The NIH Roadmap Imperatives for NIH Accelerate pace of discoveries in life sciences More rapid translation from laboratories to patients and back Develop novel approaches orders of magnitude more effective than current ones Develop new strategies NIH Roadmap Roadmap Participants were asked What are today s scientific challenges What are the roadblocks to progress What do we need to do to overcome roadblocks What can t be accomplished by any single Institute but is the responsibility of NIH as a whole The Problem Bench Bedside Practice NIH Roadmap three themes emerged New Pathways to Discovery Research Teams of the Future Re engineering the Clinical Research Enterprise Criteria for Roadmap Initiatives Is it transforming will it change how or what biomedical research is conducted in the next decades Would its outcome enhance the ability of all ICs to achieve their missions Will it be compelling to our stakeholders especially the public Is it something that no other entity can or will do New Pathways to Discovery Bench Building Blocks and Pathways Molecular Libraries Bioinformatics Computational Biology Nanomedicine Bedside Practice Biological Pathways and Networks Understand in quantitative terms how gene regulatory networks signal transduction pathways and metabolic pathways are integrated to orchestrate normal development Understand responses to internal and external stimuli in highly complex organisms Understand how pathways and networks are perturbed in disease Bioinformatics and Computational Biology Deploy a rigorous biomedical computing environment to analyze model understand and predict dynamic and complex biomedical systems Be able to integrate data and knowledge at all levels of organization Molecular Libraries Chemical Diversity Publicly available database Biologically relevant chemical space optimally populated with naturally occurring and synthetic compounds Screening Small molecule activators and inactivators available to researchers for individual functions of every gene product in human genome Drug development as needed Research Teams of the Future Interdisciplinary Research Teams Pioneer Award Bench Building Blocks and Pathways Molecular Libraries Bioinformatics Computational Biology Nanomedicine Public Private Partnerships Bedsid e Practic e Challenges to Interdisciplinary Research The current system of academic advancement favors the independent investigator Most institutions house scientists in discrete departments Interdisciplinary research teams take time to assemble and require unique resources Interdisciplinary Curriculum Development Awards Support the development of innovative courses and curricula designed to train interdisciplinary scientists Curricula can be designed for undergraduate pre doctoral or postdoctoral students or combinations of these Focus on programs that encourage the integration of quantitative physical behavioral or social sciences with the traditional biomedical sciences NIH Director s Pioneer Award New program to support individuals with untested ideas that are potentially groundbreaking Encourages innovation risk taking Totally new application and peer review process Provides 500 K year for 5 years Expected to be highly competitive Re engineering Clinical Interdisciplinary Research Research Pioneer Award Bench Building Blocks and Pathways Molecular Libraries Bioinformatics Computational Biology Nanomedicine Public Private Partnerships Bedsid e Translational Research Initiatives Practice Integrated Research Networks Clinical Research Informatics NIH Clinical Research Associates Clinical outcomes Clinical Research Policy Training Integration of Clinical Research Networks Link existing networks so clinical studies and trials can be conducted more effectively Ensure that patients physicians and scientists form true Communities of Research Translational Research Centers Provide sophisticated advice help scientists bring a new product from the bench to clinical use including Laboratory studies to understand a therapy s mechanisms of action Pre clinical drug synthesis toxicity testing Sophisticated manufacturing capacity Expert advice to ensure that drug development regulations are observed Patient Reported Disease Outcomes Establish a collaborative of investigators to improve measurement of patient reported outcomes Focus on the collection of self report data from a diverse population of individuals including racial and ethnic minorities having a variety of chronic diseases Compare the performance of specific items instruments and models across diverse clinical populations Develop common metrics by which scores on new and existing instruments can be standardized and or linked National Electronic Clinical Trials Research Network NECTAR Common data standards informatics Software application tools for protocol preparation IRB management adverse event reports Use existing networks to rapidly address questions beyond their traditional scope National Clinical Research Associates Create a diverse national group of trained and certified Goal community health care providers Providers will enroll and follow their own patients Means to accelerate translation of results into practice Steps Determine feasibility Barriers Communities Incentives needed Inventory training methods best practices Develop core competencies certification Future training programs Multidisciplinary K12 Career Development Program Goal Features Promote development of investigators from a variety of disciplines MD DDS PhD RN MPH To be trained in multidisciplinary team settings Up to 5 years of training Core didactic courses project specific training Mentored research experience in team settings Faculty and mentor support to protect their time Tuition support Annual meetings Current Polices Procedures Regulations Major Traffic Jam The clinical research community faces redundant and sometimes variable requirements to address fundamentally the same oversight concerns e g AERs COIs Variability exists not only among various Federal agencies but also within the NIH and it hampers efficiency and effectiveness Toward a Solution NIH Role NIH promotes the responsible conduct of high quality clinical research Opportunity to convene other federal agencies and to facilitate dialogue and change Roadmap Clinical Research Policy Coordination Initiative Improve coordination and simplify requirements for clinical research in ways that enhance public trust Adverse event reporting Human subjects