1st Edition
The Combination Products Handbook A Practical Guide for Combination Products and Other Combined Use Systems
Combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. According to the US Food and Drug Administration (FDA), “a combination product is one composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device and a biological product.” Examples include prefilled syringes, pen injectors, autoinjectors, inhalers, transdermal delivery systems, drug-eluting stents, and kits containing drug administration devices co-packaged with drugs and/or biological products. This handbook provides the most up-to-date information on the development of combination products, from the technology involved to successful delivery to market. The authors present important and up-to-the-minute pre- and post-market reviews of international combination product regulations, guidance, considerations, and best practices.
This handbook:
- Brings clarity of understanding for global combination products guidance and regulations
- Reviews the current state-of-the-art considerations and best practices spanning the combination product lifecycle, pre-market through post-market
- Reviews medical product classification and assignment issues faced by global regulatory authorities and industry
The editor is a recognized international Combination Products and Medical Device expert with over 35 years of industry experience and has an outstanding team of contributors. Endorsed by AAMI – Association for the Advancement of Medical Instrumentation.
Foreword
Part 1: Foundation
Chapter 1 Introduction
John Barlow Weiner
Chapter 2 What is a Combination Product?
Susan Neadle
Chapter 3 Regulatory Strategies
Suzette Roan
Chapter 4 cGMPs
Susan Neadle and Mike Wallenstein
Chapter 5 Integrated Development
Susan Neadle
Chapter 6 Risk Management
Susan Neadle, Richard Wedge, and Edwin Bills
Chapter 7 Human Factors Engineering in the Design, Development and Lifecycle of Combination Products
Shannon Hoste, Stephanie Canfield, Susan Neadle, Bjorg Hunter, Theresa Scheuble
Chapter 8 Lifecycle Management: Design Transfer through Post Market
Susan Neadle and Khaudeja Bano
Chapter 9
9A. Best Practices and Considerations for Combination Products Inspection Readiness
Susan Neadle
9B. US Combination Product Inspections
Kim Trautman
Part 2: Special Topics
Chapter 10 Supplier Quality Considerations
Fran DeGrazio and Meera Raghuram
Chapter 11 Analytical Testing Considerations
Daniel Bantz and Jennifer Riter
Chapter 12 Biological Products Considerations
Manfred Maeder
Chapter 13 Connected Health
Ryan McGowan
Chapter 14 Evolving Global Regulatory Landscape
Stephanie Goebel, Viky Verna, Chery Marty and Susan Neadle
Appendices
- Comparative Overview of Global Combination Product Regulatory Landscape
Dhiraj Behl and Susan Neadle
- Glossary
Biography
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 serves as Principal Consultant and President of Combination Products Consulting Services LLC, applying her extensive leadership, technical skills, and complex program management experience to provide international quality & compliance, regulatory, design excellence and executive advisory consulting services to the pharmaceutical, biotech and medical device industries. Among her 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, lead author on the AAMI Combination Products Steering Committee, active member in Combination Products Coalition, and serves as faculty at AAMI and at University of Maryland Baltimore County Campus College of Natural and Mathematical Sciences for Combination Products Curricula.
Susan retired from Johnson & Johnson, where her distinguished 26+ year-career included integral leadership roles in R&D, Quality Engineering, Design-to-Value, and Quality Systems Management, spanning pharmaceuticals/biotech, medical devices, and consumer health sectors, as well as strategic leadership at J&J corporate level. She served as Chair of J&J’s Design Council, advancing world-class practices in product and process design and development to drive robust, customer-centric health care solutions across J&J. She also led J&J's cross-sector Combination Products Community of Practice. Among several achievements, Susan led the team that defined and implemented the globally integrated business model to meet Combination Products health authority regulations for Janssen, J&J’s Pharmaceutical sector, and was awarded the Johnson Medal for excellence in Research and Development.
Susan also served as Executive Director and 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 was 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.
