Presents

Workshop
October 8, 2024

theme

Delving into Combination Product Challenges

In this dynamic pre-Summit day, we will explore crucial issues affecting combination products today. The day will consist of three interactive sessions on:

Digital health technologies

Aligning risk management approaches

Hot Topics Q&A

Each session will explore important issues and approaches to dealing with combination products. Prepare to increase your knowledge and diversify your learning!

View Workshop Agenda Register for the Workshop

Please note – this workshop requires a separate registration fee and is not part of the main Summit.

Don’t miss this opportunity to engage with thought leaders who have had significant impact on the global discussion around these topics!

Moderators

Ryan

Hoshi

AbbVie

Director, Regulatory Policy and Intelligence

Jason

Lipman

Sanofi

Senior Director, Global Regulatory Affairs, Device and Combination Products

Ryan

McGowan

AstraZeneca

Director, Digital Devices and Combination Products

Hemal

Mehta

Johnson & Johnson

Associate Director, Global CMC-Regulatory Affairs, Medical Devices and Combination Products

Susan

Neadle

Combination Products Consulting

Principal Consultant & President

Chin-Wei

Soo

Genentech/Roche

Global Regulatory Head – Devices and Combination Products

James

Wabby

AbbVie

Global Head – Emerging Technologies, Combination Products, and Devices

October 8th, 2024 — Combination Products Summit Workshop Agenda

October 8, 2024 @ 9:00 am

–

12:00 pm

Digital Health Technologies and Combination Products Sessions

Other

Moderators

Ryan McGowan, Director, CMC Regulatory Affairs, AstraZeneca

Ryan Hoshi, Director, Regulatory Policy and Intelligence, AbbVie

Chin Wei Soo, Global Regulatory Head – Devices and Combination Products, Genentech

Speakers

Katie Chowdhury, Director, Global Regulatory Affair, Emerging Technologies, Digital Medical Devices, & Combination Products, AbbVie

Anchal Choudhuri, Senior Consultant, Biologics Consulting

Erez Kaminski, CEO & Founder Ketryx

Elizabeth Kunkoski, Health Science Policy Analyst, Center for Drug Evaluation and Research (CDER), FDA
Bonnie Odom, Partner in the Healthcare and Life Sciences Practice, Epistein, Becker and Green

Peter Petrochenko, Associate Director in Regulatory Strategy, Regeneron Pharmaceuticals

John Schalago, Executive Director, Sr GPRD, Novartis

Eric Staib, Vice President, Corporate Quality, Syneos Health

Brandi Stockton, Managing Partner, Triality Group

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

October 8, 2024 @ 12:00 pm

–

1:00 pm

Lunch

Other

October 8, 2024 @ 1:00 pm

–

3:00 pm

Aligning Risk Management Approaches Between Sponsors, Suppliers, and CDMOs

Other

Moderators

Susan Neadle, Principal Consultant & President, Combination Products Consulting, LLC
James Wabby, Head – Global Regulatory Affairs, Emerging Technologies, Combination Products, and Devices, AbbVie Inc.

Panelists

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

Laxman Halleppanavar, Head of Project Management, Credence Med

Courtney Evans, Principal Regulatory Consultant, Suttons Creek, Inc

Facilitators

Carolyn Dorgan, Director, Technical Services, Suttons Creek, Inc.

James Wise, Combination Products Drug Delivery Devices, CSL Behring

Carsten Schaufuss, Director, Combination Products, CSL Behring

October 8, 2024 @ 3:00 pm

–

3:15 pm

Break

Other

October 8, 2024 @ 3:15 pm

–

5:15 pm

Hot Topics for Combination Products

Other

Facilitators

Jason Lipman, Senior Director, Global Regulatory Affairs, Devices and Combination Products, Sanofi

Hemal Mehta, Associate Director, Global CMC Regulatory Affairs, Medical Devices & Combination, Johnson & Johnson

Speakers

Nish Gupta, Senior Regultory Program Director, Genentech

Willy Liou, Director of Regulatory Affairs, Amgen
Amanda Matthews, Executive Director, Head of GRS Medical Devices, Pfizer

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

Abhishek Telang, Director, Device Quality and Regulatory, Merck

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

Suzette Roan, Associate VP, Head of GRA Devices, Sanofi

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.

Presents

WorkshopOctober 8, 2024

theme

Delving into Combination Product Challenges

Moderators

Ryan

Hoshi

Jason

Lipman

Ryan

McGowan

Hemal

Mehta

Susan

Neadle

Chin-Wei

Soo

James

Wabby

Digital Health Technologies and Combination Products Sessions

Lunch

Aligning Risk Management Approaches Between Sponsors, Suppliers, and CDMOs

Break

Hot Topics for Combination Products

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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Workshop
October 8, 2024