Combination Products Summit Speakers
Stiina Aarum
Scientific Officer, Scientific Advice and Protocol Assistance
European Medicines Academy(EMA)
Kent Abrahamson
Director, Combination Product and Device Development
AbbVie
Edison Alvarez
Sr. Director, Regulatory Strategic Planning for Cybersecurity
BD
Jonathan Amaya-Hodges
Director, Technical Services
Sutton Creek
Khaudeja Bano
VP, Combination Product Quality
Amgen
James Bertram
Director of the Office of Combination Products (OCP)
U.S. Food and Drug Administration (FDA)
Ashley Boam
Director, Office of Policy, Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration (FDA)
Sandy Boyd
Independent Consultant
Irene Chan
Deputy Director, Office of Medication Error Prevention and Risk Management (OMEPRM), Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration (FDA)
Tim Chesworth
Senior Director Regulatory Affairs – Devices & Digital Therapeutic
AstraZeneca
Katie Chowdhury
Director, Global Regulatory Affairs, Medical Device Team, Digital Health, Emerging Tech and Combination Products
AbbVie
Fran DeGrazio
Executive Advisor
Kymanox
Carolyn Dorgan
Director, Technical Services
Suttons Creek
Rick Friedman (Invited)
Deputy Director, Manufacturing Quality
U.S. Food and Drug Administration (FDA)
Milind Ganjawala
Division Director
U.S. Food and Drug Administration (FDA)
Kate Gillespie
Sr. Director, Global Product Vigilance and Post Market Reporting
Johnson & Johnson
Dan Groszmann
Director of Engineering,
Amgen
Geoff Hamiliton
Chief Executive Officer
Stemson Therapeutics
Ryan Hoshi
Director, Regulatory Policy and Intelligence
AbbVie
MiRa Jacobs
Assistant Director (Acting), Digital Health Policy, Center for Devices and Radiological Health
U.S. Food and Drug Administration
Theresa Jeary
Principal Technical Specialist, Medicinal & Biologics
BSI
Sujith Kallur
Regulatory Affairs Lead, Wearable Injectors,
BD Medical Pharmaceutical Systems
Joo Hee Kim
Regulatory Strategy Center for Combination Products (RSCP)
Ajou University
Kristina Lauritsen
Combination Product Policy Advisor, Center for Drug Evaluation and Research
U.S. Food and Drug Administration (FDA)
Juliane Lessard
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
US Food and Drug Administration
Jason Lipman
Senior Director, Global Regulatory Affairs, Device and Combination Products
Sanofi
Amanda Matthews
Senior Director, Regulatory CMC for Combination Products & Medical Devices
Pfizer
Ryan McGowan
Director, Digital Devices and Combination Products
AstraZeneca
Sarah Mollo
Combination Products Analyst, Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration (FDA)
Susan Neadle
Principal Consultant and President
Combination Products Consulting, LLC
Thinh Nguyen
Director of the Office of Clinical Policy & Program
U.S. Food and Drug Administration (FDA)
Chelsea O’Connell
Director, Global & Regulatory and R&D Policy
Amgen
Carrie O’Donel
Principal Device Engineer
Teva Pharmaceuticals
Steven Oh
Deputy Office Director, Office of Cellular Therapy and Human Tissue, Center for Biologics Evaluation and Research (CBER)
U.S. Food and Drug Administration (FDA)
Matthew Ondeck
Senior Manager Regulatory Affairs
Regeneron Pharmaceuticals
Suzette Roan
Associate VP, Head of GRA Devices
Sanofi
Colin Roscoe
Principal Human Factors Scientist
Teva Pharmaceuticals
Aftin Ross
Acting Deputy Director – Division of All Hazards Response, Science & Strategic Partnership, Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration (FDA)
Subhi Saadeh
Sr. Manager – Combination Products QA
Gilead Sciences
Tine Schroder-Albeck
Senior QA – Global Quality Devices
ALK A/S
Stephanie Shapley
Senior Advisor, Office of Combination Products
U.S. Food and Drug Administration (FDA)
Jiaying Shen
Distinguished Scientist
Merck
Chin-Wei Soo
Global Regulatory Head – CMC/Devices and Combination Products
Genentech
Jen Soosaar
Director of Human Factors
Core Human Factors, Inc.
Alan Stevens
Global Head of Complex Devices and Drug Delivery Systems, RA CMC Devices
AbbVie
Ramakrishna Venugopalan
Vice President – Combination Products, Drug Delivery and Sterile Packaging
AbbVie
James Wabby
Global Head, Regulatory Affairs (CoE) – Emerging Technologies, Devices, and Combination Products & Volwiler Senior Research Industry Fellow – Regulatory Science
AbbVie
Mike Wallenstein
Global Head Regulatory Medical Devices, Combination Products & Precision Medicine
Novartis
Rick Wedge
Compliance Lead / Associate Research Fellow
Pfizer
John (Barr) Weiner
Associate Director for Policy in FDA’s Office of Combination Products (OCP)
U.S. Food and Drug Administration (FDA)
Rich Wolf
Global Head of Pv Operations, Global Clinical Safety & Pharmacovigilance (GCSP)
CSL Behring
Fubin Wu
Co-founder & President
GessNet Safety Engineering
Winifred Wu
President and Principal Advisor
Strategic Regulatory Partners, LLC
Andrew Yeatts
Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration (FDA)
Rumi Young
Director, Regulatory Policy
BD