the ucsf clinical and translational science institute and campus core resources fred waldman ctsi...
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The UCSF Clinical and Translational Science Institute and Campus
Core Resources
Fred Waldman CTSI Translational Technology and Resources Program
Core Leadership RetreatNovember 6, 2007
NIH Clinical and Translational Science Awards
• Accelerate clinical and translational research - moving new discoveries into the community
• Encourage innovative approaches
• Lower barriers between disciplines
• Catalyze change: break silos, break barriers, and break conventions
• Train next generation of clinical scientists RFA issued October, 2005
Meeting the Translational Research Challenge at UCSF
• Four professional
schools
• Multiple clinical and
translational research units
• Little cross-cutting
organization
• Multiple redundancies
• Insufficient infrastructure
to support C&T research
SFGHParnassus
VAMCCancerCenter
MB
LH
MCB
The UCSF Response
The Clinical and Translational Science Institute
UCSF Clinical and Translational Science Institute
• Aimed at providing infrastructure and support for clinical and translational research Bench
Community
Clinic
UCSF Clinical and Translational Science Institute
• Aimed at providing infrastructure and support for clinical and translational research
• Involves more than 200 senior faculty members across all schools, and clinical and translational units
Bench
Community
Clinic
UCSF Clinical and Translational Science Institute
• Aimed at providing infrastructure and support for clinical and translational research
• Involves more than 200 senior faculty members across all schools, and clinical and translational units
• Designed to accommodateand to facilitate needs of allindividuals/units engaged in clinical and translational research
Bench
Community
Clinic
Enhance and Expand Our Training Programs
Training
• Clinical and translational science training
• Training in other program functions
Build the Infrastructure to Facilitate Translational Science
ResearchImplementation
ResearchDesign
Training
• Clinical and translational science training
• Training in other program functions
• Design, biostatistics, & ethics
• Translational methodologies
• Participant interactions
• Translational technologies
• Regulatory• Informatics• Community• Global health• Health policy
Provide Pathways to Successful Careers in Clinical and Translational Research
ResearchImplementation
CareerAdvancement
ResearchDesign
Training
• Clinical and translational science training
• Training in other program functions
• Design, biostatistics, & ethics
• Translational methodologies
• Participant interactions
• Translational technologies
• Regulatory• Informatics• Community• Global health• Health policy
• Pilot studies• Career
advancement
Tying It All Together
ResearchImplementation
CareerAdvancement
ResearchDesign
Training
• Research education & training
• Training in other program functions
• Design, biostatistics, & ethics
• Translational methodologies
• Participant interactions
• Translational technologies
• Regulatory• Informatics• Community• Global health• Health policy
• Pilot studies• Career
advancement
CREATION OF A“VIRTUAL HOME”
Central AdministrationWeb-based home
Collaborative Environments
CREATION OF A“VIRTUAL HOME”
Central AdministrationWeb-based home
Collaborative Environments
CTSI LeadershipProgram
Directors Team
Mike McCuneDeborah Grady – Joel Palefsky – Dan Lowenstein
• Informatics Segal/Showstack/Kamerick
• Design, Biostat, & EthicsJohnston/Bacchetti/Lo
• Translational MethodsJohnston/Rosenthal/Santi
• Research Training Hulley/Martin/Yamamoto• Global Health
McKerrow/Padian• Career Advancement
Damsky/Brown
• Regulatory SupportLee/Wiener-Kronish
• Participant InteractionSchambelan/Wara
• Translational TechWaldman/Nelson/ Derynck/Sinclair
• Pilot StudiesGiacomini/Volberding/ Waldman
• Community EngagementGrumbach/Selby
• Virtual HomeKahlon/Cameron
• Health PolicyLuft/Kahn
• Overall Integrated ApproachMcCune/Autry
• Tracking & Evaluation Breyer/Brindis
Susan Autry
Translational Technology and Resources
• Mandate to facilitate availability of campus cores to basic, translational, and clinical scientists, and to support campus core functions.
• Fund development of new technologies for campus Cores
• Developed UCSF Cores questionnaire, database, and Core Managers group. Hosting Core Leadership Retreat.
• Academic Services Coordinator (Robert Smith) available to develop technology training programs and to assist UCSF investigators in utilization of existing technology cores.
• Initial activities are being focused on campus imaging cores and tissue/histology cores
2006 Translational Technology AwardsChristopher Barker, PhD; Gladstone Institute of Cardiovascular DiseaseDNA Microarray Analysis of Formalin Fixed Paraffin Embedded Samples
Charles Chiu, MD; School of Medicine, Infectious DiseasesEstablishing a Microarray Test for Pan-Viral Identification (Virochip) as a Core Laboratory Resource
Lawrence Fong, MD; School of Medicine, Hematology/OncologyFlow Cytometry-Based Immune Markers of Clinical Disease
Steven Hall, PhD; School of Dentistry, Cell and Tissue BiologyTowards Development of Software Infrastructure to Enable Translation of Mass Spectrometry Data into Clinical Solutions
Steven Hamilton, MD, PhD; School of Medicine, PsychiatryNanoscale Sample Manipulation for Clinical Genomic Applications
Yong Huang, PhDl; School of Pharmacy, BiopharmacyBioanalytical core for clinical and translational research
Nola Hylton, PhD; School of Medicine, RadiologySmall Animal MRI Techniques for Treatment Response Assessment in Solid Tumors
Matthew Krummel, PhD; School of Medicine, PathologyHigh-Resolution Quantitative Micro-Endoscopy
Tissue Banking at UCSF
• Clinical and translational scientists can’t easily find services and tissues for studies
• Campus biospecimen service cores and repositories are not well publicized
• Need system for tracking specimens and data from the patient to the bank and from the bank to translational scientists
• Tissue inventory database (Freezerworks), surveys of tissue bank services and biospecimens, web based database to allow matching between scientists and specimen collections
BREAD (Biostats, Research Ethics, and Design)
Make available a consultation service to the clinical and translational research community -- especially important for junior investigators and early study phases (on a recharge basis)
• Biostatistics• Study Design and Implementation• Research Ethics• Data Management (Data Center and Database
design and management)
Biomedical Informatics
• Developed database design and management service
• Developed bioinformatics analysis service for high-level structured data
• Will soon beta-test the secure research environment (secure data servers with controlled access)
• Planning for research data environment, which will allow access to administrative and clinical data for research
Data Management Unit
• Consult on choice of database platform/vendor
• Design/develop/maintain/support study databases– Modular system of design
• Host study databases• Assist with querying or existing research
databases
Clinical and Translational Science Training
• Developed a clinical and translational research training program for clinical residents that began in January
• Developed a track in T1 and T2 translational research for clinical researchers to be offered in Y2
• Courses in T1 translational research for lab-based researchers are being developed
Regulatory Knowledge and Support
• Established a new business research unit to facilitate contracts and grants services
• Established new services to facilitate CHR and Conflict of Interest review and FDA submissions
• Established a seminar series focused on drug development
Clinical Research Centers
CTSI Clinical Research Center
• Consolidated three separate GCRCs into one new unit
• Added three new units at Kaiser Permanente, the VAMC, and Children’s Hospital of Oakland. A fourth new unit in the Tenderloin is being established
Community Engagement
• Hired navigators at UCSF (Paula Fleisher) and at Kaiser (Maureen Fitzpatrick) to facilitate collaborative research
• Four active groups working on: Community Clinician Relations, Community Academic Research Engagement, Communication of Research Relevance, UCSF/Kaiser partnerships
Strategic Opportunities Support Center
Cycle 1 (Spring, 2007)
• Reviewed 260 LOIs followed by 98 full applications
• Awarded 23 grants for a total of $1.06MCycle 2 (December 15, 2007)• Created campus-wide application submission
and review group in collaboration with REAC, CFAR, and Cancer Center (Resources Allocation Program -- RAP)
Resources Allocation Program – RAPhttp://rap.ucsf.edu
Pilot ProjectsPilot Research Awards for Junior Investigators in Basic and
Clinical/Translational Sciences ($30k) REAC and SOS/CTSI General Pilot Award Program in HIV/AIDS Basic Science Award Program In HIV/AIDS
Technologies and MethodsShared Instrument Awards ($75k/$30k) – must be placed into coresTranslational Technology Development Awards ($75k) – into coresNovel Clinical/Translational Methods Catalyst Awards ($30k)Technology Mini-Symposium Awards ($2500)
Multidisciplinary AwardsMultidisciplinary Research Project Planning Awards Multicenter Start-Up Planning Awards
Resources Allocation Program – RAPhttp://rap.ucsf.edu
Career DevelopmentHardship Awards New Direction Awards Under-Represented Faculty & Senior Fellows in Clinical and
Translational Research Awards Flexible Mini-Sabbatical/Leave Awards Mentored Scientist Award Program in HIV/AIDS
InternationalGlobal Health Awards Fogarty International Training Awards in HIV/AIDS International Mentored Scientist Award Program in HIV/AIDS
Tying It All Together
Virtual Home• Launched our initial website and coordinated content
development and program representation across CTSI
• Collaborated with programs on the development of web-based tools for specific information systems and service of CTSI programs, e.g., SOS, TTR, CA
• Conducted internal researcher & administration needs assessment
Additional Campus-wide Activities
• Coordination of programs shared between the CTSI and the office of the Executive Vice Chancellor
• Integration of SOS with other pilot funding sources on campus (e.g., REAC) - to form “RAP”
• Coordination of efforts across campus to prioritize and integrate clinical and translational core services
• Coordination of CTSI programs with existing campus programs aimed at industrial alliances, e.g., the Industry Alliance Coordinating Committee, the Research Administration Board, and QB3
The National CTSA ConsortiumFY2006 and 2007 CTSA Awards
RockefellerYale
MT
WY
ID
WA
OR
NV
UT
CA
AZ
ND
SD
NE
CO
NM
TX
OK
KS
AR
LA
MO
IA
MN
WI
IL IN
KY
TN
MS AL GA
FL
SC
VAWV
OH
MI
NY
PA
MD
DE
NJ CTRI
MA
ME
VT
NH
AK
HI
UC Davis
Duke
UC San Francisco
U Rochester
U Penn
Oregon HSU
UTHSC, Houston
Mayo-Rochester
U Pittsburgh
Columbia
CTSA Awards - 2007: 12CTSA Awards - 2006: 12
CWRU
Emory
JHU
UCUIowa
UM
UTSW
UW
UWisc
Vanderbilt
Wash UCornell
The National CTSA Consortium
Zerhouni/NIH:
Create a national consortium that will cooperatively address impediments to clinical and translational science
Contact Us
CTSI Website
http://ctsi.ucsf.edu
TTR – Robert Smith (502-2129)
SOS – Emy Volpe (514-0301)
http://rap.ucsf.edu
Bringing better health to more people more quickly!
QUESTIONS
What is a Core?
• A laboratory which offers services and/or equipment for use by the campus community