Business of regenerative medicine: comparability and the regulatory revolution

Join our international panel for part two of their discussion.

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Jul 09, 2018
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In the second part of our expert panel on the business of regenerative medicine, learn more about how comparability and regulation can affect a regenerative medicine’s path to commercialization. 

Plus, our panelists share their experiences of regulatory systems around the world.

Chaired by Michael May, CCRM, this panel discussion focuses on the key business challenges within regenerative medicine. Joining Michael were four leading voices in regenerative medicine and cell therapy, from research to manufacture: Robert Preti (Hitachi Chemical Advanced Therapeutics Solutions, LLC), Robert Jones (Fisher Bioservices), Carolyn Yeago (Georgia Institute of Technology) and Qasim Rafiq (UCL).

Meet the panelists

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1 Comments

Go to the profile of James L. Sherley, M.D., Ph.D.

Excellent discussion!  This panel of experts and leaders in advancing stem cell regenerative medicine provides an excellent discussion of the unmet need of a means to define the "identify, purity, and potency" of stem cell therapy products.  They highlight the importance of defining these essential factors for improving manufacturing, storage, transport, and administration of stem cell treatment products.

What puzzles us at Asymmetrex is why some of the same panelists have been reluctant to evaluate our AlphaSTEM Test^TM technology that was developed to meet this unmet need.    Asymmetrex has approached three of the panelists or their organizations about evaluating our technology.  The AlphaSTEM Test^TM technology provides the first-in-kind determination of the specific stem cell dose of complex cell preparations, including production cultures and treatment products.  In addition, the technology can determine what fraction of the quantified tissue stem cells are functional for tissue cell renewal.  These are the two essential standards that stem cell regenerative medicine needs to define the "identify, purity, and potency" of stem cell therapy products.

It strikes us at Asymmetrex that a crucial question for the stem cell regenerative medicine field, company CEOs, government funders, investors, and patients is,  "Why are some of these panelists and others like them in the stem cell supply business not evaluating Asymmetrex's validated AlphaSTEM Test^TM  technology?" 

James L. Sherley, M.D., Ph.D.

Founder and Director, Asymmetrex LLC