DESIGNING A PROGRAM FOR REVIEW OF CDER LABORATORY RESEARCHERS

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DESIGNING A PROGRAM FOR REVIEW OF CDERLABORATORY
RESEARCHERS

• Keith Webber, Ph.D.
• Acting Deputy Director
• OPS/CDER/FDA

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OUTLINE

• THE NEED
• THE LABS
• THE PLAN
• THE FUTURE

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WHY IS AN INDEPENDENT EVALUATION NEEDED?

• OBJECTIVE ASSESSEMENT OF
• SCIENTIFIC RIGOR THOROUGHNESS
• SCIENTIFIC PRODUCTIVITY
• MISSION RELEVANCE
• OBJECTIVE RECOMMENDATIONS FOR
• FUTURE DIRECTIONS
• RESOURCE ALLOCATIONS
• PROMOTIONS CONVERSIONS

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RESEARCH OFFICES
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OPS LABORATORIES
OBP - Div. Of Monoclonal Antibodies - Div. of
Therapeutic Proteins Bethesda, MD
OTR - Lab of Clinical Pharmacology - Division
of Applied Pharmacology Research -
Division of Product Quality Research White
Oak, MD
OTR - Division of Pharmaceutical
Analysis St. Louis, MO
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OFFICE OF TESTING AND RESEARCH RESEARCH PROGRAM

• EXAMPLES
• ANALYTICAL METHOD DEVELOPMENT AND
  CHARACTERIZATION
• PAT TOOLS
• NIR, RAMAN, TERAHERTZ SPECTROSCOPY
• CHEMICAL IMAGING TECHNOLOGIES
• PRODUCT TESTING
• SUPPORT BIOEQUIVALENCE CHALLENGES
• STABILITY OF REPACKAGED DRUGS
• TRANSDERMAL DELIVERY SYSTEMS
• DEVELOPMENT OF BIOMARKERS OF TOXICITIES
• DEVELOPMENT AND STANDARDIZATION OF GENOMICS
  METHODOLOGIES
• NANOTECHNOLOGY
• EVALUATION OF ANALYTICAL METHODS IN NDAs

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OFFICE OF BIOTECHNOLOGY PRODUCTS RESEARCH PROGRAM

• EXAMPLES
• MECHANISMS OF HUMORAL AND CELL-MEDIATED IMMUNE
  RESPONSES AND TOLERANCE
• INTERACTIONS BETWEEN HIV, CYTOKINES, AND CELLS OF
  THE IMMUNE SYSTEM
• MECHANISMS OF ANTHRAX LETHAL TOXIN
• MECHANISMS OF ONCOGENESIS AND TUMOR CELL
  DESTRUCTION
• MODERNIZATION OF VIRAL SAFETY APPROACHES AND
  TECHNOLOGY MECHANISMS OF SIGNAL TRANSDUCTION
• NOVEL METHODS FOR SYNTHESIS OF OLIGONUCLEOTIDES

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OFFICE OF TESTING AND RESEARCH

• SCIENCE REVIEW
• DONE INTERNALLY (OPS)
• PROMOTIONS (GS-13 ? GS-14)
• LABORATORY SCIENTIST PEER REVIEW COMMITTEE MEETS
  ON AN AD HOC BASIS TO EVALUATE SCIENTIFIC
  QUALIFICATIONS AND CONTRIBUTIONS OF
• RESEARCH SCIENTISTS PROPOSED FOR PROMOTION
• ALL RESEARCH SCIENTISTS AT GS-14 AND ABOVE TO BE
  REVIEWED EVERY 3 YEARS

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OFFICE OF TESTING AND RESEARCHLABORATORY
SCIENTIST PEER REVIEW COMMITTEE

• MIXED INTERNAL EXTERNAL MEMBERSHIP
• 3 MEMBERS FROM CDER
• DIVISION DIRECTORS OR SENIOR SCIENTIST LEVEL
• 3 MEMBERS FROM OUTSIDE
• SCIENTISTS FROM NIH OR OTHER FDA CENTERS
• REP FROM HUMAN RESOURCES MANAGEMENT
• EXEC SEC FROM OTR

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OFFICE OF BIOTECHNOLOGY PRODUCTS

• EXTERNAL SITE-VISIT COMMITTEE
• MEMBERSHIP
• CHAIR FROM ADVISORY COMMITTEE
• 1 OR 2 SELECTED SCIENTISTS PER PRINCIPAL
  INVESTIGATOR
• EXECUTIVE SECRETARY FROM AD-COM

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OFFICE OF BIOTECHNOLOGY PRODUCTS

• PROMOTION, CONVERSION, EVALUATION COMMITTEE
• PEER-REVIEW
• PURPOSE
• CONVERSION OF STAFF FELLOWS TO CIVIL SERVICE
  POSITIONS
• PROMOTION OF CIVIL SERVICE RESEARCHERS

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OFFICE OF BIOTECHNOLOGY PRODUCTS

• PROMOTION, CONVERSION, EVALUATION COMMITTEE
• MEMBERSHIP
• 2 TENURED PRINCIPAL INVESTIGATORS FROM EACH
  PRODUCT OFFICE IN CBER, PLUS OBP (TOTAL 10)
• 2 FULL-TIME REVIEWERS
• 1 HUMAN RESOURCE MANAGEMENT REP.
• 1 REP FROM CBER CENTER-DIRECTORS OFFICE

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CURRENT OTR SYSTEM
GS-13 SCIENTIST
PEER REVIEW
EVERY 3 YEARS
GS-14 SCIENTIST
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CURRENT OBP SYSTEM
SENIOR STAFF FELLOW OR GS PRINCIPAL INVESTIGATOR
PROMOTION, CONVERSION, EVALUATION COMMITTEE
SITE VISIT
PROMOTION OR CONVERSION OF STAFF MEMBER
EVERY 4 YEARS
RECOMMEND- ATION
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WORKING GROUP FORDESIGNING REVIEW PROGRAM

• OFFICE OF TESTING AND RESEARCH
• JOHN STRONG, PH.D.
• MANSOOR KHAN, PH.D.
• LUCINDA BUHSE, PH.D.
• NAKISSA SADRIEH, PH.D.
• OFFICE OF BIOTECHNOLOGY PRODUCTS
• KATHLEEN CLOUSE-STREBEL, PH.D.
• ELIZABETH (WENDY) SHORES, PH.D.
• ED MAX, M.D., PH.D.
• EMILY SHACTER, PH.D.
• OFFICE OF PHARMACEUTICAL SCIENCE
• KEITH WEBBER, PH.D.

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PROPOSED MILESTONES
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ONE POSSIBLE MODEL FORPERIODIC SITE VISITS

• ESTABLISH WORKING GROUP(S) WITH ACPS
• CHAIRED BY ACPS MEMBER(S)
• EXTERNAL AD HOC MEMBERS FOR EACH WG
• REVIEW PRINCIPAL INVESTIGATORS/TEAM LEADERS
• REPORT BACK TO ACPS FOR RATIFICATION
• OUTPUT RECOMMENDATIONS TO OPS DIRECTOR

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PROMOTIONS CONVERSIONS-POSSIBLE MODEL-

• A SEPARATE PEER-REVIEW COMMITTEE COULD BE
  ESTABLISHED TO REVIEW PERSONNEL FOR PROMOTIONS
  CONVERSIONS.
• THE COMMITTEE WOULD TAKE THE RECOMMENDATIONS FROM
  THE ACPS WORKING GROUP INTO ACCOUNT IN ITS
  DECISIONS.

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DISCUSSION

• IN ADDITION TO SCIENTIFIC RIGOR, PRODUCTIVITY,
  MISSION RELEVANCE, AND WORKLOAD, ARE THERE OTHER
  FACTORS THAT SHOULD BE CONSIDERED IN ASSESSMENTS
  OF CDER RESEARCHERS (E.G., CREATIVITY,
  INNOVATION)?
• PLEASE RECOMMEND CRITERIA FOR ASSESSING
  PRODUCTIVITY FOR THE DIFFERENT TYPES OF RESEARCH
  PROJECTS (E.G., PUBLICATIONS, COMPLETED PROJECTS,
  ETC).
• WHAT RECOMMENDATIONS DO YOU HAVE WITH REGARD TO
  BUILDING A SINGLE SYSTEM TO ASSESS THE FULL
  SPECTRUM OF CDER RESEARCH PROGRAMS?