Schneider CSR presentation 05062008

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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
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CSR workloads have grown
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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

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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

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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

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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
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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

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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)

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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)

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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)

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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

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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

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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

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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

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• 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)

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Workload data Neural Basis of Psychopathology,
Addictions, Sleep Disorders (NPAS) and SEP
BDCN-A90
Includes post mortem studies
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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), 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)

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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

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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

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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

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Workload Topics Data
CND
ANIE
CNN
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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., Alzheimers,
  Parkinsons, 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

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Proposed Study Sections

• - CNN Clinical Neuroscience Neurodegeneration
  
• applications on clinical and translational
  aspects of chronic neurodegenerative diseases
  (e.g., Alzheimers, Parkinsons, 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

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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 MEDIoften well above 100
  applications
• Previous recommendation for a molecular imaging
  review group (SEP started Oct 2007 council)

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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

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Proposed Guidelines
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

• 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.

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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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Discussion