Partnering with Academia and the NHS in Translational Medicine Pauline Williams Head of Academic Discovery Performance Unit GlaxoSmithKline

Imperatives for the pharma industry Develop medicines that meet unmet medical need De-risk development Make good decisions earlier Reduce time and cost of development Leads to a desire to work increasingly in partnership with academia and the NHS – a real opportunity for the UK

Shifting pendulum of clinical research: Source : Centre for Medicines Research. © CMR, a Thomson Reuters business North America 41% > 36% Latin America 3% > 7% Asia Pacific 2% > 10% EU Non-Core 8% > 21% EU Accession 4% > 8% Middle East & Africa 2% > 3% United Kingdom 6% > 2% Percentage of Subjects Randomized by Region for Industry Cohort, 2000 vs Clinical Trial Footprint EU Core 21% > 12%

UK is ranked 18 th in terms of Subjects Randomized in R&D trials in 2008 Globally By Region UK By Therapy Area

UK clinical trial performance – based on GSK experience: Percentage of Sites w/ 0 or 1 Subject Randomized (UK = 100) Source : GSK Business Performance Analytics | January * E5 incl. UK, Germany, France, Italy & Spain …slower to recruit patients… Slower to initiate trial… Subjects Randomized per Center per Week (UK = 100) … and more sites with 0 or only 1 subject recruited …taking longer to resolve Higher volume of queries per subject… AND, at a higher cost per patient

GSK has more UK-based industry-university collaborations than any other company Birmingham Cambridge Southampton Edinburgh Glasgow Cardiff Dundee Sheffield Leicester GSK currently has 529 active research collaborations ongoing with UK Universities Spread over 50 UK academic institutions Top five UK investments from 2000 to 2005: 1.Imperial 2.Cambridge 3.UCL 4.KCL 5.Oxford Newcastle Durham Leeds Ulster Belfast York Hull Nottingham Loughborough Warwick Manchester Liverpool Buckingham Oxford Reading Hertfordshire Essex Canterbury Brighton Portsmouth Surrey Bristol Exeter Bath Lancaster Bradford Cranfield Ipswich

Strategic intent to derive ~50% of new GSK medicines from external partnerships Virtualization of Drug Discovery External Resources Internal Resources CEDDs Pharma Centralized Control/Management De-Centralized Control/Management CEEDD model

UK remains an attractive centre for translational medicine investment World-class clinical science –Experts in their fields –High density health research –Access to state-of-the-art technology Governmental and Institutional support –OSCHR / TMB –Cooksey review, Darzi report, AMS and RCP reports Quality –Well-phenotyped patient cohorts –Coordinated recruitment –Motivated and dedicated investigators

The Golden Age? Biomedical Research Centres Academic Health Science Centres Global Medical Excellence Cluster

New Ideas, New Ways of Working, New Medicines COMMON GOALS Royal College of Physicians: Innovating for Health Patients, physicians, the pharmaceutical industry and the NHS Report of a working party February 2009

The Academic Discovery Performance Unit ACADEMIC INCUBATOR PROJECTS Innovative and flexible plans to: Drive experimental medicine into the critical path Exploit the full potential of the asset Focus on the key scientific question Quality of thought of Academics who are leaders in their field GSK’s drug development expertise applied with a light touch Greater ownership Define the strategy Integral to the project-team Committed time Exposure to risk Greater transparency Refine the strategy Flexible support Consistent and maintained oversight Share reward High Quality Assets

GSK has unique facilities to support Incubator projects Clinical Unit Cambridge, Addenbrooke’s Hospital Wellcome Trust Translational Medicine Trainees Clinical Imaging Centre, Hammersmith Hospital F2 Trainees

Opthiris: A Virtual Discovery Performance Unit Academic strategic collaborations –UCL Institute of Ophthalmology –US-based Institutions Academic Incubators Biotech “option” deals CROs Ophthiris/ GSK CRO/ Public Clinical Devel. Vehicle External Academic Scientific Collaborations External Corporate Collaborations –Medicines –Delivery

Full and timely disclosure from academia? “Brainy Gail's winning University Challenge team disqualified for fielding a ringer ” Daily Mail 2 nd March 2009

A New Age, A New Charter Commit to publish results of all studies – positive and negative Cap and publish payments to healthcare professionals Enable access to tool compounds Create shared and revolving door appointments Give access to Industry labs and projects for training, at multiple stage of a clinician scientist’s career Explore new models of shared risk, shared reward, IP pools etc. Recognise industry partners as credible and equal scientific and clinical partners Move away from perception of industry as solely a source of financial support Incentivise doctors to take part in research Engage with industry as training partners Exploit the synergies and collective excellence across academic institutions Accept a level of risk in return for longer term reward INDUSTRY NHS / ACADEMIA

Summary Innovative medicines are required to meet unmet clinical need but the scientific, regulatory and commercial hurdles are getting higher To be successful in taking new medicines into the clinic we need to change the way we work Collaboration is not driven by proximity and patriotism but by: –high quality science and medicine, –tailored infrastructure –receptive, responsive culture The UK is well-placed to deliver these