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

Sr. Director, Regulatory Strategic Planning for Cybersecurity

Jonathan

Amaya-Hodges

Sutton Creek

Director, Technical Services

Khaudeja

Bano

Ex-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

Global Head, Regulatory Affairs

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, Inc.

Director, Regulatory Policy and Intelligence

Mira

Jacobs

FDA

Division Director, Digital Health Policy, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH)

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 (CDER)

Juliane

Lessard

FDA

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

Jason

Lipman

Sanofi

Senior Director, Global Regulatory Affairs, Device and Combination Products

Amanda

Matthews

Pfizer

Executive Director, Head of GRS 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

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

Associate Director for Policy, 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, Inc.

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, Inc.

Head, Global Regulatory Affairs, 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.