Advisory Council Minutes, September 22-23, 2005

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The National Advisory General Medical Sciences (NAGMS) Council was convened in closed session for its one hundred twenty-ninth meeting at 8:30 a.m. on Thursday, September 22, 2005.

Dr. Jeremy Berg, director of the National Institute of General Medical Sciences (NIGMS), presided as chair of the meeting. After a closed session from 8:30 a.m. to 10:00 a.m., the meeting was open to the public on September 22 from 10:30 a.m. to 3:40 p.m. It was followed by a second closed session from 8:30 a.m. on September 23 until adjournment for consideration of grant applications.

Council Members Present:

Shelagh M. Ferguson-Miller, Ph.D.
Stanley Fields, Ph.D.
Kathleen M. Giacomini, Ph.D.
Eric N. Jacobsen, Ph.D.
Corey Largman, Ph.D.
Jeffrey Mason, Ph.D.
Brian W. Matthews, Ph.D., D.Sc.
Richard I. Morimoto, Ph.D.
Gregory R. Reyes, M.D., Ph.D.
Theodora E. Joan Robinson, Ph.D.
Lisa Staiano-Coico, Ph.D.
Yu-li Wang, Ph.D.
Virginia A. Zakian, Ph.D.

Members Absent:

Francine D. Berman, Ph.D.

Special Consultants Present:

Robert F. Fischetti, Ph.D.
Project Manager GM/CA-CAT
Argonne National Laboratory
Building 436, Room D002
9700 S. Cass Avenue
Argonne, IL 60439

Janet L. Smith, Ph.D.
Assistant Research Scientist
Life Sciences Institute
210 Washtenaw Avenue
Ann Arbor, MI 48109-2216

Council roster (available from NIGMS).

Members of the Public Present:

Mr. Robert Atcher, Los Alamos National Laboratory
Mr. James Bernstein, American Society for Pharmacology and Experimental Therapeutics
Ms. Eileen Resnick, Society for Women's Health Research
Ms. Angela Sharpe, Consortium of Social Science Association
Ms. Barbara Wanchisen, Federation of Behavioral, Psychological, and Cognitive Sciences

Federal Employees Present:

Dr. Anita Klein, National Science Foundation
Dr. Jermelina Tupas, National Science Foundation

NIGMS employees and other NIH employees:

Please see the sign-in sheet (available from NIGMS).

OPEN PORTION OF THE MEETING

I. Call to Order and Opening Remarks

Dr. Berg thanked the regular members of the council who were present and introduced the special consultants: Robert F. Fischetti, Ph.D., project manager GM/CA-CAT, Argonne National Laboratory and Janet L. Smith, Ph.D., assistant research scientist, Life Sciences Institute.

II. Consideration of Minutes

The minutes of the May 19-20, 2005 meeting were approved as submitted.

III. Future Meeting Dates

The following dates for future Council meetings were confirmed:

January 26-27, 2006  Thursday-Friday
May 18-19, 2006  Thursday-Friday
September 14-15, 2006 Thursday-Friday
January 25-26, 2007  Thursday-Friday 

IV. Report from the Director, NIGMS

Dr. Berg announced the appointments of Joe Ellis as director of the NIH Office of Policy for Extramural Research Administration; Barbara Mittelman, M.D., as acting director of the NIH Public Private Partnership Program; and Lisa Colpe, Ph.D., M.P.H. as senior advisor for NIH Roadmap for Medical Research. He also announced the departure of Richard Turman who left his position as NIH associate director for budget to become deputy assistant director for budget of HHS. Former Assistant Director for Budget Andy Baldus is now the acting NIH associate director for budget.

Dr. Berg commented on the occurrence of hurricane Katrina and the NIH response. NIH scientists with clinical expertise led by Dr. Zerhouni; Dr. John Gallin, director of the Clinical Center; and Dr. David Schwartz, director of the National Institute of Environmental Health Sciences, established a mobile hospital in Meridien, Mississippi for treatment of evacuees. He noted that NIGMS has been more focused on preparing for the consequences of laboratories, scientists, post-docs, and students affected by the hurricane damage, to be discussed later.

Dr. Berg noted that the Department of Health and Human Services, with the concurrence of the Office of Government Ethics, released the final NIH Ethics Regulations on August 25. These regulations maintain the ban on consulting for pharmaceutical and biotechnology companies, but significantly reduce the number of NIH staff members who are subject to new limitations of stock holdings and provide more flexibility with regard to interactions with scientific societies and other outside activities. He noted that the NIH community has reacted positively to these regulations.

Dr. Berg commented briefly on the hearings regarding the potential reauthorization of the NIH held by the House Energy and Commerce Committee led by Congressman Joe Barton. He noted that the hearings and subsequently released draft reauthorization bills have focused substantially on providing more formal structures for coordination and planning across the NIH.

Dr. Berg noted progress toward a Congressional appropriation for NIH. He noted that the House passed the HHS budget with an 0.5% increase for NIH, essentially the same as the President's budget request, while the Senate Appropriations Committee passed a budget with a 3.7% increase for NIH although this bill has not gone to the full Senate. He noted that several steps remain before the FY06 budget process is completed.

Dr. Berg commented on the PubChem discussions that have been occurring with the American Chemical Society. He noted that Dr. Zerhouni and several Institute directors have met with Dr. William Carroll, president of the American Chemistry Society, and others from the NIH leadership to understand the points of contention and to develop processes for resolving them. He indicated that NIH was committed to maintaining the development of PubChem and expressed optimism that a suitable understanding could be reached.

Finally, Dr. Berg invited the Council members to the first NIH Director's Pioneer Award symposium. He noted that NIGMS had taken over the lead on this program and that the symposium would feature both talks from the 2004 Awardees as well as the announcement by Dr. Zerhouni of the 2005 Awardees. He thanked Dr. Judith Greenberg, Shan McCollough, Ann Dieffenbach, Stacy Charland, and Marcia Cohn as well as the other members of the High-Risk Research roadmap implementation working group who worked very hard to make this year's Pioneer program a success.

V. Update on the Council Working Group for MORE

The NAGMSC Minority Opportunities in Research (MORE) working group convened for a 2-day meeting in August 2005. The group is co-chaired by Dr. Virginia A. Zakian of Princeton University and Dr. Valerie Petit Wilson of Brown University. In addition to Dr. Zakian, the eleven-member group includes two other NAGMS Council members: Dr. Jeffrey Mason, of the Armed Forces Institute of Pathology, and Dr. Richard I. Morimoto, of Northwestern University. Dr. Zakian described the group's charge to evaluate individual MORE programs, as well as to think more broadly about ways to increase the number of under-represented minorities in the biomedical research community. Dr. Zakian reported that the group's discussions have been broad, unrestricted, and thought-provoking. She and Dr. Wilson are currently preparing a report that will be presented to the full Council in January 2006 summarizing the opinions and suggestions of the working group.

Contact: Dr. Virginia A. Zakian, vzakian@Princeton.edu, 609-258-6770

VI. Report: NIGMS Training Workshop

Dr. John Norvell presented a summary of a June 2005 NIGMS workshop focused on the Institute's research training programs. Dr. Paula Flicker headed an NIGMS staff committee that organized the workshop, which was attended by 17 scientists with knowledge of the research fields spanned by NIGMS predoctoral training programs. The workshop was chaired by Dr. John Nilson of Washington State University and included scientists involved with NIGMS training grants and NIGMS training review committees. Workshop participants discussed the design and goals of NIGMS training programs, as well as national needs for research training in the basic biomedical sciences. Dr. Norvell presented to the Council a workshop summary, including recommendations, as well as NIGMS staff plans and responses.

Contact: Dr. John Norvell, norvellj@nigms.nih.gov, 301-594-0533

VII. Update on the T32 Tuition Issue

NIH has included tuition as an allowable cost on research training grants since the inception of the agency's training programs in the mid-1970s. In 1995, NIH convened a task force to consider the impact of tuition increases on training programs. At that time, NIH changed its policy and limited the tuition allowance using a formula-based approach that paid approximately 60 percent of actual tuition costs. At present, with rapidly rising tuition costs and level training budgets, NIH is now in a similar position, and significant reductions in NIH training programs are projected for future years. In June 2005, NIH issued a notice announcing a freeze on tuition allowance budgets for FY06 and plans to establish a new tuition allowance policy for FY07. Dr. John Norvell and Dr. Warren Jones reviewed the recent tuition changes and discussed plans for establishing a revised policy.

Contacts: Dr. John Norvell, norvellj@nigms.nih.gov, 301-594-0533; Dr. Warren Jones jonesw@nigms.nih.gov, 301-594-3827

VIII. Update on the Behavioral Sciences-Biological Sciences Interface Training Program

In recent years, numerous reports from NIH and the National Academies of Science have concluded that researchers will need to integrate multiple disciplinary perspectives, methodologies, and levels of analysis in order to advance our understanding of health and disease. The need for integration between traditional fields in the behavioral and biological sciences came out repeatedly in discussions of the working group on basic behavioral and social sciences of the Advisory Committee to the Director, NIH. Dr. Jeremy M. Berg described progress towards the development of an interdisciplinary training program directed toward this interface that would be a powerful mechanism for strengthening the integration of these fields of research. Given this need for cross-training in the basic behavioral and biological sciences, NIGMS has taken the lead in developing a trans-NIH predoctoral training program centered on this interface. Although the topic area is different, this new program may be modeled after several successful interfacial training programs such as the NIGMS Chemistry-Biology Interface program. The proposed program will strongly encourage faculty involvement from multiple departments spanning the behavioral and biological sciences and will provide each student in the program with cross-training and thesis opportunities in both the behavioral and biological sciences. A trans-NIH committee, chaired by Dr. Berg with representation from 13 NIH Institutes and Centers, has been established. A subcommittee, chaired by Dr. Alison Cole, is currently drafting a program announcement slated for release in early 2006 and possible funding in FY07, pending available funds.

Contact: Dr. Jeremy M. Berg, 301-594-2172

IX. Report: NIGMS Enhances Access to Synchrotron Facilities

Since 1999, NIGMS has sought to actively foster structural biology programs and investigators supported both by the Institute and within the broader scientific community by offering supplemental funding to existing synchrotron user facilities. In partnership with the National Cancer Institute (NCI), NIGMS has also established a new, state-of-the-art facility at the Advanced Photon Source, Argonne National Laboratory. Dr. Charles Edmonds discussed progress of the General Medicine and Cancer Institutes Collaborative Access Team (GM/CA-CAT) project, based upon input from Dr. Janet L. Smith, GM/CA-CAT Director, and Dr. Robert Fischetti, GM/CA-CAT Project Manager. Dr. Edmonds also commented on the effort within the context of NIGMS programmatic interests.

Contact: Dr. Charles G. Edmonds, edmondsc@nigms.nih.gov, 301-594-4428

X. GM/CA-CAT: State-of-the-Art Synchrotron Beamlines for Structural Biology

The field of structural biology has become increasingly dependent on synchrotron X-ray sources for solving both routine and challenging problems. NIGMS, together with NCI, is developing three new state-of-the-art beamlines for macromolecular crystallography at the Advanced Photon Source, Argonne National Laboratory. Dr. Janet L. Smith of the University of Michigan, who is the director of the new GM/CA-CAT facility, provided information about its ability to exploit the latest in synchrotron and beamline technology. GM/CA-CAT aims to provide small, tunable, brilliant, robust X-ray beams as well as a streamlined, user-friendly format for today's most challenging projects. GM/CA-CAT Project Manager Dr. Robert Fischetti presented technical specifications, describing progress and challenges. He noted that automated sample-handling is being developed for high-throughput structure determination as well as for traditional problem-based structural biology.

Contacts: Dr. Janet Smith, janetsmi@umich.edu, 734-615-9564; Dr. Robert Fischetti, rfischetti@anl.gov, 630-252-0660

XI. Peer Review in a Rapidly Changing Biomedical Environment

NIH's Center for Scientific Review (CSR) has a mission critical to the success of the agency's grant-funding program: to see that NIH grant applications receive fair, independent, expert, and timely reviews--free from inappropriate influences--so that NIH can fund the most promising research. While the NIH peer review system is widely viewed as second to none, it has not kept pace with the rapid changes taking place within the biomedical/academic community. CSR Director Dr. Antonio Scarpa described CSR's current plans to develop and implement needed changes, which fall into three categories based on complexity, impact, and time of implementation. First, Dr. Scarpa described possible changes in CSR operations that aim to (i) increase communications between CSR, ICs, and reviewers and applicants; (ii) increase uniformity and efficiency of review; and (iii) facilitate the work of IC program staff. Secondly, Dr. Scarpa presented potential changes in current systems that may: (i) shorten the review cycle; (ii) address concerns that clinical research is not properly evaluated; (iii) improve the assessment of innovative, high-risk/high-reward research; and (iv) improve the recruitment and retention of high-quality reviewers. Third, regarding possible new systems, Dr. Scarpa proposed the following question: If we didn't have any peer-review system and we had to design one from scratch, what would it look like? Dr. Scarpa stressed the importance of asking such questions and making the necessary changes to ensure the vitality of NIH peer review, NIH research, and the future health of people everywhere.

Contact: Dr. Antonio Scarpa, scarpat@csr.nih.gov, 301-435-1114

XII. Concept Clearance: NIGMS AIDS Structural Biology Program

Although the structures of many HIV proteins have been determined by X-ray diffraction and NMR, only a few structures of HIV components complexed with cellular components have been solved. Nonetheless, these complexes provide attractive targets for new generations of anti-AIDS drugs. Dr. James Cassatt proposed a plan to fund two centers focused upon the structural determination of complexes between HIV proteins and cellular components. Dr. Cassatt noted that no new funds will be required to finance the effort; necessary resources will be funneled from expiring AIDS-related program project grants. The new centers, to be funded in FY07, would take advantage of the technologies developed through the NIGMS Protein Structure Initiative (PSI) by setting up automated procedures for cloning, expression, and structure determination. Structures to be determined would originate from the PSI centers themselves as well as from individual research grants (R01s and R21s) linked to the centers. The linked R01s and R21s, which are expected to provide a wide range of expertise that would be coordinated with that of the centers, would be funded through a separate announcement issued by the NIAID Division of AIDS Research. Dr. Cassatt requested, and received, Council approval to initiate plans for establishing the AIDS Structural Biology Centers.

Contact: Dr. James Cassatt, cassattj@nigms.nih.gov, 301-594-0828

XIII. CLOSED PORTION OF THE MEETING

XIV. Review of Applications

A summary of applications reviewed by Council is available from NIGMS.

ADJOURNMENT

The meeting adjourned at 9:55 a.m. on Friday, September 23, 2005.

CERTIFICATION

I hereby certify that to my knowledge the foregoing minutes are accurate and complete.

Jeremy M. Berg, Ph.D.
Chair
National Advisory General
Medical Sciences Council

Ann A. Hagan, Ph.D.
Executive Secretary
National Advisory General
Medical Sciences Council