Next Wednesday, October 12, at Outsourcing in Clinical Trials New England 2022, Asymmetrex® President and CEO, James L. Sherley M.D., Ph.D., will discuss the impact of the recent introduction of technologies for stem cell dosing on the clinical trials outsourcing industry. This development in stem cell science and medicine will impact pharmaceutical drug development as well as stem cell clinical trials.
The OCTNE 2022 conference, taking place in Boston on October 12-13, is one of Arena International’s premiere industry meetings for bringing together sponsors of clinical trials with their outsourcing partners. Most of the content and focus of the meeting will be on how to improve the flow of essential products and services to clinical trial sponsors for the best experiences and medical outcomes for clinical trials subjects and patients.
Like previous OCTNE conferences, the primary focus of the October 2022 event will be outsourcing for pharmaceutical clinical trials. However, each year, as the regenerative medicine field continues to grow, so has the amount of attention given to outsourcing for cell therapy clinical trials, including stem cell therapy trials and gene therapy trials.
In recent years, stem cell biotechnology company Asymmetrex® has been a major proponent and participant for increasing attention in OCTNE conferences to developments in the supply and outsourcing of stem cell clinical trials and gene therapy clinical trials. Gene therapy trials fall under the Asymmetrex® focus for outsourcing, because many gene therapies required the successful genetic-engineering of tissue stem cells, like blood hematopoietic stem cells.
In past OCTNE presentations, Asymmetrex® President & CEO, James L. Sherley, M.D., Ph.D., anticipated the introduction of Asymmetrex’s lead innovation, kinetic stem cell (KSC) counting, into the stem cell marketplace. Now, after Asymmetrex’s introduction of online calculators for determining the specific dosage of therapeutic tissue stem cells in September of this year, Sherley plans to tell OCTNE 2022 attendees that “Stem cell dosage determination will transform the stem cell clinical trials industry, including its outsourcing.”
Asymmetrex is now partnering with automated cell counter producer OMNI Life Science to introduce the first instrument, called the CASY-PLUS, for automated rapid counting of therapeutic tissue stem cells. This capability will enable stem cell clinical trials sponsors to know the exact dosages of the stem cells in the treatments they administer to their patients for the first time in the more than half century history of stem cell medicine. Outsourced suppliers of stem cell products and stem cell culture reagents will soon need to provide dosage data, too.
The pharmaceutical and biopharmaceutical industries are not left out of the benefits of stem cell dosage determination. The KSC counting technology can be deployed for earlier detection of drug candidates that are toxic to stem cells. Stem cell-toxic drugs cause chronic organ failure, which results in an estimated $4 billion loss for pharmaceutical companies each year. With increasing validation of the utility of KSC counting for stem cell clinical trials, Sherley expects that Pharma will eventually join for the benefits of knowing the dosage of stem cells as well.
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 – stem cell-specific quantification and stem cell expansion – that have stood in the way of more-effective use of human adult tissue stem cells for regenerative medicine and drug development. Asymmetrex markets kinetic stem cell (KSC) counting, the first technology for determination of the dose and quality of tissue stem cell preparations for use in stem cell transplantation medicine and pre-clinical drug evaluations. Asymmetrex® is a member company of the Advanced Regenerative Manufacturing Institute|BioFabUSA (ARMI) and the Massachusetts Biotechnology Council (MassBio). The company’s development of online calculators for rapid stem cell counting has been funded by R&D grants from ARMI|BioFabUSA and the National Heart, Lung, and Blood Institute.