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 budget Program2003 funding2004 funding 2005 proposed budget + from 2004 level NIH27.178b28.041b28.805b794m NIAID3.703b4.3.03b4.426b123m

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 Excellence In Biodefense and Emerging Infectious Diseases (RCEs) National Biocontainment Laboratories (NBLs) Regional Biocontainment Laboratories (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 Research IANE MO KS OH

Direct Support of Research Emergency Response Enhance Regional Research On Biodefense Tri-Partite Mission Strategic 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.