BEN Event - 8th October - 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!