6th Annual Somatic Cell Therapy Symposium Tissue & IND Products

Transcription

1 6th Annual Somatic Cell Therapy Symposium Tissue & IND Products September 27, 2006 D. Michael Strong PhD, BCLD(ABB)

2 Puget Sound Blood Center Northwest Tissue Center 10 Donor Centers Bellevue Central Seattle North Seattle Tukwila Bellingham Everett Lynnwood Olympia Silverdale Vancouver 4 Laboratories Bellevue Central Seattle University District Renton

3 Seattle 921 Terry Avenue Headquarters Administrative Laboratory Services

4 Renton Testing & Tissue Processing

5 Puget Sound Blood Center PRODUCTS AND SERVICES Red Cells 173,618 Plasma FFP 57,398 Recovered 113,375 Platelets WBP 41,591 Apheresis 18,852 Donor Testing* 434,787 Lab Services* 17,750 Transfusion Service 650,115 Patient Services* 4,697 * Tests/procedures performed per year

6 Northwest Tissue Center TISSUE RECOVERY AND PROCESSING Skin 1,245 Fascia 23 Tendons 1,900 Bone 7,000 Heart Valves 46 Stem Cells 90 Cord Blood 1,067 Islet Cells 13

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8 Regulatory Organizational FDA OSHA DOL CLIA Washington NRC Washington Homeland Security IATA International Air Transport Assoc. RCW Revised Code of Washington WAC Washington Administration Code FAA Federal Aviation Association DOT Department of Transportation

9 Regulatory Product INDs Tissue/Cellular Therapy Blood Products Islet Cells / IND on a consultant basis for ITN Cord Blood / IND NMDP, AABB and/or FACT

10 Accreditation / Licensing Organizational Voluntary AABB - Transfusion Activities - Donor Center Activities - Hematopoietic Progenitor Cells (HCP) Activities - Cord Blood Activities - IRL Activities ASHI Non-voluntary EU ZLB Octapharma WA State Pharmacy Board California (CLIA) WMTS WA Medical Test Site

11 Accreditation / Licensing Product Tissue / Cell Therapy AABB Cellular Therapy AATB NMDP Cord Blood State of Illinois State of New York State of California State of Florida Islets / IND JDRF Juvenile Diabetes Research Foundation (Distribution of Islets for Research) ITN Immune Tolerance Network ICR Islet Cell Resource

12 Islet IND Islet Alone IA Sponsor: ITN Immune Tolerance Network Transplant Center: Virginia Mason University of Washington Swedish Medical Center Simultaneous Kidney / Islet - SKI Sponsor: Puget Sound Blood Center Islet After Kidney - IAK Sponsor: Puget Sound Blood Center Transplant Center: Virginia Mason Transplant Center: Swedish Medical Center Site inspection and trial pancreas isolations completed prior to site activation for IND. Laboratory was responsible for processing and documentation of the processing events. Site was inspected by CRO for adherence to protocol.

13 Cord Blood IND Sponsor: National Marrow Donor Program NMDP inspects cord blood banks and transplant centers prior to participation AABB and/or FACT accreditation required Quality Requirements - Sample availability - Donor assessment - Product quality reporting (ie. cell counts, CFU, viability, etc.) 16 participating banks around the country with almost 50,000 units available. 166 transplantation centers affiliated with NMDP are able to receive cord blood. 206 cord blood units shipped in the first half of 2006, 8 of those from PSBC / NTC.

14 Strategies Preparing for an inspection Preparation is never ending!!!!

15 Challenges Differences Frequency AABB once every 2 years AATB once every 3 years FDA once a year alternately between facilities Approach AABB Quality Systems approach Self-assessment tool is sent when standards change (survey) AATB Checklist approach S.T.A.R. Self-assessment Tool / Audit Report (checklist) FDA Guidance approach

16 Strategies Preparing for an inspection OR Against standards & regulations Internal auditing Conduct a gap analysis Measure compliance with existing processes Conduct one year prior to inspection date External auditing Contract independent assessor for pre-assessment Deficiencies Create corrective action plan & timeline Deficiencies from previous inspections are top priority

17 Strategies Preparing for an inspection Scheduling the inspection Understand the scope of the inspection What will they be looking at? Who will be arriving? With what companies are they professionally affiliated? How long do they plan to be there? Is there a list of documents that can be provided on their arrival? Whose coming when?!? With FDA you never know.

18 Strategies In house preparation Designate an inspection team These individuals are liaisons to the investigator Liaisons will be running the show Play the role of scribe and document each day Develop working relationship with the inspector Be knowledgeable of processes, standards, & regulations Know how and who to contact for answers to obscure questions Ensure access to information Review documents prior to providing to inspector

19 Strategies Inform participants and convey expectations Professionalism Short direct answers Don t guess - I don t know. Let me get back to you. - Don t speculate or give personal opinions List of requested documents - Have QA review for completeness and accuracy Stay focused on critical tasks

20 Uh-oh their here!! Stay calm and have faith that trained people will get the job done right!