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2 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

3 CSR workloads have grown YEAR# REVIEW DIVISIONS # CSR APPLICATIONS APPS per DIVISION ,64710, ,8299, ,68812,672 (2008)(3)(ca 50,688)(ca 16,896)

4 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

5 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

6 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

7 Plans are five CSR Review Divisions Division A (Neuroscience, Development and Aging) Brain Disorders and Clinical Neuroscience IRG (BDCN) Molecular, Cellular and Developmental Neuroscience IRG (MDCN) Integrative, Functional and Cognitive Neuroscience IRG (IFCN) Emerging Technologies and Training in Neuroscience IRG (ETTN) Biology of Development and Aging IRG (BDA) Behavioral and Biobehavioral Processes IRG ( BBBP) Risk, Prevention and Health Behaviors IRG (RPHB) Epidemiology and Population Sciences IRG (EPS) Healthcare Delivery and Methodologies IRG (HDM) AIDS and Related Research IRG (AARR) Division B (AIDS, Behavioral and Population Sciences) Division C (Basic and Integrative Biological Sciences) Biological Chemical and Macromolecular Biophysics IRG (BCMB) Bioengineering Sciences and Technologies IRG (BST) Genes, Genomes and Genetics IRG (GGG) Oncology 1 – Basic Translational IRG (OBT) Cell Biology IRG (CB) Interdisciplinary Molecular Sciences and Training IRG (IMST) Division D (Physiological and Pathological Sciences) Endocrinology, Metabolism, Nutrition and Reproductive Sciences IRG (EMNR) Immunology IRG (IMM) Infectious Diseases and Microbiology IRG (IDM) Digestive, Kidney and Urological Systems IRG (DKUS) Division E (Translational and Clinical Sciences) Cardiovascular and Respiratory Sciences IRG (CVR) Surgical Sciences, Biomedical Imaging and Bioengineering IRG (SBIB) Musculoskeletal, Oral And Skin Sciences IRG (MOSS) Oncology 2 – Translational Clinical IRG (OTC) Vascular and Hematology IRG (VH) Scientific Review Groups= 48 Scientific Review Groups= 50 Scientific Review Groups= 43 Scientific Review Groups= 44 Scientific Review Groups= 55

8 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

9 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)

10 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)

11 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)

12 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

13 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

14 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

15 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

16 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)

17 Workload data: Neural Basis of Psychopathology, Addictions, & Sleep Disorders (NPAS) and SEP BDCN-A90 Council 2006/5 (NPAS before SEP) /10 (NPAS avg. after SEP) /10 (SEP BDCN-A 90 Avg.) Total HS (~%) * Animal (~%)30588 * Includes post mortem studies

18 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)

19 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

20 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

21 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

22 Workload & Topics Data before splitafter split Average no. of applications = 115 (council rounds: 2007/01, 2007/05, 2007/10) Combined, average no. of applications = 120 (council rounds: 2008/01, 2008/05, 2008/10) CND CNN ANIE

23 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

24 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

25 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)

26 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

27 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:

28 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