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0 The Start of Mass Commercialization of Human Embryonic Stem Cell Lines?

BioTime, Inc. today announced an agreement with the California Institute for Regenerative Medicine (CIRM) to make five clinical-grade human embryonic stem (hES) cell lines available to California-based researchers. CIRM is the stem cell agency created when California voters supported a $3 billion funding measure for stem cell-related research and clinical translation. Under the agreement, BioTime will initially provide research grade cell lines, and within one year, BioTime will also make available GMP-grade cell lines along with certain documentation and complete DNA sequence information. The parties anticipate that the use of the GMP grade cell lines may streamline the translation of basic science to human therapies. Should the users of the cell lines and BioTime eventually sign definitive license agreements for commercial use of the cell lines, BioTime will receive a royalty on net sales.
Human embryonic stem cell lines are expandable populations of cells with the potential to generate all human cell types. However, there are many scientific and technological steps that are necessary in order to turn this potential into a reality. In recent years, research conducted around the world has shown promising results for hES cell-based therapies for a wide range of diseases. But in order to develop effective therapies for use in humans that will meet the regulatory standards of the United States Food and Drug Administration (FDA) and other regulators, the cell lines that are used to develop those therapies must fully comply with the strict current Good Manufacturing Practice (cGMP) quality standards that apply to all drugs and devices. The creation of such cell lines is a substantial undertaking.
 The GMP grade versions of these cell lines along with a letter of cross-reference to a biologics master file containing manufacturing and controls information and additional documentation needed to establish GMP compliance, and the complete genomic DNA sequence information on the cell lines, will be available to California-based researchers at a price approximating BioTime’s cost of materials by November 22, 2011. Although no royalties will be payable to BioTime by researchers who acquire the cell lines for research use, entities that desire to use the GMP-compliant cell lines for therapeutic or other commercial purposes, may do so only after signing commercialization agreements acceptable to BioTime and entitling BioTime to receive royalties on net sales not to exceed 2.0% of net sales, reducible to 1.5% if the researcher must pay any other royalties in connection with the resulting product commercialization.
The researchers will be responsible for obtaining any licenses that may be needed from third parties to use the GMP cell lines in their products. Lastly, the form of a material transfer agreement has been agreed to by CIRM and BioTime for research use. The pre-negotiation of terms will serve to help accelerate research by eliminating protracted negotiations.
“We believe this agreement is in the best interests of both the people of California and BioTime,” said Michael D. West, Ph.D., BioTime's President and CEO. “There are at least three potential benefits to the parties: First, access to cGMP-manufactured cell lines may help CIRM-funded researchers accelerate their work in a wide array of new cell-based therapies and drugs, and more quickly translate the research into improved medical outcomes for people with difficult to treat diseases. Second, the publication of the research results using these cell lines may benefit BioTime's own work to better understand the characteristics of the lines when used to manufacture human therapeutics. Lastly, BioTime may benefit from future commercial revenues from products developed as a result of this collaboration through a royalty-bearing license. The development of standards and open platforms often allows new fields of science and technology to move forward more quickly. We are grateful to the vision of CIRM in working with industry to advance this exciting science into the clinic.”
A sixth cell line designated ESI-049 is currently being evaluated by a large pharmaceutical company for exclusive use and was therefore not included in the collaborative agreement with CIRM. BioTime will retain the rights to manufacture its own research and therapeutic products from the cell lines. Additional information on the agreement is available on BioTime’s website at

After a little research I learned that are a part of  Hadassah International
which was founded by Bernice S. Tannenbaum 
who's bio tells that among other thing's she: served as National President of Hadassah, the Women’s Zionist Organization of America from 1976 to 1980. In the late 1990s she chaired the Strategic Planning Committee that proposed the creation of The Hadassah Foundation, and for the past decade she has been the Foundation’s Liaison to Hadassah’s National Board.

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