| 7.45-8.30am |
Registration |
| 8.30am |
Welcome speech by organiser |
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Introduction by Dr Glyn Stacey, ISCBI Coordinator
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| Developments from October 2007 Bar harbour meeting and remit for Clinical Grade Meeting |
| 8.45-10.45am |
Free communications session with presentations by participants on projects to establish and use stem cell for therapy. All delegates will be invited to submit abstracts on clinical grade stem cell line activity. Representative abstracts of different area of work will be selected for presentations and all abstracts will be invited as poster presentations for delegate contact time at 'breaks'. |
| Break |
|
| 11.00-12.30pm |
Presentations by regulatory bodies and ethics experts on regulatory issues in major and other international regions - invite 4-5 from abstracts primarily selected from submission to ISCF cell banking questionnaire (distributed November 2007) |
| Lunch break |
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| 1.30-3.30pm |
Cell associated risks
Tumorigenicity: issues and assays
- Definitation of tumorigenicity for stem cell lines: use for quality control of undifferentiated cells versus safety testing for differentiated products
- What are the key requirements for QC versus safety tests?
- Challenges with tumorigenicity assays?
- What experimental models are available and which is most useful?
Transforming DNA: issues and assays
- Is there an issue? Review history of use of blood and cell products and 'Biologicals' experience
- What qualified evidence for absence of risk: Is there existing data that demonstracts the level of risk?
- What abut transforming proteins and other cell products that will be present in products?
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| Break |
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| 3.45-5.50pm |
Adventitious agent testing-
Comparison of requirements in different regions: Consensus on minimum and maximum requirements
- Can safety be established by testing alone?
- What are the risks from donor cells, media, surface treatments, other reagencts including purifying antibodies?
- Draft list of important agents
- What are the approaches for research grade cell versus clinical grade?
- How can we rely on a testing result: What process validation and test control is required?
- Is testing all about virology? What principles need to be adopted for: Prions and other organisms?
Basic principles for safety evaluation: Development of a route map?
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| 6.30pm |
Dinner |
| 8.00-10.00am |
Risk reduction strategies
Donor selection:
- What are the geographical issues?
- Value of an international map of endemic microbiological issues?
- Is medical histroy necessary?
- How and when to collect medical histories?
- Media
- Process maps and identifying risks
- How to evaluate source of material and its processing?
- What formal certification mechanisms are available and how good are they?
- What is required for auditing suppliers?
Cell bank quality control and safety testing regiemes:
- What quality standards should be adopted?
- Are there guidelines that already provide suitable models?
- How to utilise 'biologicals' and transplantation regulation in relation to use of stem cell lines
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| Break |
|
| 10.15-12.00pm |
Clinical tralis with stem cell lines: Regional variation in regulation |
| Lunch break |
|
| 1.00-2.30pm |
International transfer of cells: Comparison of requirements
- What are the itnernational regulations that apply to stem cell lines for research and clinical application
- Evaluation of ethical status for transfer of a production process from one region to another
- Mutuality on informed consent?
- What secure transfer can be achieved between international regions?
- What traceability is required?
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| Break |
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| 2.45-4.15pm |
Standardisation of clinical grade stem cell
- What are the key issues for standardisation?
- Key national and international standards?
- What is required for validation of methodologies?
- How can acceptability of a test result be established in more than one country?
- What critical control materials are required?
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| Break |
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| 4.30pm |
Remaining issues or compilation of issues and topics going into a draft guidance document
- What are the critical gaps and how might they be addressed?
- Conclusion: Forward plan for outputs and proposals for further international coordination
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