# Presentation: 071056

## Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research(RCE)

- Rona Hirschberg
- Alicia Dombroski
- Susan Garges
- Michael Hevey
- NIAID
- 5/5/04

- /04

## The National Needs

- The threat of bioterrorism is real
- We need the the community to respond and help us prepare
- The goal is practical solutions
- Drugs, vaccines, diagnostics
- Translational/early clinical studies
- Basic research where needed

## Concept of RCE

- Research and development capacity for responding to bioterrorism and emerging infectious diseases
- Build infrastructure and human resources
- Address critical research needs at the national level
- A cornerstone of the NIAID biodefense effort

## The Model

- Interdisciplinary teams
- Basic > Translational > Clinical
- Flexibility
- Synergy
- Local and regional cooperation
- National coordination

## Goals for Centers

- Basic research to understand category A-C agents
- Translational capacity leading to drugs, vaccines and diagnostics
- Expanding the pool of researchers and technical personnel
- Regional facilities for the biodefense effort
- Assist emergency responses

## Regions - DHHS

- -Region I:   CT, ME, MA, NH, RI, VT
- -Region II:   NJ, NY, PR, VI
- -Region III:  DE, D.C., MD, PA, VA, WV
- -Region IV:  KY, MS, NC, TN, AL, FL, GA, SC
- -Region V:    IL, IN, MI, MN, OH, WI
- -Region VI:  AR, LA, NM, OK, TX
- -Region VII:  IA, KS, MO, NE
- -Region VIII:  CO, MT, ND, SD, UT, WY
- -Region IX:  AZ, CA, HI, NV
- -Region X:   AK, ID, OR, WA

## Regionality

- Regional hub of activity
- Must serve as a regional facilities resource
- Must respond at the regional level in the event of a biodefense emergency
- Foster new research projects and human resource development with a regional basis
- Linkages to regional institutions

- Does not need to include all institutions in the region
- May include institutions and investigators from other regions
- Funded Regional Centers will interact with each other
- Will be part of a national network

## Consortium

- An interactive group of investigators at more than one institution
- Mix of expertise and capabilities
- Big enough to get the job done
- Small enough to work

## Elements of a Center Application

- Strategic plan, management structure, administrative core
- Research program
- Scientific facilities cores
- Developmental research plan
- Career development and training programs
- Biocontainment needs and facilities
- Emergency response plans

## Strategic Plan

- Critical part of being successful
- Strengths
- Opportunities
- Action Plan
- Outcome measurements
- Continual evaluation and re-focusing
- Emergency response plans
- Research Theme

## Research Program

- Integrated research program to achieve practical solutions for category A-C agents
- Basic > translational > clinical
- At least five projects, a mix of types
- Focused on category A-C agents
- Project = R01-like or P01-like
- Balance of organisms and approaches
- State-of-the-art approaches
- Phase in and out as the research evolves

## Career Development and Training

- Increase human resources for biodefense
- At least two projects
- For individuals or groups
- One basic science, one translational/clinical
- Tied to the research
- Innovative approaches
- Many options

## Developmental Research Projects

- Small, short term start-up projects
- Funded at RCE level
- Capitalize on progress in field
- Important for flexibility
- “Graduate” into Center projects or R01s
- Need clear plans and procedures
- Key element of success
- Do not submit projects

## Administrative Core

- Manage, coordinate, supervise RCE
- Implement strategic plan
- Monitoring progress and correcting course
- Communications and linkages
- Safety, security, compliance
- Core facility use
- Commitment by PI and Institution
- Adequate support staff

## Facilities Cores

- Integral to the strategic plan and research
- Number and kinds appropriate for RCE
- Basic and translational
- Available for a biodefense emergency
- Regional resource
- Management plans and key personnel
- Leverage and linkages

## BSL 3/4 Plans

- Part of facilities
- Discuss needs
- Document available resources
- Discuss any plans that are in place
- Tell us what help you will need
- We will broker arrangements as needed

## Emergency Response Plans

- Provide scientific support for first responders, within the context of NIH’s research mission; add not duplicate
- Develop linkages to federal agencies, state and local agencies
- Have plans in place to respond
- Make facilities and staff available

## Center Relationships

- Core
- Facilities

- Response
- Plans

- Administrative
- Core
- (P.I.)

- Career
- Development

- Research
- Projects

- Developmental
- Research

## Center Interactions

- RCE

- State/Local
- Public Health

- Federal
- Agencies

- Pharmaceutical
- Companies

- Others at
- The Center

- Regional
- Academic
- Institutions

- Biotech
- Companies

## National Coordination

- To achieve overall RCE Program goals
- Biodefense Network
- PI meetings
- Investigator meetings
- Stimulate collaborations and interactions
- Facilitation by NIAID staff
- Access to information, resources, partners

## Timetable

| April  -- September | Pre-application consultation and planning |
| --- | --- |
| August 9, 2004 | Letter of intent due |
| September 9, 2004 | Application due |
| January/February  2005 | Review |
| June 2005 | Awards
 |
| Summer 2005 | Centers begin activities |

## RCE <----> NBL/RBL

- U54, focus on research and related activities
- Will need high level containment access
- PI should not be PI of NBL/RBL
- Will fund lab renovations and equipment
- Will not fund construction
- Key component of the NIAID biodefense plan

- Separate funding, separate mechanism
- BSL 3/4 service facilities
- Must work with RCEs and others
- Will not fund the research directly
- Needs different skills and experience
- Key component of the NIAID biodefense plan

## Review Considerations

- Complex, multi-factorial
- Science primary
- Meeting program goals
- Organization and administration
- Institutional commitment
- Synergy
- Leveraging

## Budget Considerations

- About $10M t.c. per year for up to 5 years
- Leveraging important
- Up to $500 K for renovations
- Other usual categories
- Budgets may be negotiated before award

## Useful Information

- URL for RFA
- http://grants1.nih.gov/grants/guide/rfa-files/RFA-AI-04-018.html
- Contacts for RCE information
- Program – Rona Hirschberg, Alicia Dombroski, Susan Garges, Michael Hevey
- Review – Katherine White
- Grants Management – Lesia Norwood or Pam Fleming