# Presentation: 075709

## Roadmap UpdatePeer Review Advisory CommitteeNovember 3, 2008

*Elizabeth L. Wilder, Ph.D.*
*Director, Division of Strategic Coordination*
*OPASI*

## Overview

- Status of the 1st and 2nd cohorts of Roadmap programs
- New policy concerning competition and review of Roadmap programs
- Changes to application and review process for Pioneer and New Innovator Programs
- Transformative R01 Program

## Status of 1st Cohort Programs 

- 8 programs have been approved for another period of Common Fund support:
- Molecular Libraries
- Nanomedicine
- Patient Reported Outcomes and Measures Information System (PROMIS)
- NIH Rapid Access to Intervention Development (RAID)
- Structural Biology of Membrane Proteins
- Technology Centers for Networks and Pathways
- Clinical Research Training Program
- National Centers for Biomedical Computing
- 3 other programs from the first cohort are ongoing: NIH Director’s Pioneer Awards, Interdisciplinary Research, and Clinical and Translational Service Awards

## Second Cohort

- Major funding for the Human Microbiome Project began in FY2007; additional initiatives were funded in FY2008 and will be in FY2009.
- Major funding for the Epigenomics Program began in FY2008; an additional initiative to be funded in FY2009.
- The New Innovator Program began in FY2007.

- Between the 1st and 2nd Cohorts:
- 14 Active, Ongoing Programs through FY2012

## Roadmap Programs and the NIH Intramural Program

- The Common Fund, which pays for the Roadmap programs, is neither intramural nor extramural and has no target percentage of funding for either.
- In the first cohort of programs, both intramural and extramural labs received funds.
- In 2007, the NIH Steering Committee determined that intramural and extramural investigators should compete for Common Fund funding unless a compelling reason exists to limit a given initiative to one or the other.
- (see _[http://grants.nih.gov/grants/guide/notice-files/NOT-RM-07-011.html](http://grants.nih.gov/grants/guide/notice-files/NOT-RM-07-011.html)_)

## IRP/ERP Competition and Review

- For the purposes of Roadmap programs where the IRP and ERP are expected to compete for funding, the IRP is to be considered equivalent to other applicant organizations.
- An Institute Director may not contribute to funding decisions for Roadmap programs that include his/her intramural investigators.
- To prevent bias or perception of bias, the Center for Scientific Review will conduct reviews where the IRP and ERP compete.

## So CSR is busy!

## EPIGENOMICS
Epigenomics Data Analysis and Coordination Center (EDACC) (2008)
Technology Development in Epigenetics (2008)
Discovery of Novel Epigenetic Marks in Mammalian Cells (2008)
Epigenomics of Human Health and Disease (2009)  
NANOMEDICINE
Nanomedicine Development Centers (2010)
STRUCTURAL BIOLOGY
Centers for Innovation in Membrane Protein Production (2009) 
RAID
National Institutes of Health Rapid Access to Interventional Development (3 competitions per year) 
Bioinformatics and Computational Biology
National Centers for Biomedical Computing (2009)
MOLECULAR LIBRARIES 
Solicitation of Assays for High Throughput Screening (HTS) in the Molecular Libraries Probe Production Centers Network (MLPCN) (3 competitions per year) 
Pilot-Scale Libraries for High-Throughput Screening (2009)
Molecular Libraries Screening Instrumentation (2009)
Assay Development for High Throughput Molecular Screening (3 competitions per year)
BUILDING BLOCKS, BIOLOGICAL PATHWAYS
Renewal of the National Technology Centers for Networks and Pathways Program (2008)
MICROBIOME
Development of New Technologies Needed for Studying the Human Microbiome (2008)
Studies of the Ethical, Legal, and Social Implications (ELSI) (2008) 
PROMIS
Patient-Reported Outcomes Measurement Information SystemTM (PROMIS) Network Center (2009). 
Patient-Reported Outcomes Measurement Information SystemTM (PROMIS) Research Sites (2009) 
Patient-Reported Outcomes Measurement Information SystemTM (PROMIS) Technology Center (2009) 
Patient-Reported Outcomes Measurement Information SystemTM (PROMIS) Statistical Center (2009)

- Epigenomics Data Analysis and Coordination Center (EDACC) (2008)
- Technology Development in Epigenetics (2008)
- Discovery of Novel Epigenetic Marks in Mammalian Cells** **(2008)
- Epigenomics of Human Health and Disease (2009)
**NANOMEDICINE**
- Nanomedicine Development Centers (2010)
**STRUCTURAL BIOLOGY**
- Centers for Innovation in Membrane Protein Production (2009)
**RAID**
- National Institutes of Health Rapid Access to Interventional Development (3 competitions per year)
**Bioinformatics and Computational Biology**
- National Centers for Biomedical Computing (2009)
**MOLECULAR LIBRARIES**** **
- Solicitation of Assays for High Throughput Screening (HTS) in the Molecular Libraries Probe Production Centers Network (MLPCN) (3 competitions per year)** **
- Pilot-Scale Libraries for High-Throughput Screening (2009)
- Molecular Libraries Screening Instrumentation (2009)
- Assay Development for High Throughput Molecular Screening (3 competitions per year)
**BUILDING BLOCKS, BIOLOGICAL PATHWAYS**
- Renewal of the National Technology Centers for Networks and Pathways Program (2008)
**MICROBIOME**
- Development of New Technologies Needed for Studying the Human Microbiome (2008)
- Studies of the Ethical, Legal, and Social Implications (ELSI) (2008)
**PROMIS**
- Patient-Reported Outcomes Measurement Information SystemTM (PROMIS) Network Center (2009).
- Patient-Reported Outcomes Measurement Information SystemTM (PROMIS) Research Sites (2009)
- Patient-Reported Outcomes Measurement Information SystemTM (PROMIS) Technology Center (2009)
- Patient-Reported Outcomes Measurement Information SystemTM (PROMIS) Statistical Center (2009)

**CSR Reviews of RM Initiatives**

## Programs where IRP and ERP do not compete

- Public data interfaces developed through NCBI (intramural only)
- High Risk/High Reward Programs (extramural only)
- Intended to overcome review obstacles to high risk research
- NIH Intramural Program was designed to encourage HRHR, so need for special emphasis is reduced
- Pioneer and New Innovator Programs reviews conducted by NIGMS

## Review hurdles to HRHR Research

- Standard NIH review is conservative to select grants that are likely to yield data and advance the field
- focuses more on operational details and less on significance, impact, and track record of the investigator
- High impact research sometimes requires going out on a limb – high risk is not well suited for standard review
- Overcoming these hurdles was a central goal in the Pioneer Program, which piloted new review method
- Shortened application, focusing on significance and track record
- Essay rather than typical format
- Preliminary data not required; applicant must be entering a new field of study
- Interviews with a subset of applicants is a key aspect of the review

## Changes in Pioneer/New Innovator Reviews 

- 2009 competition will proceed in two formal stages, with two separate Funding Opportunity Announcements.
- Pre-application stage **PAR-09-012 **-** **pre-applications will be assessed by a group of external reviewers
- Investigators whose proposals are judged to be the most outstanding will be invited to apply through a limited competition RFA - **RFA-RM-09-001** - and will be invited to NIH for interviews
- New Innovator competition will follow similar scheme, although second review will not involve interviews

## HRHR Review Strategies moving to CSR

- New HRHR program within RM is being reviewed by CSR, testing additional new review strategies
- Transformative R01 Program

## Rationale for new Program

- Roadmap Cohort 1
- Fostering Innovations Workshop (Dec ’07)
- Enhancing Peer Review
- HRHR Demonstration Oversight Group

## Transformative R01 Program

- Competition open to all potentially transformative ideas from all relevant fields
- No cost limit per project
- Announcement to be issued once per year for 5 years; each issuance to award $25M per year for 5 years
- Program is intended to address conservative review hurdles that are specific to the Extramural Community, so IRP investigators are not eligible

## Highlighted needs

- Annual strategic planning process identified areas where need for transformation is greatest - are included as **Highlighted Needs** topics:
- Science of Behavior Change
- Protein Capture
- Functional Variation in Mitochondria
- 3-D Tissue Models
- Acute to Chronic Pain Transition
- Pharmacogenomics

## Implementation: Applications

- Essay format; 8 pages
- Primary required element would be statement of paradigm disruption/creation:
- If a paradigm exists, why is it wrong and how will it be disrupted?
- If no paradigm exists, how will project create one?

## Implementation – Initial Review

- Review Criteria will focus on transformative potential – ability of application to be paradigm disrupting, not just paradigm shifting.
- Multi-tiered Review
- Initial triage by “Editorial Board”
- 3 content experts in relevant field to provide content-specific input
- “Editorial Board” to review for transformative potential; rank order the top bin
- Review to be conducted by CSR

## Implementation - Approval

- Funding Plan to be developed by subcommittee of IC Directors
- The 2nd level of review will be through the Council of Councils; IC Councils will also receive all applications as they do with other Roadmap programs.
- Ultimately, the NIH Director has final approval.

## Implementation – Post Award

- Each award will be issued by the most relevant IC.
- Post award management will be by the IC but standard management practices will be developed to ensure that program and grants management staff approach management of the awards in the same way.
- Awards will begin in FY09, with new competitions also occurring in FY10, FY11, FY12, and FY13.

## Comparison of NIH Transformative Grant Programs

|   | Pioneer | New Innovator | EUREKA | Quantum | CEBRA | T-R01 |
| --- | --- | --- | --- | --- | --- | --- |
| Grant Mechanism | DP1 | DP2 | R01 | R01 | R21 | R01 |
| Funding Source | CF/IC | CF/IC | IC (NIGMS, NINDS, NIMH, NIDA) | IC (NIBIB) | IC (NIDA) | CF/IC |
| Amount per award (direct cost) | $500 K for each of 5 yrs | $1.5 M to cover 5 years * | Up to $250K for each of 4 years (project limit - $800K) | Up to $700K for each of 3 yrs  | $100K/yr for 2 yrs | Flexible |
| # Awards Planned |  16 | 24 or more | 24 | RFA not issued in FY08 | 16 | Flexible |
| Review - Type | 1)Pre-Application X02
Electronic + 
2) Interview by panel of scientists | 1) Pre-Application X02 Electronic + 
2) IAR or teleconference | Electronic + Internet Assisted Review (GM) | Face to Face  | Electronic | Editorial Board |
|  |  |  |  |  |  |  |
|  |  |  | Electronic + Face to Face (other ICs) |  |  |  |
| Review - Locus | NIGMS on behalf of OD | NIGMS on behalf of OD | IC | IC | IC | CSR |
| PI Eligibility | All, but no Multi-PIs; domestic institutions only | Within 10 years of most recent doctoral degree; No R01 Equiv.; no multi-PI; domestic institutions only | All (including multi-PI) | All | All (including multi-PI) | All (including multi-PI) |
| * One-year total funding |  |  |  |  |  |  |