Strategic Committee
The Combination Products Summit program is carefully curated by experts across the combination products community 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
Dr. Khaudeja Bano is a physician and certified Project Management Professional with 25+ years of experience spanning clinical practice and global medical leadership. With expertise in clinical research, pharmaceutical engineering, and database administration, she has held key positions at Guidant, Abbott, AbbVie Inc, and Amgen, specializing in medical/clinical safety for devices, diagnostics, pharmaceuticals, and combination products. She currently chairs the Post Marketing Safety working group for the Combination Product Coalition (CPC).
James
Bertram
James Bertram is Director of the Office of Combination Products (OCP) at the FDA, overseeing assignment, review coordination, and postmarket activities of combination products. Previously, he was Associate Director with the Regulatory Policy and Combination Products Staff in the Office of Product Evaluation and Quality, and served as a Product Jurisdiction Officer representing CDRH across the FDA, collaborating on cross-cutting activities. He holds a BS in Mechanical Engineering from Penn State and an MS/PhD in Biomedical Engineering from Yale. James joined the FDA in 2009 as a Regenerative Medicine Fellow in the Commissioner’s Fellowship Program.
Francis
Blacha
Francis Blacha serves as Senior Vice President of Quality at Eli Lilly, overseeing Device Quality Management, Regulatory Compliance, and Digital Health initiatives. With 30+ years in quality assurance, he previously held leadership roles at Pfizer and Glaxo. He holds degrees in chemistry from Catawba College and a master’s from North Carolina State University.
Fran
DeGrazio
Fran DeGrazio serves as President & Principal Consultant at Strategic Parenteral Solutions LLC, advising executives on strategy and regulatory opportunities. She brings 35+ years of pharmaceutical packaging expertise, previously serving as Chief Scientific Officer at West Pharmaceutical Services where she held leadership roles in R&D, Quality & Regulatory, and Scientific Affairs, specializing in sterile drug delivery systems.
Ryan
Hoshi
Ryan Hoshi serves as Director of Regulatory Policy & Intelligence at AbbVie, focusing on medical devices, combination products, and digital health. Previously at FDA, he worked as international policy analyst at CDRH promoting regulatory harmonization, and held roles in CDER drug policy and as Lead Reviewer for cardiovascular devices.
Jason
Lipman
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
Ryan McGowan directs Digital Devices and Combination Products in Regulatory Affairs at AstraZeneca, developing strategies for digital health products and software as medical devices. Previously, he served as premarket reviewer and combination products team leader at FDA’s CDRH, evaluating drug delivery constituent parts and regulatory policy.
Hemal
Mehta
Hemal Mehta serves as Associate Director of Global CMC-Regulatory Affairs for Medical Devices and Combination Products at Janssen Research & Development. Previously at DePuy Synthes managing spine and trauma regulations, he also co-founded a spinal device startup and researched at Harvard Medical School. He holds degrees in Biomedical Engineering from Boston University and Engineering Science from Tennessee.
Susan
Neadle
Susan Neadle, an international expert in Combination Products, Medical Devices, and Digital Health, brings 35+ years of industry experience. Following 26 years at Johnson & Johnson, she founded Combination Products Consulting Services LLC. She chairs ISPE Combination Products CoP, contributes to industry working groups, teaches at UMBC and AAMI, and has received notable awards including the Johnson Medal.
Bonnie
Odom
Bonnie Odom serves as Partner in Healthcare and Life Sciences at Epstein Becker & Green and General Counsel to the Combination Products Coalition, where she previously served as legal counsel for nearly a decade. She specializes in FDA regulatory matters, advising pharmaceutical and device manufacturers on development strategies. She holds JD and MPH degrees from Emory University.
Andrea
Redd
Andrea Redd serves as Associate Vice President of Global Drug Delivery and Device Regulatory Affairs at Eli Lilly, bringing 24+ years of pharmaceutical industry experience. Starting in R&D and project management, she transitioned to combination products in 2014, successfully bridging drug and device regulations. Her expertise spans CMC aspects of drug development for both generic and new drug submissions.
Tine
Schroder-Albeck
Tine Albeck serves as Senior QA at ALK A/S, Denmark, overseeing quality for drug-delivery devices and combination products. She led ALK’s ISO 13485 certification and MDR compliance, specializing in design control implementation and CMO oversight. An experienced ISO 13485 auditor, she holds a Master’s in Medical Engineering from Danish Technical University.
Stephanie
Shapley
Stephanie Shapley serves as Associate Director for Policy in FDA’s Office of Combination Products, bringing over 20 years of FDA experience. Her roles have included Senior Regulatory Policy Advisor, Associate Director for Regulatory Affairs in Medical Policy, and Bioresearch Monitoring Specialist. She holds a biology degree from Binghamton University and an MBA from Sacred Heart University.
Jiaying
Shen
Jiaying Shen, PhD, serves as distinguished scientist at Merck, leading teams in Design Control, Risk Management, and Human Factors for drug delivery devices. With 17+ years in pharmaceuticals and medical devices, she previously worked at Medtronic Neuromodulation R&D and Honeywell. She holds a PhD in Industrial and System Engineering from University of Wisconsin-Madison.
Chin-Wei
Soo
Chin-Wei Soo serves as Global Regulatory Head for Combination Products, Devices, and Digital Health at Roche/Genentech, bringing 18 years of regulatory expertise. He chairs the Combination Product Coalition’s digital health working group and previously held leadership roles at Medtronic and Boston Scientific. He holds degrees in engineering, bioscience regulatory affairs, and regulatory policy.
James
Wabby
James Wabby serves as Head of Global Regulatory Affairs for Emerging Technologies, Devices, and Combination Products at AbbVie, bringing 22 years of GxP compliance experience across multiple healthcare sectors. He holds degrees from Duquesne University and certificates from Seton Hall Law and Northwestern Kellogg, while actively participating in multiple industry organizations.
Rich
Wolf
Rich Wolf serves as Vice President of Client Relations at RxLogix Corporation, following 19 years at CSL and Johnson & Johnson overseeing pharmacovigilance and case management. Previously an Accenture consultant and Airborne Ranger Infantry Officer. He holds a degree from University of Richmond and MBA from Rutgers, while advocating for Project Healing Waters Fly Fishing’s veteran programs.
Rumi
Young
Rumi Young serves as Director of Regulatory Policy at Novo Nordisk, leading innovation and market acceleration for medical devices and combination products. Previously, she was Acting Assistant Director for Injection Devices at FDA’s CDRH, following eight years at Genentech and AstraZeneca. She holds Chemistry and Material Science Engineering degrees from Cornell University.
