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Division of Hematology

Division of Hematology. Basil Golding M.D. Division Director BPAC, March 2006 Final Report on Site Visit 2005 Laboratories of Cellular Hematology, and Biochemistry & Vascular Diseases. Division of Hematology. Research/Review Units. LBVB. LCH. LH. LPD. CRB. Biochemistry &

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Division of Hematology

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  1. Division of Hematology Basil Golding M.D. Division Director BPAC, March 2006 Final Report on Site Visit 2005 Laboratories of Cellular Hematology, and Biochemistry & Vascular Diseases

  2. Division of Hematology Research/Review Units LBVB LCH LH LPD CRB Biochemistry & Vascular Biology Cellular Hematology Hemostasis Plasma Derivatives Clinical Review Branch PIs: 3 2 2 4 Total = 11

  3. CBER Mission MISSION: To ensure the safety, purity, potency and effectiveness of biological products including vaccines, blood and blood products, and cells, tissues and gene therapies for the prevention, diagnosis, and treatment of human diseases, conditions or injury. Through our mission, we also help to defend the public against the threats of emerging infectious diseases and bioterrorism.

  4. Division of Hematology Scope of Regulation and Research • Research helps solve regulatory problems (Critical Path) and serves to enhance the expertise of scientific investigators who have review responsibility for these products • Scientific evaluation of biologic products derived from blood include those • isolated from blood or plasma • analogous materials derived by recombinant DNA technology

  5. Division of Hematology Scope of Regulation and Research (contd.) • Clinical applications include : • prophylaxis and/or treatment of bleeding disorders • shock • infectious diseases • immunological deficits • replacement therapy in congenital or acquired deficiencies.

  6. Division of Hematology: Regulatory Products and Process • Applications and products: • biologics, drugs, and devices • Diverse complex proteins and carbohydrate polymers • Decisions - based on scientific data showing safety, efficacy and purity • decision-making process • internal review • presentations to Advisory Committees • conferences with manufacturers • workshops.

  7. Division of Hematology:Regulatory Process • Evaluation process of products • scientific review • laboratory investigation if needed • lot release tests • standards are developed for lot release of different products and are often distributed as CBER and/or international standards • Surveillance: • Inspections, Adverse Event Reports, product failures

  8. Division of HematologyResearch • Research Topics • coagulation • immunology • protein structure and function • blood-borne viruses and TSE/prions • oxygen-carrying compounds • platelet structure and function

  9. Site Visit ReviewLBVB: Personnel Actions • Physical Protein Chemistry Andrew Shrake, GS 14  15 (retired) • Biochemistry of Blood Substitutes Abdu Alayash, Progress Report Yiping Jia, candidate for Staff Scientist - Progress Report • Vascular Biology Felice D’Agnillo, conversion Visiting Scientist  Senior Investigator

  10. Site Visit ReviewLCH: Personnel Actions • Platelet Efficacy/Safety • Jaroslav Vostal, GS 14  15 • Microparticles • Jan Simak, Progress Report

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