How can we outsource stem cell clinical trials without counting tissue stem cells?
October 01, 2020
Adapting to the present COVID crisis, this year the 2020 Outsourcing in Clinical Trials USA Conference, one of several international clinical trials supply trade conferences organized by Arena International Events Group each year, adopted a virtual meeting format. The conference, scheduled for September 30-October 1, continued its tradition of bringing together contract research organization suppliers and company sponsors in the clinical trials supply industry to discuss new developments and best practices.
Among the many industry members invited to speak in the event, James L. Sherley, M.D., Ph.D., founder and director of Massachusetts stem cell biotechnology company Asymmetrex, presented on September 30. Dr. Sherley’s presentation highlighted a growing new area of the clinical trials supply industry. More and more, the clinical trials supply industry is considering better technology and practices to support stem cell clinical trials and gene therapy clinical trials that utilize advanced therapy medicinal products. In particular, Dr. Sherley discussed the value of implementing new quantification technologies for ATMPs developed with tissue stem cells. He answered the rhetorical question that was the title of his talk – “How can we outsource stem cell clinical trials without counting tissue stem cells?” – by detailing places in ATMP supply chains where instituting counting technologies would provide significant benefits to the stem-gene clinical trials supply industry and the patients it serves.
Sherley also presented innovation proposals for traditional pharmaceutical and biopharmaceutical clinical trials supply. He described how tissue stem cell counting technologies represented advantages both for discovery of novel drugs and for toxicology evaluations of new drug candidates. A major value presented was the opportunity for drug companies to realize hundreds of millions of dollars in reduced costs each year by using tissue stem cell counting tests for earlier identification of drugs that would fail late in clinical trials because of inducing chronic failure of organs and tissues like the liver and bone marrow. Currently applied animal toxicology studies miss many drugs with this disastrous character. Sherley described how such drugs could be detected in inexpensive cell culture tests by counting how stem cell-specific number and viability changed in their presence.
Though not a main focus of the presentation, Sherley ended his presentation with acknowledgement of Asymmetrex’s recent introduction of the first-in-kind technology for counting therapeutic tissue stem cells and determining their dosage. The company holds issued patents for the technology and its use for drug evaluations in both the U.S. and U.K. In August of this year, it published a peer-reviewed report, co-authored with its partner AlphaSTAR Corporation, that describes the new method and its applications for stem cell therapy and drug evaluations. In September, the company was awarded a research and development grant from the National Institutes of Health-National Heart, Lung, and Blood Institute for continued development of the technology and its commercialization. These plans for the company’s AlphaSTEM Test™ tissue stem cell counting technology were recently reported.
Asymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. The company’s U.S. and U.K. patent portfolio contains biotechnologies that solve the two main technical problems – production and quantification – that have stood in the way of effective use of human adult tissue stem cells for regenerative medicine and drug development. Asymmetrex markets the first technology for determination of the dose and quality of tissue stem cell preparations (the “AlphaSTEM Test™”) for use in stem cell transplantation therapies and pre-clinical drug evaluations. Asymmetrex is a member company of the Advanced Regenerative Manufacturing Institute BioFabUSA and the Massachusetts Biotechnology Council.
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