April 7, 2004, Summary
NIH Stem Cell Task Force
James Battey, NIDCD (Chair); Arlene Chiu, NINDS; Daniela Gerhard, NCI; Mahendra Rao, NIA; Pam Robey, NIDCR; Allen Spiegel, NIDDK; Richard Tasca, NICHD; John Thomas, NHLBI; Judith Vaitukaitis, NCRR
Laura Cole, NIDCD; Donald Fink, CBER/FDA; Walter Schaffer, OD/OER; Jack Spiegel, OD/OTT; Anne White-Olson, NIDCD; Baldwin Wong, NIDCD
Dr. Battey welcomed the members to the ninth meeting of the NIH Stem Cell Task Force and thanked them for their continued commitment. He announced that NIH testified on the FY 2005 budget at the Senate Labor/HHS/Education Appropriations Subcommittee hearing on April 1. During the hearing, the Subcommittee asked Dr. Zerhouni and Dr. Battey several questions about stem cell research. The House appropriations hearings for NIH are scheduled for April 21-22. Dr. Battey also announced that this Fall's NIH Research Festival will include a symposium on stem cell research. Some members of the NIH Stem Cell Task Force, as well as other NIH intramural scientists, will be invited to present their stem cell research at the Festival.
II. Approval of January 6, 2004 Meeting minutes
Dr. Vaitukaitis suggested that a paragraph from the January 6, 2004 meeting minutes be revised to read: "Create New Tools and Technologies. Supplements to infrastructure grants may be used to meet the goal of developing feeder-free media and other expansion technologies for hESCs. SBIRs can support development of reagents and technologies. With adequate justification, phase I and 2 SBIR applications may be consolidated ("Fast Track") to provide levels of funding considerably greater (e.g., $1 million dollars) than the traditional SBIR applications." The Task Force approved the remaining text of the January meeting minutes, which will be posted on the NIH Stem Cell website at http://stemcells.nih.gov/policy/taskForce/tfSummaries/pages/2004_01_06tfs.aspx
III. Third-Party Stem Cell Distribution
Dr. Rao expressed the research community's need for having a single distributor of human embryonic stem cells (hESCs) that are well characterized, have undergone strict quality control, are easy to obtain, affordable, and meet eligibility criteria for use in federally funded research. Upon hearing these needs from members of the research community, Dr. Rao has learned of a third party who is interested in providing this service. The Task Force inquired about the rights within the WARF patent and how this may permit a third party hESC distributor. The rate of progress of hESC research can be greatly accelerated by the presence of a third party distributor. NIH needs additional information about the WARF patent and the Geron license before such a proposal can be considered.
IV. Third-Party Stem Cell Training
Dr. Thomas announced that he has received a letter from a company that is interested in receiving NIH funding to teach a course on culturing hESCs. Currently, the enrollment in the five NIH-supported T15 short-term stem cell training course have been full, so this may justify the need for additional courses. NIH will be hosting the first annual meeting of the T15 instructors this June, so a better assessment of the need for future courses will be determined after this meeting. The Task Force suggested that this company be invited to present at a meeting of the NIH Stem Cell Implementation Committee.
V. Comparative Stem Cell Biology/Stem Cell Core
With efforts already underway by the NIH Stem Cell Unit to conduct side-by-side comparisons of the hESCs available on the NIH Stem Cell Registry, there is the possibility of expanding the activities of the Unit. Dr. Robey presented a proposal that will use the efforts of the Unit to conduct comparative studies between adult stem cells with hESCs. This would pave the way for establishing an NIH intramural stem cell core that can be used by the NIH institutes and centers. The Task Force discussed whether comparatives studies of this type are already being conducted by extramural scientists and requested examples of such studies. In addition, obtaining laboratory space and funding for this proposal will be a challenge. Questions were raised about the review, oversight and data sharing of these new activities that are proposed. Further discussions on this topic can be scheduled at another Task Force meeting. Currently, there is an Intramural Stem Cell User's Group for investigators exploring clinical applications of stem cell research. There is renewed interest among intramural scientists for convening a stem cell interest group for basic scientists.
VI. Fellowship Grants for Stem Cell Research
NIH recognizes that an important step in advancing the hESC research program is to develop a cadre of trained stem cell biologists. What are needed are grants supporting training of scientists at the individual and institutional level. Dr. Battey announced that NIGMS is developing an initiative that will fund individual fellowship grants specific for hESC training. The Task Force commended this effort and will determine the need for future training initiatives after assessing the level of interest from the research community.
VII. FY 2004 NIH Stem Cell Project Reporting
For the past two fiscal years, NIH institutes and centers have been reporting their hESC funding by reconciling their institute scientific coding systems with IMPAC II. Because these two systems contained different funding data, it was extremely difficult to resolve end-of-year budget reporting by reconciling between the two systems. In addition, the IMPAC II system did not contain funding data for research contracts or intramural projects. Dr. Battey met with representatives from the NIH Office of Budget and the Office of Extramural Research to establish a plan whereby future NIH reporting of hESC research projects will be based on the individual IC's scientific coding system instead of IMPAC II. Grants using hESCs will no longer be identified as such in IMPAC II (the check box will be eliminated). Members on the NIH Stem Cell Implementation Committee will have the final responsibility for reporting hESC research funding for their IC. Guidance for reporting FY 2004 hESC dollars are still being developed and will provided to the ICs soon.
VIII. Identification of Issues for Task Force Consideration
Dr. Gerhard announced progress in NCI's efforts to generate transcriptome data from hESCs and their derivatives. Recently, the NCI's Cancer Genome Anatomy Project has added hESCs to the list of cells that are analyzed by Serial Analysis of Gene Expression (SAGE). Currently the SAGE database contains one hESC library (WA09) but data from more cell lines will be available later this year. Information will also be posted on the NIH stem cell web site.
Some members of the Task Force expressed concern that hESC grant applications are doing poorly in NIH review committees. Although the NIH Center for Scientific Review (CSR) is providing guidance to the study sections assigned to review hESC grant applications, there still appears to be a lack of consideration for special issues surrounding this new field of research among the reviewers. Dr. Battey agreed to discuss the Task Force's concerns with CSR.
The Task Force discussed the need for re-issuing announcements for Administrative Supplements for hESC research. Drs. Spiegel, Thomas, Chiu, and Tasca described how their respective institutes supported the supplements. The Task Force agreed that Administrative Supplements or a similar mechanism continues to help scientists incorporate hESCs into their existing research project.
Dr. Rao asked the Task Force for clarification on how research that uses hESCs on the NIH Stem Cell Registry and non-eligible hESC lines should be parsed. Under the President's hESC policy, federal funds cannot be used to support research using non-eligible lines or derivatives of these lines. The Task Force also discussed whether an NIH-supported scientist could serve as a co-author on a manuscript that is using non-eligible lines. If the research paper clearly explains that federal funds were not used to conduct research using non-eligible cell lines, the Task Force agreed that it should be allowable.
The next meeting of the Stem Cell Task Force is tentatively scheduled for Tuesday, July 20, 2004, 9:00–11:00 AM, 31/3C05. The meeting adjourned at 11:00 AM.
If you have questions about the Task Force, please contact:
Science Policy and Planning Branch
National Institute on Deafness
and Other Communication Disorders, NIH
Bethesda, MD 20892
Phone: (301) 402-2313
Fax: (301) 402-2265