May 6, 2005, Summary
NIH Stem Cell Task Force
Members Present:
Allen Spiegel, NIDDK (Interim Co-Chair); Story Landis, NINDS (Interim Co-Chair); James Battey, NIDCD (Reinstated Chair); Daniela Gerhard, NCI; Ron McKay, NINDS; Mahendra Rao, NIA; Pam Robey, NIDCR; Mark Rohrbaugh, OD/OTT; Lana Skirboll, OD/OSP; Richard Tasca, NICHD; John Thomas, NHLBI; Judith Vaitukaitis, OD; Marion Zatz, NIGMS
Other Participants:
Tony Beck, NCRR; Laura Cole, NIDCD; Donald Fink, FDA/CBER; Gemma Flamberg, OD/OLPA; Tom Johnson, OD/OSP; Lisa Montney, NIDCD; Walter Schaffer, OD/OER; Anne White-Olson, NIDCD; Baldwin Wong, NIDCD
I. Welcome
Dr. Spiegel, interim co-chair of the NIH Stem Cell Task Force, welcomed the participants to the 13th meeting of the Task Force. He then announced that Dr. Zerhouni has reinstated Dr. Battey as the chairman of the NIH Stem Cell Task Force. Dr. Spiegel thanked Dr. Battey for his continued efforts and turned the meeting over to him. Dr. Battey thanked Drs. Spiegel and Landis for serving as acting co-chairs of the Task Force during the interim period that he was on leave from the chairmanship. Dr. Landis will be invited to serve as a permanent member on the Task Force.
II. Approval of Meeting Minutes
The Task Force approved the text of the February 4, 2005 meeting minutes, which will be posted on the NIH Stem Cell website at http://stemcells.nih.gov/policy/taskForce/tfsummaries/2005_02_04tfs.asp.
III. New Guidelines for Human Embryonic Stem Cell (hESC) Research
On April 26, 2005, the National Academy of Sciences released "Guidelines for Human Embryonic Stem Cell Research." This report was the result of a joint project between the National Academies' National Research Council and the Institute of Medicine. Just prior to the release of the report, representatives of the NIH Stem Cell Task Force were invited to a briefing by some of the committee members who developed the report. Drs. Spiegel and Landis attended this briefing and provided the Task Force with an overview of the guidelines. The purpose of these voluntary guidelines is to provide for the responsible practice of human embryonic stem cell research. The Task Force discussed the significance of these guidelines in respect to the NIH and the NIH extramural science community.
IV. Discussion of NIH Infrastructure Grant—Dr. Beck
Dr. Tony Beck informed the Task Force that NCRR received a request from one of the providers listed on the NIH Stem Cell Registry to change the Principal Investigator (PI) on the R24 Infrastructure grant. Dr. Beck explained that the current PI is relocating to another institution. Dr. Beck asked the Task Force members to evaluate the qualifications of the proposed PI on the grant. The Task Force discussed how this change in PI could impact distribution of the eligible hESC lines and cell culture training efforts supported by the grant. Continued NIH support is dependent on whether the new PI can continue to meet the goals of the Infrastructure grant.
V. Stem Cell Intellectual Property Issue—Dr. Rohrbaugh
As a follow-up to last year's NIH R24 Infrastructure grantees meeting, Dr. Mark Rohrbaugh announced that he has received draft FAQs from one of the hESC providers on the NIH Stem Cell Registry. The Task Force discussed how these FAQs, which address hESC intellectual property (IP) issues, may impede progress in the field. Dr. Rohrbaugh also discussed the meeting held with the NIH Division of Intramural Research on how the NIH might pursue IP rights for stem cell technologies developed by intramural scientists. The NIH has several Cooperative Research and Development Agreements (CRADAs) and a list of the inventions related to stem cell research. The NIH is also developing FAQ's on funding streams for research using federally approved cell lines compared to research using non-approved stem cell lines.
VI. Identification of Issues for Task Force Consideration—All Participants
Dr. Richard Tasca discussed a center grant application that was reviewed by NICHD. This application involves stem cells and has broad applications to many of the NIH institutes. Because of the large cost of the application, the Task Force discussed possible ways to co-fund the application.
VII. Adjournment
The next meeting of the NIH Stem Cell Task Force is tentatively scheduled for Tuesday, September 20, 2005, 9:00–11:00 a.m. in Building 31, Room 3C05. The meeting adjourned at 5:00 p.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