Transcript Tissue Access for Patient Benefit

Tissue Access for Patient Benefit
Smoothing the pathway between patients,
tissue donation, and research
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Consent
Regulation
Logistics
Processing
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Allied Information
Academic Research
Biotech & Pharma
Contracts
One Example of Tissue Need
It is generally agreed that there is a problem
in the ability of the Pharma Industry to
introduce safe, effective new medicines to the
market
Garnier JP (2008) Rebuilding the R&D engine in big pharma. Harvard Business Review., 86, 68-70, 72-6, 128.
Why?
The Current R&D Process
Model Species and Safety / Toxicity Testing
skin
cardiovascular
endocrine
gastrointestinal
haemopoietic
Toxicity
hepatic
neurological
urinary
other
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Percentage of human toxicities found in animals
from: Olson H et al (2000) Reg Tox Pharmacol, 32, 56-67.
100
Uses of Living Human Tissues
• Observe the tissue as it responds to a drug
• Compare the effects of a new drug to an established drug
0 min
5 min
10 min
Drug-induced constriction
Blood pressure
15 min
20 min
25 min
Drug-induced dilatation
Blood pressure
If testing in human tissue is so valuable, why is it
not used more frequently?
• Accessing tissue is difficult and expensive
• Variable human responses, preference for reproducible
animal tests
• Current methods are accepted; changing this is difficult
even if the methods are flawed
• Current methods do produce useful information
Complexity of Accessing Human Tissue
TAPb Background
Process
Tissue Supply Pathway
Consent and tissue collection
Fresh
Commercial researchers
Academic researchers
Clinical trials
Analysis
Fluid Separation
Surgical Tissue Collection
Viable Cell Cryopreservation
DNA & RNA Extraction
Flow CytometryFunctional Assays – NK
function
Fresh Frozen
2D –PAGE
Confocal microscopy
DNA methylation
analysis
Electron microscopy
FPLC
HPLC
Immunochemistry
Live cell imaging
MALDI
Mass Spectrometry
Medical chemistry
NMR
PCR
Protein sequencing
Proteomics
Tissue imaging
Transcriptomics
Long term LN storage
Current Status
• Providing tissue for international clinical trial
• Supply commercial tissue bank
• NOW:
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Royal Free wide generic consent to supply tissue for research
State-of-the-art biobanking
Sample processing and analysis services
Relationships across all major UCLP biobanks and hospitals
Relationships with cutting edge translational research academics
Relationships with NHS services, management and national
therapeutic tissue pathways (NHS BT)
TAPb Patient Links
Speakers and Attendees:
• UK Parliament MP
• Patient representatives
• Patients / public
• Regulators
• Commercial researchers
• NHS Managers
• Clinical leads
• Academic researchers
No: mainly related to objections to:
• Defence industry research
• “Selling” tissue
• Personal info accessed by third
party e.g. insurance companies
Question:
Are you comfortable with giving your
consent for researchers to use your
tissue in future research, wherever
that may be?
No
16%
Yes
84%
Development plan
• RFL model available to other UCLP Hospital
• Integrate with other London tissue suppliers
• Link with other UK Academic Health Science Centres
• European clinical trial partners
• Global biobanking partners
Genomics
Proteomics
Clinical Data
Therapy
Imaging
Thanks
Brian
Davidson
Barry
Fuller
Bill
Lindsay
Stephen
Caddick
Kirstin
Goldring