March 11, 2003, Summary
NIH Stem Cell Task Force
James Battey, NIDCD, (Chair); Arlene Chiu, NINDS; Greg Downing, NCI; Robert Hammond, NIDDK; Della Hann, OD/OER; Mahendra Rao, NIA; Pam Robey, NIDCR; Robert Strausberg, NCI; Richard Tasca, NICHD; John Thomas, NHLBI; Judith Vaitukaitis, NCRR
Tom Johnson, OD/OSP; William Lehmann, Athersys, Inc.; Richard Roblin, President's Council on Bioethics; Gil Van Bokkelen, Athersys, Inc.; Catherine Verfaillie, Univ. of Minnesota; Anne White-Olson, NIDCD; Craig Whitney, Quayle and Associates; Baldwin Wong, NIDCD
Dr. Battey welcomed the members to the fourth meeting of the NIH Stem Cell Task Force and thanked them for their time commitment.
II. Approval of January 10 Meeting Minutes
The Task Force approved the minutes of the January 10, 2003, meeting. The summary will be posted on the NIH Stem Cell Task Force Web site at http://stemcelltaskforce.nih.gov/policy/taskForce/tfSummaries/01_10_03.asp.
III. Discussion of Peer Review of Stem Cell Science Working Group Suggestions
The Peer Review of Stem Cell Science Working Group met on February 20, 2003, to assist the Task Force by making suggestions on ways to improve NIH's process of reviewing grant applications on human embryonic stem cell (hESC). The working group suggested that: 1) hESC applications be directed to a limited number of existing study sections in the NIH Center for Scientific Review (CSR) that possess the experience and expertise to address the quality of stem cell research; 2) orientation of the scientific review administrators (SRAs) and study section members be enhanced with respect to issues unique to hESC applications; and 3) grant applications for descriptive, less hypothesis-driven research relevant for advancing knowledge in stem cell biology be solicited and evaluated through a special emphasis panel.
Several Task Force members reiterated the importance of orienting the SRAs to hESC issues and stated that whatever orientation information the SRAs use should be shared with the IC scientific program staff who have hESC grant portfolios. It is also important for the grant application to list the name of the hESC line being used in the research. Dr. Chiu cited an example where a reviewer could not determine if the cell line in the application was one of the lines eligible for Federal funding. The Task Force suggested that the NIH Human Embryonic Stem Cell Registry clearly indicate all the derivations that are eligible and this list could be a resource for SRAs and investigators.
IV. Update on NIH Stem Cell Symposium, June 12, 2003
Mr. Wong announced the plans for the June 12 NIH Stem Cell Symposium (NIH Research: Recent Progress and Future Promise of Human Embryonic Stem Cells) are well underway. The morning session of the symposium will include a plenary session consisting of presentations by extramural and intramural scientists. The afternoon will include workshops and poster sessions. Dr. Zerhouni is scheduled to give closing remarks at the plenary session. Online registration for the symposium can be found at http://www.masimax.com/nihstemcells/ [link no longer active].
The Task Force suggested that the morning presentations include a session on the characterization of undifferentiated stem cells and that appropriate speakers for this topic would be Ron McKay, Bob Strausberg, Mahendra Rao and Steve Goldman.
Dr. Hammond and Dr. Vaitukaitis reminded the Task Force that a meeting of all the Infrastructure grantees would be held on June 13. The Task Force suggested that details of the Infrastructure meeting be announced at the next Task Force meeting.
Dr. Thomas mentioned that some researchers believe that several of the available hESC lines are getting old and transforming. Dr. Battey emphasized the need of the NIH stem cell characterization unit to provide a side-by-side comparison of the available lines. Dr. Rao stated that assays should be performed routinely when maintaining cells for long periods in order to check for cell transformation. Such assays would examine cell surface markers, karyotyping, SNP typing, mitochondrial sequencing, and methylation pattern and gene expression.
V. Supporting Technologies/Research Tools Working Group Meeting
Dr. Battey announced that the next working group meeting is tentatively scheduled for May 8. The working group will provide suggestions to the Task Force on steps NIH could take to improve and develop new tools and technologies to support basic research in the new field of hESC biology. Several Task Force members announced that other stem cell meetings are scheduled for May 8 which may conflict with the working group meeting. Therefore, Dr. Battey will explore an alternate date for the meeting of the supporting technologies/research tools working group.
Dr. Downing emphasized the importance of the working group and its effort to develop the technologies and tools needed to move stem cell research forward. He suggested that NIH could also employ the SBIR/STTR mechanisms to fund private sector companies that have the expertise to produce these tools and technologies. The Task Force then discussed examples of how SBIR grants, as well as cooperative agreements, could be used to develop non-hypothesis driven research tools and technologies that can be used in clinical applications. Dr. Battey agreed to raise these ideas at the upcoming working group meeting. Dr. Downing proposed that NIH sponsor a workshop later this year to explore ways for NIH to interact with small businesses on stem cell research.
VI. Identification of Issues for Task Force Consideration
Dr. Hammond announced that Dr. Allen Spiegel recently represented the Task Force at a meeting with Secretary Thompson and Terrance Dolan, Director of the Fitchburg Technology campus in Wisconsin. Dr. Dolan is seeking support for construction and operation of a contract production facility that would provide services including scaled-up GMP culture of stem cells suitable for clinical trials. Dr. Hammond suggested if the Task Force is interested in learning more about Fitchburg Technology, the Task Force could invite Dr. Dolan to a make a presentation at a future meeting.
Dr. Hammond also announced a meeting he had with Dr. Jeanne Loring, formerly with Arcos BioScience, who is serving as a scientific consultant on CyThera's infrastructure grant. She specializes in fostering alliances between academia and industry and would like to share her ideas with NIH. The Task Force suggested that Dr. Loring's expertise would be helpful at the workshop that Dr. Downing proposed.
VII. Presentation by Athersys
Athersys, Inc. is a biopharmaceutical company that is collaborating with Dr. Catherine Verfaillie (University of Minnesota) on her research using multipotent adult progenitor cells (MAPC) isolated from bone marrow. Dr. Gil Van Bokkelen, President and CEO of Athersys, presented the company's mission and goal of establishing a national public-private initiative in stem cell research and regenerative medicine. This collaboration would make available proprietary and enabling technologies from Athersys to NIH and other nonprofit centers. These technologies include MAPC, Random Activation of Gene Expression (RAGE), and GEnome-wide Cell-based Knock Out (GECKO) to NIH and other nonprofit centers on a collaborative basis.
The meeting adjourned at 11:05 a.m.
If you have questions about the Task Force, please contact:
Science Policy and Planning Branch
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and Other Communication Disorders, NIH
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Phone: (301) 402-2313
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