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Combination Products Summit 2023

Combination Products Summit 2023

Speakers

The Combination Products Summit speakers are handpicked by the Combination Products Summit Strategic Committee to deliver purpose-driven content that dives below the surface, challenge status quo, engage attendees in collaborative dialogue, and provide practical information that can be implemented. Our speakers are thought leaders who are sure to facilitate insightful discussion.

Stiina
Aarum

European Medicines Academy

Scientific Officer, Scientific Advice and Protocol Assistance

Kent
Abrahamson

AbbVie

Director, Combination Product and Device Development

Edison
Alvarez

BD

Sr. Director, Regulatory Strategic Planning for Cybersecurity

Jonathan
Amaya-Hodges

Sutton Creek

Director, Technical Services

Khaudeja
Bano

Amgen

Vice President, Combination Product Quality

James
Bertram

FDA

 Director, Office of Combination Products

Ashley
Boam

FDA

Director, Office of Policy, Center for Drug Evaluation and Research (CDER)

Sandy
Boyd

Independent Consultant

Irene
Chan

FDA

Deputy Director, Office of Medication Error Prevention and Risk Management (OMEPRM), Center for Drug Evaluation and Research (CDER)

Tim
Chesworth

AstraZeneca

Senior Director Regulatory Affairs – Devices & Digital Therapeutic

Katie
Chowdhury

AbbVie

Director, Global Regulatory Affairs, Medical Device Team, Digital Health, Emerging Tech and Combination Products

Fran
DeGrazio

Strategic Parenteral Solutions

Principal Consultant

Carolyn
Dorgan

Suttons Creek

Director, Technical Services

Rick
Friedman (Invited)

FDA

Deputy Director, Manufacturing Quality

Milind
Ganjawala

FDA

Division Director

Kate
Gillespie

Johnson & Johnson

Sr. Director, Global Product Vigilance and Post Market Reporting

Dan
Groszmann

Amgen

Director of Engineering

Geoff
Hamiliton

Stemson Therapeutics

Chief Executive Officer

Ryan
Hoshi

AbbVie

Director, Regulatory Policy and Intelligence

Mira
Jacobs

FDA

Assistant Director (Acting), Digital Health Policy, Center for Devices and Radiological Health

Theresa
Jeary

BSI

Principal Technical Specialist, Medicinal & Biologics

Sujith
Kallur

BD Medical Pharmaceutical Systems

Regulatory Affairs Lead, Wearable Injectors

Joo Hee
Kim

Ajou University

Regulatory Strategy Center for Combination Products (RSCP)

Kristina
Lauritsen

FDA

Combination Product Policy Advisor, Center for Drug Evaluation and Research

Juliane
Lessard

FDA

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

Jason
Lipman

Sanofi

Senior Director, Global Regulatory Affairs, Device and Combination Products

Amanda
Matthews

Pfizer

Senior Director, Regulatory CMC for Combination Products & Medical Devices

Ryan
McGowan

AstraZeneca

Director, Digital Devices and Combination Products

Sarah
Mollo

FDA

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

Susan
Neadle

Combination Products Consulting

Principal Consultant & President

Thinh
Nguyen

FDA

Director, Office of Clinical Policy and Programs

Chelsea
O’Connell

Amgen

Director, Global & Regulatory and R&D Policy

Carrie
O’Donel

Teva Pharmaceuticals

Principal Deice Engineer

Steven
Oh

FDA

Deputy Office Director, Office of Cellular Therapy and Human Tissue, Center for Biologics Evaluation and Research (CBER)

Matthew
Ondeck

Regeneron Pharmaceuticals

Senior Manager Regulatory Affairs

Suzette
Roan

Sanofi

Associate VP, Head of GRA Devices

Colin
Roscoe

Teva Pharmaceuticals

Principal Human Factors Scientist

Aftin
Ross

FDA

Acting Deputy Director – Division of All Hazards Response, Science & Strategic Partnership, Center for Devices and Radiological Health (CDRH)

Subhi
Saadeh

Gilead Sciences

Sr. Manager – Combination Products QA

Tine
Schroder-Albeck

ALK A/S

Senior Quality Assurance Professional

Stephanie
Shapley

FDA

Senior Advisor, Office of Combination Products

Jiaying
Shen

Merck

Distinguished Scientist, Medical Device and Combination Product Development, Regulatory and Quality

Chin-Wei
Soo

Genentech/Roche

Global Regulatory Head – Devices and Combination Products

Jen
Soosaar

Core Human Factors, Inc.

Director of Human Factors

Alan
Stevens

AbbVie

Global Head of Complex Devices and Drug Delivery Systems, RA CMC Devices

Ramakrishna
Venugopalan

AbbVie

Vice President – Combination Products, Drug Delivery and Sterile Packaging

James
Wabby

AbbVie

Global Head – Emerging Technologies, Combination Products, and Devices

Mike
Wallenstein

Novartis

Global Head Regulatory Medical Devices, Combination Products & Precision Medicine

Rick
Wedge

Pfizer

Compliance Lead / Associate Research Fellow

John (Barr)
Weiner

FDA

Associate Director for Policy, Office of Combination Products

Rich
Wolf

RxLogix Corporation

Vice President of Client Relations

Fubin
Wu

GessNet Safety Engineering

Co-founder & President

Winifred
Wu

Strategic Regulatory Partners

President and Principal Advisor

Andrew
Yeatts

FDA

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

Rumi
Young

Novo Nordisk

Director, Regulatory Policy

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.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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