1	CBER Update Hira Nakhasi, Ph.D. Director, DETTD/OBRR CBER, FDA
2	CBER Management Jesse L. Goodman, M.D., M.P.H., Director Karen Midthun, M.D. Medical Deputy Director Robert Yetter, Ph.D., Associate Director for Review Management Diane Maloney, J.D., Associate Director for Policy Sheryl Lard-Whiteford, Ph.D. CBER Ombudsman (jurisdictions) Kathy Carbone, M.D., Associate Director for Research
3	Office of Blood Research and Review Jay S. Epstein, M.D., Director Jonathan Goldsmith, M.D., Deputy Director Sayah Nedjar, Ph.D., Acting Associate Director for Regulatory Affairs C.D. Atreya, Ph.D., Acting Associate Director for Research J. Scharpf, M.P.H., Associate Director for Policy and Communications
4	OBRR Divisions Division of Emerging and Transfusion Transmitted Diseases- Director, Dr. Hira Nakhasi Division of Blood Applications- Director, Dr. Alan Williams Division of Hematology- Director, Dr. Basil Golding
5	Division of Emerging and Transfusion Transmitted Diseases Hira Nakhasi, Ph.D., Director Paul Mied, Ph.D., Deputy Director Elliot Cowan, Ph.D., Chief, Product Review Branch Indira Hewlett, Ph.D., Chief, Laboratory of Molecular Virology HIV, HTLV, Smallpox ; blood screening and diagnostics West Nile Virus; blood screening Gerardo Kaplan, Ph.D., Chief, Laboratory of Hepatitis and Related Emerging Agents HCV, HBV, HAV, BT agents; blood screening David Asher, M.D., Chief, Laboratory of Bacterial, Parasitic, and Unconventional Agents TSE, Chagas, Malaria, Leishmania,Bacterial agents; blood screening Robin Biswas, M.D., Head, Product Testing Laboratory Lot release testing of HIV, HBV, and HCV test kits
6	Devices and CBER Blood related devices – Office of Blood Research and Review Cell/tissue/gene therapy related devices -Office of Cellular, Tissue and Gene Therapies Office of Compliance and Biologics Quality
7	IVDs that Assure Safe and Effective Blood Products Donor screening tests for freedom from transmissible diseases HIV, HBV, HCV, WNV, syphilis, CMV, HTLV, Chagas, Malaria Blood grouping tests for compatible transfusions Bacterial detection systems HIV diagnostics, viral load Device instrument software
8	Significant Outside Interactions- OBRR Blood Products Advisory Committee Scientific Advisory Committee Transcripts and Documents on Web Equivalent to a device Panel Advisory Committee on Blood Safety and Availability Reports to Assistant Secretary for Health, DHHS Can consider cost PHS Blood monthly conference call All PHS agencies (FDA, CDC, NIH) and DOD
9	Update on following Topics Device Review Performance Approval of CBER devices FY ‘05 Inter-Center Activities WNV testing for screening blood donors Critical Path Challenges Future Challenges
10	Initiatives in DETTD to Assure MDUFMA Goals Are Met Training of all personnel in Managed Review Process Reviewers held accountable for adherence to Managed Review Process Quality Assurance of interactive reviews Delineation of accountability and responsibility within DETTD Communication among review staff to assure consistency in reviews
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12	MDUFMA IVD Performance 510(k)s FY 2003 FDA Time Total Time Type n (Days, Avg) (Days, Avg) Cycles Traditional 17* 67.9 79.0 1.35 Abbreviated 1 54.0 54.0 1.00 Special 8 19.9 19.9 1.00 *8 Withdrawn Data as of March 31, 2006. SEs/NSEs Only.
13	MDUFMA IVD Performance 510(k)s FY 2004 FDA Time Total Time Type n (Days, Avg) (Days, Avg) Cycles Traditional 32* 72.0 109.8 1.47 Abbreviated 1 87.0 87.0 1.00 Special 3 27.3 27.3 1.00 *1 Exempt Data as of March 31, 2006. SEs/NSEs Only.
14	MDUFMA IVD Performance 510(k)s FY 2005 FDA Time Total Time Type n (Days, Avg)* (Days, Avg)* Cycles Traditional 19* 74.6 125.3 1.63 Abbreviated 0 -- -- -- Special 3** 39.0 97.7 1.67 1 Withdrawn; 1 Additional Traditional 510(k) is pending. * 1 Additional Special 510(k) is pending. ***Times may increase with completion of pendings. Data as of March 31, 2006. SEs/NSEs Only.
15	MDUFMA IVD Performance 510(k)s FY 2006 FDA Time Total Time Type n (Days, Avg) (Days, Avg) Cycles Traditional 4* 72.0 72.0 1.00 Abbreviated 0 -- -- -- Special 3 23.0 23.0 1.00 3 Additional Traditional 510(k)s are pending. *Times may increase with completion of pendings. Data as of March 31, 2006. SEs/NSEs Only.
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17	Update on following Topics Device Review Performance Approval of CBER devices FY ‘05 Inter-Center Activities WNV testing for screening blood donors Critical Path Challenges Future Challenges
18	Selected 2005-6 Device Approvals Abbott PRISM HBcore for detection of total antibody to hepatitis B core antigen in human serum and plasma Roche COBAS AmpliScreen HBV test for direct detection of HBV DNA in human plasma Gen-Probe Procleix WNV Assay for detection of West Nile Virus RNA in plasma specimens Future device needs and promise: Emerging infectious disease testing Delivery systems for cells, vaccines, gene therapies and more
19	Selected Accomplishments Draft Guidance on Nucleic Acid Testing (NAT) for Human Immunodeficiency Virus Type 1 (HIV-1) and Hepatitis C Virus (HCV): Testing, Product Disposition, and Donor Deferral and Reentry (7/19/05) Guidance on Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection (6/30/05) Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (5/11/05)
20	Update on following Topics Device Review Performance Approval of CBER devices FY ‘05 Inter-Center Activities WNV testing for screening blood donors Critical Path Challenges Future Challenges
21	Device Outreach: Examples Workshops with OIVD IVD Industry and Professional Roundtables Participation in industry conferences and liaison Meetings: AdvaMed, OCRA, AMDM, AABB Recent stakeholders’ meeting Interaction with Blood industry through task forces as liaisons
22	Close cooperation with CDRH/OIVD Annual joint reviewer training update Reviewer “details” and shared team reviews Ongoing liaison to oversight planning meetings such as Total Product Life Cycle (TPLC) initiative Shared approach to future device electronic submissions (e-business)
23	Update on following Topics Device Review Performance Approval of CBER devices FY ‘05 Inter-Center Activities WNV testing for screening blood donors Critical Path Challenges Future Challenges
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27	Summary on WNV and Blood Safety Identification of risk for WNV in the blood safety Initiative of OBRR/CBER call for test development Collaboration between the various sectors: Government, Academia, Industry and Blood establishments FDA actions resulted in interdiction of donations made by asymptomatic donors with confirmed or suspected WNV infections Nationwide implementation of blood screening for WNV under FDA expedite approved INDs
28	Lessons Learned Challenges to industry can be met Interactive cooperation between government, academia, professional organization (AABB task force), device manufacturers and users is feasible and can generate appropriate response to public health crises Information generated in Blood Establishment may have public health value for community intervention
29	Update on following Topics Device Review Performance Approval of CBER devices FY ‘05 Inter-Center Activities WNV testing for screening blood donors Critical Path Challenges Future Challenges
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31	Critical Path Opportunity: Detection of Blood Borne Pathogens Issue Blood safety Need for development of technologies and methodologies that can screen blood donors for a large number of pathogens simultaneously
32	Critical Path Opportunity: Detection of Blood Borne Pathogens, cont. Actions Develop “multiplex” NAT and DNA microarrays for blood donor screening Develop and provide FDA reference panels Outcomes Identify critical parameters for assay development Standardized panels used as a target for industry and to assess different assays Proof of concept for novel assay development
33	Microarray for Detection of Blood-borne and BT Pathogens
34	Update on following Topics Device Review Performance Approval of CBER devices FY ‘05 Inter-Center Activities WNV testing for screening blood donors Critical Path Challenges Future Challenges
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36	FIVE LAYERS OF BLOOD SAFETY FDA’s approach is to optimize each safety layer: Donor screening and deferral based on geographic, behavioral and medical risk factors (donor education, self deferral, donor interview) Laboratory testing and deferral (HIV-1, HIV-2, HBV, HCV, HTLV-I, HTLV-II, WNV, syphilis) Deferral registries to prevent use of blood from deferred donors Quarantine controls to prevent unit release pending verification of donor suitability Investigation and correction of deviations
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42	Approaches to Protect the Blood Supply from Transfusion Transmitted Malaria Workshop to be held on July 12, 2006 Discuss the scientific issues for future policy development
43	Current Considerations There is no licensed blood screening test to detect malaria infection in donor blood TTM is prevented by donor deferral policies Incidents of TTM is all time low The biggest down side of donor based prevention is the loss of approximately 150, 000 blood donors Is a blood screening test needed to further reduce the risk of TTM and minimize the donor loss?
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45	"Thank you for your attention" Thank you for your attention