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Translational Research: Intersections of Stanford and the NIH

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1 Translational Research: Intersections of Stanford and the NIH
Importance of translational research For Stanford For the NIH Strategic Planning For Stanford: Translating Discoveries For NIH: The NIH Roadmap Opportunities for Intersection 11/22/201811/22/2018

2 Some Unique Attributes of Stanford
What is Unique About Stanford School of Medicine Private University and Medical School permitting flexibility and strategic choices Small in size but outstanding in quality of faculty and students Contiguous location of the School of Medicine with Hospitals and University – a unique opportunity for innovation and translation Outstanding portfolio of the School in research with a history of innovations and accomplishments in technology, science and medicine. Ownership of Hospitals by University as a means of fostering a strategic alliance for translational medicine and innovative patient care Location in Silicon Valley - connections to biotechnology 11/22/201811/22/2018

3 School of Medicine Mission Statement
To be a premier research-intensive medical school that improves health through leadership and collaborative discoveries and innovations in patient care, education and research. 11/22/201811/22/2018

4 Overarching Goals of the School of Medicine
Be a leader in the movement to reform and rejuvenate the educational and career development of physicians and biomedical innovators. Transform the future of biomedical, translational, and clinical research and education by fostering novel collaborative alignments between basic and clinical scientists, clinicians, and educators throughout the University, as well as with public and private partners worldwide. Earn the public’s trust and respect as a premier medical school through outstanding patient care and academic medicine 11/22/201811/22/2018

5 Strategic Planning Process
February 2002 Oct 2004 September January 2002 March On-Going Strategic Planning Organization and Development Phase Strategic Planning Implementation Phases Strategic Planning Leadership Retreats February 11/22/201811/22/2018

6 Important Relations in Integrated Strategic Planning
Medical Education Finance/Administration Graduate Education Postgraduate Education/ Training Communication Research Advocacy/Policy Patient Care Philanthropy Professoriate Information Resources & Technology 11/22/201811/22/2018

7 Major Issues Addressed at the 2002 - 2004 Leadership Retreats
Important School-Wide Issues and Questions How can we best align our basic and clinical science faculty around common goals and shared objectives What is the best way for Stanford to train future leaders in medicine and the biosciences? What is the right size for the School of Medicine and how can we accomplish our missions within the billet caps of the University? How can we best achieve our missions in interdisciplinary education and research and in translational medicine? What are the best ways to align the School to its Hospitals? Should the School have a single integrated campus or expand off-site? Should the School and/or one or both Hospitals move to a new location? 11/22/201811/22/2018

8 So, what is the right size for the School of Medicine?
About or only slightly larger than present: Full-time faculty is currently around 732 University cap for SoM faculty billets is 900 Need to develop and sustain excellence in science, education and clinical care Evolution of the Clinician-Scholar/Investigator track - recent success in achieving Principal Investigator status Development of Clinician-Educators - a work in progress 11/22/201811/22/2018

9 Uniqueness of Stanford
Excellence and the opportunities for interdisciplinary research and education is what makes Stanford unique - and what makes the whole greater than the sum of its parts! Faculty-initiated interdisciplinary collaborations Interschool collaborations Department of Bioengineering University-wide Initiatives BioX and the Clark Center Environmental Sciences International Affairs School-wide Initiatives Stanford Institutes of Medicine Cancer/Stem Cell Biology Cardiovascular Neurosciences Immunity,Transplantion, Infection 11/22/201811/22/2018

10 Scientific Themes of BioX- and Relation to the School of Medicine
Biocomputation Image processing, bioinformatics, protein folding, biomechanical simulation, remote teaching Biodesign Biorobotics, biosensors, surgical techniques, medical devices, tissue repair, image guidance, therapeutic delivery systems Imaging: molecules, cells, tissues, movement Biophysics of single molecules Chemical Biology Genomics/proteomics Systems neuroscience Regenerative Medicine 11/22/201811/22/2018

11 The Clark Center 11/22/201811/22/2018

12 Departments (24) Applied Physics Biochemistry Bioengineering
Biological Sciences Chemistry Chemical Engineering Civil & Environ. Engineering Computer Sciences Developmental Biology Electrical Engineering Genetics Geological & Environ. Sci. Health Research & Policy Mechanical Engineering Medicine Molecular Pharmacology Neurobiology Pediatrics Physics Psychology Radiology Statistics Structural Biology Surgery 11/22/201811/22/2018

13 The BioX Program Biology, Medicine, Engineering, Chemistry,
Physics, and Computer Science 11/22/201811/22/2018

14 The Stanford Institutes of Medicine
CSCI CVI ITII NIS Center for Genetics/Genomics Center for Imaging Center for Informatics/Bioinformatics 11/22/201811/22/2018

15 Developing Aligned Partnerships
Stanford University School of Medicine Stanford Hospital & Clinics Lucile Packard Children’s Hospital Cancer/Stem Cell Biology and Medicine Institute Clinical Cancer Center Cancer Center Neurosciences Institute Center for Neurosciences Center for Brain and Behavior Cardiovascular Medicine Institute Cardiac Center Heart Center Institute for Immunity, Transplantation, Infection Transplant Center 11/22/201811/22/2018

16 Supporting Translational Research
Enhancing the infrastructure to support clinical investigation Biostatistics Study design and data management Financial management Technology Transfer Project Assistance (Chris Webb) Creating a Center for Translational Research Supporting the GCRC Glaser Pediatric Research Network Stimulating translational research BioX Awards Beckman/Medicine Translational Investigation Awards Dean’s Office Awards for Translational Research 11/22/201811/22/2018

17 Educating Future Leaders
The New Stanford Curriculum Reduce the amount of time in structured classes to permit time for research and scholarly development Better balance the curriculum by including both clinical and basic science experiences throughout medical school training Develop required majors (“scholarly concentrations”) for all students to enhance independent research capabilities 11/22/201811/22/2018

18 New Stanford Curriculum
Residency and Fellowship Undergraduate Clinical Scholarly track Basic science Clinical research Molecular medicine Community Medicine Bioengineering Health economics Year 11/22/201811/22/2018

19 Scholarly Concentrations
Tracks Scholars track Original research track Current and some upcoming Scholarly Concentrations Bioethics and the Humanities Biocomputation Bioengineering Clinical Research Community Health and Public Service(MPH with Berkeley) Health Care Policy and Research Immunology Neuroscience (under development) Molecular Basis of Medicine Women’s Health Independent Study Joint Degree Programs 11/22/201811/22/2018

20 Educating Future Leaders
Graduate Students Continue to foster knowledge and skills in basic science Foster knowledge in clinical and translational medicine Masters in Clinical Science Provide opportunities for joint degrees (e.g., business, law, engineering) Role of the New Commission on Graduate Education Residents and Postdoctoral Scholars Promote opportunities for Scholarly Concentration Consider development of a PhD program for Residents/Fellows 11/22/201811/22/2018

21 Learning and Knowledge Center
BioX Stanford Hospitals Stanford Institutes of Medicine Embedded Learning Enriched Content Integrated Services Clinic Sites Personal Consultant Learning Commons Immersive Learning VA Hospital Education Research Clinical Care Self-directed, interactive learning, medical scholars Translational medicine, genomics, computational biology Clinical decisions, innovative diagnosis and treatment 11/22/201811/22/2018

22 The NIH Perspective Acute to chronic diseases Aging Population
Health Disparities Emerging Diseases Biodefense 11/22/201811/22/2018

23 NIH Perspective Science Driven Opportunities Human Genome Project
Functional Genomics Proteomics Integrative biology of disease Revolutionary Research Methodologies Information Sciences 11/22/201811/22/2018

24 NEED TO TRANSFORM MEDICAL RESEARCH IN THE 21st CENTURY
20th Century Treat disease when symptoms appear and normal function has been lost WHY: we did not understand the molecular and cellular events leading to disease Expensive in financial and disability costs 21st Century Intervene before symptoms appear and preserve normal function for as long as possible WHY: Understanding of preclinical molecular events and Ability to detect patients at risk. Orders of magnitude more effective 11/22/201811/22/2018

25 NIH Roadmap Goal Accelerate basic research discoveries and speed translation of those discoveries into clinical practice Explicitly address roadblocks that slow the pace of medical research in improving the health of the American people 11/22/201811/22/2018

26 What is the NIH Roadmap? A framework of priorities the NIH as a whole must address in order to optimize its entire research portfolio. A set of initiatives that are central to extending the quality of healthy life for people in this country and around the world. A vision for a more efficient and productive system of biomedical and behavioral research. 11/22/201811/22/2018

27 Roadblocks NIH Perspective Bench Bedside Public System Broken
11/22/201811/22/2018

28 NIH Roadmap for Medical Research
11/22/201811/22/2018

29 NIH Perspective New Pathways to Discovery
Molecular Libraries and Imaging Probes Building Blocks, Biological Pathways and Networks Structural Biology Bioinformatics and Computational Biology Nanomedicine 11/22/201811/22/2018

30 NIH Perspective Research Teams of the Future
Explore new organizational models for scientific teams Multi-disciplinary and Inter-disciplinary Larger, coordinated, resource-sharing Preserve the investigator(s)-initiated strategy 11/22/201811/22/2018

31 11/22/201811/22/2018

32 NIH Perspective Clinical Research is the Key to Translating Knowledge
11/22/201811/22/2018

33 Then: Now: NIH Perspective Translational Research: Haphazard Evolution
Cottage industry and select centers Now: Complex requirements: regulation, technology, speed, efficiency Greater links to basic science 11/22/201811/22/2018

34 Research Teams of the Future
NIH Perspective Research Teams of the Future Interdisciplinary Research Teams; Pioneer Award Public-Private Partnerships Bench Bedside Public Building Blocks and Pathways Molecular Libraries Bioinformatics and Computational Biology Structural Biology Nanomedicine 11/22/201811/22/2018

35 NIH Perspective Re-engineering the Clinical Research Enterprise
Developing new partnerships of research Patient communities Community-based health care providers Academic researchers Lower barriers to innovation Building better integrated clinical research networks Academic centers linked to community-based physicians 11/22/201811/22/2018

36 Potential Outcomes of Molecular Libraries & Imaging Probes Activities
NIH Perspective Potential Outcomes of Molecular Libraries & Imaging Probes Activities Development of research tools (molecular probes and novel assays) to facilitate studies of biology and pathophysiology Advances in biological research leading to the identification and validation of novel biological targets for therapeutics development Discovery of biological markers to monitor disease progression and to predict treatment response 11/22/201811/22/2018

37 National Centers for Biomedical Computing
NIH Perspective National Centers for Biomedical Computing Partnerships of: Computer scientists Biomedical computational scientists Experimental and clinical biomedical and behavioral researchers Focused on software rather than hardware Each National Center to have Driving Biological Projects Programs in preparation for partnerships between individual investigators and National Centers Stanford was just named one of four National Centers 11/22/201811/22/2018

38 Nanomedicine Roadmap Initiative
NIH Perspective Nanomedicine Roadmap Initiative Nanomedicine describes the interface of biology and nanotechnology to understand and treat disease. Nanomedicine is a departure from the majority of nanotechnology research in that it integrates biomolecular processes toward developing therapies. Will need to develop new tools and a nanomedicine lexicon for shared use by engineers and biologists. Next Steps: Concept Development Awards in ’04; solicitation for Nanomedicine Development Centers in ‘05 11/22/201811/22/2018

39 Research Teams of the Future
NIH Perspective Research Teams of the Future Interdisciplinary Research Teams; Pioneer Award Public-Private Partnerships Bench Bedside Public Building Blocks and Pathways Molecular Libraries Bioinformatics and Computational Biology Structural Biology Nanomedicine 11/22/201811/22/2018

40 Research Teams of the Future
NIH Perspective Research Teams of the Future Initiatives within this theme provides mechanisms for interdisciplinary research, high-risk strategies and public-private partnerships. Including: Encouraging Multi- and Interdisciplinary teams Supporting larger, coordinated, resource sharing teams Preserving investigator-initiated strategy Promoting investigators to take creative, unexplored avenues of research 11/22/201811/22/2018

41 NIH Director’s Pioneer Award
NIH Perspective NIH Director’s Pioneer Award New program to support individuals with untested, potentially groundbreaking ideas! Encourages innovation, risk-taking Totally new application and peer review process Expected to be highly competitive Expanded eligibility – (not only traditional biomedical investigators) Provides $500,000/year for 5 years One of our new Bioengineering faculty recruits, Dr. Steve Quake, was just named a recipient. Moving from Research Training, the NIH Roadmap initiatives also include a major award to recognize and celebrate, publicly, those researchers who explore ideas that were considered risky. The NIH Director’s Pioneer Award will provide funds for five years to allow these investigators to develop and test far-ranging ideas that relate to the NIH mission. The Pioneer award will not replace ongoing research projects or simply expand the funding of persons already supported. Note that not only traditional biomedical investigators are eligible for this award; there does need to be evidence of interest in exploring topics of biomedical relevance. The nomination process allows for self-nomination, and the criteria for eligibility and details of the selection process are detailed on the NIH Roadmap website. 11/22/201811/22/2018

42 Re-engineering Clinical Research
NIH Perspective Re-engineering Clinical Research Interdisciplinary Research Pioneer Award Public-Private Partnerships Bench Bedside Public Building Blocks and Pathways Molecular Libraries Bioinformatics and Computational Biology Structural Biology Nanomedicine Integrated Research Networks Clinical Research Informatics National Clinical Research Associates Clinical outcomes Clinical Research Policy Training Translational Research Initiatives 11/22/201811/22/2018

43 NIH Perspective Integration of Clinical Research Networks
Create inter-operable ‘Network of Networks’ National Electronic Clinical Trials/Research Network (NECTAR initiative) 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 11/22/201811/22/2018

44 Engaging the public in clinical research is a priority.
NIH Perspective Engaging the public in clinical research is a priority. It is not an option. 11/22/201811/22/2018

45 NIH Perspective Clinical trial participation very low
<5% of Americans enroll in cancer trials Small proportion of physicians enroll patients in more than three-quarters of all trials Need for diversity The only way we can move forward with getting the best care to our patients is by finding out what works. The cancer community has forged the way in endorsing the value of clinical trials for culling the most effective treatments for various types of malignancy. Hodgkin’s lymphoma and many childhood cancers are curable because of clinical research. We need to expand these successes to all areas of disease treatment and prevention. We need to do a better job of displacing the image of the “guinea pig” and introducing the notion that patients are an active participant in their health care. They deserve access to the newest discoveries. This requires a partnership with patients and community-based physician networks. 11/22/201811/22/2018

46 “How does the NIH Roadmap benefit research funded by NIH ICs?”
NIH Perspective “How does the NIH Roadmap benefit research funded by NIH ICs?” Speeding removal of major and fundamental roadblocks common to all diseases Institutes working together to solve issues This is a common trans-NIH pool of transforming investments open to all disease areas for competition 11/22/201811/22/2018

47 NIH Perspective The NIH Roadmap pools resources for specific enabling investments that individual Institutes could not undertake: Expanding molecular probe libraries publicly available to researchers Increasing the number of publicly available molecular probes Improving the implementation of breakthrough research trials through the creation of interdisciplinary research teams Supporting high-risk pioneering research 11/22/201811/22/2018

48 NIH Perspective The Roadmap will address core problems to accelerate research Complexity of molecular interactions that lead to disease More rapid development of promising breakthroughs Supporting translational research Exploring integration and interoperability of clinical research networks Addressing clinical research policy analysis and coordination Creating “communities of research” by involving community-based practitioners 11/22/201811/22/2018

49 Roadmap Funding (dollars in millions)
FY04 FY05 FY06 FY07 FY08 FY09 Total Pathways to Discovery 65 137 169 182 209 188 948 Research Teams 27 39 44 92 96 93 390 Clinical 38 61 120 174 214 227 833 130 237 332 448 520 507 2,172 Directors Fund ?? Total NIH in Same Period is > $220 Billions Roadmap initiative is about .9% of NIH budget Totals on table may not add due to rounding 11/22/201811/22/2018

50 Stanford and the NIH There are important areas of alignment between Stanford’s Strategic Plan “Translating Discoveries” and the NIH Roadmap There are opportunities to participate in new program areas emanating from the NIH Roadmap and to build on strategic goals of Stanford. There is the need to balance the important investments in basic research (which has been the soul of Stanford) against the more applied research portfolio emerging from the Roadmap. We must help create and develop the future - at Stanford and with the NIH. 11/22/201811/22/2018


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