Clinical and Translational Science Awards (CTSA): Re-Engineering Clinical Research and Translational Science

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1 Clinical and Translational Science Awards (CTSA): Re-Engineering Clinical Research and Translational Science Jason G. Umans, MD, PhD Associate Professor Director, Research Education, Training and Career Development GHUCCTS

2 Clinical Research and Translational Science clinical research: includes all studies of diseases and trials of treatments that take place in human subjects translational science: describes the steps between a fundamental basic discovery and its application to clinical medicine (but also the reverse)

3 Building a National CTSA Consortium WA CA OR NV ID UT MT WY CO ND SD NE KS MN IA MO WI IL IN MI KY OH PA WV VA NY VT NH DE MD ME MA RI CT NJ AZ NM OK AR TN NC SC MS AL GA TX AK LA FL HI Participating Institutions New members 2010 Members CTSA States PR

4 Impetus for the CTSA Program To ensure new discoveries lead to improved public health, clinical science must evolve to better: Implement biomedical discoveries. Develop, test, and bring new prevention strategies into medical practice more rapidly. Catalyze change - lower barriers between disciplines. Encourage creative and innovative approaches.

5 Translational Blocks in the Clinical Research Continuum T1 T2 Sung, NS et al. JAMA 289: , 2003

6 Each CTSA Institution is a home for clinical and translational science Clinical Research Ethics Trial Design NIH & other government agencies Biomedical Informatics Clinical Resources CTSA HOME Advanced Degree-Granting Programs Participant & Community Involvement Industry Biostatistics Regulatory Support Healthcare organizations

7 Guiding Principles of the CTSA Program Team Science Connectivity Partnerships CTSA Philosophy Breaking Down Institutional Barriers Collaboration

8 Goals for the CTSA Consortium The CTSA consortium has the following five goals: Building National Clinical and Translational Research Capability Training and Career Development of Clinical and Translational Scientists Enhancing Consortium-Wide Collaborations Enhancing the Health of our Communities and the Nation Encouraging T1 Translational Research

9 Georgetown-Howard Universities Center for Clinical Translational Science

10 GHUCCTS encompasses 2 Universities and University hospitals and 3 affiliated teaching hospitals in Washington DC

11 Specific Aims of GHUCCTS 1. To speed improvements in human health by stimulating innovative, multidisciplinary, and crossinstitutional research among the GHUCCTS investigators. 2. To support the careers of clinical and translational investigators through a wide variety of didactic educational programs coupled with focused mentorship. 3. To enhance clinical and translational research on underserved populations, both in the Washington DC region and nationally, prominently including minorities, the aged, and the disabled.

12 GHUCCTS Organizational Structure

13 Research Education, Training, and Career Development (RETCD) Co-Director: Pamela Carter-Nolan, PhD, MPH (HU) Director: Jason Umans, MD, PhD (MHRI) Co-Director: Renee Jenkins, PhD (HU) Establish clinical scholar (K12) and clinical investigator M.S. and certificate programs Organize specialized summer program for both undergraduate and pre-doctoral students Provide mentorship opportunities and counseling for trainees in clinical research and translational science

14 RETCD Key Programs Courses and Degree Programs MS program in Clinical and Translational Research GU Graduate School, full- or part-time Blended, largely on-line and in evening Can register for individual courses 15 credit hour certificate program soon Seminar Series Monthly Clinical Research Seminars at MWHC Monthly Health Disparities Research Seminars (alternating between GU and HU) Monthly Translational Technologies Research Seminars from ORNL (by desktop streaming) All recorded and archived online

15 RETCD Key Programs Adjunct Mentorship RETCD faculty available to facilitate mentored research interactions and to consult on career development award applications Workshops Grant writing workshops, introductory and extended Flexible regarding new topics of general interest KL2 Career Development Awards 2 new awards/y; 3y awards at 75% effort (up to $90k salary + benefits + $40k research costs +/- MS CTR tuition support Current awardees: Vicki Shanmugam (MGUH), Luisel Ricks-Santi (HU), Vanita Aroda (MHRI), Pradeep Karla (HU), Peter Turkeltaub (GUMC/MNRH), Ana Barac (MWHC) Summer Research Programs for underrepresented minority trainees Undergrad>grad/med students, n=10, 10 wk program Extended Spring/Summer option, n=4, disparities research focus

16 Design, Biostatistics, and Population Studies (DBPS) Co-Director: John Kwagyan, PhD (HU) Director: Nawar Shara, PhD (MHRI) Provide consultation and support for design and biostatistical analysis of clinical research studies Develop methodological resources for clinical research Enable access to unique populations and data sets Establish teaching programs in biostatistics and study design training and consultation

17 Clinical Research (CR) Marc Blackman, MD (WDCVAMC) Jacqueline Jonklaas, MD (GU) Thomas Obisesan, MD (HU) Steve Epstein, MD (MHRI) Direct Clinical Research Units (CRUs) formerly called General Clinical Research Centers (GCRCs) Coordinate (and provide) nursing services, specimen collection, and patient accommodations for clinical studies Allocate resources for collaborative clinical research Oversee scientific protocol review and prioritization (SEPCOM) committee Provide advice and training on clinical research design and implementation

18 Biomedical Informatics (BI) Director: Subha Madhavan, PhD (GU) Co-Director: William Southerland, PhD (HU) Build and maintain investigator web portal Provide Informatics infrastructure and tools for researchers and administrators Devise technologies to integrate molecular and phenotypic databases Develop methodologies for querying and extracting focused data from electronic health records Establish teaching programs in biomedical informatics

19 Regulatory and Ethics Knowledge and Support (REKS) Director: Sheila Cohen Zimmet, BSN, JD (GU) Co-Director: Yonette Thomas, PhD (HU) Develop electronic tools and resources to provide direction and support for investigators in regulatory issues Establish an Office of Regulatory Support to provide individualized advice to investigators on regulatory issues Establish integrated training programs in regulatory and ethics knowledge and responsible conduct of research Promote ethics research and research participant advocacy

20 Translational Technologies and Resources (TTR) Director: Steve Byers, PhD (GU) Co-Director: Victor Massari, PhD (HU) Administer all (35) core laboratories across GHUCCTS Develop an infrastructure for all shared resources: molecular; cell and tissue; systems medicine; physiology; imaging Provide training, technical assistance, consultation, and small pilot grants to clinical investigators regarding core laboratory capabilities and use

21 Translational Technologies and Resources (TTR) TTR allows any GHUCCTS investigator to access ANY shared/core resource at HU or GU on the same/best terms available to a member of the home institution or center. Imaging, Molecular, Cellular, Animal, Analytical, Informatic Resources, including mass spec, proteomics, metabolomics, genomics, epigenomics, EM, LCM, flow cytometry, advanced imaging, fmri, genetically-manipulated mice/zebrafish ional-technologies--and-resources/resources Consultation and pilot grant programs. Directed by Steve Byers (GU; [email protected]) and John Massari (HU; [email protected]) Navigators: Olga Rodriguez, [email protected] and Yuanxiu Chen [email protected]

22 Community Engagement and Research (CER) Director: Carla Williams, PhD (HU) Co-Director: Mary Ann Dutton, PhD (GU) Form bi-directional partnerships between investigators, the public, community-based organizations, and communitybased physicians Establish a Community Advocacy Research Participation Group Nurture practice-based research networks (PBRNs) Disseminate results of DC community-based research Increase representation of diverse communities in research Support small pilot projects in CER

23 Novel Translational Methodologies (NTM) Director: Jeffry Nichols, PhD (ORNL) Co-Director: Joseph Verbalis, MD (GU) Find, support and nurture collaborations between GHUCCTS clinical investigators and ORNL scientists Utilize ORNL supercomputing capacity to enhance drug discovery and design Enhance T1 research in computational biology, complex chemistry, research materials modeling & simulation, nanoscience, and molecular biophysics Provide assistance with technology transfer

24 Novel Translational Methologies (NTM) TTR allows any GHUCCTS investigator to access collaborations with ORNL intramural investigators, using unique resources, including supercomputing, analytical, and engineering facilities. Competitive funding available for shared pilot projects involving Clinical/Translational Scientists from the DC GHUCCTS institutions and ORNL investigators. For consultation regarding ORNL capabilities and potential projects, contact: Kristina (Munoz-Flores) Thiagarajan, PhD, MN, RN Director of Translational Health Sciences Computing and Computational Sciences Directorate

25 Pilot and Collaborative Studies Program (PCSP) Director: Tom Mellman, MD (HU) Engage junior and senior investigators across GHUCCTS in multidisciplinary collaborative and pilot studies that will advance clinical and translational science and address public health. Maximize utilization of relevant GHUCCTS resources. To assure that studies are performed efficiently and effectively.

26 Pilot and Collaborative Studies Program (PCSP) Pilot Grants ($25k or $100k maximum funding; 1y) Aim is to support applications for major extramural funding Cost-sharing by applicant institution Favor multidisciplinary and multi-institutional collaborations Next review cycle will begin in April 2-4 in each category funded each year; budgets matter! 7 pp application -and-collaborative-studies-program/whats-it-all-about Contact: Andre Lane, Program Coordinator, HU CTSA Navigator [email protected] or Haewon Park, GU CTSA Navigator [email protected]

27 Applications and funding by project type and PI institution at 27 months Total GU HU MedStar VA 10 0 Applications Funded IIPP ICPP

28 GHUCCTS PCSP: Disease and Discipline Cancer 7 Cellular & Molecular Lab 10 Metabolism/CV risk 4 Basic Neuroscience 2 Stress/mood disorders 4 Clinical Medicine and Dentistry 10 Epilepsy 2 Behavioral Science 3 Peridontal disease 1 Ethics 1 Aphasia 1 Health Services 1 HIV 1 Population genetics 1 Ovarian failure 1

29 PCSP Challenges Judging real, substantive, interdisciplinary and inter-institutional collaborations Balancing the supported research across disciplines while weighing local strengths Managing inter-institutional awards (finance and compliance efficiency and oversight)

30 Georgetown-Howard Universities Center for Clinical Translational Science