In October 2018, I had the honor of participating in a workshop hosted by The National Academies of Sciences, Engineering and Medicine Forum on Regenerative Medicine in Washington, DC where a broad array of stakeholders, including academic and industry experts, regulators, clinicians, patients and patient advocates met to discuss the various factors that contribute to successful regenerative engineering products.

During the workshop, we explored several factors and sources of variability in the development and clinical application of regenerative engineering products, characteristics of high-quality products, and how different clinical needs, models and contexts can inform the development of a product.

Following that discussion, DiscGenics was invited to contribute a manuscript to Regenerative Engineering and Translational Medicine (RETM) focused on identifying and managing sources of variability in cell therapy manufacturing and clinical trials. Topics covered in the review include criteria for the two potential regulatory pathways for cell therapy products in the U.S. (see my previous blog post about the difference between manufactured and minimally manipulated cell therapies); aspects involved in reproducibly manufacturing cell therapy products; and considerations for successful execution of clinical trials.

I’m proud to share that the manuscript was published in the September 2019 online edition of RETM alongside several other papers from contributors to the workshop. I’d like to thank my fellow authors, Dr. Lara Ionescu Silverman, Daniel Rodriguez-Granrose, Katie Simpson, Lindsey Hart Saxon and Dr. Kevin T. Foley for their excellent work in developing this seminal manuscript.

RETM is an international journal published by Springer-Nature covering convergence (the deep integration) of the disciplines of advanced materials science, stem cell research, the physical sciences, developmental biology, and clinical translation.