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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

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

Juliane Lessard, Director, Division of Drug Delivery, General Hospital Devices, and Human Factors, Center for Devices and Radiological Health,(CDRH), FDA

Shruti Mistry, Assistant Director, Injection Devices Team, Center for Devices and Radiological Health (CDRH), FDA

Renato Ravanello, Senior Director, Device Development, Genentech

Nathalie Vandenkoornhuyse, Executive Vice President, Regulatory Affairs, Coherus

October 9, 2024 @ 11:25 am

–

12:25 pm

Aligning Device Constituent Parts With Drug CMC Review Principles

General

Moderators

Ryan McGowan, Director, CMC Regulatory Affairs, AstraZeneca

Rumi Young, Director, Regulatory Policy, Novo Nordisk

Speakers

Kristin Benokraitis, Global Head of RegCMC Device and Combination Products, Biogen

Ashley Boam, Director Office of Policy for Pharmaceutical Quality, Office of Policy, Center for Drug Evaluation and Research (CDER), FDA

John McMichael, Director, Medical Devices & Combination Products, AstraZeneca

Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA

Suzette Roan, Associate, VP, Head of Global Regulatory Affairs Devices, Sanofi

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

Andrea Redd, Associate Vice President, Global Regulatory Affairs, Drug Delivery & Combination Products, Eli Lilly

Speakers

Brian Neely, Chemist, Center for Drug Evaluation and Research (CDER), FDA

Andrew Fine, Senior Advisor in Division of Clinical Review in Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), FDA

Chirag Walawalkar, Director, Device Design & Process Development, Merck

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

Tina Kiang, Director, Division of Regulation and Guidance (DRG), Office of Policy for Pharmaceutical Quality (OPPQ), Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), FDA

Juliane Lessard, Director, Division of Drug Delivery, General Hospital Devices, and Human Factors, Center for Devices and Radiological Health (CDRH), FDA

Chelsea O’Connell, Director, Global Regulatory and R&D Policy, Amgen

Jiaying Shen, Distinguished Scientist, Medical Device and Combination Product Development, Regulatory and Quality, Merck

Lisa Wright, Director of Regulatory Policy, Novo Nordisk

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

Ashley Boam, Director Office of Policy for Pharmaceutical Quality, Office of Policy, Center for Drug Evaluation and Research (CDER), FDA

Juliane Lessard, Director, Division of Drug Delivery, General Hospital Devices, and Human Factors, Center for Devices and Radiological Health,(CDRH), FDA

Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA

Jiaying Shen, Distinguished Scientist, Medical Device and Combination Product Development, Regulatory and Quality, Merck

Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems, RA CMC Devices, AbbVie, Inc.

October 10, 2024 @ 9:10 am

–

10:10 am

The EU COMBINE Project: Medical Devices and IVDs Used in Medicinal Product Studies

General

Moderator

Ryan McGowan, Director, CMC Regulatory Affairs, AstraZeneca

Speakers

Tim Chesworth, Senior Director, CMC Regulatory Affairs, AstraZeneca
Isabelle Clamou, Policy Officer, European Commission

Olga Tkachenko, 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

James Wabby, Head, Global Regulatory Affairs, Emerging Technologies, Combination Products, and Devices, AbbVie, Inc.

Speakers

Jonathan Amaya-Hodges, Director, Technical Services, Suttons Creek

Anjali Atal-Gupta, Director Regulatory Affairs – Cell Therapy Device Development, Novo Nordisk

Andrea Gray, Biomedical Engineering Advisor, Center for Biologics Evaluation and Research (CBER), FDA

Alex Lyness, Business Development Director – Drug Delivery, TTP PIc

Jerzy Wojcik, VP Regulatory and Quality Services, Edgeone Medical (CDMO)

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

James Bertram, Director of the Office of Combination Products (OCP), FDA

Kristina Lauritsen, Combination Products Regulator, Center for Drug Evaluation and Research (CDER), FDA

Jill Lee, Senior Director, Regulatory Policy, Novo Nordisk

Annette Marthaler, Senior Regulatory Counsel, Office of Combination Products (OCP), FDA

Chelsea O’Connell, Director, Global Regulatory and R&D Policy, Amgen

Andrew Yeatts, Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA

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

James Bertram, Director of the Office of Combination Products (OCP), FDA

Ashley Boam, Director Office of Policy for Pharmaceutical Quality, Office of Policy, Center for Drug Evaluation and Research (CDER), FDA

Andrea Gray, Biomedical Engineering Advisor, Center for Biologics Evaluation and Research (CBER), FDA

Kristina Lauritsen, Combination Products Regulator, Center for Drug Evaluation and Research (CDER), FDA

Juliane Lessard, Director, Division of Drug Delivery, General Hospital Devices, and Human Factors, Center for Devices and Radiological Health (CDRH), FDA

Patricia Love, Deputy Director, Office of Combination Products, FDA

Annette Marthaler, Senior Regulatory Counsel, Office of Combination Products, FDA

Sarah Mollo, Combination Products Analyst, Center for Devices and Radiological Health (CDRH), FDA

Stephanie Shapley, Associate Director for Policy, Office of Combination Products, FDA

Nik Thakur, Senior Program Manager, Quality and Compliance, Center for Devices and Radiological Health (CDRH), FDA

Andrew Yeatts, Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH), FDA

October 10, 2024 @ 3:00 pm

–

3:10 pm

Closeout

General

Moderator

Kim Belsky, Strategic Facilitator, Combination Products Summit, AFDO/RAPS Healthcare Products Collaborative

This conference IS co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.

Agenda from 2024

If you missed the summit, here’s what we covered:

What makes this Conference so unique?

This conference IS co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.

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