Cincinnati, OH – In July of 2015 the Xavier Health was asked by FDA to host a new event dedicated to Combination Products. Having only 90 days to produce and market a new event is no small task but the organization is well equipped having the experience in putting together similar events as the PharmaLink and MedCon Conferences.
Eighty-three attendees came together from both the pharmaceutical and medical device communities. Following breakfast the attendees were welcomed to Cincinnati by the new FDA District Director, Steve Barber. During the first session, FDA’s Director of Combination Products, Thinh Nguyen, addressed the newly issued “Combination Product Review – Intercenter Consult Process Study” that was conducted by the Office of the Commissioner. In an effort to maximize efficiency and speed to market, he discussed the barriers they have recognized that are internal to FDA operations, and shared tips on how to maximize success while they work to remove those barriers.
Brad Thompson, Counsel for Epstein, Becker & Green then shared and facilitated an advanced case study. Experts (Steve Binion from BD, Francis Blacha from Eli Lilly, Kirsten Paulsen from Pfizer and Steve Niedelman from King & Spalding) joined the stage and explored challenges facing industry through case study investigation and discussion. Attendees collaboratively discussed, debated and proposed solutions that will address industry concerns. Experts and attendees jointly navigated unchartered product lifecycle challenges as small groups of round tables worked together and then used the microphone to share solutions.
Following a networking lunch, Francis Blacha, Gobal Quality Leader – Drug Delivery System Development for Eli Lilly kicked off the first afternoon session by presenting, “How to Implement a Lifecycle Risk Management Framework.” Recognizing the growth rate of combination products through 2019, this session identified challenges associated with integrating risk management models for drug/device constituents and how utilizing a “System of Quality” approach can help overcome those challenges. He shared an example on how to develop an integrated risk management process using Safety Assurance Case methodology for managing patient risk across the product lifecyle.
Nolan Baird, Associate Director of Combination Product Development at Abbvie presented a session, “Challenges Implementing Part 4 GMP Regulations and Expectations.” It was learned that this streamlined approach to cGMPs for combination products can benefit manufacturers, but the question of how to navigate the gray areas of the 21 CFR Part 4 regulations is key to your company’s approach. Questions were raised as to successfully merging requirements from the QSRS or the Drug GMPs without missing obligations or duplicating requirements being critical to meeting FDA and customer expectations while placing a reliable product on the market. Insight was be shared on topics such as the incorporation and start of design controls, term confusion across regulations, purchasing controls, as well as stability and expiration dating pain points.
Brad Thompson returned to the front of the room to present a “How To” dedicated to Digital Health Solutions. Digital health tools including smart syringes, smart pills and databases used to track a myriad of information about patients are becoming more common. The session began by examining the regulatory classification for the digital health adjuncts to pharmaceutical care. After tackling the classification issue, attendees examined the implications of those classification on approval routes, GMP requirements and adverse event reporting.
Members of the Combination Products Summit Committee took the stage for the final session titled, “Key Takeways for FDA and Industry” and engaged each table in the audience in facilitated discussion on next steps and action plans for FDA and industry. This information was captured and will be shared in the future.
The success of this first event prompted the Committee to share tha next year’s Summit will be held over two days and take place on November 2-3. 2016.