Combination Products Summit Speakers
![Aarum, Stiina](https://healthcareproducts.org/wp-content/uploads/2023/12/Aarum-Stiina.jpg)
Stiina Aarum
Scientific Officer, Scientific Advice and Protocol Assistance
European Medicines Academy(EMA)
![Abrahamson, Kent](https://healthcareproducts.org/wp-content/uploads/2023/10/Abrahamson-Kent.jpg)
Kent Abrahamson
Director, Combination Product and Device Development
AbbVie
![Alvarez-Edison](https://healthcareproducts.org/wp-content/uploads/2023/09/Alvarez-Edison.jpg)
Edison Alvarez
Sr. Director, Regulatory Strategic Planning for Cybersecurity
BD
![Amaya-Hodges-Jonathan](https://healthcareproducts.org/wp-content/uploads/2023/09/Amaya-Hodges-Jonathan.jpg)
Jonathan Amaya-Hodges
Director, Technical Services
Sutton Creek
![Bano, Khaudeja](https://healthcareproducts.org/wp-content/uploads/2023/12/Bano-Khaudeja-1024x1024.jpg)
Khaudeja Bano
VP, Combination Product Quality
Amgen
![Bertram, James](https://healthcareproducts.org/wp-content/uploads/2023/07/Bertram-James.jpg)
James Bertram
Director of the Office of Combination Products (OCP)
U.S. Food and Drug Administration (FDA)
![boam_ashley](https://healthcareproducts.org/wp-content/uploads/2023/09/boam_ashley.jpg)
Ashley Boam
Director, Office of Policy, Center for Drug Evaluation and Research (CDER)
U.S. Food and Drug Administration (FDA)
![Sandra-Boyd-bi0gen-2021](https://healthcareproducts.org/wp-content/uploads/2022/07/Sandra-Boyd-bi0gen-2021.jpg)
Sandy Boyd
Independent Consultant
![Chan, Irene Z.](https://healthcareproducts.org/wp-content/uploads/2023/12/Chan-Irene-Z-768x1024.jpg)
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)
![chesworth-tim](https://healthcareproducts.org/wp-content/uploads/2023/09/chesworth-tim.jpg)
Tim Chesworth
Senior Director Regulatory Affairs – Devices & Digital Therapeutic
AstraZeneca
![Chowdhury, Katie](https://healthcareproducts.org/wp-content/uploads/2023/12/Chowdhury-Katie.jpg)
Katie Chowdhury
Director, Global Regulatory Affairs, Medical Device Team, Digital Health, Emerging Tech and Combination Products
AbbVie
![Fran--new2](https://healthcareproducts.org/wp-content/uploads/2023/05/Fran-new2.png)
Fran DeGrazio
Executive Advisor
Kymanox
![Dorgan-Carolyn](https://healthcareproducts.org/wp-content/uploads/2023/09/Dorgan-Carolyn.jpg)
Carolyn Dorgan
Director, Technical Services
Suttons Creek
![Friedman-Rick](https://healthcareproducts.org/wp-content/uploads/2023/09/Friedman-Rick.jpg)
Rick Friedman (Invited)
Deputy Director, Manufacturing Quality
U.S. Food and Drug Administration (FDA)
![bio-placeholder](https://healthcareproducts.org/wp-content/uploads/2023/09/bio-placeholder.png)
Milind Ganjawala
Division Director
U.S. Food and Drug Administration (FDA)
![Gillespie, Kate](https://healthcareproducts.org/wp-content/uploads/2023/12/Gillespie-Kate.jpg)
Kate Gillespie
Sr. Director, Global Product Vigilance and Post Market Reporting
Johnson & Johnson
![Groszmann, Dan](https://healthcareproducts.org/wp-content/uploads/2023/12/Groszmann-Dan-1024x683.jpg)
Dan Groszmann
Director of Engineering,
Amgen
![Hamilton, Geoff](https://healthcareproducts.org/wp-content/uploads/2023/10/Hamilton-Geoff-1024x1024.png)
Geoff Hamiliton
Chief Executive Officer
Stemson Therapeutics
![Ryan Hoshi](https://healthcareproducts.org/wp-content/uploads/2022/07/Ryan-Hoshi.jpg)
Ryan Hoshi
Director, Regulatory Policy and Intelligence
AbbVie
![Jacobs, MiRa](https://healthcareproducts.org/wp-content/uploads/2023/10/Jacobs-MiRa-810x1024.jpg)
MiRa Jacobs
Assistant Director (Acting), Digital Health Policy, Center for Devices and Radiological Health
U.S. Food and Drug Administration
![bio-placeholder](https://healthcareproducts.org/wp-content/uploads/2023/09/bio-placeholder.png)
Theresa Jeary
Principal Technical Specialist, Medicinal & Biologics
BSI
![Kallur-Sujith](https://healthcareproducts.org/wp-content/uploads/2023/09/Kallur-Sujith.jpg)
Sujith Kallur
Regulatory Affairs Lead, Wearable Injectors,
BD Medical Pharmaceutical Systems
![Kim-Joo-Hee](https://healthcareproducts.org/wp-content/uploads/2023/09/Kim-Joo-Hee.jpg)
Joo Hee Kim
Regulatory Strategy Center for Combination Products (RSCP)
Ajou University
![Lauritsen-Kristina](https://healthcareproducts.org/wp-content/uploads/2023/09/Lauritsen-Kristina.jpg)
Kristina Lauritsen
Combination Product Policy Advisor, Center for Drug Evaluation and Research
U.S. Food and Drug Administration (FDA)
![Lessard, Juliane](https://healthcareproducts.org/wp-content/uploads/2023/12/Lessard-Juliane-1024x1024.jpg)
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
![JasonLipman](https://healthcareproducts.org/wp-content/uploads/2022/08/JasonLipman-e1694580425507.jpg)
Jason Lipman
Senior Director, Global Regulatory Affairs, Device and Combination Products
Sanofi
![Matthews-Amanda](https://healthcareproducts.org/wp-content/uploads/2023/09/Matthews-Amanda.jpg)
Amanda Matthews
Senior Director, Regulatory CMC for Combination Products & Medical Devices
Pfizer
![McGowan-Ryan](https://healthcareproducts.org/wp-content/uploads/2022/07/McGowan-Ryan-1.jpg)
Ryan McGowan
Director, Digital Devices and Combination Products
AstraZeneca
![bio-placeholder](https://healthcareproducts.org/wp-content/uploads/2023/09/bio-placeholder.png)
Sarah Mollo
Combination Products Analyst, Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration (FDA)
![Susan Neadle](https://healthcareproducts.org/wp-content/uploads/2022/07/Susan-Neadle.jpg)
Susan Neadle
Principal Consultant and President
Combination Products Consulting, LLC
![Nguyen-Thinh2](https://healthcareproducts.org/wp-content/uploads/2022/07/Nguyen-Thinh2.jpg)
Thinh Nguyen
Director of the Office of Clinical Policy & Program
U.S. Food and Drug Administration (FDA)
![OConnell-Chelsea](https://healthcareproducts.org/wp-content/uploads/2023/09/OConnell-Chelsea.jpg)
Chelsea O’Connell
Director, Global & Regulatory and R&D Policy
Amgen
![O'Donel, Carrie](https://healthcareproducts.org/wp-content/uploads/2023/10/ODonel-Carrie.jpg)
Carrie O’Donel
Principal Device Engineer
Teva Pharmaceuticals
![oh_steven_s](https://healthcareproducts.org/wp-content/uploads/2023/09/oh_steven_s.jpg)
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)
![Ondeck-Matthew](https://healthcareproducts.org/wp-content/uploads/2023/09/Ondeck-Matthew.jpg)
Matthew Ondeck
Senior Manager Regulatory Affairs
Regeneron Pharmaceuticals
![Roan-Suzette](https://healthcareproducts.org/wp-content/uploads/2023/09/Roan-Suzette.jpg)
Suzette Roan
Associate VP, Head of GRA Devices
Sanofi
![Roscoe, Colin](https://healthcareproducts.org/wp-content/uploads/2023/10/Roscoe-Colin.jpg)
Colin Roscoe
Principal Human Factors Scientist
Teva Pharmaceuticals
![Ross-Aftin](https://healthcareproducts.org/wp-content/uploads/2023/09/Ross-Aftin.jpg)
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)
![Saadeh-Subhi](https://healthcareproducts.org/wp-content/uploads/2023/09/Saadeh-Subhi.jpg)
Subhi Saadeh
Sr. Manager – Combination Products QA
Gilead Sciences
![Headshot - Tine Albeck-edited](https://healthcareproducts.org/wp-content/uploads/2023/05/Headshot-Tine-Albeck-edited.png)
Tine Schroder-Albeck
Senior QA – Global Quality Devices
ALK A/S
![bio-placeholder](https://healthcareproducts.org/wp-content/uploads/2023/09/bio-placeholder.png)
Stephanie Shapley
Senior Advisor, Office of Combination Products
U.S. Food and Drug Administration (FDA)
![Shen, Jiaying](https://healthcareproducts.org/wp-content/uploads/2022/08/Shen-Jiaying.png)
Jiaying Shen
Distinguished Scientist
Merck
![Chin-Wei-Soo-genetech-2022](https://healthcareproducts.org/wp-content/uploads/2022/07/Chin-Wei-Soo-genetech-2022.jpg)
Chin-Wei Soo
Global Regulatory Head – CMC/Devices and Combination Products
Genentech
![Soosar-Jen](https://healthcareproducts.org/wp-content/uploads/2023/09/Soosar-Jen.jpg)
Jen Soosaar
Director of Human Factors
Core Human Factors, Inc.
![Stevens, Alan](https://healthcareproducts.org/wp-content/uploads/2023/11/Stevens-Alan-1-1024x1024.jpg)
Alan Stevens
Global Head of Complex Devices and Drug Delivery Systems, RA CMC Devices
AbbVie
![Venugopalan-Ramakrishna](https://healthcareproducts.org/wp-content/uploads/2023/09/Venugopalan-Ramakrishna.jpg)
Ramakrishna Venugopalan
Vice President – Combination Products, Drug Delivery and Sterile Packaging
AbbVie
![Wabby, James](https://healthcareproducts.org/wp-content/uploads/2023/05/Wabby-James.jpg)
James Wabby
Global Head, Regulatory Affairs (CoE) – Emerging Technologies, Devices, and Combination Products & Volwiler Senior Research Industry Fellow – Regulatory Science
AbbVie
![Wallenstein-Mike](https://healthcareproducts.org/wp-content/uploads/2023/09/Wallenstein-Mike.jpg)
Mike Wallenstein
Global Head Regulatory Medical Devices, Combination Products & Precision Medicine
Novartis
![Wedge-Rick](https://healthcareproducts.org/wp-content/uploads/2023/09/Wedge-Rick.jpg)
Rick Wedge
Compliance Lead / Associate Research Fellow
Pfizer
![John-Barr-Weiner](https://healthcareproducts.org/wp-content/uploads/2022/07/John-Barr-Weiner.jpg)
John (Barr) Weiner
Associate Director for Policy in FDA’s Office of Combination Products (OCP)
U.S. Food and Drug Administration (FDA)
![Richard Wolf](https://healthcareproducts.org/wp-content/uploads/2022/07/Richard-Wolf.jpg)
Rich Wolf
Global Head of Pv Operations, Global Clinical Safety & Pharmacovigilance (GCSP)
CSL Behring
![Wu-Fubin](https://healthcareproducts.org/wp-content/uploads/2023/09/Wu-Fubin.jpg)
Fubin Wu
Co-founder & President
GessNet Safety Engineering
![Wu, Winifred](https://healthcareproducts.org/wp-content/uploads/2023/12/Wu-Winifred-819x1024.jpg)
Winifred Wu
President and Principal Advisor
Strategic Regulatory Partners, LLC
![Yeatts-Andrew](https://healthcareproducts.org/wp-content/uploads/2023/09/Yeatts-Andrew.jpg)
Andrew Yeatts
Combination Product Policy Analyst, Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration (FDA)
![Headshot_RumiYoung](https://healthcareproducts.org/wp-content/uploads/2022/08/Headshot_RumiYoung-893x1024.jpg)
Rumi Young
Director, Regulatory Policy
BD