A summit focused on solutions for a dynamic industry with evolving regulations.
Combination Products Summit Strategic Committee
The Combination Products Summit Strategic Committee is made up of the following FDA officials and industry experts:
Senior QA – Global Quality Devices, 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 experience Auditor within ISO 13485.
Albeck received her Master degree in Medical Engineering from the Danish Technical University.
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).
Senior Vice President – Quality, Eli Lilly and Company
Francis Blacha is Senior Vice President, Quality for Eli Lilly and Company in Indianapolis, Indiana. In this capacity, he has responsibility for the Lilly Device Quality Management System, Device Regulatory Compliance, and Quality oversight for Lilly’s Drug Delivery System Development, Connected Care and Digital Health organizations. Before joining Lilly, Francis held various leadership positions in Quality at Pfizer and Glaxo Inc. Blacha has more than 30 years of quality assurance/quality control experience in pharmaceuticals and medical devices. He has extensive experience in guiding teams in all aspects of risk management and the practical application of design control/product realization requirements throughout the various product type life cycles. Blacha has given numerous lectures at various medical device, pharmaceutical, and combination product conferences. His bachelor’s degree in chemistry is from Catawba College, and he received a master’s degree in chemistry from North Carolina State University.
Associate Director, Biogen
Sandra Boyd is a Quality accredited (CQA and RAC) business professional with diverse experience in pharmaceutical, biotechnology, medical device, Contract Research Organization (CRO), and clinical environments. She is currently Head of the Device Development Quality department where she leads the team responsible for the quality oversight of design and development of medical devices/combination products and digital devices, and the incorporation and maintenance of these products into Biogen’s Quality Management System. Throughout her 30-plus-year career, Boyd has held positions in the R&D of antibiotics, polymers, and semiconductors; healthcare; and quality assurance for pharmaceuticals, biotechnology, and medical device/combination products. She holds a bachelor’s degree in biochemistry from the State University of New York and an MBA with a concentration in new product development from North Carolina State University.
President, Strategic Parenteral Solutions LLC
Fran DeGrazio has 35+ years of experience in the pharmaceutical packaging and delivery industry with extensive expertise in sterile drug product systems, including vial container closure systems and prefillable systems for combination products. Currently Fran is a Kymanox Executive Advisor and President & Principal Consultant for Strategic Parenteral Solutions LLS.
Prior to this she held numerous strategic & technical roles at West Pharmaceutical Services, including R&D, Quality & Regulatory, Technical Customer Support, Analytical Laboratories, Marketing and Scientific Affairs. Her final role prior to retiring from West was as Chief Scientific Officer.
Fran has presented and published numerous technical articles and book chapters. She is the recipient of the PDA Packaging Science Award for 2021, Philadelphia Business Journal 2018 Healthcare Innovators of the Greater Philadelphia Region Award and the Healthcare Businesswoman’s Association Luminary Award for West in 2017.
Director, Regulatory Policy and Intelligence, AbbVie
Ryan Hoshi is Director of Regulatory Policy & Intelligence at AbbVie and serves as the policy lead for medical devices, combination products, personalized medicine, and digital health. Before joining AbbVie, Hoshi served as an international policy analyst at the Center for Devices and Radiological Health (CDRH) and promoted international regulatory harmonization activities through the Asia Pacific Economic Cooperation Regulatory Harmonization Steering Committee Medical Device Priority Work Area, Medical Device Single Audit Program, and International Medical Device Regulators Forum. Hoshi 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.
Hoshi earned his bachelor’s degree in bioengineering from the University of California, Berkeley; his doctorate and master’s degrees in biomedical engineering from Northwestern University; and his MBA from Georgetown University.
Chief Collaboration Officer, AFDO/RAPS Healthcare Products Collaborative
Before becoming the Director of Health Technology Initiatives at AFDO/RAPS Healthcare Products Collaborative, Timothy Hsu was a member of the AI Initiative’s Core Strategic Team. He’s also spent several years working with the GMLP, AIO, and AI@POC teams in varying capacities under the Xavier Health Artificial Intelligence Initiative.
Hsu has served across the clinical, operational, and administrative spectrums in healthcare systems at pediatric, academic, research, and community hospitals. His roles in healthcare systems have included work in strategy, planning, perioperative, service line, and population health divisions. Hsu was a Product Manager in Clinical Intelligence at Premier Inc., where he was the product owner of Service Line Analytics, Cost Accounting, Patient Analytics, and Clinical Professional Partnerships. He was the market research strategist for healthcare market futures at GBBN Architects.
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.
Principal Consultant & President, Combination Products Consulting, LLC
Susan Neadle is a recognized international Combination Products, Medical Device, and Digital Health expert with over 35 years industry experience. Susan is well networked, published, and highly active in numerous industry groups with links to teaching institutions. Susan’s leadership, innovation, and best practices have been recognized with multiple awards, including the Johnson Medal, Johnson & Johnson’s highest honor for excellence in Research & Development, and most recently, as a Finalist in TOPRA’s 2021 Awards for Regulatory Affairs Excellence. She retired from a distinguished and impactful 26-year career at Johnson & Johnson. Susan is now Principal Consultant at Combination Products Consulting Services LLC, providing international Q&C, regulatory and design excellence services, to the pharm, biotech and device industries. She serves as Chair of the ISPE Combination Products CoP, and Lead Author in Combination Products Working Groups through ASTM International, AAMI and PQRI. Susan teaches curricula in Combination Products through UMBC and AAMI, as well as customized training upon request.
Director, Office of Combination Products, FDA-OCP
Thinh Nguyen has been the Director of the Office of Combination Products (OCP) in the United States Food and Drug Administration since January 2008. OCP is primarily responsible for making jurisdictional determinations, coordinating premarket reviews, ensuring consistent and appropriate post-market regulations, and developing policy, guidance, and regulations. Prior to joining OCP, Nguyen spent seven years as the Director for the Premarket Approval Section in the Center for Devices and Radiological Health where he played a key role in the passage of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) and the Medical Device User Fee Amendment of 2007 (MDUFA) legislations. During this time, he had established significant policies and written numerous guidance documents relating to the PMA programs (e.g., expedited review, user fees, PMA actions). Prior to coming to the FDA, Nguyen worked as a senior electronics engineer for the Naval Electronics Systems Engineering Center, Portsmouth, Virginia, from 1986 to 1993, where he was responsible for developing hardware/software for testing aircrafts and radar systems. Nguyen received a bachelor’s degree with honors in electrical engineering from North Carolina State in 1986.
Senior Director, Global Regulatory Affairs, Device and Combination Products, Sanofi
Jason Lipman is Senior Director of Global Regulatory Affairs for Devices and Combination Products at Sanofi. He is responsible for worldwide regulatory activities related to drug delivery devices and combination products. Jason has over 20 years of regulatory and product development experience within the medical device and pharmaceutical sector, including roles at Janssen, DePuy Synthes/Synthes Spine, and FDA’s CDRH General Hospital Devices Branch. Jason has a M.S. in Applied Biomedical Engineering from Johns Hopkins University and a B.S. in Mechanical Engineering from Tufts University, and is an active member of the Combination Products Coalition.
Senior Quality Director, Indy Device Manufacturing, Eli Lilly
David Shore is currently Senior Quality Director, Indy Device Manufacturing for Indianapolis Device Manufacturing for Eli Lilly and Company. Prior to joining Lilly, Shore held various positions in Validation, Operations and Quality at Pfizer supporting Pharmaceutical Production. He joined Lilly 15 years ago and has spent the last 12 years in the medical device Quality organization supporting site production and global supply of medical device components and subassemblies. Shore has 20-plus years of pharmaceutical and medical device experience. He received his bachelor’s degree in chemical engineering from Rose Hulman Institute of Technology.
Global Regulatory Head, Combination Products, Devices, Genentech, a member of the Roche Group
Chin-Wei Soo is the Global Regulatory Head, Combination Products, Devices, and Digital Health at Roche/Genentech. He is accountable for providing technical regulatory oversight to Roche’s entire device, combination product, and digital health portfolio, covering all large (BLA) and small molecules (NDA) throughout the product life cycle. Soo chairs the Combination Product Coalition (CPC) digital health working group.
Soo has 18 years of regulatory and quality experience, including strong expertise in combination products and digital health. Prior to joining Genentech, he was with Medtronic and Boston Scientific where he successfully led regulatory submissions and implemented quality management principles that resulted in approvals of the IN.PACTTM drug-device coated balloon, TAXUSTM drug-device coated stent, and implantable, programmable drug infusion pumps.
Soo graduated from Iowa State University with a bachelor’s degree in industrial and manufacturing systems engineering, a master of science in bioscience regulatory affairs from the Johns Hopkins University, and a doctorate in regulatory policy from the University of Southern California School of Pharmacy.
Counsel, Epstein Becker Green
Bradley Thompson is a Member of the Firm at Epstein Becker & Green, P.C. He counsels medical device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues.
Thompson regularly defends companies receiving FDA warning letters, on a wide gamut of subjects including good manufacturing practice compliance and off-label promotion. He frequently counsels companies on premarket clearance and approval strategies and on marketing strategies. When medical device companies become concerned that perhaps their employees have not followed FDA requirements, they often engage Thompson to investigate. With a special focus on drug delivery companies, Thompson also advises such companies on the unique aspects of combination product development and manufacturing.
Global Head – Emerging Technologies, Combination Products, and Devices, Abbvie
20+ years of experience in increasing quality operations, quality compliance and regulatory affairs responsibilities within the GxP regulated environment pertaining to Medical Devices, Technology Medicinal Delivery Platforms, Complex Generics, Companion Diagnostics, Digital Medicine, and Combination Product areas. Regularly provide AbbVie therapeutic franchise units regulatory counsel and strategy to all aspects within the quality management system and regulatory affairs
- CMC Global Dossiers/Global Device Regulatory Strategies
- EU MDR/IVDR – Person Responsible for Regulatory Compliance (PRRC)
- 21 CFR Part 3 and Part 4 – Combination Products, CE Marking, ISO 13485:2016/MDSAP
- International Regulatory Affairs
- Represent AbbVie as the U.S Agent regarding FDA matters for international medical device facilities
- Actively participate in industry trade organizations and serve on standards committees.
John “Barr” Weiner
Associate Director for Policy, Office of Combination Products, FDA-OCP
John Weiner is the Associate Director for Policy in the Food and Drug Administration’s Office of Combination Products, which is tasked with the classification and assignment for regulation of therapeutic products (drugs, devices, biological products, and combination products), and with ensuring the sound and consistent regulation of combination products. Prior to joining OCP, Weiner was an Associate Chief Counsel in FDA’s Office of Chief Counsel, advising the agency on various issues including regulation of drugs and cross-cutting topics including the regulation of products that use nanotechnology. Before coming to FDA, Weiner was in private practice in the areas of food and drug, environmental, and related aspects of public international and trade law. He has published and lectured on topics in all three areas. Weiner received a bachelor’s degree from Princeton University and a J.D. with honors from the Columbia University School of Law.
Global Head of Pv Operations, Global Clinical Safety & Pharmacovigilance (GCSP), CSL Behring
Rich Wolf is the Executive Director, Pv Operations in the GCSP group at CSL Behring. He directs Case Management, Medical Evaluation, Manufacturing Site Pharmacovigilance Representative, Pv Business Process and Technology, and Pv Combination Products & Device Center of Excellence groups.
Rich has been with CSL for the past 7 years having spent the prior 12 years working across many areas in Global Medical Safety at Johnson and Johnson.
Prior to joining the pharmaceutical industry Rich spent 5 years at Accenture and was an Airborne Ranger qualified Infantry Officer. He earned his undergraduate degree from the University of Richmond and MBA from Rutgers University.
CSL Behring is a global leader in the plasma protein biotherapeutics industry. They research, develop, manufacture and market biotherapies that are used to treat serious and rare conditions. Rich is an advocate for Project Healing Waters Fly Fishing – Project Healing Waters Fly Fishing, Inc. is dedicated to the physical and emotional rehabilitation of disabled active military service personnel and disabled veterans through fly fishing and associated activities including education and outings.
Distinguished Scientist, Medical Device and Combination Product Development, Regulatory and Quality, Merck
Jiaying Shen obtained her Ph.D in Industrial and System Engineering from University of Wisconsin – Madison and she has over 17 year experience in pharmaceutical and medical device industry. She is currently a distinguished scientist in the device development department at Merck, managing a large team that are responsible for Design Control, Risk Management, Human Factors activities and other Device Quality and Regulatory issues for drug delivery devices. She also leads several product development projects, from pre-clinical phases all the way through post market commercial support. Prior to join Merck, she worked at Medtronic Neuromodulation R&D and Honeywell automation and control laboratory.
Associate Director, CMC, Regulatory Affairs, Janssen
Steve Vesole supports regulatory activities related to drug-device combination products including pre- and post-approval submissions at Janssen. He works with global regulatory, supply chain, and commercial partners to provide region specific device regulatory guidance. Prior to working in regulatory affairs, Steve supported the design and development of delivery devices for large and small molecule drug products as a device engineer. Steve holds a BS in Polymer Science and Engineering and MS in Biomedical Engineering from Case Western Reserve University.
Director, Regulatory Policy, BD
Rumi Young, Meng, RAC is the Director of Regulatory Policy at Becton Dickinson (BD). In this role she leads a team that advances policies to speed time to market, promote innovation and ensure reasonable regulatory requirements for medical devices, diagnostics and combination products. Rumi joined BD from FDA where she spent four years in CDRH’s Division of Drug Delivery, General Hospital and Human Factors. As Acting Assistant Director for Injection Devices, her team was responsible for the approval of drug delivery injection devices and combination products such as syringes, auto injectors, pen injectors, on-body injectors and smart connected devices. Prior to FDA Rumi worked at Genentech and AstraZeneca for eight years in combination product development. Rumi has both a Bachelors in Chemistry and Chemical Biology and Masters in Engineering in Material Science from Cornell University.