Regional Centers of Excellence Program in Biodefense

Regional Centers of Excellence Program in

Biodefense

Samuel L. Stanley, Jr., M.D.

Director, Midwest Regional Center of Excellence in Biodefense and Emerging

Infectious Diseases Research

What is the threat?

• Biological Weapons – Terrorism

• Access to weaponized agents.

• Simple microbiology “garage laboratory”.

• Complex molecular biology—access to sophisticated equipment, sophisticated know-how.

Emerging Infectious Diseases

Biodefense Research Agenda

NIH/NIAID budgetProgram 2003 funding 2004

funding2005 proposed budget

+ from 2004 level

NIH 27.178b 28.041b 28.805b 794m

NIAID 3.703b 4.3.03b 4.426b 123m

Research Resources

• Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research

• National Biocontainment Laboratories/Regional Biocontainment Laboratories

• Animal Model Development• Biodefense and Emerging Infections Research

Resources Program• Training Programs• Centers of Human Immunology

NIAID

DMID

RCE/PRCE/NBL/RBL Network Interactions

Regional Centers for ExcellenceIn Biodefense and EmergingInfectious Diseases (RCEs)

National BiocontainmentLaboratories (NBLs)

Regional BiocontainmentLaboratories (RBLs)

NIAID Biodefense

The Model

• Interdisciplinary teams• Basic > Translational > Clinical• Flexibility/Self-Eval• Synergy• Local and regional cooperation• National coordination• Parallel, but intersecting tracks –

translational and basic

NIAID Agenda

RCE Program

Midwest Regional Center of Excellence in Biodefense and Emerging Infectious

Diseases ResearchIA

NE

MO

KS

OH

Direct Support of Research

Emergency ResponseEnhance Regional

ResearchOn Biodefense

Tri-Partite MissionStrategic Projects

Developmental Projects

New Opportunities

Core Facilities

Education

Fellowship Programs Provision of surge capacity

Expertise in vaccine/diagnostics

How did we apply for our center?

• Read the RFA– Detailed point by point analysis—what are they

actually looking for in one of these Centers– Clear understanding of deadlines– Clear understanding of funding amounts– Contact program officers with specific

questions/clarifications– Attending informational meetings from NIH

How did we apply for our center?

• Appointed an institutional leader– Time and willingness to serve– Expertise in the proposed area– Senior enough to interact with leaders– Commitment to project—willing to put above

immediate institutional interests

How did we apply for our center?

• Early assessment of our strengths and weaknesses re: the RFA– Based on national reputation– Funding (Crisp)– Core Resources– Distinguished faculty– Current activity in the area

How did we apply for our center?• Reached out to outside partners—key

partner first.– Identification of the key person at the partner

institution—science/clinically based, not administratively based.

– Established basis for partnership—money based on merit--creation of SAC

– Came from a position of strength (already plans in place—major institution for the region)

How did we apply for our center?

• Open/transparent competition among partner institutions—prelim grant submission

• Long meeting of SAC to develop strategic plan• One voice writing for most sections• Attempt to meet all requirements of RFA but

science tailored for peer review• Multiple funding opportunities within grant to

allow involvement of all institutions—something for everyone

Summary• MRCE—new NIH paradigm to more

rapidly integrate basic and translational research leading to product development.

• Opportunities for research support through Developmental Projects Program.

• Opportunities for education through Clinical Translational Fellowship program

• Opportunities for education through Biosafety Training Program.

Summary• Read the RFA• Identify a leader• Objective look at strengths and weaknesses• Identification of partners that will enhance the

application• Establishment of rules for funding that will be

seen as reasonable and equitable• Group input into strategic plan• One voice writing where possible• Meet the RFA requirements, but remember peer

review will focus on scientific content.