Translational Research

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1 Translational Research Paddy Johnston Chair, MRC Translational Research Overview Group October 2012

2 Translational Research Strategy and its delivery To accelerate patient benefit and increase economic impact - and speed uptake in healthcare - included in the MRC s objectives are: To increase the scale and speed of progress from discovery into early clinical evaluation To strengthen R & D in areas which underpin and enable translation, where there are currently bottlenecks To strengthen the quality and scale of infrastructure for translational research To improve progression of innovative interventions into late Phase II and Phase III clinical trials To improve partnership working, and To enhance skills and capacity underpinning all of these areas

3 Translation What is it? Turning discoveries into clinical benefits, while maintaining the basic research that drives it. Basic medical research Prototype discovery and design Pre-clinical development Early clinical trials Late clinical trials The MRC s translational strategy: builds on the MRC s existing role in pushing forward basic knowledge to improve people s health and wealth. strengthens the support and oversight of the translational processes.

4 Translation of basic research takes time 1973 Mouse antibodies isolated by César Milstein and George Köhler (MRC Laboratory of Molecular Biology) 1986 Michael Neuberger and Sir Greg Winter humanise mouse antibodies Sir Greg develops and patents technology for producing antibodies in vitro 2003 MRC-developed Humira licensed to treat UK arthritis patients monoclonal antibody drugs on market for treating breast cancer, leukaemia, asthma, arthritis, psoriasis and transplant rejection 2011 Antibodies make up 1/3 of new drugs for cancer, arthritis and asthma; global antibody market estimated to be worth $40bn

5 Targeting angiogenesis: anti-vegf MoAb Inhibiting antibodies VEG F VEGF recept or Antibodies inhibiting VEGF Soluble VEGF receptors (VEGF-Trap) P P P P Small-molecules inhibiting VEGF receptors (TKIs) Angiogenesis P P TKIs = tyrosine kinase inhibitors

6 MRC translational activities TSB Translational Research Support Developmental Pathway Funding Scheme Developmental Clinical Studies Translational Stem Cell Research Programme NIHR Basic research Prototype discovery and design Pre-clinical development Early clinical trials Late clinical trials Continued commitment to basic lab, clinical and population research Targeted initiatives to alleviate bottlenecks Infrastructure/Resources Methodology Training Capacity building

7 MRC Translational Research Funding Schemes MRC /Astra Zeneca Alliance Experimental Medicine Challenge grants Reviewed through the MRC Boards Separate funding pot - 60M/3yrs Stratified Medicine Initiative Reviewed by bespoke Panels 60M/4yrs Translational Stem Cell Research Committee (TSCRC) Aimed at advancing stem cell research towards clinical use or application Confidence in Concept (CIC) fund

8 MRC Funding Schemes Developmental Pathway Funding Scheme/ Developmental Clinical Studies (DPFS/DCS) Reviewed through the DPFS/DCS Panel Funds pre-clinical development and early clinical testing of novel therapeutics, devices and diagnostics, including repurposing of existing therapies Milestone driven Invested 82m to support over 100 DPFS and DCS studies 10m to develop portfolio to 6 Universities

9 The Biomedical Catalyst UK Life Sciences Strategy announced the creation of a 3 year 180m Biomedical Catalyst programme. (Launched by Prime Minister in December 2011) Aims to deliver growth to the UK life sciences sector through supporting and driving the development of life sciences, with intention; To help grow UK SMEs to become competitive and sustainable To establish the UK as a leading environment for businesses interested in cutting-edge early patient studies To leverage increased investment into UK based innovative medical businesses To increase collaboration between academia and the commercial sector To enable the pull through of academic research into a commercial sector

10 MRC/AstraZeneca: Partnership with AstraZeneca MRC investing 10M in world leading, open innovation collaboration with AstraZeneca. 22 compounds available, representing a variety of targets and mechanisms. Aimed at increasing better understanding of mechanisms of human disease and development of potential therapeutic interventions Transformational in stimulating relationships between academia and industry IP on compounds retained by AstraZeneca; IP arising from research retained by academic institution

11 Experimental Medicine Challenge Grants Encourage ambitious, longer term programmes exploring mechanisms in humans 60m over 3 years - 20m per year one application round per year outline/full applications Challenge-led approach (major questions, high-value awards or particularly innovative approaches) Focus on understanding disease mechanisms (underpins priorities in stratified medicine, translational research) Main body of work must be in human participants

12 Experimental Medicine Challenge Grants Collaborative and multi-disciplinary approaches encouraged Novel approaches encouraged where appropriate Potential for industry links through MICA framework Opportunity to utilise NIHR and charitable clinical research infrastructure Studies should be methodologically and statistically rigorous

13 Stratified medicine Tools Affected population Phenotype/ Clinical Presentation Outputs Disease strata Uses Diagnostics Biomarker validation Rx trials Genetic / Molecular Therapeutic Response Commercial Pharma, biotech, devices Academic

14 Stratified Medicine Initiative Launched in December 2012, the 60m Stratified Medicine Initiative aims to develop disease-specific research consortia, involving industry partners, to exploring mechanisms underpinning disease stratification. 30 outline applications were received by the January 2012 deadline. There were six short-listed applications for full proposals: two in asthma, two in rheumatoid arthritis, one in Gaucher s disease and one in rheumatoid arthritis. Five full applications were received in four disease areas. Partner with funders on the TSB led Stratified Medicine Innovation platform to ensure alignment Funding decision due Autumn 2012.

15 MRC partnerships with NHS EME Programme -Its remit includes evaluations of new treatments, including therapeutics (small molecule and biologic), psychological interventions, public health, diagnostics and medical devices MRC/NIHR Phenome Centre - Funded by the MRC and NIHR (joint 10m grant) and led by Imperial College London and King's College London Uk Biobank - 90m project to collect and disseminate health information (measurements, questionnaire data and biological samples) on 500,000 UK adults between 40 and 69.

16 Research facilities for experimental medicine NIHR Biomedical Research Centres NIHR Biomedical Research Units Health Sciences Scotland partners NISCHR All-Wales Academic Health Science Collaboration (NISCHR AHSC) partners

17 MRC Partnership with Industry The MRC has a variety of funding schemes that encourage researchers to work more closely with industry. Developmental Pathway Funding Scheme/Developmental Clinical Studies MRC/TSB Biomedical Catalyst MRC Industry Collaboration Agreement (MICA) Translational Stem Cell Research Programme (TSCRP) MRC AstraZeneca Alliance

18 Institute of Health Sciences Centre for Public Health Centre for Infection & Immunity Wellcome Clinical Research Facility Centre for Cancer Research & Cell Biology Centre for Vision & Vascular Disease

19 Institute of Health Sciences

20 Centre for Cancer Research & Cell Biology

21 The Centre for Infection and Immunity

22 The Wellcome Wolfson Research Institute

23 QUB Health Sciences Institute CLINICAL / HOSPITAL Basic CCRCB National University Hospita Pathological data Clinical Presentation Therapy & Follow-up

Translational Research The Way Forward Large Science Integrated Biology Program From Genes to man is a medical, scientific, mathematical and partnership challenge

24 Translational Research The Way Forward Large Science Integrated Biology Program From Genes to man is a medical, scientific, mathematical and partnership challenge Clinical Trial Networks Biomedical Centres of excellence. E Health Strong Clinical & Translational Research programmes and networks Acad/Pharma/Biotech Partnerships

26 Training People Skills Enable Scientists to build successful collaborations and make the most of Open Careers between Industry and Academia Industrial CASE Awards m funded by MRC Knowledge Transfer Partnership (KTP1) Postdoc to Academia to Industry Fellowship Partnership Awards Increased Clinical Research Training Fellows and Intermediate Senior Clinical Fellows MRC Clinical Pharmacology and Pathology Fellowship Programmes

Increasing the impact of MRC research

Increasing the impact of MRC research Declan Mulkeen Director, Research Programmes July 2011 Humanised antibodies four decades 1973 Mouse antibodies isolated by César Milstein and George Köhler (MRC Laboratory