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