Driving Engagement and Exploring Innovation for Combination Products
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Agenda
The 2025 program lineup will be announced soon. Please explore the 2024 agenda for an idea of what you’ll experience in Providence.
2024 Program Lineup
October 8, 2024 @ 9:00 am
–
5:15 pm
Pre-Summit Workshop: Delving Into Combination Product Challenges
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
FDA Office Hours
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 @ 7:00 am
–
8:00 am
Breakfast
Other
October 9, 2024 @ 8:00 am
–
8:30 am
Let’s Make a Difference
General
Moderator
Kim Belsky, Strategic Facilitator, Combination Products Summit, AFDO/RAPS Healthcare Products Collaborative
October 9, 2024 @ 8:30 am
–
9:15 am
The Solutions Exchange
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
From the Desk of the FDA Office of Combination Products – Strategic Priorities
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 @ 10:00 am
–
10:25 am
Break
Other
October 9, 2024 @ 10:25 am
–
11:25 am
Regulatory and Technical Considerations for On-Body Delivery Systems (OBDS)
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
Aligning Device Constituent Parts With Drug CMC Review Principles
General
Moderators
Speakers
October 9, 2024 @ 12:25 pm
–
1:40 pm
Networking Lunch With Table Topics
General
October 9, 2024 @ 1:40 pm
–
2:25 pm
Challenges with Demonstrating Generic Substitutability for DDCs
General
Moderator
Speakers
October 9, 2024 @ 2:25 pm
–
3:25 pm
Opportunities for Platform Technologies to Streamline Combination Product Development
General
Moderator
Ryan Hoshi, Director, Regulatory Policy & Intelligence, AbbVie, Inc.
Speakers
October 9, 2024 @ 3:25 pm
–
3:50 pm
Break
Other
October 9, 2024 @ 3:50 pm
–
4:50 pm
Harmonizing U.S. FDA’s QMSR to ISO 13485: Impact to Combination Products
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
Closeout
General
Moderator
Kim Belsky, Strategic Facilitator, Combination Products Summit, AFDO/RAPS Healthcare Products Collaborative
October 9, 2024 @ 5:30 pm
–
7:00 pm
Networking Recetion
General
October 10, 2024 @ 7:00 am
–
8:00 am
Breakfast
Other
October 10, 2024 @ 8:00 am
–
8:10 am
Opening
General
Moderator
Kim Belsky, Strategic Facilitator/MedCon-Combination Products Summit, AFDO/RAPS Healthcare Products Collaborative
October 10, 2024 @ 8:10 am
–
9:10 am
Building Your Combination Product – Taking the Leap From Clinical to Commercial
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
The EU COMBINE Project: Medical Devices and IVDs Used in Medicinal Product Studies
General
Moderator
Speakers
Isabelle Clamou, Policy Officer, European Commission
October 10, 2024 @ 10:10 am
–
10:35 am
Break
Other
October 10, 2024 @ 10:35 am
–
11:20 am
Navigating Use-Related Risk Analysis (URRA) and Comparative Analysis in the Human Factors (HF) Process
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
Innovative Combination Products for the Next Generation of Medicine
General
Moderator
Speakers
October 10, 2024 @ 12:20 pm
–
1:20 pm
Lunch
Other
October 10, 2024 @ 1:20 pm
–
2:00 pm
Advancing Combination Product Development Through FDA User Fee Programs, PDUFA, MDUFA, and Beyond
General
Moderator
Ryan Hoshi, Director, Regulatory Policy & Intelligence, AbbVie, Inc.
Speakers
October 10, 2024 @ 2:00 pm
–
3:00 pm
Fireside Chat
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
Closeout
General
Moderator
Kim Belsky, Strategic Facilitator, Combination Products Summit, AFDO/RAPS Healthcare Products Collaborative