Tissue Access for Patient Benefit Smoothing the pathway between patients, tissue donation, and research Consent Regulation Logistics Processing 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 hepatic neurological urinary other Percentage of human toxicities found in animals Toxicity from: Olson H et al (2000) Reg Tox Pharmacol, 32,

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 Drug-induced constriction Drug-induced dilatation 0 min10 min15 min20 min25 min5 min Blood pressure

If testing in human tissue is so valuable, why is it not used more frequently? Accessing tissue is difficult and expensive Current methods do produce useful information Variable human responses, preference for reproducible animal tests Current methods are accepted; changing this is difficult even if the methods are flawed

Complexity of Accessing Human Tissue

TAPb Background

Process Fresh

Consent and tissue collection Fresh Direct delivery Sample Processing Commercial researchers Academic researchers Clinical trials Fluid Separation Surgical Tissue Collection Viable Cell Cryopreservation DNA & RNA Extraction Flow Cytometry- Functional Assays – NK function 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 Analysis Tissue Supply Pathway Fresh Frozen

Current Status Providing tissue for international clinical trial Supply commercial tissue bank NOW: –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 Question: Are you comfortable with giving your consent for researchers to use your tissue in future research, wherever that may be? No: mainly related to objections to: Defence industry research “Selling” tissue Personal info accessed by third party e.g. insurance companies Speakers and Attendees: UK Parliament MP Patient representatives Patients / public Regulators Commercial researchers NHS Managers Clinical leads Academic researchers

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 Therapy Imaging Clinical Data

Thanks Brian Davidson Barry Fuller Bill Lindsay Stephen Caddick Kirstin Goldring