1. DESIGNING A PROGRAM FOR REVIEW OF CDER LABORATORY RESEARCHERS Keith Webber, Ph.D. Acting Deputy Director OPS/CDER/FDA

2. OUTLINE THE NEED THE LABS THE PLAN THE FUTURE

3. 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

4. RESEARCH OFFICES OFFICE OF PHARMACEUTICAL SCIENCE OFFICE OF TESTING AND RESEARCH DIVISION OF APPLIED PHARACOLOGY RESEARCH DIVISION OF PHARMACEUTICAL ANALYSIS DIVISION OF PRODUCT QUALITY RESEARCH LABORATORY OF CLINICAL PHARMACOLOGY OFFICE OF BIOTECHNOLOGY PRODUCTS DIVISION OF MONOCLONAL ANTIBODIES DIVISION OF THERAPEUTIC PROTEINS

5. 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

6. 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

7. 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

8. 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

9. 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 RESEARCH LABORATORY SCIENTIST PEER REVIEW COMMITTEE

10. 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

11. OFFICE OF BIOTECHNOLOGY PRODUCTS PROMOTION, CONVERSION, EVALUATION COMMITTEE PEER-REVIEW PURPOSE –CONVERSION OF STAFF FELLOWS TO CIVIL SERVICE POSITIONS –PROMOTION OF CIVIL SERVICE RESEARCHERS

12. 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

13. CURRENT OTR SYSTEM GS-13 SCIENTIST PEER REVIEW GS-14 SCIENTIST EVERY 3 YEARS

14. CURRENT OBP SYSTEM SENIOR STAFF FELLOW OR GS PRINCIPAL INVESTIGATOR SITE VISIT RECOMMEND- ATION PROMOTION, CONVERSION, EVALUATION COMMITTEE PROMOTION OR CONVERSION OF STAFF MEMBER EVERY 4 YEARS

15. WORKING GROUP FOR DESIGNING 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.

16. PROPOSED MILESTONES MILESTONESCHEDULE FINALIZE PROPOSALMARCH 2006 PRESENT TO ACPSAPRIL 2006 ESTABLISH PROCEDURESJULY 2006 SEND TO ACPSAUGUST 2006 ACPS TRAININGOCTOBER 2006 FIRST SITE-VISITDEC. 2006

17. ONE POSSIBLE MODEL FOR PERIODIC 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

18. 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.

19. 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?