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September 20, 2005, Summary

NIH Stem Cell Task Force

Members Present:

James Battey, NIDCD (Chair); Barbara Alving, NCRR; Tony Beck, NCRR; Ron McKay, NINDS; Mark Rohrbaugh, OD/OTT; Richard Tasca, NICHD; John Thomas, NHLBI; Elizabeth Wilder, NIDDK; Marion Zatz, NIGMS

Other Participants:

Anne Clark, CSR; Laura Cole, NIDCD; Sherry Dupere, CSR; Donald Fink, FDA/CBER; Tom Johnson, OD/OSP; Lisa Montney, NIDCD; David Owens, NINDS; Anne White-Olson, NIDCD; Baldwin Wong, NIDCD

I. Welcome

Dr. Battey, Chair of the NIH Stem Cell Task Force, welcomed the participants to the fourteenth meeting of the Task Force.

II. Approval of Meeting Minutes

The Task Force approved the text of the May 6, 2005, meeting minutes, which will be posted on the NIH Stem Cell website at http://stemcells.nih.gov/policy/taskForce/2005_05_06tfs.asp.

III. Update on National Stem Cell Bank

Dr. Battey gave a brief update written by Dr. John Harding (NCRR) on the status of the proposals submitted in response to an RFP for the National Stem Cell Bank. The received proposals were peer-reviewed in May 2005. After review, two proposals were deemed to be in the competitive range. Both applications are still under consideration and are in the negotiation phase. The NIH expects to award the contract in the fall of 2005.

IV. Update on Centers of Excellence in Translational Human Stem Cell Research

Dr. David Owens described NIH's progress on the applications submitted to the RFA on Centers of Excellence for Translational Human Stem Cell Research. NINDS convened a special emphasis panel in July 2005 to conduct the review of the applications. The applications were pre-assigned to NINDS, NIDDK or NHLBI. Following review, the top scoring applications were presented to the NINDS Advisory Councils for secondary review. The NIH expects to make awards in the fall of 2005.

V. Update on CSR Stem Cell Activities

As a follow-up to the October 27, 2004, meeting of the Task Force, Dr. Anne Clark (Research Integrity Officer and Associate Director, Division of Receipt and Referral) and Dr. Sherry Dupere (Chief of the Biology of Development and Aging IRG) at CSR presented an update of CSR's hESC grant activities. Dr. Dupere serves as the lead contact at CSR for hESC grant application review.

In the past few years, modifications have been made to improve the review process of and increase the number of hESC grant applications to NIH. Dr. Clark presented on CSR's role in these efforts:

  • CSR has been:
    • Verifying that applications using hESC are appropriately flagged in IMPACII.
    • Ensuring that the names of the hESC lines to be used are listed in the Description for all grant applications.
    • Assigning hESC applications primarily to seven existing, standing study sections.
    • Providing specific instructions to SRAs who handle the review of hESC applications in CSR. Sherry Dupere is responsible for orienting the SRAs.
  • NIH has added a hESC checkbox in the new PHS398 grant application form (required as of 5/10/2005)
    • There is also a text box for investigators to indicate which cell lines they plan to use. The investigators are also asked to list the cell line in the description, as well; however, 90% of the applications do not list the cell lines in the description.
    • There have been several instances where the checkbox has been checked, but the application does not involve hESC research. CSR is verifying these discrepancies with the principal investigator.
  • Data was presented on the numbers of hESC applications received and reviewed in CSR.
    • Total applications have increased many fold since 2003.
    • Over 70 hESCs applications were received in the last round with 50 being reviewed at CSR.
    • There is increased diversity in applications.
    • 10 applications for 01/2006 were assigned to IRGs, which do not typically review hESC
    • Investigators may often request their application be assigned to a particular Study Section, which does not typically review hESC applications.
  • How CSR will be handling hESC applications in upcoming rounds.
    • Verify that applications which are checked "Yes" on the form are actually conducting hESC research.
    • Cell line name will be needed on the application form but not needed in the Description.
    • Assign applications to the most appropriate Study Section based on the proposed project.
    • Provide update instructions to reviewers.

Dr. Dupere presented on the updated guidance and training for SRAs and Reviewers involved in hESC applications. There are five approaches being conducted:

  1. conduct formal Training of SRAs
  2. develop an SRA Handbook
  3. develop Reviewer Instruction on CD
  4. post instructions on CSR intranet and internet
  5. send email instructions to IRG chiefs and SRAs, including links to the NIH Stem Cell Registry website.

Discussion followed about what happens to amended applications. Dr. Dupere announced that revised applications go back to the same study section. The Task Force asked Dr. Dupere to provide data on the funding success rate by mechanism and by type (Type 1 vs. Type 2) for new applications. Due to the increased number of applications, the diversity of the proposed projects (hESCs may be only a small component in the entire project), and the range of priority scores generally match those of non-hESC applications, CSR proposed that all hESCs applications be mainstreamed into subject study sections instead of limiting them to the seven hESC cluster study sections. Based on the data presented, the Task Force concurred with this proposal. All hESC grant applications will be mainstreamed beginning with applications submitted for the October 2005 receipt round.

VI. Update of NIH-India Stem Cell Meeting

Mr. Baldwin Wong announed that a delegation from the Government of India visited the NIH on August 24, 2005. Included in their visit was a meeting w representatives from the NIH Stem Cell Task Force to discuss areas of mutual interest in stem cell research. The delegation included Secretary of the Department of Biotechnology (DBT) Raj Bhan and Director-General of the Indian Council of Medical Research (ICMR) Nirmal Ganguly. They both expressed great enthusiasm about expanding Indo-U.S. collaboration on stem cell research in terms of training, hESC grant processes, and regulatory issues.

In addition, the delegation informed NIH about the status of the ten hESC derivations in India that are listed on the NIH Stem Cell Registry. ICMR and DBT also developed new draft stem cell research guidelines for India. Drs. Gangulay and Bhan shared these guidelines with NIH and asked the Task Force to provide comments. Previous concerns regarding India's prohibition on sharing stem cell lines were no longer an issue in the new draft stem cell guidelines.

The Task Force suggested that the Indian Government consider joining the International Stem Cell Forum in order to become involved with the international effort of stem cell research. Mr. Wong will develop a letter on behalf of the Task Force in response to the comments on the draft guidelines and to follow-up with the action items from the August meeting.

VII. Evaluation of T15 hESC Culturing Courses

Mr. Baldwin Wong reported that his office conducted an evaluation of the five current T15 hESC short-term training courses. The evaluation was based on enrollment data from courses conducted May 2003 to January 2005. The evaluation found that 30% of the course enrollees came from foreign institutions, enrollees or their labs were currently funded by 18 different ICs, a minority of the enrollees (<20%) are currently NIH-funded, and a somewhat larger minority of the labs from which enrollees come are NIH funded (~35%).

VIII. Identification of Issues for Task Force Consideration

There was a brief discussion of how investigators handle the commingling of funding research using eligible versus non-eligible hESC lines in extramural laboratories. The NIH developed FAQs on funding streams for research using federally approved cell lines compared to research using non-approved stem cell lines. These FAQs were submitted to Office of General Council for review.

Dr. McKay discussed the role of NIH supporting the development of a standard hESC culturing kit. He will develop a proposal to the Task Force for consideration in the future.

Dr. Tony Beck announced that the NCRR awarded two Science Education Partnership Awards (SEPA) related to stem cells, which encourage collaborations between scientists, community groups, and other organizations to enhance public understanding of the life sciences. The awards were given to the Maryland Science Center (public outreach on stem cells) and the University of Washington (curriculum for 9-12 grades on the ethics of stem cells).

Dr. John Thomas announced that NHLBI is preparing to make awards for specialized centers for cell-based therapy.

There was a brief discussion on whether there are potential roadblocks to moving the field of hESCs research forward in spite of NIHs efforts in research training, administrative supplements, and other initiatives. It was the consensus that, in general, the field is moving forward. In fact, many scientists are enrolling in the T15 training courses and more new hESC grant applications are being received by NIH and subsequently funded.

IX. Adjournment

The next meeting of the NIH Stem Cell Task Force is tentatively scheduled for December 6, 2005, 9:00 a.m.–11:00 a.m., in 31/3C-05. The meeting adjourned at 10:30 a.m.

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
E-mail: stemcell@mail.nih.gov