Last week, the Akron team joined more than 1,600 participants from 50+ countries at the annual meeting of the International Society for Cell and Gene Therapy (ISCT) in Montreal. Chaired by David DiGiusto, PhD (Stanford School of Medicine), Sarah Nikiforow, MD, PhD (Dana Farber Cancer Institute), and Denis-Claude Roy, MD, FRCPC (Hôpital Maisonneuve-Rosemont), the meeting reflected the industry’s rapid growth in recent years, as many new products have reached market, and many more continue to work their way through the clinical pipeline.
For the first time, plenary sessions featured talks from both the pioneers responsible for the therapy breakthroughs, as well as the commercial entities bringing these products to market. The ISCT Presidential Task Force session on the use of unproven cellular therapies featured the FDA and Health Canada’s perspectives on the regulation of these therapies, and featured a patient’s story navigating the regulatory and unregulated landscape. Akron Biotech’s CEO, Claudia Zylberberg, PhD, gave a presentation titled “Progress in the World of Standards for Cell and Gene Therapies.”
In the lead-up to the annual meeting, ISCT published proceedings from a gathering that Akron convened with the support of the Argentine Association of Pharmacy and Industrial Biochemistry (SAFYBI) at the Argentine National Administration of Drugs, Food, and Technology (ANMAT) on February 7, 2018. The meeting was attended by several U.S.-based thought leaders in the area of regenerative medicine, including Bruce Levine, PhD (University of Pennsylvania), Isabelle Riviere, PhD (Memorial Sloan Kettering Cancer Center), Brock Reeve (Harvard Stem Cell Institute), and Claudia Zylberberg, PhD (Akron Biotech). The summary, published as part of ISCT’s Telegraft member newsletter, focuses on the evolving regulatory landscape for advanced therapies in Argentina. You can read it here.
During the meeting, Dr. Carlos Chiale, head of ANMAT, walked through some of the new regulations being developed in partnership with the Ministry of Health as well as the National Coordinating Body for Ablation and Transplantation (INCUCAI). The U.S. team discussed the evolving regulatory landscape in the U.S., including the 21st Century Cures Act and the Regenerative Medicine Advanced Therapy (RMAT) designation, as well as ongoing efforts by the Standards Coordinating Body (SCB) to create industry standards for ancillary material qualification, transportation, banking, cell counting and others.
This meeting was the first of many efforts to harmonize regulatory pathways and identify opportunities for collaboration with the companies, clinical centers, and research institutions that populate Argentina’s emerging regenerative medicine sector. For more details on the meeting and on emerging opportunities for collaboration in Argentina, check out the full summary. Akron welcomes ISCT’s continued growth and looks forward to participating in meetings this fall at the ISCT Europe 2018 Regional Meeting in Florence, Italy, and next year at the ISCT 2019 Annual Meeting in Melbourne, Australia.