belsky, Strategic Facilitator, Combination Products Summit, AFDO/RAPS Healthcare Products Collaborative