VIRC Courses

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Please see below for more information on VIRC-developed courses taught at UC Davis

Vertically Integrated Projects (VIP) Program: POTENCY

SAS 098/SAS 198 (Starting Fall 2016)

The Challenge: Development of cellular therapies for clinical use in animals and people involves a concerted effort by a sponsor to fully understand the final formulated product as it relates to identity, purity, sterility, stability and bioactivity. In particular, demonstration of potency (the dose needed to observe a desired response), and efficacy (whether the needed response is achievable at any dose that does not produce toxicity) are clearly defined by the FDA. Cellular therapies must show “the specific ability or capacity of the product, as indicated by appropriate laboratory test or by adequately controlled clinical data obtained through the administration of the product in the manner intended, to affect a given result”.  This purposely vague definition invites interpretation as to how potency and efficacy should be handled in the context of cellular therapies.  As such, several leaders in the field of regenerative medicine have defined potency as “a quantitative measure of relevant biologic function based on the attributes that are linked to relevant biologic properties”.  From this definition it is clear, that assays that predict potency and efficacy should be: 1) Quantitative, 2) Related to the products mechanism of action (MOA), and 3) Functional/biological.  Despite this guidance, industry continues to struggle with developing robust quantitative platforms to test regenerative medicine therapeutics for both potency and efficacy. Additionally, there exist no standards to validate the hundreds of potential assays that could be used for stem cell testing.   The goal for the POTENCY VIP team is to create and qualify a “universal”, off the shelf, assay platform that could be used to quantitatively predict potency and efficacy and toxicity of stem cell products before release to a patient (see figure, right).  The long-term goal of the POTENCY Project Team will be to devise and validate relatively high throughput, high content, in vitro assays to test multiple samples/batches of stem cell products in parallel before they are considered further for use in animals or humans as potential regenerative cures. This project requires a multidisciplinary team of mentors that will draw students with academic pursuits in molecular and cellular biology, biomedical engineering, biotechnology, and physiological sciences. The POTENCY project mentoring team will be drawn from faculty residing in the School of Veterinary Medicine, School of Medicine and College of Engineering.

Instructors

David Simpson, VIRC Associate Director, Assistant Adjunct Professor – dlsimpson@ucdavis.edu

Isaac Pessah, Associate Dean of Research and Graduate Education School of Veterinary Medicine, Professor of Molecular Biosciences – inpessah@ucdavis.edu