Advisory Council Meeting Minutes - May 28, 2009

Council Members Present

Dr. William F. Bria, II
Dr. Nancy J. Brown
Dr. Valerie Copié
Dr. Henry N. Ginsberg
Dr. Roland F. Hirsch, liaison member, Department of Energy
Dr. Dallas M. Hyde
Dr. Joel Kupersmith
Dr. Henry Lewis, III
Dr. Mark O. Lively, III
Dr. Thomas J. Rosol
Dr. Janet L. Smith
Dr. Joel R. Stiles
Col. James A. Swaby
Dr. David S. Weir
Dr. M. Roy Wilson
Dr. M. Christine Zink

Council Members Absent

Ms. Wendy Chaite, Esq.
Dr. James P. Collins, liaison member, National Science Foundation
Dr. James E. Heubi
Dr. Kevin B. Johnson
Dr. Mark V. Pauly
Dr. Richard A. Rudick

Special Invited Guests for Open Session

Dr. Robert A. Branch, University of Pittsburgh
Dr. Ann L. Chester, West Virginia University
Dr. Ian C. Davis, Ohio State University
Dr. Larry J. Forney, University of Idaho
Dr. Kenneth J. Holroyd, Vanderbilt University
Dr. James F. Padbury, Women and Infants Hospital of Rhode Island
Dr. Ellie E. Schoenbaum, Albert Einstein College of Medicine
Dr. Charles Wood, University of Nebraska – Lincoln

Staff of Other NIH Components

Ms. Tracy Chen, National Institute of Neurological Disorders and Stroke
Ms. Andrea M. Romaniuk, National Institute of Neurological Disorders and Stroke

Others Present

Mr. Chris DaCosta, PPD, Inc.
Dr. Donna J. Dean, Lewis-Burke Associates
Ms. Blair A. Feldman, Lewis-Burke Associates
Mr. Stephen J. Heinig, Association of American Medical Colleges
Ms. Marnie W. Isabella, Center for Information Technology
Dr. Irena Tartakovsky, Association of American Medical Colleges

Open Session

I. Call to Order: Dr. Barbara M. Alving, director, NCRR

Dr. Alving officially called the meeting to order and welcomed members and guests to the 142nd meeting of the National Advisory Research Resources Council.

II. Consideration of Minutes: Dr. Barbara M. Alving

The minutes of the Council meeting held on February 12, 2009, were approved as written.

III. Report of the Director: Dr. Barbara M. Alving

View Dr. Alving's presentation (2MB PPT, requires Microsoft Office PowerPoint or free PowerPoint Viewer)

A. Introduction of New Council Members and Council Member Update

Dr. Alving introduced four new members of the Council:

Dr. Mark O. Lively, III is professor of biochemistry at Wake Forest University School of Medicine, where since 1983 he has directed the protein and DNA chemistry laboratories in the Biomolecular Resource Facility of the Comprehensive Cancer Center. The laboratories under his direction support a large number of NIH-funded research projects. In his current research, he is studying proteins involved in cancer, gastroesophageal reflux, reproduction and hypertension. He is a past president of the Association of Biomolecular Resource Facilities and the incoming president of the Federation of American Societies for Experimental Biology. Dr. Lively has been an active peer reviewer for a wide range of NCRR grant programs.

Dr. Joel R. Stiles is director of the National Resource for Biomedical Supercomputing (NRBSC) at the Pittsburgh Supercomputing Center and associate professor in the Department of Biological Sciences and the Lane Center for Computational Biology at Carnegie Mellon University. Dr. Stiles also holds faculty appointments in the departments of neuroscience and computational biology at the University of Pittsburgh. His current research interests encompass cell and tissue modeling for personalized medicine, with a focus on synaptic and cellular microphysiology. He is a principal co-author of MCell, a Monte Carlo simulator of cellular microphysiology, and he is also the principal architect of DReAMM (Design, Render, and Animate MCell Models). Dr. Stiles directs educational outreach activities at NRBSC, including the Computational Modules in Science Teaching program.

Dr. David S. Weir is director of the University of Delaware's Office of Economic Innovation and Partnerships, created in 2008 to foster economic development. Before being asked to lead this new initiative, Dr. Weir was the founding director of the Delaware Biotechnology Institute, a partnership among state government, academia and industry. With a doctorate and postdoctoral experience in chemical physics, Dr. Weir lectured at the University of St. Andrews in Scotland before joining the DuPont Company in Wilmington, Del. During his 35-year career with DuPont, Dr. Weir held leadership positions in the business and scientific arenas and participated in the discovery, development and marketing of major DuPont product innovations in the polymer, fiber and agriculture business segments. After retiring from DuPont, Dr. Weir was named director of Grupo Vicunha, a Brazilian textile conglomerate, with the particular role of helping the group develop improved business and management processes.

Dr. M. Christine Zink is a professor and director of the Molecular and Comparative Pathobiology Department at the Johns Hopkins University School of Medicine. She holds doctorates in veterinary medicine and macrophage biology from the University of Guelph in Ontario, Canada. Dr. Zink is a veterinary pathologist and an expert in pathogenesis of infectious diseases. Her simian immunodeficiency virus (SIV)/macaque model of HIV-induced central nervous system disease is widely considered to be the premier model for the study of the pathogenesis of HIV-associated neurologic, pulmonary and cardiac disease. Her research helped initiate ongoing clinical trials in the United States and Africa to examine whether the antibiotic minocycline will prevent neurologic manifestations of HIV infection. She also directs training programs in comparative pathology and laboratory animal medicine and is the director of admissions for the cellular and molecular medicine graduate program at Hopkins.

Dr. Alving congratulated Dr. Henry Lewis for receiving the 2009 American Pharmacists Association's Hugo H. Schaefer Award, which recognizes outstanding voluntary contributions to the organization, the profession and society.

B. NIH Leadership

Dr. Raynard S. Kington continues to serve as acting director of NIH and, in that role, has directed activities related to the American Recovery and Reinvestment Act of 2009 (ARRA).

C. Budget Update

On March 11, 2009, President Obama signed into law the $410 billion Omnibus Appropriations Act for FY 2009. NCRR's appropriation for FY 2009 is $1.226 billion, a 6.1 percent increase over FY 2008. Among NCRR programs, the largest allocation at 35 percent, is for Clinical and Translational Science Awards (CTSAs) and General Clinical Research Centers. The second largest program area of the NCRR budget is the Institutional Development Awards (IDeA), at 19 percent, followed by the Biomedical Technology Research Centers, at 13 percent.

The President's budget for FY 2010 was released on May 7, 2009, and includes $30.838 billion for NIH, an increase of $0.443 billion over FY 2009. NCRR's budget request for FY 2010 is $1.252 billion, an increase of $0.026 billion over FY 2009. The additional funds will support the continued expansion of the CTSA consortium and maintain all of NCRR's other programs.

D. Program Updates

Clinical Research

CTSAs: In April, the University of Cincinnati became the 39th member of the CTSA consortium, funded from the first round of 2009 applications. The announcement about new awards approved by the Council today will be made in late June or July in conjunction with awardees' announcements and events. When the program is fully implemented, it will support 60 CTSAs across the nation.

CTSA Strategic Goals: The CTSA Consortium Steering Committee approved a fifth strategic goal on April 9, 2009. Metrics have been identified to measure progress on the first four goals. In achieving Goal 5 - enhancing the education and training requirement for T1 investigators - input from stakeholders, including academia, industry and regulatory agencies, will be sought.

Goal 1

Clinical research management
Research infrastructure
Phenotyping — human and preclinical models

The directors of the National Primate Research Centers (NPRCs) held their semiannual meeting on April 3, 2009, in Bethesda, Md. Major topics of discussion included NPRCs' extensive consortium-based activities, specific collaborative projects with CTSAs and the use of the Biomedical Informatics Research Network infrastructure for federating data across the eight NPRCs.

NCRR is working with the National Institute of General Medical Sciences to hold a workshop June 4–5, 2009, to discuss plans for NIH support of life science research at the new Brookhaven National Synchrotron Light Source, known as NSLS-II. At the workshop, a panel of experts will provide guidance about the new facility. Council member Dr. Janet L. Smith will be participating in the workshop.

E. Awards Received by NCRR

Three NCRR products have received NIH Plain Language Awards: The NCRR Reporter, the NCRR e-Newsletter, and the video: NCRR Overview: Harnessing Innovation to Enhance Human Health. In addition, in the International Technical Publications Competition sponsored by the Society for Technical Communication, NCRR's strategic plan won an Award of Excellence and the NCRR Reporter won a Distinguished Technical Publication Award.

F. Upcoming Workshops and Meetings

Second Annual Clinical Research Management Workshop
NCRR and the Yale Center for Clinical Investigation are co-sponsoring this workshop, to be held June 22–23 in the Natcher Conference Center. Representatives from CTSAs, NIH, the Food and Drug Administration, industry and nonprofit research foundations will discuss methods to improve processes in clinical research management. The workshop is designed to foster the development of networking relationships among counterparts at CTSA sites and advance the initiation of CTSA consortium-wide projects.

Future of Telehealth: Essential Tools and Technologies for Clinical Research and Care
Stakeholders in telehealth from government agencies, academic institutions, health care organizations and technology companies will participate in this workshop, to be held June 25–26 in the Natcher Conference Center. Participants will review the state of telehealth science and technology, identify gaps in knowledge, and explore ways to advance the field. Recommendations will be made about ways to further telehealth applications for clinical care, clinical and translational research, and health education and training, with the ultimate goals of broadening participation in research and improving health outcomes in medically underserved communities. NCRR is sponsoring the workshop with the National Library of Medicine, National Institute of Biomedical Imaging and Bioengineering, National Center on Minority Health and Health Disparities, Health Resources and Services Administration, Indian Health Service, Internet2 and American Telemedicine Association.

Workshop on Efficient Management and Utilization of Core Facilities
The agenda for this workshop grew out of 135 responses to a Request for Information that NCRR issued in early 2009 soliciting input from the extramural research community about concerns and experiences with research cores. The workshop, to take place in the Natcher Conference Center July 14–15, 2009, will explore the issues identified and provide a forum to propose improvements. Individuals who use, manage, regulate and fund resource cores will participate.

Advancing Rare Diseases Research through Networks and Collaboration
NCRR and the NIH Office of Rare Diseases Research are co-sponsoring this conference, to be held on July 16 in the Natcher Conference Center. The meeting will provide a forum to highlight successful collaborations and discuss lessons learned from the Rare Diseases Clinical Research Network. The essential role of patient advocacy groups to facilitate research and accrual of patients will be emphasized. Participants will discuss best practices for translation of basic discoveries into clinical practice in rare diseases.

Merck-Merial NIH National Veterinary Scholars Symposium
August 6, 2009
Raleigh, N.C.

8th Annual Mutant Mouse Regional Resource Center Program Meeting
October 15–16, 2009
Bethesda, Md.

7th Annual Symposium on Non Human Primate Models of AIDS
October 28, 2009
Boston

G. Personnel Update

IV. Current Status of ARRA Activities: Dr. Gregory K. Farber, deputy director, Office of Extramural Activities, NCRR

NCRR will administer ARRA funds totaling more than $1.6 billion, in addition to funds made available from the NIH Office of the Director. ARRA funds were allocated in three categories: construction ($1 billion), instrumentation ($300 million), and science research ($310 million).

Construction: NCRR has issued two program announcements, one for extramural research facilities improvement (C06 grants) and one for core facilities improvement (G20 grants). The awards range from $1 million to $15 million and have four application deadlines ranging from May 6 to September 17, 2009.

Instrumentation: Applications have been received for new rounds of Shared Instrumentation Grants of $100,000 to $500,000 and High-End Instrumentation Grants of $600,000 to $8 million. NCRR is also using ARRA funds to support highly meritorious but unfunded applications from the last cycle of these grants, and more than 80 grants have been awarded so far.

Summer Research Experience: These grants support high school or college students or high school teachers in laboratories that have received an NCRR award. Twenty-nine awards are being made, totaling approximately $2 million.

Competitive Revisions: These grants will be made by other NIH Institutes and Centers, with NCRR providing the funds. The grants support expansion of active NIH-funded projects.

Enabling National Networking of Scientists and Resource Discovery: These grants support the development or enhancement of networking infrastructure. ARRA funds totaling $30 million are being made available for these grants.

Challenge Grants: NCRR will use approximately $2 million in ARRA funds for these grants, which support studies addressing challenges that could have a high impact on biomedical and behavioral research.

Administrative Supplements: These grants provide supplemental administrative funds to accelerate the pace of active NIH research grants. NCRR has specified that applications must enhance or facilitate one of six areas of research to be eligible: 1) translational (T1 and T2) research; 2) an NCRR informatics pilot project; 3) the CTSA consortium strategic goals; 4) collaborative community engagement research; 5) development of the research workforce and dissemination of science education, or 6) development and dissemination of public education about science and research. NCRR plans to use roughly $240 million to support these administrative supplements.

V. Clinical Research Training at Einstein — From K30 to CTSA: Dr. Ellie E. Schoenbaum, professor of epidemiology and population health, medicine, and obstetrics and gynecology and women's health; director, Clinical Research Training Program, Albert Einstein College of Medicine

Dr. Schoenbaum described the background and current status of the Clinical Research Training Program (CRTP) at Albert Einstein College of Medicine, which joined the CTSA consortium in 2008. CRTP has a didactic core coupled with a mentored research project that results in a paper submitted for publication. The classes are small (around 15–17 students per year), and the program requires 50 percent protected time for participation. CRTP makes training in grant writing skills a priority, so each scholar graduates with a career development award.

In conjunction with its teaching hospital, Montefiore Medical Center, Einstein began CRTP in 1998 as a two-year Master of Science program in clinical research for physicians. In 2000, the program received funding from NCRR through a K30 grant. In 2005, CRTP began its MD-MS program, admitting up to three medical students each year.

The 112 scholars who graduated from CRTP between 2000 and 2009 came from 15 different medical specialties. Close to 60 percent of these graduates specialized in internal medicine or pediatrics. Dr. Schoenbaum noted that 19 scholars have come from the departments of emergency medicine and obstetrics and gynecology, primarily because these two departments have chairs who actively promote clinical and translational research and offer a fair amount of protected time. Numerous other departments have sent only one or two scholars. Dr. Schoenbaum said that finding mentors in these specialties is a challenge, and CRTP is exploring ways to use CTSA resources to foster clinical research in those departments.

Noting that the prestige of membership in the CTSA consortium enhances the program's access to other departments, Dr. Schoenbaum said the training program recently began enrolling scholars in allied professions, such as dentistry and nursing. CRTP also began offering a doctorate in clinical investigation. Einstein's Graduate Division of Biomedical Sciences houses this track, which represents a major culture change from the division's long tradition in basic science research.

Dr. Schoenbaum concluded by noting that new metrics are needed to evaluate the effectiveness of educational programs in clinical and translational research. She said that evaluation should go beyond such traditional measures as the number of papers published and the number and types of grants obtained to include such elements as industry partnerships and community involvement.

VI. Building a Research Career on the SERCA — Becoming an Independent Veterinary Scientist: Dr. Ian C. Davis, assistant professor of veterinary biosciences, Ohio State University

Dr. Davis, who holds a doctorate in veterinary medicine from the University of Bristol, U.K., used his experience to describe how receiving NCRR's Special Emphasis Research Career Award (SERCA) in Pathology and Comparative Medicine helped him become an independent researcher. NCRR's SERCA is unique among NIH awards because only veterinarians can compete for it.

After receiving his doctorate at the University of Alabama at Birmingham (UAB), Dr. Davis began using mice to study respiratory syncytial virus (RSV) and developed a hypothesis regarding the role of viruses in the transport of ions by respiratory epithelia. Using a live murine model, he demonstrated how RSV reduces the ability of the lungs to clear fluids. Despite having three significant findings from this SERCA-funded research, Dr. Davis realized that securing R01 funding for additional studies would be a challenge because of the difficulty in distinguishing his work from that of his mentor at UAB.

Dr. Davis moved to Ohio State University (OSU) three years ago to establish himself as an independent researcher. To accomplish this goal, he pursued several objectives: secure additional funding for research, develop new lines of research distinct from those of his mentor at UAB and develop collaborations with researchers both within and outside OSU. He said his collaboration with clinical researchers has expanded because OSU has veterinary and medical schools on the same campus and because he is studying human disease in an animal model. For example, his research has described the effect of influenza infection on arterial oxygen saturation. In another example, a researcher studying the effect of cigarette smoke on mice was able to add lung function data to his histopathology research, thereby doubling the amount of data for the same research costs.

Of the 10 research grants for which Dr. Davis has applied since January 2007, three have been successful. He is currently applying for an R01 grant with the National Institute of Allergy and Infectious Diseases.

Dr. Davis concluded by saying that he seeks to inspire veterinary students to go into research and sees that as an important challenge to all in the field.

VII. SEPA/INBRE/CTSA Partnerships — The K-12 to Undergraduate Pipeline and Community-Based Participatory Research: Dr. Ann L. Chester, assistant vice president for health sciences for social justice, Robert C. Byrd Health Sciences Center, West Virginia University; director, West Virginia Health Sciences and Technology Academy; and Dr. Robert A. Branch, professor of medicine and pharmacology and program director, Montefiore Clinical and Translational Research Center, University of Pittsburgh

Dr. Chester explained that the West Virginia Health Sciences and Technology Academy (HSTA) is a math and science program for students in grades 9–12 funded by NCRR's Science Education Partnership Award (SEPA) program. Begun in 1994, HSTA operates in 26 West Virginia counties to increase the number of minority and underrepresented students in rural communities who go to college and pursue careers as health care practitioners. Dr. Chester emphasized that involvement of community volunteers who serve on local boards of directors is key to HSTA's success.

Dr. Chester said that HSTA has more than 80 teachers, each of whom leads a club of 10 students who receive a tuition waiver at a West Virginia college or university if they fulfill certain requirements. They must attend weekly after-school meetings, complete and present a yearly science project, attend two on-campus summer institutes, participate in field trips, complete 75 hours of community service and attend the annual HSTA Science Symposium.

Although West Virginia's population is largely white, 36 percent of HSTA students are African American. Most (53 percent) are financially disadvantaged, and 58 percent are the first in their families to go to college. The program has had 1,118 graduates, 97 percent of whom have gone to college, compared to 56 percent in the general West Virginia population. Of those who have gone to college, 90 percent receive four-year degrees, compared to less than 50 percent of college entrants statewide, and 56 percent major in health sciences.

Dr. Chester explained that HSTA has used funding from NCRR's INBRE program to hire a college liaison who guides HSTA graduates into undergraduate institutions with INBRE-funded laboratories. This liaison helps students find college mentors and maintains a tracking system to follow the progress of each HSTA graduate.

Dr. Branch, program director of the CTSA-funded Clinical and Translational Science Institute (CTSI) at the University of Pittsburgh, informed the Council that CTSI and HSTA had worked together to develop a community-based participatory research (CBPR) model that focuses on the family unit in designing a diabetes prevention and obesity management intervention. HSTA club members receive training in clinical research, ethical study design, the role of an institutional review board and regulatory compliance. Then they gather data from family members, develop a family diabetes risk score and involve their families in a weight-management program. As part of this process, HSTA students learn about evidence-based medicine and gain knowledge about diabetes, genetics, metabolic syndrome, weight management and diabetes risk prevention.

Last year, 210 students and 18 mentors received the initial training in clinical research, and those students recruited nearly 1,000 family members into the study. This year, 350 additional students have completed the training and are ready to recruit family members.

Dr. Branch presented data on the prevalence of obesity and diabetes in the West Virginia counties with participating HSTA clubs. In these counties, which represent the poorest communities in the state, the prevalence of obesity is 50 percent, the highest rate ever observed in the United States. The rate of diabetes is close to 20 percent for individuals over 30 years of age and was shown to be associated with obesity in family members.

The data from 140 families were analyzed and presented graphically to provide each family with its own health information. The analyses have been used to create a health management system within the context of the family's unique environment, genetics, economics and other influences. Dr. Branch noted that this project demonstrates that adolescents are able to conduct CBPR, and it offers a new model for health care in underserved communities, including empowering the community to take a larger role in their own health care. The University of Pittsburgh researchers believe this model of family intervention will be applicable to other areas of health care and in other communities.

Dr. Branch concluded by asking the Council members to recognize the infrastructure that allowed this single pilot study to take place, with funding from three different NCRR programs: SEPA, INBRE and CTSA. He also noted that CBPR does not fit neatly into any of NIH's primarily disease-based institutes, adding that the NIH Roadmap initiatives could develop an appropriate mechanism for this work. Dr. Branch said that the HSTA pilot demonstration offers proof of principle, but it has no ongoing support to sustain it outside of NCRR. He called on educators and health care providers to keep the community in the discussion when seeking government funding.

VIII. An Overview of the National Association of IDeA Principal Investigators: Dr. Charles Wood, professor of biological sciences, University of Nebraska-Lincoln; president, NAIPI

Dr. Wood described the development of the National Association of IDeA Principal Investigators (NAIPI), which began as a working group in January 2008. The association currently represents more than 100 principal investigators for studies funded by NCRR's IDeA program, which includes INBREs and Centers of Biomedical Research Excellence (COBRE). Dr. Wood noted that the 84 COBREs represent 15 different scientific themes, and 18 themes emerge from the 23 INBREs, through which 311 projects are currently in progress. NAIPI promotes communication and sharing of resources among principal investigators working in the same scientific area.

Dr. Wood explained the organizational structure of NAIPI, which has 20 members representing four geographic regions of the country. Each region has a five-person council with three representatives from COBREs and two from INBREs. Annual regional meetings are scheduled for 2009 to provide opportunities to present research findings and foster collaboration. A Web site (www.naipi.org external link, opens in new window

) has been launched and will continue to expand.

The goals of NAIPI's 2009 strategic plan are to: 1) document successes of the IDeA program, using numeric metrics and narrative data, to promote public relations and ensure future funding; 2) expand and enhance appreciation of the role of the IDeA program in building cutting-edge biomedical research in the United States; 3) promote interactions and collaborations throughout the IDeA scientific community; 4) increase skills of emerging investigators; and 5) promote the development of long-term business plans and best practices for core facilities.

IX. National Association of IDeA Principal Investigators Web Site and Communications Work Group: Dr. James F. Padbury, professor of pediatrics, Brown University; pediatrician-in-chief, Women and Infants Hospital of Rhode Island; chair, NAIPI Web Site and Communications Work Group

Dr. Padbury informed the Council that, after receiving numerous proposals, NAIPI's Web Site and Communications Work Group chose the Delaware Biotechnology Institute to build the NAIPI Web site. He demonstrated use of the Web site, which has pull-down menus for such standard information as history and bylaws and a U.S. map on which the IDeA states are highlighted.

To avoid duplicating efforts or resources, Dr. Padbury explained that the NAIPI Web site links to the Vermont Genetics Network for information on core facilities. The Vermont Genetics Network, which is part of the Network of IDeA-funded Core Laboratories (NICL), had already developed a searchable database of IDeA core facilities, providing information about services, laboratories and other resources. Dr. Padbury said that NICL has a mission similar to that of NAIPI, which is to support, encourage and facilitate resource sharing and collaboration among NCRR-funded cores and shared-resource facilities.

The NAIPI Web Site and Communications Work Group plans to issue passwords to all IDeA principal investigators, giving them read/write privileges so that they can populate the Web site with information about their expertise and the tools available at their facilities. All the information on the NIAPI Web site, such as funded projects and principal investigators' publications, will be publically available and searchable by keyword. Dr. Padbury said that developing this database is the first priority now that the Web site has been created. Other work group plans are to develop an online bulletin board and other mechanisms to enhance communication.

Dr. Padbury concluded by noting that COBRE and INBRE principal investigators have been highly successful in obtaining competitive grants and that the Web site will be a vehicle for highlighting their successes as well as a tool enabling them to work together more closely and to work with CTSA programs.

X. Innovation in Biomedical Research: Dr. Larry J. Forney, professor of biology and chair, Department of Biological Sciences; director, Initiative for Bioinformatics and Evolutionary Studies, University of Idaho

Dr. Forney reported that he and colleagues at the University of Idaho have taken an interdisciplinary approach to research, merging the biological sciences of biology, ecology and genomics with the computational disciplines of mathematics, statistics and computer science. This approach resulted in the Initiative for Bioinformatics and Evolutionary Studies (IBEST), funded through NCRR's COBRE program. Dr. Forney emphasized that IBEST investigators interact across disciplines in mentoring, grant writing and review, research and publishing. He noted that the university's small campus facilitates informal and productive communication.

Dr. Forney said that Idaho's COBRE grant supports research on the evolution of pathogens and parasites that affect human health. Investigators develop predictive models using information from empirical studies to better understand evolutionary processes. He presented an example of research involving a plasmid, a small bit of DNA that resides in bacteria and encodes genes for antibiotic resistance. Their research has shown how a mutation in the trfA gene of the plasmid interacts with the host DNA over time to develop antibiotic resistance in the host bacterium. In a second example of interdisciplinary work, Dr. Forney described research in the evolution of antibiotic resistance in bacterial biofilms.

Dr. Forney explained that such studies call for DNA sequencing technology as well as a mix of expertise, including experimental design, data acquisition, databases, computation of data storage, data analysis and interpretation, and data rendering. The university already had expertise in two of these areas and has used COBRE and INBRE funding to hire the additional individuals needed to create a bioinformatics core facility. This resource will be available to other institutions and researchers in western IDeA states.

The bioinformatics resources developed at the University of Idaho have also led to an award through NIH's Human Microbiome Project to study the human vaginal microbiome. The university will collaborate on this project with the University of Maryland and the University of Alabama at Birmingham. Whereas the other institutions will conduct genome sequencing and collect clinical data, the University of Idaho will analyze these data and develop mathematical models to predict the resiliency of different kinds of vaginal communities and risk to bacterial vaginosis.

XI. Advancing T1 Translational Research with Public-Private Partnerships: Dr. Kenneth J. Holroyd, assistant vice chancellor for research, Vanderbilt University Medical Center; co-chair, CTSA Public-Private Partnerships Key Function Committee

Dr. Holroyd informed the Council that through his long experience representing both academia and industry, he has observed that academic scientists and physicians typically find industry counterparts to work with in a partnership, but academia often does not have representatives educated and experienced in business to work with industry professionals. He suggested the term "alliantist" to describe an academic who works on alliances in a professional capacity.

Dr. Holroyd reported that Vanderbilt University Medical Center has 484 projects sponsored by 180 different companies. This support totals $125 million and represents about 15 percent of Vanderbilt's research budget. Close to 80 percent of the funding is for clinical research, and nearly 20 percent supports preclinical and basic research. Dr. Holroyd said the master agreements Vanderbilt has with 40 companies have shortened the time needed for final negotiations by about 15 days.

Corporate-sponsored research at Vanderbilt has increased from $85 million to $125 million since Vanderbilt joined the CTSA consortium in 2007. He credited Vanderbilt's Institute for Clinical and Translational Research for bringing together a variety of business, regulatory and clinical research services that have facilitated corporate sponsorship.

Dr. Holroyd described several examples of partnerships between Vanderbilt and biopharmaceutical and biotechnology companies on T1 projects, including the alliance begun in 2005 with AstraZeneca Oncology. Both Vanderbilt and AstraZeneca have teams that coordinate activities and keep projects moving forward.

Dr. Holroyd suggested three ways to facilitate public-private partnerships: 1) fostering the development of the alliantist professional role; 2) creating opportunities for more career exchange between industry and academia, including successful re-entry of individuals from industry to the university; and 3) developing standard contract language.

Among opportunities for clinical researchers to partner with industry, Dr. Holroyd described "precompetitive" research in areas of interest to industry that will not result directly in a product to be patented. Dr. Holroyd reported that the CTSA Public-Private Partnership Committee is working on a process to identify and match pharmaceutical companies and CTSA investigators interested in drug repositioning (i.e., finding new uses for drugs already marketed or in the pipeline). Another committee project is "legal harmonization," which is developing standard contract clauses that could be used by institutions within the CTSA consortium. Finally, an education subcommittee is working on an educational module intended for academicians interested in corporate alliances.

Closed Session

This portion of the Council meeting was closed to the public in accordance with the determination that it concerned matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code, and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).

Council members discussed procedures and policies regarding voting and confidentiality of application materials, committee discussions and recommendations. Members absented themselves from the meeting during discussion of and voting on applications from their own institutions or other applications in which there was a potential conflict of interest, real or apparent.

XII. Application Review

The Council reviewed 199 applications (with total direct costs of $205,568,238). The Council concurred with the review of all applications.

Adjournment

Certification

We hereby certify that, to the best of our knowledge, the foregoing minutes and supplements are accurate and complete.

/s/
Dr. Barbara M. Alving
Chair, National Advisory Research Resources Council
and
Director, National Center for Research Resources, NIH
July 22, 2009

/s/
Dr. Louise E. Ramm
Executive Secretary, National Advisory Research Resources Council
and
Deputy Director, National Center for Research Resources, NIH
July 16, 2009

These minutes will be formally considered by the Council at its next meeting; corrections or notations will be incorporated into the minutes of that meeting.