AFDO RAPS Healthcare Products Collaborative
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2024 Combo Logo FDA
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Strategic Committee

The Combination Products Summit program is carefully curated by experts across the healthcare products industry to ensure the highest quality discussions, knowledge exchange, and collaboration opportunities. We thank them for their hard work and dedication to this important event.

Khaudeja
Bano

Vice President, Combination Product Quality

Amgen

Khaudeja Bano is a physician with a master’s degree in clinical research and a Pharmaceutical Engineering Certification; she is also a Database Administrator and a certified Project Management Professional. Including her clinical practice, Bano has more than 25 years of professional experience. She has held several global medical positions at Guidant, Abbott, AbbVie Inc., and now Amgen. Her career includes global medical/clinical and safety leadership roles in devices, diagnostics, pharmaceuticals, and combination products. She currently serves as the chair for the Post Marketing Safety working group for the Combination Product Coalition (CPC).

Kim
Belsky

Strategic Facilitator for MedCon and Combination Products Summit

AFDO/RAPS Healthcare Products Collaborative

James
Bertram

 Director, Office of Combination Products

FDA

James Bertram is currently the Director of the Office of Combination Products (OCP) in the United States Food and Drug Administration (FDA). OCP is responsible for the assignment of combination products to FDA’s medical product centers for review, helps coordinate timely, effective, and aligned reviews of combination products and oversees the postmarket activities of combination products. Prior to joining OCP, James was the Associate Director with the Regulatory Policy and Combination Products Staff which supported the Office of Product Evaluation and Quality in CDRH. In addition, he served as a Product Jurisdiction Officer representing CDRH across the FDA. In this capacity, James collaborated across the Agency on cross-cutting activities, many of which apply to the review and regulation of combination products. After receiving a BS in Mechanical Engineering from Pennsylvania State University and a MS/PhD in Biomedical Engineering from Yale University, James joined the FDA in 2009 as a Regenerative Medicine Fellow in the Commissioner’s Fellowship Program. 

Francis
Blacha

Senior Vice President of Quality

Eli Lilly and Company 

Francis Blacha is Senior Vice President of Quality at Eli Lilly and Company, overseeing the Device Quality Management System, Regulatory Compliance, and Quality for Drug Delivery System Development, Connected Care, and Digital Health. He has over 30 years of quality assurance/control experience, having held leadership positions at Pfizer and Glaxo Inc. Blacha is experienced in risk management and design control across product life cycles. He holds a bachelor’s degree in chemistry from Catawba College and a master’s degree from North Carolina State University.

Fran
DeGrazio

Principal Consultant

Strategic Parenteral Solutions

Fran DeGrazio has over 35 years of expertise in pharmaceutical packaging and delivery, specializing in sterile drug product systems and combination products. As President of Strategic Parenteral Solutions LLC, she advises on strategy, growth, and regulatory opportunities. Previously, she held various roles at West Pharmaceutical Services, including Chief Scientific Officer. Fran is active in industry committees and has published numerous articles and book chapters, including in The Combination Products Handbook (2023). She has received several awards, including the PDA Packaging Science Award (2021) and the HBA Luminary Award (2017).

Ryan
Hoshi

Director, Regulatory Policy and Intelligence

AbbVie

Ryan Hoshi is the Director of Regulatory Policy & Intelligence at AbbVie, leading policy for medical devices, combination products, personalized medicine, and digital health. Previously, he was an international policy analyst at the Center for Devices and Radiological Health (CDRH), where he promoted regulatory harmonization through various international forums. He also worked on drug policy at the Center for Drug Evaluation and Research (CDER) and as a Lead Reviewer in CDRH on interventional cardiology devices and drug-eluting stents.

Jason
Lipman

Senior Director, Global Regulatory Affairs, Device and Combination Products

Sanofi

Jason Lipman is the Senior Director of Global Regulatory Affairs for Devices and Combination Products at Sanofi, overseeing worldwide regulatory activities for drug delivery devices and combination products. With over 20 years of experience, he has held roles at Janssen, DePuy Synthes, and the FDA’s CDRH. Jason holds an M.S. in Applied Biomedical Engineering from Johns Hopkins University and a B.S. in Mechanical Engineering from Tufts University, and he is an active member of the Combination Products Coalition.

Ryan
McGowan

Director, Digital Devices and Combination Products

AstraZeneca

Ryan McGowan is the Director of Digital Devices and Combination Products in Regulatory Affairs at AstraZeneca. He has responsibility for developing regulatory strategies for the approval of digital health products including software as a medical device. Prior to joining AstraZeneca, McGowan was a premarket reviewer and combination products team leader at FDA’s Center for Devices and Radiological Health where he evaluated and influenced regulatory policy for drug delivery constituent parts of combination products.

Hemal
Mehta

Associate Director, Global CMC-Regulatory Affairs, Medical Devices and Combination Products

Johnson & Johnson

Hemal is Associate Director of Global CMC-Regulatory Affairs for Medical Devices and Combination Products at Janssen Research & Development, overseeing worldwide regulatory activities. He joined Janssen in 2015 from DePuy Synthes, where he worked on Spine and Trauma regulatory teams and managed Evidence Development for medical device reimbursement. Hemal co-founded a spinal medical device start-up and was a Research Assistant at Harvard Medical School’s Orthopedic Biomechanics Laboratory. He holds an M.S. in Biomedical Engineering from Boston University and a B.S. in Engineering Science from the University of Tennessee, Knoxville.

Susan
Neadle

Principal Consultant & President

Combination Products Consulting

Susan Neadle is an international expert in Combination Products, Medical Devices, and Digital Health with over 35 years of industry experience. She has received multiple awards, including the Johnson Medal and a finalist position in TOPRA’s 2021 Awards for Regulatory Affairs Excellence. After a distinguished 26-year career at Johnson & Johnson, she now runs Combination Products Consulting Services LLC, offering global Q&C, regulatory, and design services. Susan chairs the ISPE Combination Products CoP and contributes to ASTM, AAMI, and PQRI working groups. She also teaches Combination Products courses at UMBC and AAMI.

Thinh
Nguyen

Director, Office of Clinical Policy and Programs

FDA

Thinh Nguyen has been with the FDA since 2008, first as Director of the Office of Combination Products (OCP) and now as Director of the Office of Clinical Policy and Programs. He oversees jurisdictional determinations, premarket reviews, post-market regulations, and policy development. Previously, he was Director for the Premarket Approval Section at the Center for Devices and Radiological Health, contributing to key legislations like MDUFMA and MDUFA. Before the FDA, Nguyen was a senior electronics engineer at the Naval Electronics Systems Engineering Center. He holds a bachelor’s degree in electrical engineering from North Carolina State.

Bonnie
Odom

Partner in the Healthcare and Life Sciences Practice

Epstein Becker & Green, P.C.

Bonnie Odom is a Partner in the Healthcare and Life Sciences Practice of Epstein Becker & Green, P.C., and serves as General Counsel to the Combination Products Coalition. Prior to assuming this General Counsel role, Bonnie supported the Combination Product Coalition as legal counsel for nearly a decade. Bonnie’s practice focuses primarily on FDA regulatory matters, including advising pharmaceutical and device manufacturers on product development and approval strategies and a variety of other FDA and health regulatory compliance-related issues. Bonnie holds JD and MPH degrees from Emory University.  

Andrea
Redd

Associate Vice President, Global Regulatory Affairs, Drug Delivery & Combination Products

Eli Lilly

Bio coming soon

Tine
Schroder-Albeck

Senior Quality Assurance Professional

ALK A/S

Tine Albeck is a Senior QA for ALK A/S, Denmark. She has the responsibility of Quality oversight for ALK’s development of drug-delivery devices and Combination Products, and the incorporation and maintenance of these products into ALK’s Quality Management System. Albeck has extensive experience in guiding teams in the practical application of design control requirements throughout the various life cycles of the products and was project manager to ensure ALK became ISO 13485 certified and compliance towards the MDR requirements. Albeck has extensive experience in CMO oversight and is an experienced Auditor within ISO 13485.  Albeck received her Master degree in Medical Engineering from the Danish Technical University.

Jiaying
Shen

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

Merck

Jiaying Shen, Ph.D., brings over 17 years of industry experience in pharmaceuticals and medical devices. Currently a distinguished scientist at Merck, she manages a team overseeing Design Control, Risk Management, Human Factors, and other device quality and regulatory issues for drug delivery devices. Leading multiple product development projects from pre-clinical phases to post-market support, Jiaying previously worked at Medtronic Neuromodulation R&D and Honeywell Automation and Control Laboratory after earning her Ph.D. in Industrial and System Engineering from the University of Wisconsin – Madison.

Chin-Wei
Soo

Global Regulatory Head – Devices and Combination Products

Genentech

Chin-Wei Soo is the Global Regulatory Head for Combination Products, Devices, and Digital Health at Roche/Genentech. With 18 years of regulatory and quality experience, he oversees technical regulatory aspects for Roche’s entire portfolio throughout its life cycle. Soo also chairs the Combination Product Coalition’s digital health working group. Prior to his current role, he held leadership positions at Medtronic and Boston Scientific, where he led successful regulatory submissions. Soo holds degrees in industrial and manufacturing systems engineering, bioscience regulatory affairs, and regulatory policy.

James
Wabby

Global Head – Emerging Technologies, Combination Products, and Devices

AbbVie

With 20+ years of experience, specialized in quality operations, compliance, and regulatory affairs across Medical Devices, Technology Medicinal Delivery Platforms, Complex Generics, Companion Diagnostics, Digital Medicine, and Combination Products. Provide strategic regulatory counsel to AbbVie franchise units and expertise in CMC Global Dossiers, EU MDR/IVDR compliance, 21 CFR Part 3 and Part 4, CE Marking, and ISO 13485:2016/MDSAP. Represent AbbVie as U.S. Agent for FDA matters. Active involvement in industry trade organizations and standards committees.

John (Barr)
Weiner

Associate Director for Policy, Office of Combination Products

FDA

John Weiner serves as the Associate Director for Policy at the FDA’s Office of Combination Products. His responsibilities include classifying and regulating therapeutic products and ensuring consistent regulation of combination products. Before joining OCP, Weiner was an Associate Chief Counsel at FDA’s Office of Chief Counsel, where he advised on drug regulation and cross-cutting topics like nanotechnology. Prior to FDA, he practiced law in food and drug, environmental, and international trade law. Weiner holds a bachelor’s degree from Princeton University and a J.D. with honors from Columbia University School of Law.

Rich
Wolf

Global Head of Pv Operations, Global Clinical Safety & Pharmacovigilance

CSL Behring

Rich Wolf is the Executive Director of Pv Operations at CSL Behring’s GCSP group. With 7 years at CSL and 12 years at Johnson & Johnson, he oversees Case Management, Medical Evaluation, Pv Business Process & Technology, and Pv Combination Products & Device Center of Excellence groups. Before joining the pharmaceutical industry, Rich spent 5 years at Accenture and served as an Airborne Ranger qualified Infantry Officer. He holds a degree from the University of Richmond and an MBA from Rutgers University. CSL Behring is a global leader in plasma protein biotherapeutics, focusing on treating serious and rare conditions. Rich is an advocate for Project Healing Waters Fly Fishing, supporting disabled military personnel and veterans through fly fishing rehabilitation programs.

Rumi
Young

Director, Regulatory Policy

Novo Nordisk

Rumi Young, Meng, RAC, serves as the Director of Regulatory Policy at Novo Nordisk, leading a team dedicated to accelerating time to market, fostering innovation, and ensuring reasonable regulatory requirements for medical devices, diagnostics, and combination products. Previously at the FDA’s CDRH Division of Drug Delivery, General Hospital, and Human Factors, Rumi played a key role as Acting Assistant Director for Injection Devices, overseeing the approval of various drug delivery injection devices and combination products. With eight years of experience at Genentech and AstraZeneca in combination product development, Rumi holds a Bachelor’s in Chemistry and Chemical Biology and a Master’s in Engineering in Material Science from Cornell University.

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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