Malcolm Moos, Medical Officer of Division of Cellular and Gene Therapies at FDA to give Featured Presentation at the 4th International Stem Cell Research & Therapeutics, Apr 17-18, 2008 in Boston, MAMalcolm Moos, Medical Officer of the Division of Cellular and Gene Therapies at the Food and Drug Administration (FDA) will give the featured presentation at the 4th International Stem Cell Research & Therapeutics, Apr 17-18, 2008 in
Boston, MA.
At the conference, Dr. Moos will discuss product characterization questions and challenges in cell-based therapies. Therapeutic interventions with cells or engineered tissues promise to provide effective treatments for conditions refractory to conventional approaches. Notwithstanding this potential, development of such products poses new obstacles. Because living cells and tissues cannot be sterilized, microbiological safety is an even greater concern than for conventional biologics. The difficulty is compounded by product shelf lives that are often short, so 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.
Another challenge is identification of analytical procedures that can predict the clinical performance of these products reliably. A crucial technological issue is that these products are highly complex with respect to the analytical methods available for their characterization and analysis. A formidable problem for products consisting of single cell types, it is even more challenging for products containing mixed cell populations. Furthermore, analytical characteristics associated with both desirable and undesirable in vivo characteristics of these products may be unknown, necessitating a well-planned and comprehensive set of development studies to characterize them analytically and ultimately select tests suitable for monitoring product manufacture and ultimately as product release specifications. During the presentation, Dr. Moos will explore these questions and discuss possible strategies for addressing them in a practical manner.
The conference also features presentations from other leading organizations such as Genzyme, Geron, Joint Committee on Health Care Financing (by Senator Richard Moore), Merck, MIT, Novartis, Pfizer, Sangamo BioSciences, Sanofi Aventis, Stemagen, UCSB, University of Van Amsterdam, Whitehead Institute, and many more. The full agenda is available online at www.gtcbio.com.
GTCbio’s 4th Stem Cell Research & Therapeutics will take place on April 17-18, 2008 in Boston, MA and will cover Stem Cell Biology, Adult Stem Cells, Embryonic Stem Cells, Differentiation of Stem Cells, Epigenomics & Reprogramming of Stem Cells, Regenerative Medicine & Therapeutics, Stem Cell Imaging, Regulatory Aspects & Funding Opportunities, Cancer Stem Cells, and Stem Cell Applications in Drug Discovery.
For more information including a detailed agenda, exhibitor opportunities and registration information visit http://gtcbio.com/userAgenda.aspx?id=120 ABOUT GTCbio GTCbio organizes conferences specifically for the biomedical and biopharmaceutical industries. Our goal is to facilitate the exchange of biopharmaceutical and biomedical intelligence between industry leaders, academic and government organizations, and the financial community. GTCbio is a subsidiary of Global Technology Community, LLC, a privately held company founded in 2002.Contact: GTCBIO
(626)
256-6405,
(626)
256-6460 fax, [email protected]
