Combination Products Summit Speakers
Kent Abrahamson
Director of Engineering – Combination Product 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)
Francis Blacha
Associate VP, Device Quality, IDM
Eli Lilly
Ashley Boam (Invited)
Director, Office of Policy, Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration (FDA)
Christelle Bouygues (Invited)
Regulatory Affairs Senior Officer
European Medicine Agency (EMA)
Sandy Boyd
Independent Consultant
Tim Chesworth
Senior Director Regulatory Affairs – Devices & Digital Therapeutic
AstraZeneca
Katie Chowdhury (Invited)
Director, Global Regulatory Affairs, Medical Device Team, Digital Health, Emerging Tech and Combination Products
AbbVie
Fran DeGrazio
Executive Advisor
Kymanox
Carolyn Dorgan
Combination Product Development, Regulatory and Quality Consulting
Suttons Creek
Rick Friedman (Invited)
Deputy Director, Manufacturing Quality
U.S. Food and Drug Administration (FDA)
Kate Gillespie
Sr. Director, Global Product Vigilance and Post Market Reporting
Johnson & Johnson
Ryan Hoshi
Director, Regulatory Policy and Intelligence
AbbVie
Sujith Kallur
Regulatory Affairs Manager
BD
Agnes Sitta Kijo
Technical Officer, Facilitated Products Introduction Team
World Health Organization (WHO)
Joo Hee Kim
Regulatory Strategy Center for Combination Products (RSCP)
Ajou University
Kristina Lauristen (Invited)
Combination Products Regulator, Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration (FDA)
Jake Lindstrom (Invited)
Assistant Director, Infusion Devices, Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration (FDA)
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
Hemal Mehta
Associate Director, Global CMC Regulatory Affairs, Medical Devices & Combination Products
Janssen Pharmaceutical (J&J)
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
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
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, Quality
Gilead Sciences
Tine Schroder-Albeck
Senior QA – Global Quality Devices
ALK A/S
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 (Invited)
Assistant Director, Injections Team, Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration (FDA)
Johnathan Sutch
Principal Medicinal Expert
BSI
Ramakrishna Venugopalan
Vice President, CPD & DD, BioCMC Development Sciences
AbbVie
James Wabby
Global Head, Regulatory Affairs (CoE) – Emerging Technologies, Devices, and Combination Products & Volwiler Senior Research Industry Fellow – Regulatory Science
AbbVie
Mike Wallenstien
Global Head Regulatory Medical Devices, Combination Products & Precision Medicine
Novartis
Rick Wedge
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
Dan Wozinksi
Device Expert, Center of Device Excellence
Sanofi
Fubin Wu
Co-founder
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