Division of Hematology

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 HematologyRegulatory 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 DAgnillo, conversion Visiting Scientist
  ? Senior Investigator

10
Site Visit ReviewLCH Personnel Actions

• Platelet Efficacy/Safety
• Jaroslav Vostal, GS 14 ? 15
• Microparticles
• Jan Simak, Progress Report