DESIGNING A PROGRAM FOR REVIEW OF CDER

LABORATORY RESEARCHERS

Keith Webber, Ph.D.

Acting Deputy Director

OPS/CDER/FDA

OUTLINE

• THE NEED

• THE LABS

• THE PLAN

• THE FUTURE

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

RESEARCH OFFICES

OFFICE OFPHARMACEUTICAL SCIENCE

OFFICE OFTESTING AND RESEARCH

OFFICE OFBIOTECHNOLOGY PRODUCTS

DIVISION OFPHARMACEUTICAL

ANALYSIS

DIVISION OF APPLIEDPHARACOLOGY RESEARCH

DIVISION OF PRODUCTQUALITY RESEARCH

DIVISION OFMONOCLONAL ANTIBODIES

DIVISION OFTHERAPEUTIC PROTEINS

LABORATORY OFCLINICAL PHARMACOLOGY

OPS LABORATORIES

OTR - Division of Pharmaceutical Analysis

St. Louis, MO

OTR- Lab of Clinical Pharmacology- Division of Applied Pharmacology Research- Division of Product Quality Research

White Oak, MD

OBP- Div. Of Monoclonal Antibodies- Div. of Therapeutic Proteins

Bethesda, MD

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

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

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

OFFICE OF TESTING AND RESEARCH

• 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

OFFICE OF TESTING AND RESEARCHLABORATORY SCIENTIST PEER REVIEW COMMITTEE

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

OFFICE OF BIOTECHNOLOGY PRODUCTS

PROMOTION, CONVERSION, EVALUATION COMMITTEE

• PEER-REVIEW

• PURPOSE– CONVERSION OF STAFF FELLOWS TO

CIVIL SERVICE POSITIONS– PROMOTION OF CIVIL SERVICE

RESEARCHERS

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-DIRECTOR’S OFFICE

CURRENT OTR SYSTEM

GS-13SCIENTIST

PEERREVIEW

GS-14SCIENTIST

EVERY3 YEARS

CURRENT OBP SYSTEMSENIOR

STAFF FELLOWOR

GS PRINCIPALINVESTIGATOR

SITE VISIT

RECOMMEND-ATION

PROMOTION,CONVERSION,EVALUATIONCOMMITTEE

PROMOTIONOR

CONVERSIONOF

STAFF MEMBER

EVERY4 YEARS

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 SCIENCEKEITH WEBBER, PH.D.

PROPOSED MILESTONES

MILESTONE SCHEDULE

FINALIZE PROPOSAL MARCH 2006

PRESENT TO ACPS APRIL 2006

ESTABLISH PROCEDURES JULY 2006

SEND TO ACPS AUGUST 2006

ACPS TRAINING OCTOBER 2006

FIRST SITE-VISIT DEC. 2006

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

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.

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?