Communities of Practice Profiles: Shaping the Future of the Combination Products Industry
Combination Products is one of ISPE’s newest Communities of Practice (CoPs). It started as a Special Interest Group to help people in the industry collaborate and learn from each other.
According to ISPE Combination Products Communities of Practice Chair Susan Neadle, “a combination product is composed of two or more differently regulated medical products, i.e., constituent parts, that are to be used together, or are being studied for use together, to achieve an intended use, indication, or effect. Given terminology differences across jurisdictions, these products are sometimes more broadly referred to as ‘combined use systems.’
“Such combined use inherently raises questions that need to be considered and that may lead to a range of risk management approaches during product development and postmarket life cycle. There are a plethora of examples spanning a wide gamut of therapeutic areas: for example, drug-prefilled syringes and autoinjectors, metered-dose inhalers, medicinal patches, drug-eluting discs, drug-eluting stents, and, increasingly, connected health applications. The regulatory frameworks for these products vary from country to country. In the US, each constituent part retains its regulatory identity in a combination product. The cGMPs that apply to each constituent part of a combination product also apply to the combination product, and necessitate assessment of, and controls for, any potential interactions of the constituent parts. ”
The Combination Products Communities of Practice is “focused on the evolution of combination products technology and combined use systems, as well as the shipping global landscape of regulatory expectations for these products,” Neadle said.
Communities of Practice Development
“I became active in the combination products space during my 26-year career with Johnson & Johnson,” Neadle said. “While there, I provided end-to-end global functional and program leadership for drug-device combination products, establishing an integrated cross-functional business model to meet combination products’ health authority regulations while still ensuring the business sustained growth momentum.
“I saw an opportunity to collaborate with and support colleagues across the industry in this space and got approval to start a special interest group in ISPE. We started with about eight people five years ago, and now are a full-fledged Communities of Practice, with more than 55 active members from US, Europe, Canada, and India.”
In addition to serving as Chair of the Communities of Practice, Neadle is Principal Consultant, Combination Products Consulting Services, LLC; she also serves as lead author on both the ASTM International Combination Products Standard and AAMI Combination Products Committees, teaches a master’s curriculum on combination products at University of Maryland Baltimore as part of ISPE Workforce of the Future initiative, serves on AAMI faculty, and is active on a number of other impactful industry committees.
Pharmaceutical Engineering® recently spoke with Neadle about the Communities of Practice and issues related to the importance of combination products in the industry.
Why Is Your Communities of Practice’s Work Critical to ISPE and the Industry?
Combination products are designed to offer greater benefits than the drugs or devices acting alone, and increasingly, drugs are dependent on medical devices for their administration. This is particularly the case in the rapidly growing biologics space. Couple this with connected health and the promise of improved healthcare through digital technologies, and the possibilities seem endless. Health authorities recognize that bringing together these drug and device systems brings more risk and complexity, and they are shifting their regulatory frameworks to ensure safety, efficacy, and functionality of the combined use systems.
Our charter includes four main priorities. We want to (1) raise awareness regarding the evolving global combination product regulatory landscape; (2) help shape evolving regulations through commenting, industry publications, and advocacy—we have already submitted comments this year on evolving regulations to the European Medicines Agency, Health Canada, US FDA, and the World Health Organization; (3) educate our members by sharing best practices, supporting successful combination product development through postmarket life cycle management; and (4) be a space for combination products networking and collaboration.
What Is Most Important for ISPE Members To Know about the Communities of Practice?
We have industry representatives spanning international pharmaceutical, biotech, and device companies, as well as consultants. We have monthly presentations on a range of interest areas by Communities of Practice members and guest speakers covering current state-of-the-art technology, quality, and regulatory hot topics.
Our Communities of Practice also has subteams. For example, we have a subteam on regulatory intelligence and another that is supporting the ISPE effort to develop a streamlined Module 2 QoS to incorporate combination product considerations.
The Communities of Practice meets monthly. Our agenda always includes at least one hot topic presentation by industry leaders. For example, Edwin Bills, Principal Consultant, ELB Consulting, presented on risk management and ISO 14971:2019 at a recent meeting. I presented on the US FDA’s proposed rule for 21 CFR 820 and global combination products harmonization efforts. Jennifer Riter, Senior Director, West Pharmaceutical Services, presented on extractables and leachables in primary containment systems and medical devices. We have also had presentations on combination product essential performance requirements, human factors, post marketing safety reporting, digital health, reliability, and validation. The presentations are recorded and minutes issued so that CoP members have access to the great presentations and discussions after the meetings.
Another way that we have shared information about combination products is through blogs on iSpeak. For example, one of our Communities of Practice members, Ryan Hoshi, Director, Regulatory Policy and Intelligence, AbbVie, recently published a blog on digital health. We are also planning to submit articles to Pharmaceutical Engineering on combination product EPRs, human factors, and digital health.
At the 2022 ISPE Annual Meeting & Expo in Orlando, Florida, representatives from the US FDA commented on evolving regulations and enforcement, and Boaz Eitan, CTO, Eitan Medical, presented on evolutions in technical solutions for medicinal therapies.
How Can ISPE Members Become Involved In the Communities of Practice?
Just reach out! You can email me directly at sneadle@ combinationprod.com.
