Stakeholders are motivated – and ready – to implement practical, achievable changes to advance cellular therapy and regenerative medicine. This was a theme throughout the third Regenerative Medicine InterCHANGE, hosted by FACT virtually on January 25, 2022. The event was initially scheduled to be in Miami, Florida as part of Phacilitate’s Advanced Therapies Week, but changed to a virtual format due to the ripple effect of the increase in COVID-19 cases in the previous month.
A total of 36 attendees, representing 23 organizations and various areas of subject matter expertise, participated. Participating organizations included professional societies, health care providers, industry, information technology groups, advocacy organizations, accrediting organizations, and multistakeholder groups.
The three main objectives of the event were to:
- Discuss regulatory requirements for the collection of starting material, applying approaches taken from currently licensed cellular therapies to anticipate and influence requirements for additional cell sources being investigated.
- Develop a collaborative approach to educational and training programs, building and supporting a thriving workforce by leveraging the resources of academia and industry sectors.
- Identify steps in the Investigational New Drug (IND) application, licensure, or equivalent regulatory process that could be addressed to reduce time and cost requirements in order to increase patient access to cellular therapies.
Each of these objectives were the topic of panel discussions. Panelists included a wide variety of stakeholders, whose perspectives brought fresh ideas to address challenges experienced among many different types of cellular therapy products. Audience participation was excellent, with attendees sharing ideas for many actionable solutions. A summary of the discussions and identified action items is currently being drafted.
Intermingled through the event were FACT Accreditation Success Story videos. Two videos highlighted successful multistakeholder efforts, including the ISBT 128 Standard 18 for labeling collected cells intended for further manufacture and streamlined site certification processes. The third and final video was a special message from a cellular therapy patient, shared by the Cord Blood Association, who encouraged cellular therapy professionals to continue their good work and be proud of their accomplishments.
The InterCHANGE planning committee and moderators, listed below, successfully narrowed seemingly daunting challenges into solution-driven discussions:
- Ian McNiece, PhD: Chair, FACT Regenerative Medicine Task Force and Executive Consultant at CellMED
- Joanne Kurtzberg, MD: Member, FACT Regenerative Medicine Task Force; President, Cord Blood Association; and Director of the Marcus Center for Cellular Cures and the Carolinas Cord Blood Bank, Duke
- Corinne Goldberg, MD: Medical Director, Carolinas and South Carolina Region of the American Red Cross
- David Moolten, MD: Medical Director, Penn-Jersey Region of the American Red Cross
- Colleen Delaney, MD, MSc: Vice President, Cord Blood Association and Founder and Chief Scientific Officer of Deverra Therapeutics
We look forward to sharing the full summary with the cellular therapy field in the future. In the meantime, we would like to express a hearty thank you to the following organizations for participating in the event and for all your efforts to advance quality cellular therapy for the benefit of patients.