Update on Clinical Translational Research - Ramm.pdfUpdate on Clinical Translational Research DCM Resource Directors Meeting May 10, 2010 Louise E. Ramm, Ph.D. Deputy Director National

National Center forResearch ResourcesNATIONAL INSTITUTES OF HEALTH T r a n s l a t I n g r e s e a r c h f r o m b a s i c d i s c o v e r y t o i m p r o v e d p a t I e n t c a r e

Update on Clinical Translational

Research

DCM Resource Directors Meeting

May 10, 2010

Louise E. Ramm, Ph.D.Deputy Director

National Center for Research Resources

National Institute of Health

NCRR

Clinical

Community

National Center for Research Resources (NCRR)Translating research from basic discovery to improved patient care

Improved

patient care

Pre-clinical

imaging &

informatics

advances

clinical research

support

research

capacity

& training

community

engagement

science

education

animal model

resources

NCRR

Challenges for NIH: The Translation Gap

Source: Butler D. Translational research: Crossing the valley of death. Nature. 2008;453:840–2.

NCRR

NCRR Supports the Continuum of Biomedical Research

2. NCRR provides NIH-supported laboratories and clinical researchers with the infrastructure, tools, and training they need to understand, detect, treat, and prevent diseases

3. NCRR helps build partnerships and networks among grantees to create a matrix of research support

1. NCRR provides animal models that bridge basic science and human medicine through specialized laboratory animals and research facilities

NCRR

Together, NCRR’s four integrated and complementary areas accelerate

and enhance research along the entire continuum of biomedical science.

NCRR’s 4 Programmatic Divisions

Working Synergistically

Comparative Medicine —

Essential to Translational Research

Translation

from

basic science to

human studies

Translation

of

new knowledge

into clinical practice

Basic

Research

Clinical

Research

Improved

Health

Adapted from Sung et al. (2003) JAMA, 289, 1278-89.

Copyright © (2003) American Medical Association. All Rights reserved.

NCRR

Nonhuman Primates

Rodents

Aquatics

Comparative models (e.g., Pigs, Invertebrates)

Genetic and Information Resources

Division of Comparative Medicine

Research and Resources

NCRR

~50 Centers in 5 Broad Areas

Scope: from basic discovery to clinical research

Scale: from molecule to organism

Technology for

Structural Biology

Synchrotron

x-ray

technologies

Electron

microscopy

Magnetic

resonance

Technology for

Systems Biology

Mass

spectrometry

Proteomics

Glycomics &

glyco-technology

Flow cytometry

Optics & Laser

Technology

Microscopy

Fluorescence

spectroscopy

In Vivo diagnosis

Imaging

Technology

MRI

Image-guided

therapy

PET

CAT

Ultrasound

Informatics

Resources

Genetics

Modeling of

complex systems

Molecular

dynamics

Visualization

Imaging

informatics

Biomedical Technology Research Centers (BTRCs)

NCRR

Division of Research Infrastructure Centers

Research Centers in Minority Institutions (RCMI)

IDeA Networks of Biomedical Research Excellence (INBRE)

Centers of Biomedical Research Excellence (COBRE)

NCRR

Improve the way biomedical research is

conducted across the country

Reduce the time it takes for laboratory

discoveries to become treatments for patients

Engage communities in clinical research efforts

Train a new generation of clinical and

translational researchers

Led by the National Center for Research Resources

the CTSA program supports a national consortium

of medical research institutions that work together

and share a common vision to:

www.CTSAWeb.org

Goals of the CTSA Program

NCRR

Building a National CTSA Consortium 46 CTSA sites in 26 states;60 sites when fully implemented

WA

OR

CA

NV

AZ

NM

MT

UT

WY

CO

SD

ND

NE

KS

OK

TXAK

AR

MO

IA

MN

WI

IL IN

MI

OH

KY

TN

MS AL GA

FL

LA

NC

SC

VAWV

PA

NY

VTNH

ME

MA

DEMD

RI

ID

HI

PR

NJ

= IDeA-Eligible State and CTSA Member

= CTSA State

= IDeA-Eligible States

NCRR

Clinical and Translational Science Awards (CTSA)

Training

LicensingBusiness

Informatics

Pilot Projects

Regulatory Support, Biostatistics, Trial Design

Participant and Community Engagement

Clinical Resources and Ethics

NCRR

Training Clinical and Translational Scientists

CTSA Education and Career Development Committee

Developed in partnership with CTSA institutions, NIH, other

government agencies and industry

Core Competencies in Clinical and Translational Research

Topics teach students how to:

Move basic discoveries through the patent process

Work with technology transfer offices

Explore opportunities with venture capital companies to

initiate commercialization

TL1 and KL2 Awards

NCRR

Public-Private Partnerships (PPP) Example:

The West Coast Licensing Partnership

Adds value by bundling related technologies over individual tools and technologies

Strengthens inter-institutional relationships between member partners

Increases global access to research tools by promotion of non-exclusive licensing

Provides simple one-stop licensing of technologies from multiple institutions

Saves time and money from negotiating multiple license agreements

Oregon CTSA is part of a group of institutions willing to designate a subset of their technologies for marketing and licensing purposes

NCRR

CTSA Consortium – Building Connections with Business Schools

Develop business plans, design, and implement community

surveys

Create innovative cross-educational programs

Develop case studies to pilot programs

Collaborate with international colleagues

Prepare cost analyses

Protect CTSA-developed patents

Form industry partnership programs

CTSA are partnering with business schools to:

NCRR

Resource Networking and Collaboration Vanderbilt Institute for Clinical and Translational Research

StarBRITE

web-based portal

which provides

“one-stop”

shopping for

research needs

Currently

authorized users

only

ResearchMatch

National recruitment

Registry

Centralized, disease-

neutral Web portal to

connect researchers to

research volunteers

Includes over 37 CTSAs

REDCap

Web-based tools

that support data

capture and

dissemination for

clinical and

translational

research

Leader in patient recruitment and research resource software

development

NCRR

Two Web-based initiatives bring power of Internet-based tools,

exemplified by social networking to biomedical research

Harvard Medical School

eagle-i: Networking Research Resources Across America

Will create a federated national informatics network

9 institutions participating

Goal is to enable any investigator across America to discover research

resources that are presently invisible

University of Florida

VIVO: Enabling National Networking of Scientists

Will create a social network to enable connections among the scientific

community and create pathways that lead to others they know

6 institutions participating

Resource Networking and Collaboration through

NCRR Recovery Act (ARRA) Funds

www.ncrr.nih.gov/u24

NCRR

CTSA Pilot Projects with DCM

Fund pilot projects aimed at creating new and/or strengthening interactions between NCRR supported ABMRs and nationally-oriented clinical and translational research institutions (e.g. CTSAs, Research Centers in Minority Institutions Infrastructure for Clinical and Translational Research)

Identify and support collaborative research interactions that would be competitive for future research funding

Funded awards in 2009

Funding Opportunity RFA-RR-08-011

Revision Award Mechanism for Support of Animal and Biological

Materials Resources (ABMR) to Develop Translational Pilot Projects

with Investigators at Clinical and Translational Research Institutions

(P40, P51, U42)

NCRR

CTSA – Providing Local Leveraging Opportunities

Yerkes National PrimateResearch Center

Kaiser PermanenteGeorgia

Atlanta VAMedical Center

Complex Carbohydrate Research Center

at U GeorgiaGeorgia Bio

Georgia Research Alliance

Emory University

MorehouseSchool of Medicine

CDC

GeorgiaTech

Children’sHealthcareof Atlanta

Atlanta Clinical and Translational Science Institute (Atlanta-CTSI)

at Emory University

NCRR

Interactions with Government, Industry and Academia

University of Pennsylvania CTSA Example

http://www.itmat.upenn.edu/ctsa/caep/index.shtml

Exploring business practices and best

management models in developing

collaborations in the pre-competitive

space

Looking to develop workgroups to

address barriers to collaboration

Engaging both the private and non-

profit sector to identify gaps and

opportunities for partnership and

collaboration with CTSA institutions.

Commercialization and

Entrepreneurship Program (CAEP)

NCRR

2010 Opportunities for Research and NIH Francis Collins, Director, NIH

Benefiting health care reform

Focusing on global health

1 January 2010 Vol 327

Science, Issue 5961,

Pages 36-37

Applying high throughput technologies

Translating basic science discoveries

into new and better treatments

Reinvigorating and empowering the

biomedical research community

NCRRwww.ncrr.nih.gov

Questions, Comments,

and Discussion