022 - "What Chapter are you in?" with Susan Neadle

On this episode, we were joined by Susan Neadle. If you work on Combination Products, Susan is someone you need to know. Her and I discuss: Her career starting in consumer health and pivoting into Medical Devices then Pharmaceuticals Design to Value, Design Excellence and Process Excellence The History of Combination Products regulation and what it was like implementing 21 CFR Part 4 as it was revealed. Creating future plans using tools like the Merlin Exercise, and Future/Back Vocabulary in Combination Products AAMI TIR 48 and TIR 105 Her involvement in ASTM, AAMI, ISPE, FPIA, DIA, AFDA, TOPRA and RAPS Prioritization, Passion and her upcoming book ------------------------------------- Susan Neadle, MS, BS, FAAO is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience. Networked, published, highly active in numerous industry groups and with links to a number of teaching institutions, Susan brings deep knowledge, and genuine passion for sharing that knowledge, with others. 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 is Principal Consultant and President of Combination Products Consulting Services LLC, applying her extensive leadership and technical skills and experience to provide hands-on design-to-value, program management, quality & compliance, and regulatory consulting services, for pharmaceutical, biotech and medical device industries. Among her many significant industry affiliations and contributions, she serves as Chair of the ISPE Combination Products CoP, lead author on the ASTM International Combination Products Standard Committee, and teaches a Master’s Curriculum on Combination Products at University of Maryland Baltimore Campus. Most recently, Susan served as Head of Combination Products, Medical Devices, Digital Health & IVD Regulatory Affairs at Amgen, providing strategic leadership in global combination products/ device regulatory development and portfolio/project management from initial clinical investigation through registration and commercial lifecycle. She served as an advisor for internal regulatory policy priorities, health authority engagement and submissions approaches through strategic engagement and mentoring of colleagues for individual projects and portfolio. She led interactions with multiple global health authorities, and served as a catalyst for external consortium deliverables and strategic direction. Susan retired from Johnson & Johnson. Her distinguished career there of more than 25 years included integral leadership roles in R&D, Quality Engineering, Design-to-Value, Risk Management and Quality Systems, spanning pharmaceuticals, medical devices, and consumer health sectors, including strategic Enterprise leadership as Chair of J&J’s Design Council, advancing world-class practices in customer-centric product/process design and development. She led the team that defined and successfully implemented the globally integrated business model to meet Combination Products regulations for Janssen.