WORKSHOP DESCRIPTION

Delivering a combination product to market and maintaining safety and performance on market requires a comprehensive understanding regulatory requirements for risk management. Product risks can arise from design, manufacturing, and human factors considerations, however there are also broader development risks impacting combination product development such as managing presentation changes in clinical and commercial phases.

COMBINATION PRODUCTS RISK MANAGEMENT

The combined use of two or more differently regulated constituent parts with one another can present new and significant risks and risk management considerations. Combination product risk management therefore serves as the underpinning to both combination product development and lifecycle management, including post marketing modifications, surveillance and reporting.  In this workshop we will review combination product risk management expectations and best practices –  drug-agnostic and combined use-  working through examples together.  We will underscore the critical connections between development risk management activities and post market to ensure safe use of the combination product designed with a patient-centric approach.

BRIDGING BETWEEN COMBINATION PRODUCT DRUG DELIVERY DEVICE PRESENTATIONS: STRATEGIES TO LEVERAGE DATA AND MINIMIZE PATIENT BURDEN

The safety and efficacy of combination products rely on both the pharmaceutical and device constituent parts performing properly. However, the realities of pharmaceutical and device constituent development are such that the availability of components for pivotal studies may be incongruent, or changes may need to be made to only one portion of the system. In some cases, it is not practical or in the best interest of patients to mandate the collection of new clinical data for changes in drug delivery device presentation that may not impact safety and/or efficacy of the combination product. For this reason, in 2019 the US FDA issued a draft guidance on “Bridging for Drug-Device and Biologic-Device Combination Products” which describes a suggested approach for identifying the minimum viable data needed to bridge prior conclusions of product safety, efficacy, and performance between drug delivery device presentations.

This workshop will provide an overview of combination product bridging techniques and the US FDA’s draft guidance, present case studies demonstrating the applications of those techniques, and provide the audience with opportunities to apply bridging tools to hypothetical product changes. 

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Workshop Leaders

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).

Ryan McGowan

Director of Digital Devices and Combination Products within CMC Regulatory Affairs, AstraZeneca

Ryan McGowan is a Director of Digital Devices and Combination Products within CMC Regulatory Affairs at AstraZeneca. He has responsibility for developing regulatory strategies for the approval of digital health products including software as a medical device as well as traditional parenteral and inhalation combination products. 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.

John McMichael

Director of Devices & Digital Therapeutics within CMC Regulatory Affairs, AstraZeneca

John McMichael is a Director of Devices & Digital Therapeutics within CMC Regulatory Affairs at AstraZeneca. Prior to joining AstraZeneca, he acted as a Combination Products Team Lead within CDRH at the FDA. McMichael has extensive regulatory experience with all types of Combination Products throughout the entire product life cycle, including digital therapeutics. McMichael has a background in biomedical engineering; his bachelor’s degree is from the University of Virginia and his master’s is from Johns Hopkins University.

Susan Neadle

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.  She is well networked, published, and highly active in numerous industry groups with links to teaching institutions. Neadle’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.  Neadle retired from a distinguished and impactful 26-year career at Johnson & Johnson.  She 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.   Neadle serves as Chair of the ISPE Combination Products CoP, and Lead Author in Combination Products Working Groups through ASTM International,  AAMI and PQRI.  She teaches curricula in Combination Products through UMBC and AAMI, as well as customized training upon request. 

Jiaying Shen

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