Presents
Combination Products Summit took place October 29th to 10th, 2024
Providence, RI
Strategic Committee
The Combination Products Summit program was 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
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).
Kim
Belsky
Kim Belsky has over thirty years of experience in the medical product industry. She a diverse background including roles in R&D, quality control, quality assurance, and regulatory affairs across a wide range of products including pharmaceuticals, biologics, combination products, and medical devices. Opportunities that foster collaboration, address challenges, and have the potential to benefit all stakeholders to ultimately enhance patient health inspire her.
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 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
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 President & Principal Consultant for Strategic Parenteral Solutions LLC. In her current role she advises executives on strategy, growth, technical and regulatory opportunities. 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.
Ryan
Hoshi
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
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 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
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
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.
Bonnie
Odom
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
Andrea Redd is the current Associate Vice President of the Global Drug Delivery and Device regulatory affairs team at Eli Lilly headquartered in Indianapolis, Indiana. With over 24 years of experience in the pharmaceutical industry, Andrea has held multiple positions in R&D, project management, and regulatory affairs, with a primary focus on the CMC aspects of drug development for both generic and new drug product submissions. She transitioned into combination products in 2014 and her expertise in both drug and device regulations has enabled her to successfully bridge the gaps that are often seen when a company that is heavily focused on drug product development enters into the combination product space.
Tine
Schroder-Albeck
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.
Stephanie
Shapley
Stephanie Shapley is Associate Director for Policy in FDA’s Office of Combination Products, working collaboratively across FDA on combination product policy development and issues. Stephanie has been with the FDA for over 20 years in the following capacities and offices: Senior Regulatory Policy Advisor in multiple offices within the Office of Commissioner, Associate Director for Regulatory Affairs in the Office of Medical Policy Initiatives/Office of Medical Policy in the Center for Drug Evaluation and Research, and Bioresearch Monitoring Specialist in the Office of Regulatory Affairs. Stephanie received a B.S. in biology from Binghamton University and an M.B.A. from Sacred Heart University.
Jiaying
Shen
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
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
James Wabby is Head of Global Regulatory Affairs (CoE) – Emerging Technologies, Devices, and Combination Products at AbbVie. He brings 22 years of GxP compliance experience across Nutritional, Cosmetic, Pharmaceutical, Generic, Biologic, Medical Device and Combination Product sectors. James holds a BSc in Biology and MHMS in Health Law from Duquesne University, certificates from Seton Hall Law School and Northwestern’s Kellogg School of Management. He actively participates in RAPS, DIA, FDLI, ISPE, PDA, ASTM, AFDO/RAPS, OCRA, and ASQ Orange Empire Section.
Rich
Wolf
Rich Wolf is the Vice President of Client Relations at RxLogix Corporation. 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
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.
