Malcolm Moos of FDA/CBER/OCTGT to Present at the Stem Cell Summit 2013 on Apr. 29-30, 2013 in Boston
Malcolm Moos, Medical Officer of Cellular,Tissue and Gene Therapies at the Center for Biologics Evaluation and Research of FDA will present on "Characterization of cell-based regenerative medicine products-current challenges and possible solutions" at the Stem Cell Summit 2013 on April 29-30, 2013 in Boston, MA.
- (1888PressRelease) April 12, 2013 - Therapeutic interventions with cells or engineered tissues promise to provide effective treatments for conditions refractory to conventional approaches. However, development of such products poses new obstacles. Because living cells and tissues cannot be sterilized, microbiological safety is an even greater concern than for other regulated products. The difficulty is compounded by product shelf lives that are often so short that conventional safety testing using compendial methods is not practical. Though rapid methods are under development, there is limited experience with these techniques, and their use may require careful qualification studies.
Variability observed both in preclinical experiments and clinical studies with cell-based products suggest the possibility that heretofore unidentified subpopulations within a heterogeneous product may exert a disproportionate effect on product effectiveness or safety. This uncertainty could confound pivotal trials needed to establish clinical effectiveness. During the presentation, Dr. Moos will explore these questions and discuss possible strategies for addressing them in a practical manner, first to meet regulatory requirements for initiation of human trials, and subsequently for marketing approval.
Dr. Malcolm Moos Jr. is a Medical Officer at FDA/CBER/OCTGT that supports regulatory decisions in the emerging area of cellular therapy. His current research interests are to define how evaluating the status of major cell signaling pathways (BMP, Wnt, etc.) can be used in conjunction with recent developments in systems biology to characterize cell-based products more accurately and to improve product design. His awards include the Harvey W.
Wiley Medal, the Center Director's Targeted Research Award (twice), the Center Director's Distinguished Service Award, and thirty-one others.
Stem Cell Summit 2013 includes two parallel tracks and this summit provides cutting-edge information on developments in all areas of stem cell research including the biology, medicine, applications, regulations, and commercialization of stem cells.
Track A: Stem Cell Research & Regenerative Medicine:
Joint Session: Funding Opportunities
Joint Session: Regulatory Guidance & Updates
Session: Advances in iPS & ES Cells
Session: Advances in Adult Stem Cells
Session: New Paradigms for Cell Therapy
Track B: Stem Cell Commercialization & Partnering:
Joint Session: Funding Opportunities
Joint Session: Regulatory Guidance & Update
Session: Novel Technologies in Stem Cell Research
Session: Overcoming Challenges in Clinical Development
Session: Commercialization: Bringing Therapeutics to Market
Session: Partnerships & Acquisitions
Summit Agenda: www.gtcbio.com/stemcellsummit/agenda
Summit Speaker List: www.gtcbio.com/stemcellsummit/speakers
For more information, please visit www.gtcbio.com
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