The 8th Perinatal Stem Cell Society Congress/Workshop is taking place November 3, 2022, at the Westin Beach Resort in Fort Lauderdale, FL.
$599 Early Bird Ticket Sales Close Oct. 15th
After Oct. 15th the price is $899
Please register here
As a patient advocate, my aim is to create affordable access to safe stem cell and biologic therapies in the United States. There is an opportunity to work with FDA at this time to make substantial and long-lasting changes to the IND pathways. I have called this one-day workshop so that the industry can come together, not to challenge the FDA, but to work with FDA to find solutions that will enable access to life changing therapies for patients in the U.S.
The FDA’s willingness to listen and to work with industry is clearly demonstrated by the participation in this workshop of Peter Marks, M.D., Ph.D. , who is the director of the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). He will be participating in this Workshop and will be available to take questions from attendees. The FDA also signaled in May to be considering new criteria for human cells, tissues, and tissue-based products to not be regulated as BLAs.
As recently as October 4th, the FDA announced the creation of a new “Super Office” within the Center of Biologics Research and Evaluation (CBER).
The 8th Perinatal Congress is being held at a critical junction for the perinatal stem cell and biologics field. It is critical for the industry to come together now to communicate with the FDA the struggles that the industry is facing. The current regulatory pathway makes it incredibly difficult for smaller companies to achieve success. Companies such as Celularity and Mesoblast, which have market caps of hundreds of millions of dollars, are struggling to reach market approval. If these companies are unable to successfully work the current IND process to bring a product to the market through the regulatory pathways that exist in the United States, then what hope is there for smaller companies?
If companies feel like the traditional pathways are not viable, then they resort to actions that are not beneficial for patients. Corners are cut and aggressive marketing takes place, and it is the patient that suffers.
Currently, many companies are seeking to open offshore clinics or to partner with offshore clinics, because this is a way to bring their product to patients and to make revenue. It is a shame that the current situation in the United States is forcing the best companies from our country to do business in Mexico, Colombia, Costa Rica, Honduras, Panama, and other countries worldwide that have opened their arms to stem cell and biologic therapies.
I believe that it is important to work with U.S. FDA and that the FDA is more willing to partner with Industry than ever before, especially in light of Supreme Court recent rulings. In these rulings, the Supreme Court has ignored the question of Agency Deference, and in doing, sets up a potential new precedent that the agency is no longer entitled to deference. This sea change position sets the stage for the recent court case between the U.S. FDA and Cell Surgical Network, in which the FDA suffered a significant loss.
It is for this reason that there is now an opportunity to work with FDA as partners to create new IND pathways for biologics and stem cell therapies, so that U.S. companies can ultimately secure market approvals.
The point of this conference is that companies wish to work with the U.S. FDA, not to circumvent the regulatory agency. We want to do business in the United States and we also want safety parameters that protect patients. A robust regulatory system is the best way to do this, but we need a regulatory system that allows for achievable success.
It is time for a paradigm shift that enables companies to actually make it to the market with stem cell and biologic products. To date, there has not been one regenerative medicine, stem cell, or biological product that has gained market approval. This is unacceptable. It is 2022. Many of us have been working in this space for 20 – 30 years without one company achieving success.
With the White House putting out an executive order to enhance the United States Biotech space—and the U.S. Department of Health and Human Services (HHS) taking action in response to this White House order—I believe there is real opportunity to make progress.
I hope that you can join the Perinatal Stem Cell Society on Thursday, November 3, 2022 at the Westin in Fort Lauderdale, Florida, for the 8th Perinatal Stem Cell Society Conference/Workshop.
To register, please visit Perinatalstemcells.com.
Sincerely,
Kyle Cetrulo
Founder and President since 2013
International Perinatal Stem Cell Society Inc. (501(C)3 Nonprofit Corporation
www.perinatalstemcells.com