FORT LAUDERDALE, Fla., Oct. 26, 2022 /PRNewswire/ — The Perinatal Stem Cell Society has organized a workshop Nov. 3 in Fort Lauderdale, Fla. and streamed to unite the biologics industry and work with the FDA towards a patient-centered goal.
“I called this one-day workshop so the industry can partner with the Food and Drug Administration to find solutions that will enable access to affordable stem cell therapies and biological treatments for patients in the United States,” said CEO and co-founder Kyle Cetrulo.
Peter Marks, M.D., Ph.D., the Director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration will present and answer questions at the 8th Perinatal Stem Cell Society Workshop. FDA’s willingness to listen and to work with industry is clearly demonstrated by the participation in this workshop by Dr. Marks.
“We are calling this meeting due to recent developments, there is now a small window for action. We want to partner with the FDA to make significant changes to the IND pathway that will make it more likely a company can gain market approval to deliver life-changing products to patients who need these therapies.”
IND pathways are the primary way new drugs and biologics are approved to be tested in human beings. Biologics are medical treatments derived from living organisms.
“Why is there a window of opportunity now?” Cetrulo said. “In a few recent rulings, the Supreme Court decided that the FDA is no longer entitled to consideration. This sea change position set the stage for the recent court case between the FDA and Cell Surgical Network in which the FDA suffered a significant loss.”
In September, a federal judge in California ruled the Network’s surgical procedure using patients’ stem cells to treat a range of medical conditions does not fall under the FDA’s regulatory jurisdiction.
Cetrulo expects the FDA to appeal the decision. But for the first time the agency will have to defend 21 CFR 1271 1.15. B in the code of federal regulations that speak to the use of expanded cells.
The 8th Perinatal Stem Cell Society Industry Workshop will be held 8 a.m. to 4 p.m. in The Westin Fort Lauderdale Beach Resort. Tickets are $899 and include breakfast, lunch and snacks. Virtual streaming registration for listen/watch only is also available for $499.
ABOUT INTERNATIONAL PERINATAL STEM CELL SOCIETY
Patient advocate Kyle Cetrulo founded the International Perinatal Stem Cell Society in 2013 to provide a platform for collaboration and the dissemination of information about perinatal stem cells. The non-profit organization was founded on the basic principle that stem cells from perinatal tissues contain enormous potential to treat many diseases and disorders. The society organizes world-class scientific meetings. Videos on speakers at the 2020 and 2019 conferences are posted on the society’s website: https://www.perinatalstemcells.com/.
SOURCE Perinatal Stem Cell Society