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  1. Archived File The file below has been archived for historical reference purposes only. The content and links are no longer maintained and may be outdated. See the OER Public Archive Home Page for more details about archived files.

  2. PEER REVIEW ADVISORY COMMITTEE Update on CSR Realignments Don Schneider, Ph.D. April 30, 2008 National Institutes of HealthU.S. Department of Health and Human Services

  3. CSR workloads have grown

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

  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 * Includes post mortem studies

  18. Cross-cutting Working Group for NPAS reorganizationMarch 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), LoisWinsky (NIMH), LindaBrady (NIMH), Larry Refolo (NINDS), Ellen Witt (NIAAA), Lisa Neuhold (NIAAA) • CSR Staff: Anita MillerSostek (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) realignmentMarch 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. before split after 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) Workload & Topics Data CND ANIE CNN

  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 onclinical 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. 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 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.

  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

  29. Discussion

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