Advisory Council Minutes, May 24-25, 2018

The National Advisory General Medical Sciences (NAGMS) Council was convened in closed session for its one hundred sixty-seventh meeting at 9 a.m. on Thursday, May 24, 2018.

Dr. Jon R. Lorsch, director of the National Institute of General Medical Sciences (NIGMS), presided as chair of the meeting. After a closed session from 9 a.m. to 3:15 p.m. on May 24, the meeting was open to the public on May 25 from 8:30 a.m. to 12:17 p.m.

Council Members Present

Goldie S. Byrd, Ph.D.
William A. Gern, Ph.D.
Kaye Husbands Fealing, Ph.D.
Tarun M. Kapoor, Ph.D.
Sabeeha Merchant, Ph.D.
Guy Padbury, Ph.D.
Sean B. Seymore, Ph.D., J.D.
Ronald M. Przygodzki, M.D.
Cathy Wu, Ph.D.

Special Consultants Present

Celeste Berg, Ph.D.
Professor
Department of Genome Sciences and Molecular and Cellular Biology Program
University of Washington
Seattle, WA 98195-5065

Anne E. Carpenter, Ph.D.
Institute Scientist
Broad Institute of Harvard and MIT
Cambridge, MA 02142

Enrique M. De La Cruz, Ph.D.
Professor
Department of Molecular Biophysics and Biochemistry
Yale University
New Haven, CT 06520

Rahul M. Kohli, M.D., Ph.D.
Assistant Professor
Division of Infectious Disease
Department of Biochemistry and Biophysics
University of Pennsylvania School of Medicine
Philadelphia, PA 19104-6073

James M. Olzmann, Ph.D.
Assistant Professor
Department of Nutritional Sciences and Toxicology
University of California, Berkeley
Berkeley, CA 94720-3104

John Younger, M.D., M.S.
Director
Chief Technology Officer
Akadeum Life Sciences, Inc.
Ann Arbor, MI 48103

Council roster (available from NIGMS)

Members of the Public Present

Dr. Amanda Field, Association of American Medical Colleges
Dr. Howard Garrison, Federation of American Societies for Experimental Biology
Steve Heinig, Association of American Medical Colleges
Frank Krause, Federation of American Societies for Experimental Biology
André Porter, American Society for Biochemistry and Molecular Biology
Dr. Debra Schwinn, University of Iowa
Dr. Yvette Seger, Federation of American Societies for Experimental Biology
Dr. Erika Shugart, American Society for Cell Biology
Jen Sizemore, Columbus Tech
Dr. James Skeath, Washington University
Sharon Swan, American Society for Clinical Pharmacology and Therapeutics

NIGMS and Other NIH Employees

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

Other Federal Employees Present

Dr. Misty Hegganess, U.S. Census Bureau

OPEN PORTION OF THE MEETING

I. Call to Order and Opening Remarks

Dr. Lorsch thanked the regular members of the Council who were present and introduced the special consultants. He then introduced and welcomed the guests in attendance.

II. Consideration of Minutes

The minutes of the January 18-19, 2018, meeting were approved as submitted.

III. Future Meeting Dates

The following dates for future Council meetings were confirmed:

September 13-14, 2018
January 24-25, 2019
May 16-17, 2019
Thursday-Friday
Thursday-Friday
Thursday-Friday

IV. NIGMS Director’s Report

NIGMS Director Dr. Jon R. Lorsch thanked the Council and NIGMS staff for their continued diligence in making Council meetings possible and successful. In highlighting staff changes in and out of the Institute, he noted the retirement of Dr. Howard Garrison of the Federation of American Societies for Experimental Biology (FASEB), a past Council member and longtime ally of the Institute and biomedical research. Recently announced retirements from NIH include Dr. Richard Nakamura, director of NIH's Center for Scientific Review, leaving after a 39-year career at the agency;, and Dr. James Battey, director of the National Institute on Deafness and Other Communication Disorders, leaving after two decades leading NIDCD. Dr. Lorsch then highlighted recent honors to staff including Dr. Fred Taylor, earning the honorary Council on Undergraduate Research Fellow's Award; Jose Lopez, who was featured in a profile and on the cover of Hispanic Executive; and Dr. Dick Okita, the namesake of a new Early Career Achievement Award from the American Society for Pharmacology and Experimental Therapeutics.

Dr. Lorsch highlighted recent outreach activities, including the USA Science and Engineering Festival (the nation's largest Science-Technology-Engineering-Math (STEM) event), a visit to Rachel Carson Elementary School in Gaithersburg, and the upcoming launch of a revamped NIGMS website. A Congressional visit to West Virginia coincided with the Science Education Partnership Award-funded Health Sciences and Technology Academy graduation. This successful program promotes science education, literacy, and biomedical careers to youth from low socioeconomic backgrounds and provides financial assistance for higher education for underserved students.

Programmatic news includes recently instituted changes to the NIGMS Postdoctoral Research Associate Training program, a competitive intramural fellowship detailed in a new funding announcement. Dr. Lorsch also described changes to the NIGMS Academic Research Enhancement Awards program, returning its focus to its original intent to support undergraduate training. He reported that the Institute's research project grant success rate holds steady at approximately 30 percent, and that the "cumulative investigator rate"—essentially a measure of grantee retention over time—has been rising since 2013. This is in keeping with the Institute's strategic goal to focus on the number of investigators funded in addition to the application success rate when managing the NIGMS research portfolio. There has been a steep increase in the number of early-stage investigators (ESIs) applying for funding from the Institute since the launch of the Maximizing Investigators' Research Award (MIRA) program (60 percent between 2015 and 2017) as well as a nearly two-fold increase in the number of ESIs funded by NIGMS per year. NIGMS program evaluation staff continue to monitor the demographics of review outcomes for the MIRA program to ensure fairness and equity. One encouraging statistic is that MIRA ESI recipients continue to trend younger (by about one year) compared to NIGMS ESIs receiving R01s.

Contact: Dr. Jon Lorsch, jon.lorsch@nih.gov, 301-594-2172

V. Scientific Solutions for the Opioid Crisis

The misuse of and addiction to opioids—including prescription pain relievers, heroin, and synthetic opioids such as fentanyl—has resulted in a national crisis that we have not yet been able to revert. National Institute on Drug Abuse Director Dr. Nora Volkow noted that the origin of this crisis rests with the U.S. health care system itself, driven by aggressive pain treatment practices that ultimately led to over-prescription of opioids and the later emergence of heroin and other extremely potent opioid derivatives. She stated that innovative scientific solutions will play an important role in controlling the opioid crisis now and in preventing a future recurrence. In April 2018, NIH launched the HEAL (Helping to End Addiction Long-term) Initiative, an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. NIH is pursuing several approaches, including a public-private partnership to help accelerate therapeutic developments in three areas: 1) better opioid overdose-reversal and prevention interventions;, 2) new and improved medications and technologies for the treatment of opioid use disorders (OUD) including vaccines and brain-stimulation based technologies as well as development of new formulations of currently available OUD medications (methadone, buprenorphine naltrexone) to facilitate compliance;, and 3) analgesics with less abuse potential and alternative non-medication based treatments to manage chronic pain. Dr. Volkow also stated that NIH is funding implementation research to increase access to currently available OUD treatments and for overdose reversal by developing models of care within the health care system that engage psychiatrists, emergency departments, pain and infectious disease clinics, primary care physicians, gyneco-obstetricians, nurses, and pharmacists.

Contact: Dr. Nora D. Volkow, nvolkow@nida.nih.gov, 301-443-6480

VI. Concept Clearances: MARC, U-RISE, G-RISE, IMSD

NIGMS has a longstanding commitment to developing a diverse pool of biomedical scientists through a variety of institutional training and student development programs. Based on stakeholders' feedback through requests for information (NOT-GM-15-108; NOT-GM-17-017) as well as extensive analyses and discussions with NIH staff and the grantee community, NIGMS intends to make changes to the programs designed to enhance diversity in the biomedical research workforce. The changes are designed to 1) provide equity of trainee support across programs, 2) prevent programmatic overlap, 3) align grant mechanisms with programmatic goals, 4) place institutions with similar research activity into separate tracks for review and funding decisions, and 5) strengthen NIGMS' ability to evaluate the success of the programs. Dr. Alison Gammie requested, and received, Council approval to issue revised funding announcements for four programs: the Initiative for Maximizing Student Development (IMSD), the Research Initiative for Scientific Enhancement (U-RISE and G-RISE), and the Maximizing Access to Research Careers - Undergraduate Student Training in Academic Research (MARC).

The revised strategy aims to minimize duplication of diversity-focused NIGMS programs through institutional eligibility criteria through the following proposed changes:

  • Convert the current RISE research education program into two separate training programs at research-active institutions: one for support of undergraduates (Undergraduate Research Initiative for Student Enhancement, U-RISE) and the other for support of graduate students training for a Ph.D. (Graduate Initiative for Student Enhancement, G-RISE).
  • Convert the current IMSD research education program into a training mechanism that supports graduate students training for a Ph.D. at research-intensive institutions. IMSD programs that currently support undergraduates are encouraged to apply for the MARC program.
  • Reissue the MARC funding announcement. The MARC training programs will support research-oriented undergraduates at research-intensive institutions.
  • Improve long-term tracking and posting of program trainee outcomes.

Contact: Dr. Alison Gammie, alison.gammie@nih.gov, 301-594-3900

VII. Concept Clearance: Better Defining Growth Medium to Improve Reproducibility of Cell Culture

Fetal bovine serum is the most widely used growth supplement for cell culture. Although serum is an effective growth promotor, it is variable in its composition, activity, and effects on cellular phenotypes, leading to reproducibility concerns. Dr. Amanda Melillo described plans to issue a funding announcement to support SBIR/STTR projects to develop reliable and cost-effective tools to better define growth medium and improve reproducibility of cell culture. The funding announcement will support technologies and products to expedite 1) development of serum substitutes, 2) identification of serum constituents that are effective in promoting the culture and responses of specific cell lines, and 3) troubleshooting of experimental variation stemming from variability in serum. Dr. Melillo requested, and received, Council approval to craft a funding announcement with a projected date for first awards in April 2019.

Contact: Dr. Amanda Melillo, amanda.melillo@nih.gov, 301-594-0943

VIII. Evaluation of the NIGMS Bridges to the Doctorate (B2D) Program

The NIGMS Office of Program Planning, Analysis, and Evaluation (OPAE) coordinated an evaluation of the Institute's Bridges to the Doctorate (B2D) program to inform decisions regarding the future of the program. Dr. James Skeath of Washington University in St. Louis chaired a sub-committee of the NIGMS Council composed of members of the scientific and academic community with relevant expertise and experience to assess B2D. Dr. Skeath presented the findings of this group that met on May 2, 2018; he discussed assessments based on indicators of outcomes of the program in terms of M.S. and Ph.D. degree completion and ultimate career positions for B2D participants, particularly for those from groups underrepresented in biomedical research. Dr. Skeath noted that data quality and availability presented significant challenges in the B2D evaluation, and, in turn, in deriving conclusions. He also described asymmetric success across programs. Based on the findings, the sub-committee recommends 1) improving data collection, especially longitudinal tracking of trainees; and 2) focusing on successful programs and applying best practices to others.

Contact: Dr. James Skeath, jskeath@genetics.wustl.edu, 314-362-0535

IX. NIGMS T32 Institutional Clinical Postdoctoral Research Training Program Evaluation

OPAE also coordinated an evaluation of the Institute's T32 Clinical Postdoctoral Research Training (CPRT) Program to inform decisions regarding the future of the program. Dr. Debra Schwinn of the University of Iowa chaired a sub-committee of the NIGMS Council composed of members of the scientific and academic community with relevant expertise and experience to assess CPRT. Dr. Schwinn presented the findings of this group that met on May 9, 2018; she discussed indicators of success of the program in encouraging clinicians in focused areas (Medical Genetics; Clinical Pharmacology;, Burn, Trauma, and Perioperative Care;, and Anesthesiology) in terms of career outcomes and products of appointees compared with non-appointee peer groups. Dr. Schwinn noted difficulty in acquiring accurate data to support a rigorous evaluation but reported positive outcomes from the data available.: The CPRT remains an important on-ramp for physician-scientist research careers and provides research training for physicians in fields appropriate for NIGMS support.

Contact: Dr. Debra Schwinn, debra-schwinn@uiowa.edu, 319-353-7303

X. Public Comment Period

Dr. Erika Shugart, executive director of the American Society for Cell Biology (ASCB), provided updates on recent society activities and noted support for continued, positive engagement with NIGMS. She described a recent Hill Day and mentioned ASCB's continuing efforts to study and improve research assessment through the San Francisco Declaration on Research Assessment (DORA).

Sharon Swan, chief executive officer of the American Society for Clinical Pharmacology and Therapeutics voiced the organization's strong support for NIGMS' CPRT T32 program, noting its importance for cultivating the nation's physician-scientist workforce.

André Porter, science policy analyst at the American Society for Biochemistry and Molecular Biology, thanked NIGMS for continued engagement and leadership, characterizing NIGMS as an institute to be emulated across NIH regarding support of researchers across the biomedical career trajectory.

FASEB's Dr. Howard Garrison described the group's largest Hill Day to date and noted online posting of fact sheets on federal funding by district​. He also described a recent successful workshop on T32 training grants co-hosted by the Association of American Medical Colleges and the Howard Hughes Medical Institute and the posting of webinars on professional development and science-policy fellowships. Finally, he expressed gratitude for the opportunity to work with NIGMS for more than three decades.

CLOSED PORTION OF THE MEETING

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

ADJOURNMENT

The meeting adjourned at 12:17 p.m. on May 25, 2018.

CERTIFICATION

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

 

Jon R. Lorsch, Ph.D.
Chair
National Advisory General
Medical Sciences Council

 

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