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NCTR Overview

NCTR Overview. Daniel A. Casciano, Ph.D. National Center for Toxicological Research. Organization of Presentation. Some information on FDA Organization of the NCTR Function of SAB. Office of International and Constituent Relations. Office of Policy, Planning, and Legislation. Office of

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NCTR Overview

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  1. NCTR Overview Daniel A. Casciano, Ph.D. National Center for Toxicological Research

  2. Organization of Presentation • Some information on FDA • Organization of the NCTR • Function of SAB

  3. Office of International and Constituent Relations Office of Policy, Planning, and Legislation Office of Management and Systems Office of Regulatory Affairs Center for Biologics Evaluation and Research Center for Food Safety and Applied Nutrition Center for Drug Evaluation and Research Center for Veterinary Medicine Center for Devices and Radiological Health National Center for Toxicological Research Department of Health and Human ServicesFood and Drug Administration Office of the CommissionerCommissioner of Food and Drugs Office of Equal Opportunity Office of the Administrative Law Judge Office of the Senior Associate Commissioner Office of the Chief Counsel

  4. Center for Drug Evaluation and Research • MISSION: The Center assures that safe and effective drugs are available to the American people. • ISSUES: Prescription Drug User Fee Act (PDUFA), Adverse Events Reporting, Gene Therapy, Monitoring Drug Information and Advertising, Drug Quality, Drug Safety

  5. Center for Food Safety and Applied Nutrition • MISSION: The Center is responsible for promoting and protecting the public’s health and economic interest by ensuring that the nation’s food supply is safe, sanitary, wholesome, and honestly labeled. The program also ensures that cosmetic products are safe and properly labeled. • ISSUES: Food Safety, Joint Institute for Food Safety and Applied Nutrition, Dietary Supplements, Food Labeling, Seafood Decomposition, Phototoxicity(a Hydroxy acids)

  6. Center for Veterinary Medicine • MISSION: CVM is responsible for ensuring that animal drugs and medicated feeds are safe and effective for their intended uses and that food from treated animals is safe for human consumption. • ISSUES: Food Safety, Antibiotic Resistance, Aquaculture.

  7. Center for Devices and Radiological Health • MISSION: The mission of CDRH is to protect the public health by providing reasonable assurance of the safety and effectiveness of medical devices and by eliminating unnecessary human exposure to radiation emitted from electronic products (medical, industrial, and consumer). • ISSUES: Reuse of Single-Use Medical Devices, Medical Device Surveillance, Medical Errors, Regulations, FDAMA, Reengineering, Device GMP Inspections, Tissue-Based Products (BSE/TSE), Genetic Assay Kits, People Scanners (X-Rays), Ultrasound, Electro-magnetic Radiation

  8. Center for Biologics Evaluation and Research • MISSION: The mission of CBER is to protect and enhance the public health through regulation of biological and related products including blood, vaccines, therapeutics and related drugs and devices according to statutory authorities. • ISSUES: Biologic Review Actions, Major Drug Approvals, Vaccine Approvals, Bioterrorism,Research in Proteomics, Compliance Activities, Action Plans (Blood, Tissue, Devices), Xenotransplantation

  9. Office of Regulatory Affairs • MISSION: The Office of Regulatory Affairs (ORA) is the lead office for all Field activities of the Food and Drug Administration. • ISSUES: International Harmonization, Imports, Leveraging (EPA, States), Seafood and Dairy Exports, Laboratory Information Bulletins, Research, Bioresearch Monitoring Program (BIMO), Adverse Action Reports (All Centers), Recalls, Seafood Decomposition, Bacterial Contamination

  10. DEPARTMENT OF HEALTH AND HUMAN SERVICESFOOD AND DRUG ADMINISTRATIONNATIONAL CENTER FOR TOXICOLOGICAL RESEARCH Office of the Director Office of Research Office of Management Division of Biochemical Division of Genetic Office of Management Office of Planning, Toxicology and Reproductive Services Finance, and Toxicology Information Technology Division of Biometry Division of Microbiology Division of Facilities, Division of Planning and Risk Assessment Engineering and Maintenance Division of Chemistry Division of Division of Division of Financial Neurotoxicology Administrative Management Services Division of Veterinary Division of Molecular Division of Services Epidemiology Information Technology

  11. Division of Microbiology National Center for Toxicological Research Food and Drug Administration Jefferson, Arkansas Carl E. Cerniglia, Ph.D. Director

  12. DIVISION OF MOLECULAR EPIDEMIOLOGYOVERVIEW Fred F. Kadlubar, Ph.D. Director

  13. Division ofBiochemical Toxicology Frederick A. Beland, Ph.D. Director

  14. Division of Genetic and Reproductive Toxicology Martha M. Moore, Ph.D. Director

  15. Division of Neurotoxicology William Slikker, Jr., Ph.D. Director

  16. Division of Biometry and Risk Assessment Ralph L. Kodell, Ph.D. Director

  17. Division of Chemistry Robert J. Turesky, Ph.D. Director

  18. Division of Veterinary Services William M. Witt, D.V.M., Ph.D. Director

  19. FDA/NCTR/NIEHS Interagency Agreement William T. Allaben, Ph.D.

  20. NCTR RESOURCESFDA Allocation

  21. FTE ALLOCATION

  22. NCTR RESOURCES

  23. Out-year Budget RequestsFY2002

  24. Out-year Budget RequestsFY2003 • Premarket Review: Proteomics, Genomics, Gene Chip, Microarray and Bioinformatics to Support and Guide Premarket Review ($2,646,000) • Antimicrobial Resistance ($500,000) • Dietary Supplements ($500,000) • Food Safety ($12,000,000) • Cost of Living ($2,953,000)

  25. What Do We Do For FDA? • NTP Bioassay • Food Safety Initiative • Fresh Tag™ • Bioterrorism • Intellectual Resource

  26. Fundamental Research • DNA adduct • Artificial GI tract • Estrogen and computational toxicology • Nutrition (PCR) • Transgenic animals • Risk Assessment procedures • Operant behavior • Toxicogenomics, Proteomics

  27. Function of SAB • Advise NCTR Director on science, budget and other issues (NCSS subcommittee) • Members serve on full SAB for review of site-visit reports • Members serve as chair and/or committee member of program/division site-visit teams

  28. Toxicology in the Next Millenium

  29. Toxicology Data Continuum Protein Modification Adaptation, repair or damage Gene expression Protein synthesis Dysfxn TOXICITY! D functional Activity Biochemical Mechanism Proteomic Genomic Cellular Organism Tissue/Organ

  30. DNA DNA RNA RNA Proteins Proteins Transcriptome Transcriptome Proteome Proteome Genome Genome CGTCCAACTGACG TCTACAGGCTTAT TTAGCGCTATAAG AGTCATACCTGTA TATATATAGGCGA ATTCGCCACGTAG TACCCGGGTAT….. CGTCCAACTGACG TCTACAGGCTTAT TTAGCGCTATAAG AGTCATACCTGTA TATATATAGGCGA ATTCGCCACGTAG TACCCGGGTAT….. DNA sequencing DNA sequencing cDNA arrays cDNA arrays 2D- PAGE 2D- PAGE

  31. Better Predictive Tests • DNA- and protein-based technologies • Transgenics • Biomarkers (rodent/human homologues) • Alternative to animals • Computational Science

  32. Current Genomics Project at the NCTR • Human genotyping • Gene expression profiles

  33. NCTR Gene Expression Microarray Project Effects of Chemical Toxicants on Gene Expression Profiles • Expose rat cells in primary culture to a variety of toxicants; evaluate gene expression. • Expose intact animal to same toxicants; evaluate gene expression in interested organ. • Expose human cells in primary culture to same toxicants; evaluate gene expression. • Predict in vivo human response.

  34. Development of SNP-Chips • High throughput genotyping using DNA microarray technology will be used to allow facile genetic screening of human populations for: • Adverse Drug Reactions • Cancer Susceptibility, Early Diagnosis & • Recurrence • Drug Efficacy in Subsets of the Population • Individualized Drug Dosing Rapid screening for variant genes involved in metabolism, DNA repair, and cellular homeostasis should allow the selection of genetically heterogeneous groups for inclusion in clinical trials and thereby increase our ability to protect public health in a diverse population.

  35. Developing Proteomics

  36. Problems • Commercial vs. In-house development of chips • Toxicogenomics staffing

  37. Some Solutions • Creative recruitment (Cellular and Molecular Toxicology Group) • Leveraging • Collaboration • IPA

  38. Toxicology Data Continuum Protein Modification Adaptation, repair or damage Gene expression Protein synthesis Dysfxn TOXICITY! D functional Activity Biochemical Mechanism Proteomic Genomic Cellular Organism Tissue/Organ

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