November 3, 2022

The Perinatal Stem Cell Society held its 8th Annual Congress in Miami Florida last weekend. This event was significant in that it addressed the most recent regulatory landscape regarding the future of Perinatal Biologics. Recent government regulations and significant court cases have changed the view of these products in the eyes of the community and the government. 

Perinatal stem cells offer tremendous benefits for a wide range of clinical afflictions in which there are no other viable or effective treatments.

Bernie Siegel, JD gave a unique perspective on the future of the industry as he’s been involved in the Regenerative Medicine foundation for the last 20 years.

KEY NOTE SPEAKER Camillo Ricordi, MD discussed the role of perinatal biologics in fighting the pandemic by using MSCs to combat Covid symptoms and other potential pandemic-related events.

Peter Marks gave a presentation / update on the FDA’s position and regulatory strategies for companies seeking INDs and BLAs

The afternoon featured...

Ian White, PhD; Duncan Ross, PhD; and Mari Mitrani, MD, PhD, discussing the challenges from an industry perspective and the implications of creating consistent, homogeneous products while conducting the appropriate safety characterization and clinical activities to document the safety and effectiveness of their products. Everyone agreed that the regulatory frameworks need to include new opportunities to take into account for historical publication studies and findings.

And finally, Michael Druckman and his team from Hogan Lovells, discussed various strategies in the regulatory pathway for perinatal manufacturers and looked at pathway examples for different derivatives of Perinatal Biologics like Wharton’s Jelly, Exosomes, and Amniotic Fluid.

All in all, I think that the industry benefited tremendously from the efforts of Kyle Cetrulo, President of Perinatal Stem Cell Society

Boston BioLife was honored to be part of the 8th Annual Congressand we look forward to joining forces with Kyle in the future to create a relevant content that pushes the scientific boundary of medicine.