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   Update on CSR Realignments

      Don Schneider, Ph.D.

                                          April 30, 2008

             National Institutes of Health
             U.S. Department of Health and Human Services   2
         CSR workloads have grown
YEAR         # REVIEW       # CSR       APPS per

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
  - Better clustering by division, e.g., neuroscience
  - Enhanced review context for clinical and multi-disciplinary

  - More even for IRG Chiefs, 8-12 SROs each (now 3-20)
  - Fewer applications per division, 10,000 a year

     PRAC & Division Realignment Process
  - PRAC WG for concept discussion
  - Internal & external community involvement
  - PRAC Meeting for final discussion

  - 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

• Name changes based on sensitivities, balancing
  basic, translational, and clinical research

• Apr 30, 2008, PRAC Meeting, final discussion
                                  Plans are five CSR Review Divisions
         Division A                       Division B                    Division C                         Division D                     Division E
(Neuroscience, Development            (AIDS, Behavioral           (Basic and Integrative               (Physiological and            (Translational and
         and Aging)                and Population Sciences)        Biological Sciences)              Pathological Sciences)           Clinical Sciences)

                                                                                                        Endocrinology, Metabolism,
       Brain Disorders and                  Behavioral and            Biological Chemical and                                           Cardiovascular and
                                                                                                               Nutrition and
       Clinical Neuroscience            Biobehavioral Processes      Macromolecular Biophysics                                         Respiratory Sciences
                                                                                                          Reproductive Sciences
            IRG (BDCN)                       IRG ( BBBP)                    IRG (BCMB)                                                      IRG (CVR)
                                                                                                               IRG (EMNR)

     Molecular, Cellular and            Risk, Prevention and           Bioengineering Sciences                                        Surgical Sciences, Biomedical
   Developmental Neuroscience            Health Behaviors                 and Technologies                                             Imaging and Bioengineering
                                                                                                                IRG (IMM)
          IRG (MDCN)                        IRG (RPHB)                        IRG (BST)                                                         IRG (SBIB)

                                         Epidemiology and             Cell Biology IRG (CB)                 Infectious Diseases        Musculoskeletal, Oral
    Integrative, Functional and         Population Sciences                                                   and Microbiology          And Skin Sciences
      Cognitive Neuroscience                 IRG (EPS)                                                           IRG (IDM)                IRG (MOSS)
             IRG (IFCN)                                                   Genes, Genomes
                                                                           and Genetics
                                         Healthcare Delivery                IRG (GGG)                     Digestive, Kidney and           Oncology 2 –
                                         and Methodologies                                                 Urological Systems          Translational Clinical
   Emerging Technologies and
                                             IRG (HDM)                                                        IRG (DKUS)                    IRG (OTC)
    Training in Neuroscience
           IRG (ETTN)                                                    Oncology 1 – Basic
                                                                       Translational IRG (OBT)
                                             AIDS and                                                                                      Vascular and
                                          Related Research                                                                                  Hematology
    Biology of Development and              IRG (AARR)                                                                                       IRG (VH)
               Aging                                                   Interdisciplinary Molecular
             IRG (BDA)                                                   Sciences and Training
                                                                               IRG (IMST)

          Scientific                        Scientific                          Scientific                       Scientific                   Scientific
           Review                            Review                              Review                           Review                       Review
          Groups=                           Groups=                             Groups=                          Groups=                      Groups=
              48                                44                                  55                               43                           50                  7
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
  - 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

•   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
• 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
• 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
• 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

                              2006/5      200610 -2008/10    200610 -2008/10
          Council          (NPAS before   (NPAS avg. after    (SEP BDCN-A
                               SEP)            SEP)              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

•   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
  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
                         before split                                                         after split
                     Average no. of applications = 115                   Combined, average no. of applications = 120
                (council rounds: 2007/01, 2007/05, 2007/10)              (council rounds: 2008/01, 2008/05, 2008/10)

                                                                                        Other, 29,
CND                Other (41)                   Epilepsy,
                                                                       Dementia (8)
                                                                                                             Epilepsy (62)
                     12%                        (66) 19%                  4%                                     28%

ALS (3) 1%                                                               Spinal cord                           (56) 27%
                                                                       injury (14) 7%
                                                       related, (48)        Traumatic
                                                                            brain injury
Movement                                                   14%
                                                                             (42) 20%                               ANIE
(58) 17%                                                                        Other (21)14%

                                                      Traumatic           Huntington's
                                                                           Disease                             Alzheimer's
 Alzheimer's                                          brain injury          (1)1%                             Disease (75)
Disease, (84)                                          (32) 9%                                                     50%

    24%                                                                    ALS (7) 5%
                                  Vascular        Spinal cord
                                Dementia, (3)     injury, (11)
                                    1%                3%

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
• 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’

• New society and Journal of Molecular Imaging

• MEDI reviewer request to split off the molecular

• 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
• Development of instrumentation uniquely required for probe-
  based imaging.
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

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