Letter from the President
After decades of discovering new therapies, improving quality, and increasing patient access, the FACT community of accredited organizations and expert inspectors has much wisdom to share. Fortunately, several opportunities exist for us to provide advice and direct the future of cellular therapy. It is our responsibility to take advantage of those opportunities.
Over the past several years, FACT has submitted numerous comments to regulatory agencies, participated in multistakeholder groups, and has built relationships with industry. We can therefore assure you that your input is incredibly valued. We also know that our field is one in which we all are open to new ideas for the sake of advancing cellular therapies for the patients. Our unwavering commitment, though, is to safety and quality. To that end, I encourage you to please continue to provide feedback (especially when requested!) and advocate for the importance of accreditation. In this newsletter, we have included several announcements that include requests for comments from the United States Food and Drug Administration (FDA) and the Standards Coordinating Body, as well as updates from the FACT Professional Relations Committee.
Finally, to highlight FACT’s goal to recognize the value of communicating and sharing the knowledge from our accredited organizations and inspectorate within our own network, we are inviting guest authors to contribute to our “Just the FACTs” newsletter. I therefore encourage you to read the piece written by Eunice Kim and Heather Steinmetz on “Qualification and Validation” that is adapted from a well-received presentation from a previous FACT event. If you would like to submit an article or article topic for consideration for inclusion in the newsletter please do not hesitate to reach out to: firstname.lastname@example.org. Once again, I want to thank you for all you do to enhance the cell therapy field to ultimately improve outcomes for the patients we serve!
Catherine Bollard, MD