Subcommittee
meeting of the
Office of Blood Research and Review
AGENDA
8:00
a.m. Welcome and Introduction of
Committee
OSV Chair
Conflict
of Interest Statement
8:10 Introduction/Charge to Committee
Dr. Karen Midthun
Deputy Director, Center for Biologics Evaluation and Research
CBER Mission
CBER Program Structure
8:35 Overview of CBER Research Programs
Kathryn Carbone, M.D.
Associate Director for Research
8:55 Overview Office of Blood Research and Review (OBRR)
Jay S. Epstein, M.D. Director, OBRR
Office Mission and Structure
Regulatory Activities and Priorities
Research Program Introduction
9:20 Q & A for Deputy Director, CBER, Associate Director for Research, CBER & Office Director, OBRR
9:30 Break
9:45 Overview of the Research Program of the Division of Blood Applications
Alan Williams, Ph.D., Director DBA
10:05 Q&A
Subcommittee
meeting of the
10:15 Overview of the Research Program of the Division of Emerging and Transfusion Transmitted Diseases
Hira L. Nakhasi, Ph.D., Director, DETTD
Scope/Mission/Regulatory Relevance/Public Health Impact
Division Research Program Structure & Research
Accomplishments
Regulatory and Product Contributions/Relevance/Expertise
Five-year Objectives
11:10 Q and A
11:20 Overview of the Research Program of the Division of Hematology
Basil Golding, M.D. Director, DH
Scope/Mission/Regulatory Relevance/Public Health Impact
Division Research Program Structure & Research Programs
Accomplishments
Regulatory and product contributions/relevance/expertise
Five-year Objectives
12:05 p.m. Q&A
12:15 Open Public Hearing
1:15 Lunch
Introduction of CBER Panel and Questions to Panel by committee (Drs. Epstein, Nakhasi, Golding, Williams, Scott, Vostal, Alayash, Mied, Asher, Hewlett, Kaplan, Biswas, Cowan, Abbondanzo, Silverman, Lozier
3:30 Closed Executive Session of
Committee
4:45 Oral Summary (Deputy Director, Assoc. Dir. Research, CBER, Office Director and Division Directors, OBRR)
5:00 Adjourn