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Executive Director's Report As the challenges and opportunities of 2005 closed, the Friends looked back at another successful year of advocacy. From our Patient Advocacy Day and Congressional Health Fair to our Research Panel Discussion and annual Gala, the Friends continue to carry the message that investment in oral health research is essential. True to our mission, the Friends remain dedicated to promoting the extraordinary research by NIDCR scientists. Happy New Year, Alec Stone Protein Induces Dental Pulp Stem Cells Into Dentin-Forming Odontoblasts When dentists examine patients with a damaged tooth that has become infected and abscessed, or filled with tissue-eroding fluid, they typically have two options: Root canal or extraction. But for patients with less advanced infections that have yet to abscess, there is a third, tooth-saving possibility called direct pulp capping. Much like cleaning and bandaging a wound, the procedure requires the dentist to sterilize the infection, remove all signs of decay, and refill the hole in the tooth to allow the remaining healthy tissue to regenerate. And therein lies a challenge. When dentists fill the tooth, they can never be certain that its natural, highly mineralized dentin matrix will reform during the healing process as a needed buffer between the filling and the pulp tissue inside the tooth. Without an adequate dentin bridge, the direct contact between filling and pulp can irritate the tooth, lead to inflammation, and ultimately additional dental work. To help dentists solve this problem, scientists have turned their attention to the adult stem cells that reside within the dental pulp and which can be transformed with appropriate stimuli to produce a dentin-secreting cell called an odontoblast. In the December issue of the journal Gene Therapy, NIDCR grantees report taking an important step forward in learning to coax dental pulp stem cells to differentiate into what appear to be odontoblasts. Working with laboratory rats, the scientists implanted bits of a collagen protein matrix into the dental pulp of the molars and waited to see what happened. Each bit was saturated with a recombinant form of a gene called dentin matrix 1(DMP1), which encodes a dentin protein that their earlier work showed can induce undifferentiated mesenchymal cells to differentiate into odontoblast-like cells. After two and four weeks, they found DMP1 had a similar effect in the rat molars as in their cell-culture experiments, prompting the dental pulp stem cells to differentiate into cells that, "had the potential to regenerate dentin-like tissue." The dentin-like qualities of the regenerated tissue included: newly formed collagen matrix, protein markers for the differentiated cells that are specific to odontoblasts, and calcified deposits. To read more about this study, visit www.ncbi.nlm.nih.gov NIDCR Launches Import Study on TMJ and Muscle Disorders Body The National Institute of Dental and Craniofacial Research (NIDCR), part of the National Institutes of Health, announced the launch of a seven-year clinical study that could accelerate research on better pain-controlling treatments for a jaw condition called temporomandibular joint and muscle disorders (TMJDs). Called Orofacial Pain: Prospective Evaluation and Risk Assessment, or OPPERA, the $19.1 million project marks the first-ever large, prospective clinical study to identify risk factors that contribute to someone developing a TMJ disorder. A prospective study looks forward in time, tracking volunteers over several months or years to monitor the onset and natural course of a disease. During the OPPERA study, scientists will track 3,200 healthy volunteers from three to five years to see how many develop the disorder. According to Dr. William Maixner, the study's principal investigator and a scientist at the University of North Carolina in Chapel Hill, those who develop TMJ problems will open a critical and largely unexplored window on the early stages of the disorders, pointing the researchers toward genes and other biologic factors that might contribute to pain sensitivity. Maixner said the high-quality data generated from this prospective vantage point could provide the future impetus to refine diagnostic criteria for TMJ disorders, consider new approaches to treatment, and predict a person's natural susceptibility to develop a chronic pain condition. "This is a timely study that will greatly enhance the scientific underpinnings of research on TMJDs," said NIDCR director Dr. Lawrence Tabak. "Most importantly, it will accelerate the pace of the science and seed valuable new leads that impact virtually every aspect of care for the disorders." "This study represents an important step forward not only for TMJD research but pain research in general," said NIH director Dr. Elias Zerhouni. "It marks one of the first - if not the first – prospective clinical studies to identify risk factors for a chronic pain condition. It's quite possible that some of the findings that arise from this study will be applicable to other musculoskeletal pain conditions." Although TMJ disorders vary in their duration and severity, for some people the pain becomes a permanent feature of their lives, and controlling it can be an exercise in frustration for them and their doctors. In the absence of generally accepted, science-based guidelines for managing TMJ disorders, health care providers have tried to help patients using a variety of approaches, often with unsatisfactory results. This study builds on the recent completion of a successful three-year, prospective pilot study in North Carolina that involved 240 healthy women who initially had no history of a TMJ disorder. In the OPPERA study, participants may be both male and female. All must be between the ages of 14 and 44, in good health, and have had no previous TMJ problems. Based on the results of the pilot study, Maixner said an estimated 200 volunteers may develop their first TMJ disorder during their participation in OPPERA. "A large prospective study on a TMJ disorder would have been futile just a decade ago because not enough was known about the basic mechanisms that control human pain," said Maixner. "It's only been within the last few years that an adequate conceptual framework has emerged, and I'm very hopeful OPPERA will identify key genetic, physiologic, and psychological variables that tell us more about patients and, ultimately, lead to more effective treatment approaches." NIDCR Update NIH Medicine for the Public Series Dushanka V. Kleinman Resumes NIDCR Duties Pamela McInnes Named CIDI Director Dr. McInnes has received numerous honors and awards including the NIH Director's Award, 2005; the DHHS Secretary's Award for Distinguished Service, 2003; the NIH Director's Award, 2002 and 1996. She has continued to be active in trans-NIH affairs: NIH Representative to the OSTP Task Force on Deemed Exports Controls; NIH Representative on OSTP Interagency Groups on Transborder Movement of Research Materials; Member, FDA Vaccines and Related Biologic Products Advisory Committee; and the US Interagency Group on Influenza Pandemic Preparedness. Introducing The NIH Extramural Nexus The National Institutes of Health Office of Extramural Research (OER) welcomes you to your first update on NIH extramural issues via the NIH Extramural Nexus. The OER is the hub for grants policy and operations, grants administration, and the coordination of NIH's extramural programs and activities. Through the Nexus, the OER will provide the external scientific community with updates on NIH policies and activities as well as an opportunity to gain a better understanding of the operation of extramural programs. We intend the Nexus to be a two-way communications portal — we will be listening to you and plan to modify the content of the Nexus accordingly. The Nexus appears at a time of considerable change at the NIH. Among other things, the President has signed the FY 2006 budget and we have developed financial operations policies; we are moving quickly to electronic submission of applications; we are considering new policies to facilitate the careers of new investigators; and, we are redesigning our grant programs to recognize the contribution of multiple members of research teams. Each bimonthly issue of the NIH Extramural Nexus will acquaint readers with topical information about extramural policies and initiatives as well as the various programs that comprise the OER. In the articles below, identified by the Nexus Symbol you will be introduced to NIH FY 2006 financial operations policies, the status of Electronic Submission, the Division of Extramural Inventions & Technology Resources, the Multiple Principal Investigator and New Investigator initiatives, and NIH's Public Access Policy — all important extramural issues and components integral to the NIH mission. In future months, in conjunction with providing information about policy, the Nexus will highlight many other aspects of the NIH's extramural program. Patient Advocacy Spotlight: HIVDENT HIVDENT is a not-for-profit coalition of concerned health care professionals committed to assuring access to high quality oral health care services for adults, adolescents, and children living with HIV disease. HIVDENT disseminates state-of-the-art treatment information and shares expertise in advocacy, development, training, integration, and evaluation of oral health services for the HIV-infected population. The primary mechanism by which HIVDENT initially intends to accomplish its mission is via this web site. Inside, not only will you find several sections on the oral manifestations of HIV disease and a large picture gallery, but information on infection control, post-exposure protocols, pediatric/adolescent care, medications, funding and other resources. Through an easily accessible e-mail system, health care professionals and consumers alike are able to communicate directly with our Faculty, some of the foremost international experts in these fields. or more information, visit: www.hivdent.org NIH Funds Two New Biomedical Technology Resource Centers More Than $18 Million Will Support Development of Image Guided Therapies and Biochemistry Studies Brigham and Women's Hospital of Boston will receive $15 million over five years in a cooperative agreement to establish a national Image guided Therapy (IGT) Center. The new resource will provide a unique, "one-stop-shopping" research, training, and service center that will develop and make available to scientists and clinicians image processing and display tools; dynamic and adaptive Magnetic Resonance Imaging methods; novel therapy techniques; and image-guided robotics. The funding will allow the IGT Center to expand its range of research areas to include cardiovascular interventions and targeted drug delivery. "We believe this collaborative, multidisciplinary center will develop innovative image guided intervention technologies that will enable effective, less invasive clinical treatments that are not only more economical, but also produce better results for patients," said Barbara M. Alving, M.D., Acting Director of NCRR. A portion of the $15 million in NIH support to the IGT resource will come from the National Cancer Institute and the National Institute of Biomedical Imaging and Bioengineering. Through the second award, NCRR will provide Indiana University in Bloomington with $3.2 million over three years to launch the National Center for Glycomics and Glycoproteomics to advance the study of carbohydrate molecules. A relatively new field that uses sophisticated tools and methods, glycomics is the study of complex sugar molecules that are attached to many proteins and lipids found in the blood, on the surfaces of cells, and in other places in the human body. These sugar chains are critical to numerous processes from normal growth and development to the body's ability to fight infection. One way these molecules do their jobs is through subtle changes in their structures. A better understanding of these structures, how they work, and how changes in these molecules cause illness or are affected by medicines could lead to the discoveries of new treatments for a multitude of diseases. "Until recently, glycobiology was an underappreciated and poorly understood discipline. Scientists' increasing ability to create model systems in which carbohydrate-related genes can be easily manipulated is allowing us, for the first time, to understand the function of these molecules in the context of complex systems. This flood of biological information is creating a great demand for analytical tools for the characterization of these systems, and this new center will provide critical resources to address that growing need," according to Michael Marron, Ph.D., NCRR's Director of Biomedical Technology Research and Research Resources. The center will focus on effective coupling of high resolution molecular separations with mass spectrometry to generate a complete analytical system for high-sensitivity glycoprotein investigations. Its staff will facilitate collaborative investigations of glycoprotein markers associated with cancer and alcoholism; endocrinology-centered studies including fertilization; and comparative research involving plants and animals. Educational activities will be conducted to disseminate developments in instrumentation and techniques to a wider audience via short courses, a seminar program, and graduate and postdoctoral training. The National Center for Research Resources (NCRR) provides laboratory scientists and clinical researchers with environments and tools that they can use to prevent, detect, and treat a wide range of diseases. This support enables discoveries that begin at the molecular and cellular level, move to animal-based studies, and then are translated to patient-oriented clinical research, resulting in cures and treatments for both common and rare diseases. NCRR connects researchers with patients and communities across the nation to bring the power of shared resources and research to improve human health. For more information, visit www.ncrr.nih.gov. International Consortium Completes Map of Human Genetic Variation New Tool Speeding the Discovery of Genes for Common Diseases In a paper in the Oct. 27 issue of the journal "Nature," more than 200 researchers from Canada, China, Japan, Nigeria, the United Kingdom and the United States describe the initial results from their public-private effort to chart the patterns of genetic variation that are common in the world's population. The results provide overwhelming evidence that variation in the human genome is organized into local neighborhoods, called haplotypes, which usually are inherited as intact blocks of information. At the project's outset in October 2002, the consortium set an ambitious goal of creating a human haplotype map, or HapMap, within three years. The "Nature" paper marks the attainment of that goal with its detailed description of the Phase I HapMap, consisting of more than 1 million markers of genetic variation, called single nucleotide polymorphisms (SNPs). The consortium is also nearing completion of the Phase II HapMap that will contain nearly three times more markers than the initial version and will enable researchers to focus their gene searches even more precisely on specific regions of the genome. "This represents a milestone for medical research. Built upon the foundation laid by the human genome sequence, the HapMap provides a powerful new tool for exploring the root causes of common diseases. Such understanding is required for researchers to develop new and much-needed approaches to prevent, diagnose and treat diseases, such as diabetes, bipolar disorder, cancer and many others," said David Altshuler, M.D., Ph.D., of The Broad Institute of Harvard and MIT in Cambridge, Mass., who along with Peter Donnelly, Ph.D., of the University of Oxford in England are the paper's corresponding authors. The International HapMap Consortium is a public-private partnership of scientists and funding agencies from Canada, China, Japan, Nigeria, the United Kingdom and the United States. The U.S. component of the $138 million international project is led by the National Human Genome Research Institute (NHGRI) on behalf of the 20 institutes, centers and offices of the National Institutes of Health (NIH) that contributed funding. NIH Rolls Out Electronic Grant Submission Stacks and stacks of grant application packages on paper will soon be a thing of the past at the National Institutes of Health (NIH) as it readies to receive grant applications electronically through the federal portal of Grants.gov, marking a major change in the way it has traditionally conducted its grants submission business. Instead, bits and bytes will be part of the new grant submission lexicon at NIH as it launches a new state-of-the-art way for applicants to submit their grant applications electronically. Beginning with the receipt date of Dec. 1, 2005, NIH will require all its SBIR/STTR grant applicants to electronically submit their competing grants. NIH plans to transition all of its competing grant programs one by one from paper to electronic by May 2007. NIH's electronic submission timeline is available at era.nih.gov/ElectronicReceipt. Electronic submission and grants administration will result in significant savings to the government and holds promise for shortening the time period from grant submission to award. NIH expects to eliminate approximately 200 million pieces of paper a year and reduce the costs of scanning, data entry, data validation, printing, and reproduction. Grant images will be very clear and in color. Efficiencies gained will benefit both NIH and its partner institutions. Even as it switches from paper to electronic submission, NIH is also moving simultaneously from its PHS398 application form to the new SF424 (R&R) application form. Every application via Grants.gov to NIH will need to come in on the new SF424 (R&R) form. An applicant will fill out the application package and upload it to Grants.gov; the NIH system will then retrieve it and produce a system-generated application online. NIH officially began its conversion from paper to electronic on October 18, when it posted its first SBIR/STTR grant solicitations on Grants.gov, requiring applicants to download and submit electronic SF424 Research and Related (R&R) grant applications through the federal site. According to Funding Opportunity Numbers PA-06-006 (fedgrants.gov/Applicants/HHS/NIH/NIH/PA-06-006/Grant.html) and PA-06-007 (fedgrants.gov/Applicants/HHS/NIH/NIH/PA-06-007/Grant.html), effective for the December 1, 2005 submission date, Small Business Research Innovation Program (SBIR) and Small Business Technology Transfer Program (STTR) grant applicants for non-AIDS-related grants must submit SF424 (R&R) application packages through Grants.gov. NIH will no longer accept paper applications for these grant programs. NIH announced its plans to phase in its new application process in the NIH Guide for Grants and Contracts on August 19 (see grants.nih.gov/grants/guide/notice-files/NOT-OD-05-067.html). There will be specific notices preceding the conversion of each grant program (a.k.a. mechanism). All competing applications will use the new form and process by May 2007. Raymond Dionne, DDS, PhD, Joins NINR as Scientific Director U.S. Department of Health and Human Services, NIH, NINR Dr. Dionne comes to NINR from the National Institute of Dental and Craniofacial Research (NIDCR) where he served as Chief, Pain and Neurosensory Mechanism Branch. Dionne earned a D.D.S. from the Georgetown University School of Dentistry, Washington, D.C. and a Ph.D. in Pharmacology from the Medical College of Virginia, Richmond. Dr. Dionne is nationally recognized for his research on pain management, specifically, variability in pain sensitivity. He has published more than 100 scientific manuscripts relating to his work on pain and pain control. In his new role, Dr. Dionne will lead a developing group of independent principal investigators conducting research in the basic, behavioral, and clinical sciences relevant to NINR's mission and will help chart the future of a growing nursing and bio-behavioral research community across the NIH. The intramural program contributes to nursing science through the investigation of biobehavioral mechanisms associated with the symptoms of acute and chronic illness. "We are excited that Dr. Dionne will lead our Intramural program," said Dr. Patricia A. Grady, Director, NINR. "He is an accomplished scientist, and his energy and experience in conducting clinical research and mentoring young investigators will be instrumental in advancing NINR's intramural program," Dr. Grady added. The primary mission of the NINR, one of 27 Institutes and Centers at the National Institutes of Health, is to support clinical and basic research and establish a scientific basis for the care of individuals across the life span. For additional information, visit the NINR Web site at ninr.nih.gov. U.S. Surgeon General Urges Americans to Know Their Family Health History HHS Offers Improved Computer Tool; Brigham & Women's Hospital Joins Effort "This Thanksgiving marks the second annual National Family History Day. I encourage all families to take time on this day -- or at any other family gathering throughout the year -- to collect important health history information that can benefit all family members," Dr. Carmona said. "Even with all the high-tech tests, medicines and procedures available in today's modern health-care setting, family health history remains the cornerstone of our efforts to prevent disease and promote personal health. It's clear that knowing your family history can save your life." Dr. Carmona released an updated, Web-based version of a free, computerized tool that organizes family health information into a printout that people can take to health-care professionals to help determine whether they are at higher risk for disease. The tool, called "My Family Health Portrait," is available at www.hhs.gov/familyhistory. "Not only is Brigham and Women's a nationally recognized hospital and major academic medical center, it, like many hospitals, is a major employer in its community. I commend Brigham and Women's for recognizing that collecting a family history can improve the health of their employees, as well as the health of the employee's family members living throughout the community," said Elias A. Zerhouni, M.D., director of the National Institutes of Health (NIH), which is a partner in the U.S. Surgeon General's Family History Initiative. "Building on the foundation laid by the Human Genome Project, we have made tremendous strides towards developing ways to identify and quickly test for the glitches that we all carry in our genes. But we aren't there yet. So, the best thing each of us can do right now to help our health-care providers develop a personalized disease prevention plan is to gather a family health history," said Francis S. Collins, M.D., Ph.D., director of the National Human Genome Research Institute (NHGRI), part of the NIH. Briefs Address Policy Issues Pertaining to EPSDT and Oral Health The Maternal and Child Health Bureau's National Oral Health Policy Center has released two technical issue briefs pertaining to Medicaid's Early Periodic Screening, Diagnostic and Treatment (EPSDT) program and oral health. The brief titled The CMS Form-416 Report: Understanding Its Use in Assessing Dental Care Utilization in Medicaid's Early Periodic Screening, Diagnostic and Treatment (EPSDT) Service for Children, provides an overview of the origins, construction, and revisions of the Centers for Medicare and Medicaid Services' Form-416 report, the most common source of data on children's utilization of dental services in Medicaid. A commentary on appropriate uses of data found in the report and measures that may be derived from them are also included. The brief is available at www.healthychild.ucla.edu/.../416technicalbrieffinal.pdf. HHS Honors Those Making a Difference in Lives of Persons with Disabilities The Department of Health and Human Services presented the Secretary's Highest Recognition Award to seven individuals and organizations in celebration of National Disability Awareness Month. "This Administration is committed to providing opportunities for persons with disabilities of all kinds," HHS Secretary Mike Leavitt said. "These awards celebrate their achievements to use their skills and talents to improve lives in communities across this nation." HHS' Office on Disability Director Margaret J. Giannini, M.D, added, "This celebration reminds America that disability does not mean inability, and that all Americans can be involved in the life of their community, as active members of their families and neighborhoods, in schools, workplaces and places of worship. These honorees are helping 54 million persons with disabilities live the goals of the President's New Freedom Initiative. We salute them." This third annual award ceremony, hosted by the Office on Disability, will highlight the contributions of leaders in corporate America, advocacy, the arts, education, and public service to advance the goals of the Americans with Disabilities Act and President Bush's New Freedom Initiative. The New Freedom Initiative, among President Bush's first policy efforts, is working in public-private partnerships to eliminate barriers that keep persons with disabilities from participating fully in community life. Some of the award recipients are persons with disabilities who are leading by example. For more information on the Office on Disability, HHS' disability efforts and the New Freedom Initiative, go to www.hhs.gov/od. ADHA Institute for Oral Health Research Grant Review Program Grant competition provides funding for research projects specializing in dental hygiene. The final deadline for the competition is Monday, January 30, 2006. Download an application now at www.adha.org/institute. Submit the completed application to: Executive Administrator OHRC Bulletin The National Maternal and Child Oral Health Resource Center (OHRC) is pleased to announce the latest issue of the Oral Health Resource Bulletin: Volume XIII. The resource bulletin contains descriptions of recently released materials including guidelines and standards, programmatic descriptions, policy reports, and materials for professional education and training. The URL for this resource bulletin is: www.mchoralhealth.org/PDFs/ResBltnXIII.pdf A copy of the resource bulletin is available at no charge from the HRSA Information Center, 2070 Chain Bridge Road, Suite 450, Vienna, VA, 22182-2536, phone: (888) ASK-HRSA (275-4772), fax: (703) 821-2098, e-mail: ask@hrsa.gov. Electronic copies of all OHRC materials are: available on the OHRC Web site at www.mchoralhealth.org/materials/index.lasso. Funding Opportunities International Research Ethics Education And Curriculum Development Award NIH Support for Conferences and Scientific Meetings (R13/U13) Academic Research Enhancement Award (R15) Training in Translational Research in Neurobiology of Disease (T32) Course Development in the Neurobiology of Disease (R25) Prescription Opioid Use and Abuse in the Treatment of Pain (R01, R03, R21, R25) Development of Recombinase-Expressing ("Driver") Mouse Lines for Studying the Nervous System (U01) International Clinical, Operational and Health Services Research Training Award (ICOHRTA) [D43] Dissemination and Implementation Research in Health (R03) Dissemination and Implementation Research in Health (R21) Request for Information (RFI): Tools and Resources for Neurodegeneration Research (Neuroscience Blueprint)
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