Released on: March 19, 2008, 4:13 pm

Press Release Author: Malcolm Moos

Industry: Biotech

Press Release Summary: Malcolm 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.



Press Release Body: 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, infogtcbio@gtcbio.com




Web Site: http://gtcbio.com

Contact Details: Contact: GTCBIO 434 W Foothill Blvd., Monrovia, Ca. 91016(626)
256-6405, (626) 256-6460 fax, infogtcbio@gtcbio.com