1	UK Program Presentation - approach to technology development and commercialization Dominique E. Kleyn, Head of BioPharma Business Development and Dr Cathy J. Tralau-Stewart, Head Drug Discovery Program Imperial College London, South Kensington, London SW7 2AZ, UK
2	Why collaborate?
3	Why Imperial? Global leader in Science, Technology & Medicine World-wide top 10 for academic excellence 1^st in Europe for Technology 3^rd in Europe for Biomedicine and Science Critical mass of activity Total Income >$1 billion Research Income >$400 million Circa 3,000 active research groups Comprehensive portfolio of research Research in all key therapeutic areas Basic and translational approaches Multidisciplinary cross-cutting themes
4	Why now? Increasing trend towards outsourcing in industry Increasing desire and preparedness for translational studies in academia
5	Some specific research interests Identifying and validating targets Biomarkers for safety and efficacy Diagnostic and prognostic assays Patient stratification Clinical studies and patient cohorts Device development Surgical techniques and devices Health systems
6	General research interests at Imperial
7	Summary New networks bring new information Exchanging knowledge Identifying new collaborators New networks bring new opportunities Planning new research avenues (joint publications) Making new discoveries (joint inventions) Exploiting complementary assets (shared revenues)
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9	Translating novel drug targets towards clinical validation at Imperial College London
10	The current Pharma drug discovery model Failing to translate novel targets to clinical validation Hypotheses do not translate Single targets not sufficient to achieve efficacy Screens which do not reflect efficacy in man PK/PD mismatches Poor therapeutic indices leading to sub-optimal dosing Animal disease models misleading The search for the universal cure-all blockbuster with high/ broad market penetration Focusing on known and validated drug targets rather than novel approaches …Pharma need to collaborate with academia
11	But there are basic structural issues “One of the ways to capitalise on new discoveries is to close the gap between academia and industry; there are issues about doing the work that fall between basic research and commercial development.” David Baltimore, President of California Institute of Medicine “the huge concern [is] that many discoveries at the academic level were not translating into treatments available to patients.” Janet Woodcock, FDA Deputy Commissioner
12	An example of success: Anti-TNF Therapy for rheumatoid arthritis
13	The Opportunity……. ‘the existing global pharmacopoeia still only consists of fewer than 1,000 frequently prescribed drugs’ ‘US Pharmacopeia consists of 1,357 unique drugs of which 1,204 are small molecules and 166 are biological entities’ ‘~3,000-10,000 genes that are disease modifying’ ‘~3,000 genes code for ‘druggable’ targets’ ‘current drugs with known mode of action act through only 324 distinct molecular targets’ (ChemBioNews) Thus a small percentage of potential targets fall into the ‘druggable definition’
14	The full value of academic research is not being effectively translated into products
15	Academic drug discovery
16	Drug Discovery Facility
17	Drug Discovery Cycles
18	A novel model for drug discovery An improved model for industry collaboration and translation of innovative concepts The improved exploitation of the wealth of inter-disciplinary research and knowledge within the College The leveraging of more than £200m pa research funding The translation of fundamental and innovative concepts into data sets which appeal to industrial partners The development of projects which fulfil the academic mission
19	DDF ‘Business model’ A core group of industry qualified and experienced drug discovery scientists within the College A ‘virtual biotech-like’ business model co-ordinating and project managing drug discovery projects Co-ordination of projects to a industry recognisable project plans Interacting with College groups, spin-outs and contractors Delivering data sets which Industrial partners will be familiar with Partnering and collaborating with industrial organisations Human clinical validation of novel/ highly novel targets across therapeutic areas
20	Industry expertise in an academic environment DDF Core staff: Dr Cathy Tralau-Stewart, Head of Drug Discovery Programme Ex Associate Director Lead Optimisation pharmacology, Respiratory Inflammation CEDD GSK Dr Albert Jaxa-Chamiec, Head Medicinal Chemistry Ex Director Chemistry Neurosciences CEDD GSK Dr Caroline Low, Head of Molecular Modelling Ex Head Molecular Modelling, James Black Foundation Academics (main): Professor Anthony GM Barrett Professor Philip-Ashton Rickardt Organic Chemistry Immunology Professor Paul Freemont Professor Julia Buckingham Structural Biology Pharmacology Professor Mike Sternberg Professor R Charles Coombes Bioinformatics Oncology Executive Committee: Sir Richard Sykes, Prof Nagy Habib, Dr Colin Wyatt, Prof Paul Freemont, Dr Chris Towler
21	Projects
22	1. DDF Potential Project Portfolio Infection (Malaria, Hep C, Flu, URTIs, resistant bacteria, FMDV (cattle) etc) Oncology (Breast, Prostate, Ovarian, Leukaemias, metastasis etc) CNS (Alzheimer's, Memory, Neuropathy, Pain, Stroke etc) Inflammation (RA, Asthma, Scarring) Others (Diabetes, Anaesthesia etc )
23	2. DDF funded projects Malaria novel target specific for malaria parasite preparing assay for screening Drug resistant bacteria (MRSA) novel target crystal structure complete preparing assay for screening Memory / Alzheimers peptide therapeutic In vivo PoC data novel MoA Breast cancer novel target up-regulated in human breast cancer preparing assay for screening Platinum resistant ovarian cancer novel ‘niche’ target chemical ’leads’ available target validation ongoing
24	3. More advanced projects We are currently starting to support some projects which are more advanced with database searching, compound acquisition, SAR, expertise etc with a view to further investment as appropriate: Anti-inflammatories for rheumatoid arthritis etc Biological for therapy of metastatic breast cancer small molecule program may follow Novel Anaesthetic
25	Partnerships
26	Contact www.imperial.ac.uk Cathy Tralau-Stewart PhD Email : c.tralau@imperial.ac.uk Tel: +44 (0)20 7594 2160