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