Date: May 25, 2004
Place: Building 31C, Conference Room 10
National Institutes of Health
Bethesda, MD 20892
The 175th meeting of the National Advisory Dental and Craniofacial Research Council (NADCRC) was convened on May 25, 2004, at 9:10 a.m., in Building 31C, Conference Room 10, National Institutes of Health (NIH), Bethesda, Maryland. The meeting was open to the public from 9:10 a.m. to 1:00 p.m., followed by the closed session for Council business and consideration of grant applications from 2:30 p.m. until adjournment at 4:30 p.m. Dr. Lawrence A. Tabak presided as Chair.
Members Present:
Dr. Louise T. Chow
Dr. Nereyda P. Clark
Dr. Matthew J. Doyle
Dr. Raymond J. Fonseca
Dr. Linda G. Griffith
Dr. Mark C. Herzberg
Dr. Howard K. Kuramitsu
Dr. Josephine Lai
Dr. Francis L. Macrina
Dr. Harold Morris
Dr. Linda C. Niessen
Dr. Michael J. Reed
Dr. George W. Taylor, Jr.
Members of the Public Present:
Dr. Lynda Bonewald, Lefkowitz Professor, and Director, Bone Biology Research Program, University of Missouri at Kansas City, and Chair, Board of Scientific Counselors, NIDCR (participation by teleconference)
Mr. Jack Bresch, Associate Executive Director, American Dental Education Association (ADEA), Washington, DC
Ms. Jackie Chmar, Legislative and Regulatory Policy, ADEA, Washington DC
Dr. Aida Chohayeb, Professor, Howard University, Washington, DC
Dr. Robert J. Collins, Deputy Executive Director, American Association for Dental Research, Alexandria, VA
Dr. Karl Haden, Associate Executive Director for Educational Policy and Research, ADEA, Washington DC
Dr. Manuel F. Morales, Adjunct Research Professor, University of the Pacific, and Professor Emeritus, University of California at San Francisco
Dr. Jonathan P. Schuermann, Research Scientist, University of Missouri, Columbia, MO
Federal Employees Present:
National Institute of Dental and Craniofacial Research:
Dr. Lawrence A. Tabak, Director, NIDCR
Dr. Albert Avila, Director, Intramural Research Fellows Program, Office of Education, Office of the Director (OD)
Dr. Bruce Baum, Chief, Gene Therapy and Therapeutics Branch, Division of Intramural Research (DIR)
Ms. Carolyn Baum, Committee Management Specialist and Council Secretary, OD
Dr. Sangeeta Bhargava, Health Scientist Administrator and Program Director, Immunology and Immunotherapy Program, Division of Basic and Translational Sciences (DBTS)
Dr. Henning Birkedal-Hansen, Acting Deputy Director, NIDCR
Ms. Karina Boehm, Chief, Health Promotion Branch, Office of Communications and Health Education (OCHE)
Dr. Norman S. Braveman, Executive Secretary, NADCRC and NIDCR Board of Scientific Counselors, and Assistant to the Director, NIDCR
Dr. Patricia S. Bryant, Health Scientist Administrator and Program Director, Behavioral and Social Sciences Research Program, Division of Population and Health Promotion Sciences (DPHPS)
Ms. Sharrell S. Butler, Diversity Program Manager, OD
Ms. Gabrielle Cannick, Special Volunteer, DPHPS
Ms. María Teresa Canto, Health Scientist Administrator and Program Director, Population Studies Program, DPHPS
Dr. Lois K. Cohen, Associate Director for International Health, NIDCR, and Director, Office of International Health (OIH)
Mr. George J. Coy, Chief, Financial Management Branch, Office of Administrative Management (OAM)
Mr. Kevin Crist, Grants Management Specialist, Division of Extramural Activities (DEA)
Ms. Mary Daley, Chief Grants Management Officer, Grants Management Branch (GMB), DEA
Ms. Yvonne H. du Buy, Associate Director for Management, and Chief, OAM
Dr. Caswell A. Evans, Director, National Oral Health Initiative, Office of the Surgeon General, and NIDCR
Mr. William Foley, Grants Management Specialist, DEA
Dr. Isabel Garcia, Acting Director, Office of Science Policy and Analysis (OSPA), and Co-Director, Residency Program in Dental Public Health at NIDCR, DPHPS
Ms. Christen Geiler, Computer Specialist, Office of Information Technology (OIT), OD
Dr. Sharon Gordon, Special Assistant for Research Training, Career Development, and Education, OD
Dr. Sven-Ulrik Gorr, Director, Applied and Translational Research Program, Center for Biotechnology and Innovation (CBI)
Dr. Kevin Hardwick, International Health Officer, OIH, and Special Assistant for Research Infrastructure and Curriculum Development, OD
Dr. Thomas Hart, Clinical Director, NIDCR
Dr. H. George Hausch, Acting Director, DEA
Dr. Jeffrey Hyman, Epidemiologist, Health Policy, Analysis, and Development Branch (HPAD), DPHPS
Ms. Lorrayne Jackson, Extramural Research Analyst and Outreach Specialist, OD
Ms. Mary Kelly, Scientific Review Specialist, Scientific Review Branch (SRB), DEA
Dr. Lynn King, Scientific Review Administrator, DEA
Dr. Albert Kingman, Chief, Biostatistics Core, DPHPS
Dr. Eleni Kousvelari, Director, CBI
Dr. John W. Kusiak, Health Scientist Administrator and Program Director, Molecular and Cellular Neurobiology Program, DBTS
Ms. Wendy A. Liffers, Associate Director for Policy Integration, OD
Ms. Carol Loose, Budget Analyst, Financial Management Branch, OAM
Ms. Jane Lura-Brown, Program Analyst, DPHPS
Dr. Dennis F. Mangan, Acting Deputy Director, DBTS, and Chief, Infectious Diseases and Immunity Branch, DBTS
Dr. Nathalie Morin, Dental Public Health Resident, DASPA
Dr. Richard L. Mowery, Chief, Clinical, Epidemiology and Behavioral Research Branch, DPHPS
Mr. Christopher Myers, Lead Grants Management Specialist, GMB, DEA
Dr. Mostafa Nokta, Health Scientist Administrator and Program Director, AIDS and Oral Manifestations of Immunosuppression Program, DBTS
Dr. Ruth Nowjack-Raymer, Health Scientist Administrator and Program Director, Health
Disparities Research Program, DPHPS
Ms. Sonia Penafiel, Grants Technical Assistant, CBI
Ms. Helen Pham, Grants Management Specialist, GMB, DEA
Dr. Bruce L. Pihlstrom, Acting Director, DPHPS
Dr. Pamela Robey, Acting Scientific Director, DIR
Ms. Diana Rutberg, Grants Management Specialist, GMB, DEA
Ms. Rebecca Roper, Scientific Review Administrator, DEA
Dr. Ann L. Sandberg, Acting Director, DBTS
Dr. Robert H. Selwitz, Chief, HPAD, and Co-Director, Residency Program in Dental Public Health at NIDCR, DPHPS
Ms. Patricia Sheridan, Information Specialist, OCHE
Dr. Yasaman Shirazi, Health Scientist Administrator and Program Director, Epithelial Cell Regulation and Transformation Program, DBTS
Dr. Lillian Shum, Health Scientist Administrator and Program Director, Physiology, Pharmacogenetics, and Injury Program, DBTS
Dr. Rochelle Small, Health Scientist Administrator and Program Director, Developmental Biology and Mammalian Genetics Program, DBTS
Ms. Amy Zukowski, Budget Analyst, OD
Ms. Traci Walker, Committee Management Assistant, OD
Mr. Robert Tarwater, Grants Management Specialist, GMB, DEA
Ms. Anne Welkener, Financial Analyst, DEA
Ms. Dolores A. Wells, Program Analyst, OSPA, OD
Ms. Mary Ann Williamson, Computer Specialist, OIT, OD
Ms. Shalanda Young, Public Health Analyst, OCHE
Other Federal Employees:
Dr. James A. Lipton, Senior Advisor to the Chief Dental Officer, U.S. Public Health Service
Dr. William Maas, Director, Division of Oral Health, Centers for Disease Control and Prevention, Chamblee, GA
Dr. Robert Mecklenburg, Consultant, National Cancer Institute, NIH
OPEN PORTION OF THE MEETING
I. CALL TO ORDER
Dr. Lawrence A. Tabak, Director, NIDCR, called the meeting to order. He invited the Council members and attendees to introduce themselves. Dr. Tabak and the Council congratulated and applauded Dr. Jonathan P. Schuermann for attaining his doctoral degree, which was awarded by the University of Missouri, Columbia.
II. APPROVAL OF MINUTES
The minutes of the Council’s meeting on January 20, 2004, were considered and unanimously approved.
III. FUTURE COUNCIL MEETING DATES
The following dates for future Council meetings were confirmed:
September 28, 2004
January 28, 2005
June 10, 2005
September 23, 2005
January 23, 2006
May 22, 2006
September 18, 2006
IV. REPORT OF THE DIRECTOR
Dr. Tabak presented an overview of NIDCR activities, advances, and personnel changes since the previous Council meeting, highlighting items from the written Director's Report (see Attachment III).
Activities of the NIDCR Director. Dr. Tabak noted that he has visited more than half of the U.S. schools of dentistry. Continuing to inform others about the NIH Roadmap, he recently spoke at a National Academy of Sciences’ meeting on facilitating interdisciplinary research and at the Brigham & Women’s 2004 Research Planning Retreat. The NIDCR web site includes an interview with Dr. Tabak on how the NIH Roadmap will facilitate dental research in the 21st century (see http://www.nidcr.nih.gov/Research/ResearchResults/InterviewsOHR/TIS022004.htm)
Activities of the Deputy Director. Dr. Henning Birkedal-Hansen represented NIDCR at a number of formal functions. He serves on a Health Resources and Services Administration/NIH planning group that is discussing the potential for collaboration in oral health research and services.
Budget Update. The NIDCR final budget for Fiscal Year (FY) 2004 is approximately $383.3 million, which includes approximately $1.3 million for NIH Roadmap activities. During the past several months, the Senate and House of Representatives appropriations subcommittees held hearings on the President’s Budget for 2005, which requests approximately $394.1 million for NIDCR. The NIH Director, Dr. Elias Zerhouni, testified for NIH, and Dr. Tabak, along with other institute and center (IC) directors, attended to answer questions.
DHHS/NIH/NIDCR Activities. Dr. Tabak reported that NIDCR has received very positive feedback on a progress review of the Oral Health focus area of Healthy People 2010, which was held March 17. For the review, Chief Dental Officer Dushanka V. Kleinman gave the opening remarks, and Dr. Tabak described NIDCR activities to achieve the national oral health objectives.
Dr. Alice Horowitz, Senior Scientist, Division of Population and Health Promotion Sciences (DPHPS), NIDCR, has an important role in this area.
Dr. Tabak noted that the Oral Health Toolkit has been completed and that copies have been mailed to all state dental directors and others upon request. He encouraged Council members to view the rich set of materials offered in the toolkit (which is available at: http://www.nidcr.nih.gov/EducationalResources/DentalHealthProf/HealthyPeople2010/
On March 26, the Food and Drug Administration approved the use of oral fluid samples with a rapid human immunodeficiency virus (HIV) diagnostic test kit. Previously, rapid tests relied on blood. Dr. Tabak noted that the Centers for Disease Control and Prevention (CDC) estimates that one-fourth of the approximately 900,000 HIV-infected people in the United States are not aware of their infection. Officials hope that the OraQuick test will increase HIV testing in community sites and homes.
The CDC’s National Center for Health Statistics has released the Oral Health Examination Data of the National Health and Nutrition Examination Survey (NHANES), 1999–2000. The three datasets are Oral Health (Dentition Section), Oral Health (Periodontal Section), and Oral Health (Recommendation of Care/Referral Section). The data and documentation are available on the NHANES web site at: http://www.cdc.gov/nchs/about/major/nhanes/NHANES99_00.htm.
Dr. Tabak noted that the NIH Director has asked a group of NIH institutes, including NIDCR, to forge a trans-NIH blueprint for brain research. The blueprint is likely to target three areas: infrastructure, technology development, and common research themes. Dr. Tabak anticipated that this effort will renew interest in brain research at NIH.
On May 6, the NIH Blue Ribbon Panel on Conflict of Interest Policies provided recommendations to the Advisory Committee to the Director, NIH. Dr. Zerhouni had established this panel as a working group of the advisory committee, to study issues about NIH researchers’ consulting with outside groups. Drs. Bruce Alberts and Norman R. Augustine co-chaired the panel. Its report is available at: http://www.nih.gov/about/ethics_COI_panelreport.htm.
Scientific Advances. Dr. Tabak highlighted two recent advances among the many that NIDCR scientists have made since the previous Council meeting. In a paper published in the May issue of the Journal of Clinical Investigation, NIDCR scientist Dr. Michael J. Iadarola and colleagues describe a potential new and more targeted treatment for chronic intractable pain. In dogs with severe osteoarthritis, cancer-related pain, or both, the team of scientists was able to appreciably improve the quality and length of their life by selectively deleting specific nerve cells that convey severe pain in the nervous system. In the laboratory, the selective deleting of C-fiber neurons from among various human neurons cultured together indicates that this strategy might also work in humans. Dr. Tabak encouraged the Council members to read the published paper.
On March 29, a team of scientists reported online in the Proceedings of the National Academy of Sciences that it had finished assembling the complete genome for Treponema denticola, a putative oral pathogen. This research was supported by NIDCR, and the T. denticola sequence is publicly available at GenBank: http://www.ncbi.nlm.nih.gov/Genbank/index.html under accession number AE017226.
Meetings and Workshops. NIDCR hosted its fifth annual Patient Advocates Forum on April 17 at NIH. For the 16 patient advocates representing 14 organizations, NIDCR provided briefings on the NIH Roadmap, updates on activities at NIDCR and the National Oral Health Information Clearinghouse, and a tour of the National Library of Medicine (NLM).
On April 19–20, NIDCR hosted a conference at NIH on professional skills development for NIDCR-supported trainees and directors of training programs. On May 6–7, NIDCR sponsored a very successful clinical trials workshop at NIH, entitled “Methods for Enhancing the Efficiency of Dental/Oral Health Clinical Trials: Current Status, Future Possibilities.”
At the annual meeting of the International Association for Dental Research (IADR), held March 10–13, NIDCR staff had active roles which included organization of various symposia and workshops. On May 3–5, in Los Angeles, California, several NIDCR staff members gave presentations at the 2004 National Oral Health Conference, the fifth joint annual meeting of the American Association of Public Health Dentistry and the Association of State and Territorial Dental Directors. The CDC provides major funding for these conferences.
On December 17, 2003, NIDCR sponsored the “Herschel S. Horowitz Memorial Symposium: a Celebration of His Science and His Legacy” to honor the life and work of Dr. Horowitz who passed away last August. Council members and friends from around the world attended the symposium, held at NIH. Dr. Horowitz was a pioneer in dental epidemiology and fluoride studies. He conducted extensive research on fluoridation and promoted fluoridation to improve public health.
Division Updates. Dr. Tabak referred the Council members to the written Report of the Director. He highlighted the following four items. (1) NIDCR has developed a CD entitled “Facing Your Future: Research Training and Career Development Opportunities.” The CD is appropriate for different groups, ranging from high school students to independent scientists. After final testing, NIDCR will distribute it at conferences and other training-related events.
(2) Five dental students received the highly competitive Howard Hughes Research Training Fellowship. This award supports a year-long residential experience for medical and dental students, to enable them to obtain hands-on training in basic research. Dr. Tabak noted that a record number of nine dental students applied in 2004, and he thanked Council members and NIDCR staff for encouraging dental students to apply.
(3) NIDCR extended the NIDCR Summer Dental Student Award to eight dental students this year. The students, who attend dental schools around the country, are assigned a research mentor and are exposed to the latest advances in oral health research.
(4) NIDCR recently established the Center for Biotechnology and Innovation (CBI) to take advantage of NIDCR’s momentum in using biotechnology to improve oral health. Dr. Eleni Kousvelari is the Acting Director. An organizational chart for this new center was included in the packet of division reports provided to Council.
Personnel Changes. Dr. Kousvelari introduced Dr. Sven-Ulrick Gorr, who joined NIDCR in March. Dr. Gorr is Director, Applied and Translational Research Program, CBI.
Dr. Tabak noted that Dr. Sharon Gordon, Special Assistant for Research Training, Career Development, and Education, Office of the Director (OD), NIDCR, will be leaving government service on June 18 to become Director for Curriculum Innovation and Management, University of Maryland Dental School, Baltimore. A search is underway for a replacement. In the interim, Dr. Kevin Hardwick, International Health Officer, Office of International Health, and Special Assistant for Research Infrastructure and Curriculum Development, OD, will assume Dr. Gordon’s responsibilities. The Council thanked Dr. Gordon for all her efforts while at NIDCR.
The written Director’s Report provides additional details on all these and other items (see Attachment III).
V. REPORT ON TRAINING AND CAREER DEVELOPMENT
Dr. Gordon reported on NIDCR funding of extramural research training and career development awards. She noted that NIDCR supports most of the research training of oral health researchers in the United States. In FY 2003, approximately 12 percent of the NIDCR budget was spent on extramural research training and career development and intramural training. Focusing on extramural support, she compared the trends for three main research training awards [National Research Service Award (NRSA) fellowships (F awards), institutional NRSAs (T32 awards), and short-term research training (T35) awards] with the trends for individual and institutional research career development (K) awards.
Dr. Gordon distributed a 3-page leaflet summarizing the NIDCR programs—for predoctoral students, postdoctoral and postgraduate students, and independent scientists. Detailed information about these programs is available on the NIDCR web site at http://028.nihmcmspauth2.cit.nih.gov/www.nidcr2.nih.gov/, and questions can be directed to NIDCR at nidcrtraining@mail.nih.gov.
Dr. Gordon noted that, from FY 1999 through FY 2003, overall NIDCR support for research training (F, T32, and T35) awards increased, due to an increase in stipends, but the number of institutional awards decreased. These trends reflect those across NIH. For individual career development (K) awards, both the funding and number of awards have increased during the same time period. The increase in number of awards reflects a similar trend across NIH.
In FY 2003, the total dollars expended for research training awards (approximately $11.8 million) were comparable to those expended for individual K awards (approximately $10.5 million). The increase in funding since FY 1999 was much greater for individual K awards (rising from approximately $3.0 million) than for research training awards (rising from approximately $7.9 million).
Dr. Gordon noted that NIDCR’s increased focus on individual, rather than institutional, awards is reflected in the success rates of former NIDCR research trainees and K awardees who subsequently receive investigator-initiated (R01) research grants. The data for NRSA awardees and K awardees (receiving a Dentist-Scientist Award, or DSA) during FY 1985–2000 show that 47 percent of those who had had individual NRSAs subsequently received an R01 award, compared with 34 percent of those on an institutional NRSA; for K awardees, the percentages are 64 percent for those who had had an individual DSA and 48 percent for those on an institutional DSA.
In summary, Dr. Gordon noted that the purpose of NIH research training programs is to develop independent scientists. The NIDCR data indicate the following: (a) Individual awardees are more successful; (b) the number and funding of individual K awards have increased, reflecting NIDCR’s commitment to fund more individual awards; and (c) the level of support for the separate NRSA programs has remained fairly constant, although NIDCR supports fewer and larger institutional awards. Short-term training, previously supported under the T35 mechanism, is now provided within the institutional NRSA (T32) program.
Discussion. Dr. Gordon suggested two topics for Council’s discussion: the relative merit of institutional and individual awards, and the possible reinstatement of a separate T35 mechanism. She noted that use of the T35 mechanism to support short-term training has decreased across NIH. The rationale for this change is that short-term training is enhanced by being included in institutional T32 programs, which offer a stronger base of role models and research. Dr. Gordon noted that NIDCR has not conducted a formal evaluation of performance outcomes for T35 trainees.
Extramural and intramural training. In discussion with staff, the Council determined that the total levels of support for extramural training and intramural training were comparable (approximately $22 million and $18 million, respectively). The Council and staff agreed that more analysis is needed to evaluate the experience and outcomes of extramural and intramural trainees and that the results of this evaluation would be helpful for guiding decisions about changes in the programs (e.g., reinstating the T35 program, emphasizing individual or institutional awards).
Evaluation of training outcomes. Dr. Tabak encouraged the Council to advise NIDCR on appropriate evaluation criteria for measuring the success of NIDCR trainees. He noted that the NIDCR database primarily includes information on former trainees’ current position, publications, and receipt of NIDCR grant funding; no additional information is available, for example, on other grant or industry funding. The traditional measure of success has been application for and receipt of R01s, and other criteria may be equally or more appropriate. The Council noted that receipt of an R01 should not be the only outcome for measuring success, especially for dental students. An additional measure could be creation and dissemination of knowledge (e.g., online publications).
Dr. Tabak noted that, with its evolving database, NIDCR can track trainee’s performance in real time, build in prospective evaluation tools, and obtain and incorporate information from the directors of training programs. The Council encouraged NIDCR to partner with other organizations to survey its awardees.
Individual and institutional awards. Several Council members expressed a preference for individual, rather than, institutional awards—for both predoctoral and postdoctoral training and career development. They noted that (a) students who apply for individual awards may be more entrepreneurial and have more defined research directions than students who are included in institutional awards; and (b) predoctoral students should be engaged in their own training, and this involvement is less likely to happen with institutional awards than with individual awards.
Other members encouraged NIDCR to identify the successful features of institutional programs and to build on these successes. They encouraged NIDCR to (a) evaluate the newer T32 programs, which differ from older T32 programs, on their own merits; (b) redesign the T32 award administratively to serve as a catalyst for training, rather than as a stipend for students; and (c) consider creating a hybrid institutional–individual award for which students would apply individually.
Dr. Gordon noted that both individual and institutional awards have a role and place in research training and career development programs. She suggested that institutional programs can serve to stimulate students’ interest in research and encourage them to apply for individual awards. She noted that NIDCR intends to evaluate all of its research training and career development programs and will be able to do this with the new database structure. Dr. Tabak asked the Council members to forward their further suggestions, particularly regarding parameters for prospective evaluations, to him or Dr. Hardwick.
Professional Skills Development Conference
Dr. Mark Herzberg, commented on the NIDCR Professional Skills Development Conference, held April 19–20 at NIH. A brief report of the conference was distributed to the Council members and attendees. The conference consisted of a series of science-related skill building workshops on personnel management, preparation and negotiation of employment packages, and grantwriting. Held for NIDCR trainees and program directors, the aim was to address conceptual and practical issues involved in becoming an independent investigator.
He noted that the conference attendees were very enthusiastic about all aspects of the conference—the format, presentations, scientific highlights, and discussion time. Commenting from the perspective of a program director, he suggested that NIDCR could: (a) prepare and post an annual calendar of all NIDCR events (e.g., meetings, conferences); (b) enhance the science poster session (e.g., by including a job fair); (c) invite deans of dental schools to these conferences; and (d) hold these conferences on an annual basis (though not necessarily at NIH). Dr. Tabak thanked Dr. Herzberg for his positive feedback.
VI. DISCUSSION: PREPARING CLINICIANS FOR BIOLOGICALLY BASED DENTISTRY
Dr. Manuel F. Morales, Adjunct Research Professor, University of the Pacific, and Professor Emeritus, University of California at San Francisco, shared his thoughts on issues and challenges in dental education. Noting that he has carefully observed a thriving dental school for the past 15 years, he urged NIDCR to take a lead role in helping dental education “catch up” with pure science and medical education. Dr. Morales specifically proposed that NIDCR organize a web-site course to inform dental students and faculty about four overlapping subsciences: genomics, proteomics, bioinformatics, and imaging. He emphasized that, together, these sciences are the basis for future understanding, at the atomic-molecular level, of how organisms replicate, grow, differentiate, and repair. The sciences offer researchers the possibility of devising totally rational ways of coping with diverse human adversities—from “in-born” defects, accidents, or intrusions by hostile microbes.
While medical schools have recognized the importance of these subsciences, dental schools have lagged in this recognition and are still promoting correction of human adversities by mechanical means and semi-empirical pharmacology. Dr. Morales asserted that dentistry, like medicine, must transit from a “mechanical” era to a “biology-based” era. Dentistry must catch up with pure science, and this catch-up is urgent and will be difficult. Whereas students and young investigators and faculty may have at least a verbal knowledge of the new sciences, senior faculty—who design curricula, make policy and promotion decisions, and serve as role models for students—are far less informed. Dr. Morales noted that any attempt to remedy the knowledge gap in dental education must target effectively this influential, and perhaps more refractory, sector of the faculty.
Dr. Morales urged NIDCR to “carry the ball.” He noted that NIDCR has the prestige of being part of NIH; is viewed by the dental profession as being its “voice” in government; has recognized and is already addressing the problem in complementary ways; has the scientific competence for leadership; and has an unparalleled perspective of relevant activity nationwide. Dr. Morales proposed that the web-based course include (a) a logical organization of material skillfully written as a “textbook,” and (b) illustrative accounts, drawn from extramural grantees, of practical instances in which the new approaches appear successful. He cited the successful science pamphlets developed for the public by the National Institute of General Medical Sciences (NIGMS) as a worthy model. The substance should be presented effectively and simply and give course “graduates” an understanding of central ideas and a respect for the possibilities for applying these ideas to the care and treatment of patients. The ultimate aim would be to positively impact training and practice by improving dental education.
Discussion
Dr. Tabak thanked Dr. Morales for his concern about the dental profession and for summarizing a major issue for the dental profession. The Council also expressed their appreciation for the important insights that Dr. Morales provided from outside the profession. NIDCR staff noted that the teaching of oral biology in dental schools has failed—teachers are “not engaged” in the discipline and a culture of science is lacking in the schools. The Council suggested that dental schools need to build alliances with medical schools to remediate and update the dental school curriculum and that individuals, not curriculum committees, must be the catalyst for change. The members noted that dentistry is still mostly perceived as a practice “done with hands,” not “with minds,” and that the teaching of clinical dentistry must be updated as well. They asserted that the future of dentistry as a profession needs to be examined and that role models of future dental practitioners need to be developed.
Staff commented that, with regard to the teaching of genomics, NIDCR is participating in an effort led by the National Coalition for Health Professional Education in Genetics (NCHPEG) to develop a course in genetics for faculty and students. The web-based course will be available to dental schools and will link to NIGMS publications.
In followup, Dr. Morales emphasized the need for a logically constructed course (not a web-site treatise) that integrates genomics with proteomics, bioinformatics, and imaging and that specifically targets senior academic dentists, who are less informed and somewhat naïve about the new sciences, compared with dental students. He envisioned that the course would directly utilize and expand on the content of the NIGMS pamphlets to endow them with a dental flavor and to include imaging and dental clinical applications. The preparation of materials for the course could be guided by NIDCR scientists in the Division of Intramural Research who have expertise in writing about science and the education of dentists.
VII. INTRODUCING GENETICS INTO DENTAL SCHOOL CURRICULUM
Dr. Thomas Hart, Clinical Director, NIDCR, presented an overview of genetics education in U.S. dental schools. He described the findings of a survey of the status of genetics education in 54 schools, conducted in 2001, and the contents of a potential dental genetics course. By incorporating genetics education into their curricula, dental schools will significantly impact the integration of genetics into oral medicine.
Dr. Hart noted that, since the early 1990s, the Human Genome Project has been the major force in precipitating discoveries in molecular biology, genetics, and genomics and the “industrialization” of science, which has been made possible by high-throughput laboratory research techniques and computer capabilities. The application of genomic information and technologies has fundamentally altered the study of human diseases, and the etiology of these diseases is now being defined in terms of gene–gene and/or gene–environment interactions. How to use this new information clinically is a primary focus of biomedical research and must be at the forefront of dentistry as well.
While at the University of Pittsburgh in 2001, Dr. Hart teamed with other scientists to assess the status of genetic education in 54 U.S. dental schools. The survey was constructed to build on the previous survey of genetics education, conducted in 1975. A comparison of the results of the two surveys shows that dental schools do not view genetics as an applied science and have been slow to integrate genetics into the curriculum. The number of dental schools that offer a formal course in genetics has actually declined, from nine to eight, and fewer schools than before have plans for a genetics course in the future. The number of hours of genetic instruction, in schools where this instruction is integrated into the curriculum, and the number of lecture hours of a genetics course have increased dramatically.
The specific findings of the 2001 survey are as follows: Only one dental school requires a genetics course as a prerequisite for entering the school; eight schools have a specific course solely dedicated to teaching genetics; most faculty and students perceive a need for genetics instruction in the curriculum; and most faculty think that the genetics instruction currently in the curriculum is adequate to prepare students for their board examinations. For the 45 schools that reported not having a formal genetics course, one-half indicated a perceived lack of faculty interest and a lack of time in the curriculum. Almost all of the schools indicated that genetics was integrated into other classes—mostly biochemistry, microbiology, and pathobiology—but the time (minutes) devoted to teaching specific genetics concepts varied widely. The total hours given to these concepts ranged from less than 1 hour to 121 hours. In comparison, the data for the eight schools that reported having a formal genetics course indicate that these schools devote more time to genetics, provide more substantive detail and standardized presentation of basic concepts, and have more continuity in instruction.
Dr. Hart noted that many diseases with dental, oral, and craniofacial manifestations of importance for oral medicine have a genetic basis. Of the approximately 4,000 inherited human disorders, 30 percent to 40 percent involve genetic craniofacial conditions. Future dental practitioners must understand basic and advanced genetics concepts to understand the clinical impact of genomics on oral and craniofacial tissues. The translational paradigm that fostered the Human Genome Project was that if scientists could identify the specific genes that underlie disease, clinicians could understand the underlying basic biological defects, improve the classification of diseases, develop better diagnostic tools, and develop better treatments. Having a full working knowledge of genetics and genomics will be essential to practitioners’ ability to perform preventive medicine and offer appropriate therapies.
Based on the survey results and the need for effective clinical application of genomics, the Pittsburgh team considered developing a dental genetics course. The key challenges were dental faculties’ lack of familiarity with genetics, the reliance on medical examples in existing dental genetics courses, and dental students’ failure to perceive a need for genetics education. The course envisaged would consist of two parts: a 12-week didactic part adapted from medical genetics textbooks, and a 10-week clinical relevance part adapted from chapters in Dr. Robert Gorlin’s textbook, Syndromes of the Head and Neck (Oxford University Press 2002). Emphasis would be on the content, which would be developed and presented in multiple modalities.
Dr. Hart suggested that the expertise and resources of the dental community could be leveraged to develop this course in partnership with other organizations, such as NCHPEG and the American Society for Human Genetics. The aim would be to develop a web-based/DVD course that could be shared by all dental schools, offer a common teaching experience and enable researchers to establish which teaching methods are effective, and provide consistency for establishing dental competencies.
Discussion
Dr. Tabak asked the Council to address two questions: (i) Should NIDCR be involved in catalyzing and creating curriculum materials for dental schools and, if so, at what level? (ii) Who is the target audience for such a course—entering dental students, faculty, and/or practitioners? The Council encouraged NIDCR to “be in the business” of disseminating knowledge, as well as creating knowledge, and to target all audiences. The members encouraged NIDCR to (a) partner with NLM in the development of “virtual” courses for dentistry; (b) specify the types of training to be included in research training and career development awards; and (c) develop a partnership with the American Dental Association to encourage the Council on Dental Accreditation to include competency in genetics and the other new sciences on board examinations.
The Council expressed concern that NIDCR may have to decrease its budget for ongoing or other activities if the Institute assumed this new role. Dr. Tabak encouraged the Council to deliberate and provide advice on priorities for NIDCR. He noted several alternatives: NIDCR could try to catalyze the needed changes externally (e.g., by funding curriculum development grants); internally (e.g., by developing materials in-house, similar to NIGMS); or through a combined approach (e.g., by extending the NIDCR Professional Skills Development Conference concept to include faculty at different levels).
The Council emphasized the need for simultaneous, concerted efforts by NIDCR, the dental professional associations, and dental schools. For example, NIDCR could specify that applicants for research grants should have a working knowledge of genetics and must indicate how the results of their research could be adopted into educational curricula and clinical practice. The American Dental Education Association could utilize the information gained from these applicants for its efforts to strengthen dental school curricula. The Council on Dental Accreditation could review its competencies for the new sciences. And, dental schools could encourage faculty to take courses in these sciences from other university departments. The Council noted that multiple partners may well pursue similar activities simultaneously.
Dr. Tabak summarized the actions suggested by the Council for NIDCR as follows: NIDCR should be involved in catalyzing and creating change in dental school curricula; NIDCR needs to determine the best entry points for promoting this change (i.e., which alternative approaches are appropriate and likely to be effective); and NIDCR should explore the issue of accreditation further.
VIII. REPORT OF CLINICAL TRIALS WORKSHOP
Dr. Bruce L. Pihlstrom, Acting Director, DPHPS, and Council member Dr. George Taylor reported on the May 6–7 NIDCR workshop on enhancing clinical trials. Dr. Pihlstrom reviewed the goals, definitions, and content of the workshop, and Dr. Taylor commented on the presentations. Approximately 200 participants from academia and government attended the workshop, entitled “Methods for Enhancing the Efficiency of Dental/Oral Health Clinical Trials: Current Status, Future Possibilities.” A report containing the meeting agenda, speaker abstracts and biographies, and participant list was distributed to the Council.
Dr. Pihlstrom noted that the overall goal of the workshop was to identify research opportunities to enhance the efficiency of dental/oral health clinical trials. Two subgoals were to assess the state of the science and to identify future research needs for biomarkers, surrogate endpoints, and new technologies for clinical trials in oral diseases. The participants used the definitions for clinical and surrogate endpoints and for biological markers that were adopted by the Biomarker Definitions Working Group in 1999. Dr. Pihlstrom noted the potential uses of biomarkers (in pre-development, pre-clinical, and Phase I–III clinical trials and clinical practice) and the difficulty of validating biomarkers and of evaluating treatment effects based on biomarkers.
The workshop sessions addressed the current use of biomarkers, surrogate endpoints, and other approaches to enhance the efficiency of clinical trials on various diseases; applications of biomarkers, surrogate endpoints, and new technologies to clinical trials of oral diseases and conditions; the state of the science of methods and technologies; and “next steps,” including regulatory considerations. One presentation, for example, highlighted the use of quantitative laser fluorescence to document changes in the area and volume of decalcification on the tooth surface over time. This technology would enable researchers to measure decalcification and remineralization—possible biomarkers of dental decay—and to intervene early before caries are established.
Dr. Pihlstrom summarized the remarks of a reactor panel at the workshop as follows: (a) There has been a dramatic increase in information and knowledge and an unparalleled development of new technologies. (b) The efficiency of clinical trials in dental and oral health is limited by the poor resolution of clinical diagnostic tools and the inability to identify active disease sites. (c) Oral diseases are complex and involve gene–environment interactions of multiple genes. (d) To establish biomarkers of complex oral diseases, scientists must understand these interactions; profile microbial components of flora and of health and disease states in oral disease; and apply genomics, proteomics, and informatics. (e) The application of biomarkers and new technologies should focus on the major oral diseases—periodontitis and caries. To advance clinical trials in dental and oral health, researchers must apply the tools of biology (i.e., an understanding of mechanisms, technologies); organize cooperative clinical study groups and share samples; utilize standardized, well-defined patient and control populations; and partner with colleagues working on related diseases (e.g., infectious, autoimmune, mucosal conditions).
Dr. Pihlstrom emphasized that the “take-home message” is “get to work.” Three specific actions are needed: (i) Increase the translational research workforce; (ii) define potential biomarkers and useful outcome markers in many more well-designed clinical studies, and (iii) apply the many biotechnology tools available to better understand the pathogenic mechanisms of oral disease.
Dr. Taylor reported that the content of the workshop was substantive and that the scope of the presentations, in relation to the NIH Roadmap, was very helpful. He noted that most of the workshop related to the first thematic area of the Roadmap—New Pathways to Discovery. In addressing this area—the development of new knowledge—the participants focused on the identification of endpoints and the use of biomarkers as endpoints in clinical trials.
Dr. Taylor suggested that additional NIDCR workshops could focus on the two other thematic areas of the Roadmap—Research Teams of the Future and Re-engineering the Clinical Research Enterprise. With regard to the former, participants could discuss, for example, the importance and need for interdisciplinary collaborations to discern the interplay between oral and systemic conditions. With regard to the latter, participants could address the re-engineering of clinical oral health research—for example, ways to enhance recruitment and retention of participants in clinical studies and application of other methodologies related to the implementation of clinical trials.
Discussion
The Council noted that the response to the workshop has been very positive. The members encouraged NIDCR to identify actionable items for follow up. They suggested, for example, that NIDCR could (a) ask research grant applicants seeking support for multicenter clinical trials to include a component in their study to evaluate biomarkers or alternative methods for establishing endpoints; (b) establish a publicly available repository to compile information on endpoints; (c) educate study sections about the need to evaluate surrogate, or secondary, outcomes; and (d) partner with other NIH components (e.g., the National Heart, Lung, and Blood Institute) to develop and issue a Request for Applications to promote use of high-technology measures to develop new panels of biomarkers for specific oral–systemic conditions. Noting the high cost of developing panels of biomarkers, the Council encouraged NIDCR to enjoin other stakeholders in this effort to maximize efficiency and investments.
Dr. Norman S. Braveman, Executive Secretary, NADCRC, encouraged the Council to communicate further with Dr. Pihlstrom and NIDCR staff on these and other possible actionable items.
IX. CONCEPT CLEARANCES
NIDCR staff presented the following two concepts for Council’s review and approval.
Metagenomics Analyses of the Oral Microbiome
Dr. Dennis F. Mangan, Acting Deputy Director, Division of Basic and Translational Sciences (DBTS), and Chief, Infectious Diseases and Immunity Branch, DBTS, presented a concept for a Program Announcement that would solicit proposals to develop new insights into the role of microbes in human oral health and disease. The invited research would address the total oral microbial community using a metagenomics approach built upon recent developments in DNA sequencing, gene assembly, and bioinformatics. Dr. Mangan noted that the oral cavity is a “cesspool” of numerous and qualitatively different microbes. Little is known about the estimated 500–700 species of microbes, and nothing is known about at least 40 percent of the microbes in the oral cavity. During the past 8 years, NIDCR has encouraged studies of genomics and proteomics, including the sequencing of bacterial genomes. Capitalizing on this research and by using a cost-effective metagenomics approach, researchers can identify microbes that cannot be cultured and can analyze their genomes. Dr. Mangan noted that researchers have recently confirmed and documented the utility of this technique for studying the genomes of all microbes in soil and water samples. By encouraging the application of metagenomics to study the oral microbial environment, NIDCR hopes to foster development of an entire compendium of DNA and genes from all microbes in the oral cavity.
The Council unanimously approved the concept.
Senior Scientist Mentor Award
Dr. Gordon presented a concept to provide support for established investigators who are conducting research in areas relevant to the NIDCR mission to enable them to have protected time for their research and for mentoring the basic research of dentist-scientists in training. The objectives are to establish a cadre of exceptional investigators to mentor dentists committed to a research career and to provide a mechanism for linking strong scientific mentors with trainees in dental, oral, and craniofacial research. NIDCR would use the K05 grant mechanism for this award. Dr. Gordon noted that good scientific mentorship is critical for making research progress and developing scientific careers. NIDCR participates in NIH support of the Midcareer Investigator Award in Patient-Oriented Research (the K24), but does not have a comparable, or any, award to support mentorship in the basic sciences. Several other NIH components support a Senior Scientist Award using the K05 mechanism, and NIDCR could draw on their experience with this mechanism.
In discussion, the Council asked for clarification of the nature and use of the K05 mechanism. Members questioned the need for an additional award to support the research and mentorship activities of established investigators. They suggested that all senior scientists are already involved in these activities and that the award would be viewed by dental school administrators as salary relief. Dr. Tabak noted that NIDCR developed the concept based on earlier discussions of how to interest the best scientific mentors in the training of young scientists.
The Council disapproved the concept unanimously.
X. INTRAMURAL POSTER PRESENTATIONS
During the Council’s lunch break, Council members had an opportunity to meet 12 postdoctoral intramural trainees and discuss their research during a poster session. NIDCR highlighted the research of two research fellows from each of the NIDCR’s six intramural branches. Council members were provided an abstract book which had both a poster abstract and a brief biographical sketch from each presenter. Dr. Albert Avila, Director, Intramural Research Fellowship Program, Office of Education, NIDCR, organized the event. The session was well attended by Council members and by NIDCR administrators and scientists, and those who attended made many favorable comments.
The research fellows are using advanced, state-of-the-art techniques and methodologies to understand the formation and development of salivary glands, teeth, and other components of the craniofacial complex; repair and regeneration of damaged organs and tissues; detection and sensation of taste; formation of blood vessels; development and progression of head and neck cancer; structural pathways and genetic components of pain sensitivity; and presence of and susceptibility to HIV infection in the oral cavity.
Intramural fellows in NIDCR’s Craniofacial Developmental Biology and Regeneration Branch are studying the role of fibronectin matrix and kinase signaling in the morphogenesis of salivary gland branching and the function of epiprofin expressed in the epithelium of developing teeth, hair follicles, and limb buds. In the Craniofacial and Skeletal Diseases Branch, fellows are elucidating the function of small integrin-binding ligand, N-linked glycoproteins in normal salivary glands and the role of two small leucine-rich proteoglycans (biglycan and decoran) in controlling aspects of craniofacial growth and organization. Research fellows in the Gene Therapy and Therapeutics Branch are clarifying the differentiation of human bone-marrow-derived cells into buccal epithelial cells and re-engineering salivary glands to serve as stable endogenous bioreactors for systemic gene therapy.
In the Oral Infection and Immunity Branch, fellows are studying factors that underlie HIV-1 infection in tonsils and the receptors, signaling, and logic that govern coding of sweet, umami, and bitter tastes. Intramural fellows in the Oral and Pharyngeal Cancer Branch are delineating the action of a class of semaphorin proteins that promote angiogenesis and the signaling pathways for the protein kinase Akt in head and neck squamous cell carcinoma. In the Pain and Neurosensory Mechanisms Branch, research fellows are describing the action of intracellular calcium signals in mediating pain sensations and the genetic influences on acute pain sensitivity in humans.
CLOSED PORTION OF THE MEETING
This portion of the meeting was closed to the public in accordance with the determination that it was concerned with 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).
There was a discussion of 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. Members were asked to sign a statement to this effect.
XI. REVIEW OF APPLICATIONS
Grant Review
The Council considered 438 applications requesting $101,092,632 in total costs. The Council recommended 322 applications for a total cost of $79,821,669 (see Attachment II).
ADJOURNMENT
The meeting was adjourned at 4:30 p.m. on May 25, 2004.
CERTIFICATION
I hereby certify that the foregoing minutes are accurate and complete.
_________________________ _________________________
Dr. Lawrence A. Tabak Dr. Norman S. Braveman
Chairperson Executive Secretary
National Advisory Dental and National Advisory Dental and
Craniofacial Research Council Craniofacial Research Council
ATTACHMENTS
I. Roster of Council Members
II. Table of Council Actions
III. Director's Report to the NADCRC, May 2004
NOTE: A complete set of open-portion handouts is available
from the Executive Secretary.