1. The Realisation of Research Chris Williams Senior Business Manager Mars Bai Legal Affairs Executive Biobanks: The role of UCL Business

2. An Introduction to UCL Business PLC  Most universities have a Technology Transfer office:  Imperial Innovations, Cambridge Enterprise, Isis Innovations (Oxford).  UCLB is a wholly owned subsidiary of UCL:  Our remit is to support the translation and dissemination of UCL research through commercialisation of UCL’s intellectual assets.  Moorfields, GOSH, RFH and UCLH.  UCLB is a commercial entity:  Financially self-sufficient  55 Employees  Profitable  Strong Board with industry expertise  Part of UCL Enterprise

3.  Our remit is to support the translation and dissemination of UCL research through commercialisation of UCL’s intellectual assets.  Four core business aspects  Service to UCL (and others)  Investment – Licensing  Investment – Company creation  Investment – Product development to market An Introduction to UCL Business PLC

4.  Our remit is to support the translation and dissemination of UCL research through commercialisation of UCL’s intellectual assets.  Four core business aspects  Service to UCL (and others) MTAs  Investment – Licensing Commercial Access to Material  Investment – Company creation Abcodia Ltd  Investment – Product development to market Biobanks: the role of UCL Business PLC

5. Material Transfer Agreements Materials transfer agreements (MTAs) govern the transfer of one or more materials from the owner/custodian/authorised licensee to another entity who may wish to use the material for research purposes.

6. Why MTAs? HTA compliance “If human tissue is transferred between establishments given to minimising the likelihood of theft, damage or loss during transport. Some form of formal arrangement, for example, as part of a Material Transfer Agreements (MTA) should define how the human tissue is preserved, any potential contamination risks associated with it and who is responsible for disposal if applicable.” – Section 112, HTA Code of Practice 9 Liabilities Publication Acknowledgement Further information on human tissue transfer: http://www.ucl.ac.uk/slms/research/human-tissue-act Further information on MTAs: http://www.uclb.com/what-we-do/are-you-a-ucl- researcher/material-transfer-agreements

9. Improve efficiency −Avoid negotiation phase −Automate the application and approval process −Cut out paperwork and physical signatures The Realisation of Research Facilitate monitoring and management of agreements −Exportable reporting Attract interest from external organisations

10.  Our remit is to support the translation and dissemination of UCL research through commercialisation of UCL’s intellectual assets.  Four core business aspects  Service to UCL (and others) MTAs  Investment – Licensing Commercial Access to Material  Investment – Company creation Abcodia Ltd  Investment – Product development to market Biobanks: the role of UCL Business PLC

11. Commercial Access to Material Why do industry want to access biobanks:  Biomarker discovery and validation.  Discovery\validation targets for therapeutic intervention.  Screening therapeutics toxicology\efficacy  Access to the wealth of clinical/experimental expertise at UCL and Partner Hospitals. Why should we engage with industry:  Collaborative research / commercial impact.  Income generation to maintain the biobank resource.  Income generation to supplement research.

12. Commercial Access to Material Important considerations:  Permissions  Grant\funder terms and conditions  Value of samples Licensing:  Fee for access  Non-exclusive license to material  Value Add

13.  Our remit is to support the translation and dissemination of UCL research through commercialisation of UCL’s intellectual assets.  Four core business aspects  Service to UCL (and others) MTAs  Investment – Licensing Commercial Access to Material  Investment – Company creation Abcodia Ltd  Investment – Product development to market Biobanks: the role of UCL Business PLC

14. Company Creation  UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS)  Professors Jacobs and Menon UCL IfWH  Incorporated 2010  Licensed in IPRs and pre-existing license  Secured VC-funding alongside UCLB  Winner of four awards in December 2012  Exploitation of a unique cohort of longitudinal serum samples for biomarker discovery and validation

15.  Formed from one of the world’s largest cancer screening studies (UKCTOCS)  Funded by MRC, CRUK, NHS.  Collection from >200,000 female volunteers across the UK  Post-menopausal, free from disease at the start of the collection  Repeat samples collected annually from 50,000 volunteers, for up to 10 years  Total of 5 million aliquots of serum, stored sealed straws in liquid nitrogen at -176C  DNA and protein measurable  Associated Clinical Data  Detailed demographic information, including lifestyle data  Emergent disease incidence, plus family disease history  Cancer: Trachea, Bronchus and Lung, Breast, Ovarian, Colorectal, Pancreatic, Bladder and Liver  Non Cancer : Hypertension, diabetes, Angina, Rheumatoid Arthritis, Osteoarthritis, Parkinson’s, Senile dementia.  Ethics and approval  Volunteer consent and ethics approval in place for commercial use Study Overview

16.  Uniquely allows within-subject experimental designs  Longitudinal measures of molecular change, ahead of emergent disease  Avoids the need to seek ‘matched’ controls, enables improved measures of sensitivity  Use of the large numbers of subjects remaining disease-free to provide statistical power in cross-subject designs  Biomarker Discovery and Validation  Diagnostics, prognostics or at risk screening  Access for industry at commercial rates.  No cost for academic access. Commercial Opportunities

17. Any questions? Chris Williams Senior Business Manager Mars Bai Legal Affairs Executive UCL Business PLC The Network Building 97 Tottenham Court Road London W1T 4TP Tel: 020 7679 9000 Web: www.uclb.com Email: m.bai@uclb.comm.bai@uclb.com Email: c.williams@uclb.comc.williams@uclb.com Further information on HTA: http://www.ucl.ac.uk/slms/research/human- tissue-act Further information on MTAs: http://www.uclb.com/what-we-do/are-you-a-ucl- researcher/material-transfer-agreements Further information on UKCTOS: http://www.instituteforwomenshealth.ucl.ac.uk/ac ademic_research/gynaecologicalcancer/gcrc/ukct ocs Further information on Abcodia: http://www.abcodia.com/