# Presentation: 071053

## PEER REVIEW ADVISORY COMMITTEE

**PEER REVIEW ADVISORY COMMITTEE**
**Update on CSR Realignments**
**Don Schneider, Ph.D.**

**National Institutes of Health****U.S. Department of Health and Human Services**

**April 30, 2008**

## CSR workloads have grown

| YEAR | # REVIEW 
DIVISIONS | # CSR
APPLICATIONS | APPS per
DIVISION |
| --- | --- | --- | --- |
| 1999 | 3 | 31,647 | 10,549 |
| 2003 | 4 | 38,829 | 9,708 |
| 2007 | 4 | 50,688 | 12,672 |
| (2008) | (3) | (ca 50,688) | (ca 16,896) |

## Science and Workloads drive realignments

**SCIENCE**
**	****- Better clustering by division, e.g., neuroscience**
**	****- Enhanced review context for clinical and multi-disciplinary applications**
**WORKLOADS**
**	****- More even for IRG Chiefs, 8-12 SROs each (now 3-20)**
**	****- Fewer applications per division, 10,000 a year**

## PRAC & Division Realignment Process

**PROCESS**
**	****- PRAC WG for concept discussion**
**	****- Internal & external community involvement**
**	****- PRAC Meeting for final discussion**
**PRIOR PRAC ACTIONS**
**	****- Apr 19, 2007, PRAC Meeting, approval of fourth, cross-cutting neuroscience IRG, ETTN**
**	****- Jul 20, 2007, PRAC WG, concept approval of Division A**
**	****- Aug 27, 2007, PRAC Meeting, approval of Division A**
**	****- Nov 6, 2007, PRAC WG, concept approval of Division B**
**	****- Dec 3, 2007, PRAC Meeting, approval of Division B**

## Cont. PRAC & Division Realignment Process

**Jan 22, 2008, PRAC WG (video), discuss Division C**
**Feb 20, 2008, PRAC WG (phone), concept approval of Division C and discuss Divisions D & E, enthusiasm for overall concept**
**Mar & Apr, open to internal and external communities**
**Name changes based on sensitivities, balancing basic, translational, and clinical research**
**Apr 30, 2008, PRAC Meeting, final discussion**

## Plans are five CSR Review Divisions

**Scientific **
**Review **
**Groups=**
**48**

**Scientific **
**Review **
**Groups=**
**50**

**Scientific **
**Review **
**Groups=**
**43**

**Scientific **
**Review **
**Groups=**
**44**

**Scientific **
**Review **
**Groups=**
**55**

## Proposed realignments include new divisions, IRGs, & study sections

**Divisions 5**
**	****- A & B approved previously**
**	****- ****C, D, & E**
**	****- Three new DD positions**
**IRGs 9**
**	****- ETTN, EPS, & HDM approved previously**
**	****- ****OBT, IMST, DKUS, CVR, OTC, & VH**
**	****- Five new IRG Chief positions**
**Study sections ****3 splits**
**	****- NPAS split into NPAS & PMDA**
**	****- CND split into CNN & ANIE**
**	****- MEDI split into MEDI & CMIP**

## Realignment yields new IRGs

**Emerging Technologies & Training in Neuroscience, Epidemiology & Population Sciences, and Healthcare Delivery & Methodologies previously approved (3)**
**Oncology 1 – Basic Translational, Interdisciplinary Molecular Sciences & Training, Digestive, Kidney & Urological Systems, Cardiovascular & Respiratory Sciences, Oncology 2 – Translational Clinical, and Vascular & Hematology (6)**
**Net gain of 2 IRGs (gain 5 Chiefs)**

## Basic half of Oncology becomes a new IRG, OBT

**Oncology 1 – Basic Translational (OBT)**
**Cancer Molecular Pathobiology (CAMP)**
**Cancer Etiology (CE)**
**Cancer Genetics (CG)**
**Molecular Oncogenesis (MONC)**
**Tumor Cell Biology (TCB)**
**Tumor Microenvironment (TME)**
**Tumor Progression & Metastasis (TPM)**
**(in Division C)**

## Fellowships and SBIRs will be pooled in IMST

**Interdisciplinary Molecular Sciences & Training IRG (IMST)**
**Fellowships**
**Program Projects (P01s)**
**Shared Instrumentation (S10s)**
**Small Business (SBIRs)**
**(in Division C)**

## Digestive, Kidney, and Urological study sections will be clustered in a new IRG, DKUS

**(In Division D)**
**Xenobiotic and Nutrient Disposition & Action (XNDA)**
**Gastrointestinal Cell & Molecular Biology (GCMB)**
**Gastrointestinal Mucosal Pathobiology (GMPB)**
**Hepatobiliary Pathophysiology (HBPP)**
**Clinical & Integrative Gastrointestinal Pathobiology (CIGP)**
**Cellular & Molecular Biology of the Kidney (CMBK)**
**Pathobiology of Kidney Disease (PBKD)**
**Urologic & Kidney Development & Genitourinary Diseases (UKGD)**
**Fellowship & SBIR panels**

## Cardiovascular & Respiratory study sections will be clustered in a new IRG, CVR 

**(in Division E)**
**Lung Cellular, Molecular & Immunobiology (LCMI)**
**Lung Injury, Repair, & Remodeling (LIRR)**
**Respiratory, Integrative Biology & Translational Research (RIBT)**
**Cardiovascular Differentiation & Development (CDD)**
**Cardiac Contractility, Hypertrophy, and Failure (CCHF)**
**Electrical Signaling, Ion Transport & Arrhythmias (ESTA)**
**Myocardial Ischemia & Metabolism (MIM)**
**Clinical & Integrative Cardiovascular Sciences (CICS)**
**Fellowship & SBIR panels**

## Translational-Clinical half of Oncology becomes a new IRG, OTC

**(in Division E)**
**Basic Mechanisms of Cancer Therapeutics (BMCT)**
**Cancer Biomarkers (CBSS)**
**Chemo/Dietary Prevention (CDP)**
**Cancer Immunopathology & Immunotherapy (CII)**
**Clinical Oncology (CONC)**
**Drug Discovery & Molecular Pharmacology (DMP)**
**Developmental Therapeutics (DT)**
**Radiation Therapeutics & Biology (RTB)**
**SBIR panels**

## Vascular & Hematology study sections will be clustered in a new IRG, VH

**(in Division E)**
**Erythrocycte & Leukocyte Biology (ELB)**
**Hematopoiesis (HP)**
**Hemostasis & Thrombosis (HT)**
**Hypertension & Microcirculation (HM)**
**Vascular Cell & Molecular Biology (VCMB)**
**Atherosclerosis & Inflammation of Cardivascular System (AICS)**
**Vascular Biology, Clinical Hematology, & SBIR panels**

**   ****Workloads drive splitting **
**of three study sections**
**Increasing number of applications (100+)**
**Working Group examination**
**Draft guidelines, with shared interests (mostly internal to IRGs, no significant changes in shared interests outside IRGs)**

## Workload data: Neural Basis of Psychopathology, Addictions, & Sleep Disorders (NPAS) and  SEP BDCN-A90

| Council | 2006/5
(NPAS before SEP) | 
200610 -2008/10
(NPAS avg. after SEP)
 | 200610 -2008/10
(SEP BDCN-A 90 Avg.) |
| --- | --- | --- | --- |
| Total | 111 | 77 | 42 |
| HS (~%) | 70 | 95+ | 12* |
| Animal (~%) | 30 | 5 | 88 |

*** ****Includes post mortem studies**

## Cross-cutting Working Group for NPAS reorganizationMarch 12, 2008 teleconference

**Huda Akil, UM, Ann Arbor**
**Robert Freedman, UC, Denver**
**Michela Gallagher, JHU**
**Vahram Haroutunian, Mt Sinai Sch Med, NY**
**Daniel Javitt, NYU**
**Bita Moghaddam, U Pittsburgh**
**James O'Donnel, WVU**
_*Program staff: *_Steven Grant (NIDA), Susan Volman (NIDA), Douglas Meinecke ( NIMH), Lois Winsky (NIMH), Linda Brady (NIMH), Larry Refolo (NINDS), Ellen Witt (NIAAA), Lisa Neuhold (NIAAA)
_*CSR Staff: *_Anita Miller* *Sostek (DCPS), René Etcheberrigaray (BDCN), Boris Sokolov, Boris (BDCN), Julius Cinque (BDCN), Christine Melchior (IFCN), Carole Jelsema (MDCN), Joseph Rudolph (ETTN)

## NPAS Working Group Comments & Recommendations

**SEP creation has resulted in a better focuses and more manageable workload for NPAS**
**Maintain NPAS focus on clinical/translational human studies**
**Human post-mortem studies should remain in NPAS**
**Organize a new study section (based on ZRG1 BDCN-A90S SEP) to review multidisciplinary and translational oriented studies that use models and basic science approaches within a disease/clinical context **
**Elaborate scientific descriptions**
**Refine overlaps/boundaries with the existing study sections**
**Aim to broaden ICs covered**

## Proposed Study Sections

**-  NPAS: ****Neural Basis of Psychopathology, Addictions and Sleep Disorders:**
**	**applications addressing the neurobiological basis of addictive, behavioral, cognitive and emotional disorders across the life span, emphasizing clinical and human postmortem studies** **
**-  PMDA: ****Pathophysiological Basis of Mental Disorders and Addictions**
**	**applications on the neural basis of mental and addictive disorders focusing on translational approaches and/or laboratory animals within a clinically/disease relevant context

## Cross-cutting Working Group for Clinical Neuroscience & Disease (CND) realignmentMarch 11, 2008, teleconference

**Roger Albin, U Michigan**
**Etty Benveniste, U Alabama**
**Gregory del Zoppo, U Washington**
**Norman Foster, U Utah**
**Edward Hall, U Kentucky**
**David Hovda, UCLA**
**William Jagust, U Berkeley, UIUC**
**Theresa Jones, UTexas, Austin**
**Brian Litt, U Penn**
**Michael Moseley, Stanford U**
**Steven Roper, U Florida**
**Christopher Ross, JHU**
**Gary Wenk, OSU**
**Karen Wilcox, U Utah**
**William Young, UCSF**
**NIH staff: Neil Buckholtz (NIA), Ramona Hicks (NINDS), Margaret Jacobs (NINDS); CSR – Seetha Bhagavan, René Etcheberrigaray, Anita Miller Sostek**

## Workload & Topics Data

**CND**

**CNN**

**ANIE**

## CND Working Group Comments & Recommendations

**Maintain neuroscience context**
**Rationale and proposed split of CND is appropriate and a move in the right direction**
**Increased in the focus of scientific topics within each study section**
**Manageable volume of applications would enhance quality of peer review**
**Form two regular study sections (60-80 applications each)**
**	****-  CNN: Clinical Neuroscience & Neurodegeneration **
**	**applications on clinical components of chronic neurodegenerative diseases (*e.g*., Alzheimer’s, Parkinson’s, dystonia/ataxia, ALS)
**	****- ANIE: Acute Neural Injury and Epilepsy:**
**	**clinical aspects of acute insults to the brain (*e.g*., stroke, traumatic brain injury, spinal cord injury) & epilepsy

## Proposed Study Sections

**-  CNN: Clinical Neuroscience & Neurodegeneration **
**	**applications on clinical and translational aspects of chronic neurodegenerative diseases (*e.g*., Alzheimer’s, Parkinson’s, dystonia/ataxia, ALS)
**-  ANIE: Acute Neural Injury and Epilepsy:**
**	**applications on** **clinical and translational aspects of acute insults to the brain (*e.g*., stroke, traumatic brain injury, spinal cord injury) & epilepsy

## Medical Imaging (MEDI) Realignment Issues

**Emergence of ‘Clinical Molecular Imaging’ applications**
**New society and *****Journal of Molecular Imaging***
**MEDI reviewer request to split off the molecular imaging**
**Large size of MEDI—often well above 100 applications**
**Previous recommendation for a molecular imaging review group (SEP started Oct 2007 council)**

## MEDI Working Group

**Richard Ehman, MD, Mayo Clinic**
**Victor Davila-Roman, MD, Washington University**
**Katherine Ferrara, PhD, Univ. of California, Davis**
**Robert Gillies, PhD, Univ. of Arizona**
**Robert Grossman, MD, NY Univ. Sch. of Med.**
**Kathryn Morton, MD, Univ. of Utah**
**Eva Sevick-Muraca, PhD, Baylor College of Med.**
**Henry Vanbrocklin, PhD, Univ. of California SF**
**Warren Warren, PhD, Duke Univ.**
**NIH: Alan Mclaughlin, PhD, NIBIB; Anne Menkens, PhD, NCI; CSR: Eileen Bradley, ScD; Anita Miller Sostek, PhD**

##                Proposed Guidelines

**Clinical Molecular Imaging and  Probe Development (CMIP)**
**Development, synthesis, selection, optimization, and validation of novel diagnostic or therapeutic pharmaceuticals or molecular signatures, intended for use in translational and clinical imaging studies. **
**Emphasis is on targeting, metabolism, effectiveness, toxicology, biodistribution, and pathological findings for imaging cells, tissues, organs, and whole body in animals and humans. **
**Development of instrumentation uniquely required for probe-based imaging.   **

**	****Areas to be reviewed: Development, synthesis, selection, optimization, and validation of novel diagnostic or therapeutic pharmaceuticals or molecular signatures, intended for use in translational and clinical imaging studies. Emphasis is on targeting, metabolism, effectiveness, toxicology, biodistribution, and pathological findings for imaging cells, tissues, organs, and whole body in animals and humans. Development of instrumentation uniquely required for**
**probe-based imaging.   Examples include:**

## Proposed realignments include new divisions, IRGs, & study sections

**Divisions 5**
**	****- A & B approved previously**
**	****- C, D, & E (****approval sought****)**
**	****- Three new DD positions (one approved previously)**
**IRGs 9**
**	****- ETTN, EPS, & HDM approved previously**
**	****- OBT, IMST, DKUS, CVR, OTC, & VH (****approval sought****)**
**	****- Five new IRG Chief positions (one hired, Rudolph ETTN)**
**Study sections 3 splits (****approval sought****)**
**	****- NPAS split into NPAS & PMDA**
**	****- CND split into CNN & ANIE**
**	****- MEDI split into MEDI & CMIP**

## Discussion