Date: September 24, 2009
Place: Building 31
Conference Room 10
National Institutes of Health
Bethesda, Maryland
The 192nd meeting of the National Advisory Dental and Craniofacial Research Council (NADCRC) was convened on September 24, 2009, at 8:35 a.m., in Building 31, Conference Room 10, National Institutes of Health (NIH), Bethesda, Maryland. The meeting was open to the public from 8:35 a.m. to 11:02 a.m.; it was followed by the closed session for Council business and consideration of grant applications from 11:30 a.m. until adjournment at 12 p.m. Dr. Isabel Garcia presided as Chair.
OPEN SESSION
Members Present
Dr. Carole A. Anderson
Dr. Gilda A. Barabino
Dr. Marianne Bronner-Fraser
Dr. Anna I. Dongari-Bagtzoglou (ad hoc)
Dr. Rena N. D’Souza
Dr. Cecile A. Feldman
Dr. Franklin Garcia-Godoy
Dr. David Chris Johnsen (ad hoc)
Dr. KyungMann Kim
Dr. Steve Martino (ad hoc)
Dr. Laurie K. McCauley
Dr. Harold Morris (ex officio)
Dr. Malcolm L. Snead
Dr. Philip P. Stashenko
Col. Kraig S. Vandewalle (ex officio)
Dr. Karin N. Westlund-High
Dr. Robert J. Weyant
Members of the Public
Dr. Peter Anas, Executive Director, Friends of NIDCR, Washington, D.C.
Dr. Robert Burns, Manager of Legislative and Regulatory Policy, American Dental Association, Washington, D.C.
Ms. Kim D’Abreu, Associate Director, Center for Educational Policy and Research, American Dental Education Association (ADEA), Washington, D.C.
Ms. Deborah Darcy, Director, Congressional Affairs, ADEA, Washington, D.C.
Dr. Arthur DeCarlo, President and Chief Science Officer, Agenta Biotechnologies, Birmingham, AL
Dr. Andréa Ferreira Zandoná, Associate Professor, Indiana University School of Dentistry, Indianapolis
Ms. Monette McKinnon, Director of Legislative Policy Development, ADEA, Washington, D.C.
Ms. Myla Moss, Director, Congressional Relations and Regulatory Affairs, ADEA, Washington, D.C.
Dr. Gregory Stoute, Fellow, ADEA, and Associate Professor, Boston University, Henry M. Goldman School of Dental Medicine, MA
Dr. Louis Terracio, Associate Dean for Research, New York University College of Dentistry, New York, NY
Federal Employees Present
National Institute of Dental and Craniofacial Research
Dr. Lawrence A. Tabak, Director
Dr. Isabel Garcia, Deputy Director
Dr. Alicia Dombroski, Executive Secretary, and Director, Division of Extramural Activities (DEA)
Dr. Robert C. Angerer, Scientific Director, Division of Intramural Research (DIR)
Dr. Kathryn M. Carbone, Deputy Scientific Director, DIR
Dr. Pamela McInnes, Director, Division of Extramural Research (DER)
Dr. Amy Bany Adams, Director, Office of Science Policy and Analysis (OSPA)
Dr. Margo Adesanya, OSPA
Dr. Jane Atkinson, DER, Center for Clinical Research (CCR)
Dr. Bradley Christian, OSPA, NIDCR Dental Public Health Residency Program
Dr. David Clark, DER, Behavioral and Social Sciences Research Branch (BSSRB)Ms. Michelle Culp, Office of the Director (OD), Office of Clinical Trials Operations and Management (OCTOM)
Ms. Mary Daley-Greenwood, Grants Management Branch (GMB)
Mr. Bret Dean, Office of Administrative Management (OAM), Financial Management Branch (FMB)
Dr. Donald DeNucci, DER, CCR
Dr. James L. Drummond, DER, Integrative Biology and Infectious Diseases Branch (IBIDB)
Dr. Leslie Frieden, DEA, Research Training and Career Development Branch (RTCDB)
Dr. Sue Hamann, OSPA
Dr. Holli Hamilton, DER
Dr. Kevin Hardwick, DEA, RTCDB
Dr. Emily L. Harris, DER, Translational Genomics Research Branch (TGRB)
Dr. Victor Henriquez, DEA, Scientific Review Branch (SRB)
Mr. Justin Hentges, DEA, GMB
Mr. Gabriel Hidalgo, DEA
Dr. Jonathan Horsford, DEA, SRB
Ms. Mary Kelly, DEA, SRB
Dr. Frances Kim, DER, CCR
Dr. Lynn King, DEA, SRB
Dr. Raj Krishnaraju, DEA, SRB
Dr. John W. Kusiak, DER, IBIDB
Ms. Carol Loose, OAM, FMB
Dr. Nadya Lumelsky, DER, IBIDB
Dr. R. Dwayne Lunsford, DER, IBIDB
Ms. Jayne Lura-Brown, DER
Ms. Marsha Mason, OD, Division of Extramural Activities Support (DEAS)
Dr. Ruth Nowjack-Raymer, DER, CCR
Mr. John Prue, Director, Office of Information Technology (OIT)
Dr. Jayalakshmi Raman, DEA, SRB
Dr. Melissa Riddle, DER, BSSRB
Ms. Delores Robinson, DEA
Dr. Isaac Rodriguez-Chavez, DER, IBIDB
Dr. Steven Scholnick, DER, TGRB
Dr. Yasaman Shirazi, DER, IBIDB
Dr. Lillian Shum, DER, IBIDB
Dr. Rebecca Wagenaar-Miller, DEA, SRB
Dr. Jason Wan, DER, IBIDB
Dr. Lois K. Cohen, Consultant
Ms. Yvonne H. duBuy, Consultant
Other Federal Employees:
Dr. Penny Wung Burgoon, Office of the Director (OD), NIH
Dr. Mary Fran Deutsch, OD/NIH, Office of Extramural Research (OER), Office of Policy for Extramural Research Administration (OPERA)
Ms. Elizabeth Jones, Center for Information Technology (CIT), NIH
Dr. Rajiv Kumar, Center for Scientific Review (CSR), NIH
Mr. Larry Sutton, OD, NIH
Ms. Diane Widmer, CIT, NIH
I. WELCOME AND INTRODUCTIONS
Dr. Isabel Garcia, Deputy Director, NIDCR, called the 192nd meeting of the Council to order. She noted that Dr. Lawrence Tabak, Director, NIDCR, has completed his service as Acting Principal Deputy Director, NIH, and would be arriving shortly. Dr. Garcia introduced three guests whose appointments as Council members are in process: Dr. Anna Dongari-Bagtzoglou, Dr. David Chris Johnsen, and Dr. Steve Martino. She thanked these individuals for participating in the meeting as ad hoc Council members.
Dr. Garcia asked particular NIDCR staff members to introduce new appointments within NIDCR. Dr. David Clark has joined the Behavioral and Social Sciences Research Branch in the Division of Extramural Research (DER), and Dr. Jayalakshmi Raman has joined the Scientific Review Branch in the Division of Extramural Activities (DEA). Dr. Garcia noted that Dr. Amy Bany Adams has been appointed director of the Office of Science Policy and Analysis (OSPA). Within OSPA, Dr. Bradley Christian and Dr. Astha Singhal are residents in the NIDCR Dental Public Health Residency Program, which is co-directed by Dr. Garcia and a new appointee, Dr. Amit Chattopadhyay. Also joining OSPA is Dr. Margo Adesanya, who recently returned to NIDCR as a contractor.
Dr. Garcia reported that two NIDCR staff retired recently. Dr. Paul Kolenbrander, who served in the Oral Infection and Immunity Branch of the Division of Intramural Research (DIR), retired after 31 years with NIDCR, and Dr. Kathy Hayes, who served in OSPA and other NIDCR offices, retired after more than 20 years with the Public Health Service.
The Council applauded the new staff and the service of the two retirees. Dr. Garcia invited all guests to introduce themselves.
II. FUTURE MEETING DATES
- January 25, 2010
- May 20, 2010
- September 27, 2010
- January 24, 2011
- May 23, 2011
- September 19, 2011
III. APPROVAL OF MINUTES
Dr. Alicia Dombroski, Executive Secretary, invited the Council to consider and approve the minutes of the May 22, 2009, Council meeting. The Council unanimously approved the minutes.
IV. CONCEPT CLEARANCES
Dr. Alicia Dombroski, DEA
Dr. Dombroski introduced staff presentations of four concepts for Council’s review and approval. Each concept clearance entailed staff’s description of the proposed research initiative, comments by two Council lead discussants, and Council’s discussion and consideration of approval. The four concepts and Council actions are summarized below.
Collaborative Research on the Transition from Acute to Chronic Pain:
New Models and Measures in Clinical and Preclinical Pain Research
Dr. John Kusiak, DER, IBIDB
Dr. Kusiak presented a proposed concept to support collaborative research on the transition from acute to chronic pain. The three objectives would be (i) to assemble multidisciplinary research teams with expertise in basic and clinical pain research and related expertise outside the pain field to provide novel, collaborative approaches for studying the transition; (ii) to discover biological and behavioral mechanisms that drive the transition; and (iii) to develop new preclinical and clinical models and measures of pain appropriate for these studies. Dr. Kusiak noted that knowledge to determine who will transition to a chronic pain state and to prevent this transition is lacking and that current models of pain do not reflect the complexity of chronic pain states in humans. Currently, NIDCR and NIH research is focused on the mechanisms of acute pain responses and treatment of chronic pain conditions, while little emphasis is given to the transition of acute to chronic pain. The proposed concept would help to fulfill unmet patient needs, such as prediction of risk, prevention, and treatment of chronic pain and therapies to prevent the transition to chronicity. The concept aligns with, but is distinct from, trans-NIH pain initiatives in the NIH Roadmap for Medical Research and the NIH Blueprint for Neuroscience Research.
Discussion
Dr. Westlund-High and Dr. Feldman responded as the Council’s lead discussants. They agreed that the concept summarizes well the directions needed in pain research and that the best way to proceed is to support multidisciplinary research keyed to the transition from acute to chronic pain. Dr. Feldman observed that this is a critical research area and that it is imperative for NIDCR to continue to unlock the mysteries of this transition.
The Council unanimously approved the concept.
Pathophysiology and Clinical Studies of Bisphosphonate-Associated
Osteonecrosis of the Jaw
Dr. Jane Atkinson, DER, CCR
Dr. Atkinson presented a concept to increase understanding of the pathophysiology, natural history, and best treatments for osteonecrosis of the jaw (ONJ) associated with drug therapies. She stated that bisphosphonates are used to prevent and treat osteoporosis and to manage the hypercalcemia and skeletal complications of patients with cancer. In 2003, reports appeared in the literature that bisphosphonate use was linked to the development of ONJ in patients, primarily those receiving higher-dose, intravenous forms for cancer treatment. Rare cases of ONJ have been reported in those using anti-resorptive biological agents for treatment of cancer bone complications and osteoporosis. To better understand ONJ, the NIDCR proposes to solicit investigator-initiated applications to address the following research priorities: (i) define the pathophysiology of ONJ in both animal and human studies; (ii) provide more accurate estimates of the prevalence of ONJ, establish the natural history of ONJ, and generate preliminary estimates of ONJ treatment success; (iii) determine and validate risk factors for ONJ; and (iv) study the pathophysiology and clinical features of new anti-resorptive drugs possibly associated with ONJ.
Discussion
The Council’s lead discussants, Dr. McCauley and Dr. Stashenko, agreed that NIDCR needs to continue its involvement and high visibility with this research topic. Dr. McCauley noted that the clinical rationale is compelling in that ONJ exclusively affects the jaw, patients are at risk, ONJ is a challenging condition to treat, and a fear of ONJ among patients and care providers can compromise patient treatment. She noted further that there are only a few case studies and a paucity of data on the prevalence, risk factors, diagnosis, and mechanisms of ONJ. Dr. Stashenko applauded the all-encompassing scope of the proposed concept, from epidemiology to basic research and possible development of animal models. He concluded that the proposed concept is timely, important, and relevant to NIDCR.
The Council unanimously approved the concept.
Building a Genetic and Genomic Knowledge Base in Dental and
Craniofacial Conditions and Diseases
Dr. Emily L. Harris, DER, TGRB
Dr. Harris presented a concept to encourage research on dental and craniofacial conditions and diseases that will identify promising areas of the genome and/or characterize and elucidate the function of genetic variants that affect risk of dental and craniofacial disease in humans. The ultimate goal would be to drive development of effective diagnostic, therapeutic, and preventive approaches. She noted that many dental and craniofacial conditions cluster in families, but little is known about specific genetic risk factors. The NIDCR portfolio of translational genetics research has fostered a depth of understanding of oral clefts, emerging data on genome-wide associations in dental caries and dental fluorosis, and identification of candidate genes for various dental and craniofacial conditions. Through the proposed concept, NIDCR would foster research on current genome-wide technologies (e.g., SNP genotyping), follow up on leads from genome-wide approaches (e.g., fine-mapping), continue to study candidate genes, and pursue gene–environment interactions. The NIDCR also would encourage researchers to build on established resources and to collaborate with established laboratories.
Discussion
The Council’s lead discussants, Dr. Weyant and Dr. D’Souza, welcomed this well-captured addition to the NIDCR research portfolio. Dr. Weyant noted that researchers have not been able to take advantage of new technologies and opportunities and that the knowledge base, previously focused on clefting and dental caries, is very limited in several areas.
The Council unanimously approved the concept.
Feasibility Testing Towards Development of Effective Behavioral and
Social Interventions to Improve Oral and Craniofacial Health
Dr. Melissa Riddle, DER, BSSRB
Dr. Riddle presented a concept to support pilot testing of behavioral or social interventions to improve oral and craniofacial health. Specifically, the concept would adapt NIDCR’s R34 clinical trial planning grant to pilot tests of the acceptability and feasibility of behavioral and social interventions in target communities, the proposed mechanisms of action of interventions, and the sustainability of interventions, when appropriate. The aim is to fulfill multiple goals: (i) to move toward a more rigorous model of behavioral and social intervention research, (ii) to provide additional tools for addressing oral health disparities, and (iii) to equip investigators to compete successfully for research grants that support full-scale testing of promising behavioral and social interventions. Dr. Riddle noted that the proposed concept reflects a convergence of recommendations from various workshops held in 2009 and parallels the use of R34 funding opportunities by other NIH institutes and centers.
Discussion
The lead discussants, Dr. Anderson and Dr. Weyant, agreed that the proposed concept is both interesting and needed and that it would encourage research models that cross “silo” areas and focus on mechanisms. Dr. Garcia noted that behavioral and social sciences research is an important area, as indicated in the NIDCR Strategic Plan 2009–2013, and is being revitalized at NIDCR.
The Council unanimously approved the concept.
V. REPORT OF THE DIRECTOR
AMERICAN RECOVERY AND REINVESTMENT ACT (ARRA) UPDATE ENHANCING PEER REVIEW UPDATE
Dr. Lawrence Tabak
Dr. Tabak presented updates on NIDCR and NIH activities related to the American Recovery and Reinvestment Act and Enhancing Peer Review. He referred the Council to his written report for detailed information on other recent NIDCR activities.
Dr. Tabak welcomed the ad hoc Council members. He noted that the terms of three Council members would expire after the Council meeting. Dr. Tabak expressed his deep gratitude to Dr. Bronner-Fraser, Dr. Feldman, and Dr. Stashenko, for their service on the Council and he presented each with a certificate and small gift.
ARRA Update
Dr. Tabak encouraged the Council to say “thank you” to the President and the Congress for the extraordinary opportunities provided by ARRA to improve the nation’s health and economy. He noted that the NIH has received $10 billion in ARRA funding, most of which ($8.2 billion) is funding extramural scientific research through the institutes and centers (ICs), the Office of the Director (OD), and the common fund for Roadmap initiatives. The remaining funds are supporting renovation and repair of extramural research facilities, equipment purchases, renovation and repair of intramural facilities, and comparative effectiveness research through the Agency for Healthcare Research and Quality (AHRQ). The NIH strategy in allocating ARRA monies is focused on two actions: (i) stimulation and acceleration of biomedical research through existing mechanisms (i.e., extending the NIH payline to fund additional meritorious applications and administrative supplements for ongoing research projects, and (ii) expansion of science by funding new programs (e.g., competitive supplements and new NIH-wide and IC-specific programs).
As of September 14, the NIDCR portion of ARRA funds was slightly more than $100 million. These funds were distributed approximately as follows: 30 percent to payline extensions, 23 percent to NIH Challenge Grants in Health and Science Research (RC1s), 12 percent to Grand Opportunities (GO) grants (RC2s), and 10 percent to biomedical core centers (P30s). Smaller percentages were allocated to training, small business programs, intramural research facilities and equipment, and research management and support. A remaining 3 percent was designated for out-year allocations for the first three items.
Dr. Tabak noted that funding and allocations are updated several times a day and that NIDCR has almost completed the allocation of ARRA funds. He emphasized that the overwhelming majority of allocated funds supports activities that were peer reviewed and that allocations based on administrative decisions were reviewed with equal rigor. NIDCR’s ARRA funds were distributed across 32 states. Addressing the distribution of funds among RC1s, RC2s, and P30s, Dr. Tabak reported the following: (i) Out of 453 RC1 applications received, NIDCR funded 27 (at a total cost of approximately $23.5 million) and OD funded 3; (ii) out of 49 RC2 applications received, NIDCR funded 10 (at a total cost of approximately $12.4 million) and OD co-funded 2; and (iii) out of 19 P30 applications received, NIDCR funded 7 (at a total cost of approximately $10.4 million). Dr. Tabak mentioned that the quality and number of RC1 and P30 awards exceeded NIDCR’s expectations. Most of the RC1 awards were for translational research, followed by research on enabling technologies, clinical and/or comparative effectiveness research, and genomics. Reflecting the strength and breadth of the research community, the RC2 awards included, for example, the biomechanisms of oral disease, detection of oral lesions, genome-wide associations, genetics of oral cancer, and pain circuitry.
For Fiscal Year (FY) 2010, NIDCR is participating in the following limited competitions for ARRA funding: Academic Research Enhancement Award (AREA) (R15); Biomedical Research, Development, and Growth to Spur the Acceleration of New Technologies (BRDG-SPAN) Pilot Program (RC3); Small Business Catalyst Awards for Accelerating Innovative Research (R43); and Building Sustainable Community-Linked Infrastructure to Enable Health Science Research (RC4). The NIDCR also may be able to fund additional supplements. All ARRA opportunities are described in full on the NIDCR website (see http://www.nidcr.nih.gov/recovery/).
In closing, Dr. Tabak noted that an extensive effort is under way to track the outputs and outcomes of ARRA funding. He referred the Council to the NIH’s new online Research Portfolio Online Reporting Tool (RePORT) (http://report.nih.gov/recovery/arragrants.cfm), which lists all NIH grants by states and, eventually, will list grants by IC. Government-wide information is available at http://www.recovery.gov. Dr. Tabak strongly encouraged all grantees to register on the NIH portal for grantee organizations and to report their Recovery data (e.g., the number of jobs created, expenditures).
Enhancing Peer Review Update
Dr. Tabak noted that the changes NIH has instituted in peer review created a good groundwork for handling ARRA funding opportunities. He referred the Council to the NIH website on enhancing peer review (http://enhancing-peer-review.nih.gov/). This initiative began in July 2007, and phased implementation of selected actions began in September 2008. From January to June 2009, the ICs phased out A2 applications and identified and distinguished new investigator (NI) and early-stage investigator (ESI) applications. Put in place were enhanced review criteria, a new scoring system (1–9), scoring of individual review criteria, and templates for structured critiques. Dr. Tabak noted that applications to be reviewed in January 2010 will have shorter page limits (e.g., for research plans) and a structure and content aligned with review criteria. Reviewers will use the 1–9 scoring system, score individual core criteria and overall importance and priority, and provide more concise summary statements.
In closing, Dr. Tabak thanked the extramural community for its magnificent response to ARRA funding opportunities and the NIH initiative to enhance peer review. He thanked NIDCR staff overall and identified specific individuals who played key roles in these efforts. The Council members applauded, saying that the level of effort and actions of NIDCR staff were truly impressive over the past 9 months. The Council, staff, and other participants rose to applaud Dr. Tabak.
CLOSED SESSION
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).
VI. REVIEW OF APPLICATIONS
Grant Review
The Council considered 1,107 applications requesting $325,296,554 in total costs. The Council recommended 417 applications for a total cost of $120,184,767 (see Attachment II).
ADJOURNMENT
The meeting was adjourned at 12 p.m. on September 24, 2009.
CERTIFICATION
I hereby certify that the foregoing minutes are accurate and complete.
________________________ _________________________
Dr. Lawrence A. Tabak Dr. Alicia Dombroski
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, September 2009
NOTE: A complete set of open-session handouts is available
from the Executive Secretary.