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Angela Osborne Presentation - Personalised Healthcare Revolution
- 1. Bristol Enterprise Network the Personalised Health Care Revolution Getting to Personalised Health Care 8th October 2009 Clifton Pavilion, Bristol Zoo
- 2. Getting to Personalised Healthcare Agenda • Introduction to Regenerative Medicine • Regenerative Medicine – Manufacturing Challenges • Regenerative Medicine – Star Gazing!!
- 3. Getting to Personalised Health Care INTRODUCTION TO REGENERATIVE MEDICINE
- 4. T cells: Target cancers Fight infection Regulate immune activity Stem Cells: Cardiac repair Neurological repair Organ reconstruction Regenerative medicine replaces or regenerates human cells, tissue or organs, to restore or establish normal function Mason & Dunnill, 2008 Tissue cells: Islet cells in diabetes treatment Hepatocytes in liver disease •Autologous A to A (person specific). •Allogeneic A to B (person specific) or A to many (bulk biopharma) •Cell Therapy / Gene Therapy / Tissue Engineering
- 5. Regenerative Medicine Product Lifecycle Select Small scale Science Development Trials Product manufacture Large scale Approval Purchase Logistics Delivery manufacture Person specific cellular products don’t fit the infrastructure currently in place for traditional pharmaceuticals and biopharmaceuticals
- 6. Getting to Personalised Health Care REGENERATIVE MEDICINE – MANUFACTURING CHALLENGES
- 7. Typical T Cell Process •Research/ Medical equipment •Manual process •2-3 weeks/therapy •Takes space •Beginning to focus on GMP/scale out
- 8. Guy’s Hospital, London Cell Therapy Trials Facility Guy’s Cell Therapy Facility •Location Layout •GMP Processes •Contractors •Funding •Staffing •Where to next? Departments involved: •Nephrology & Transplantation •Oncology •Dermatology •Immunobiology
- 9. KCH Denmark Hill Clinical Research Facility Diversity: •Bone marrow processing •Cell therapies KCH Cell Therapy Unit Layout •Gene therapies •Liver/pancreas cell isolation Departments involved: •Diabetes •Liver Studies •Cardiology •Neurosciences •Haematology
- 10. Getting to Personalised Health Care REGENERATIVE MEDICINE – STAR GAZING
- 11. Regenerative Medicine – Star Gazing!! Patient Gene Diagnostics Interventions Follow-up Mapping Person Direct Gene Bedside Remote Bulk Specific Therapy Autologous Autologous Allogeneic Allogeneic •Autologous A to A (person specific). •Allogeneic A to B (person specific) or A to many (bulk biopharma) Regenerative Medicine Specialist Suppliers: Suppliers: •Diagnostic equipment •R&D •Process equipment •Organs •Raw materials/consumables •Tissues •Assay / QC •Cells •Hospital / bedside equipment •Viral vectors •Logistic providers
- 12. The Regenerative Medicine Journey Future! Now!
- 13. Regenerative Medicine - challenges 2. Select 4. Small scale 1. Science 3. Development 5. Trials Product manufacture •Step change. •Expensive •How to value •Negligible process development or •Global, fast, patient life- manufacturing capacity. broad. time benefit? •Process equipment not developed. •Fragmented •Confused regulatory environment. •Risk. •Skill shortage. 7. Large scale 6. Approval 8. Purchase 9. Logistics 10. Delivery manufacture •No appropriate •Fast, local •More: local, smaller, •Complex •No capacity or contracts / •Low shelf life diagnostic approvals capability at scale. relationships in •Cold chain •Less: longer term process •No supply chain. place. chronic. •Public acceptance?
- 14. Thank you!