GSK R&D. Dr Ashley Bates Discovery Research GlaxoSmithKline Australia. Greenford (UK) Harlow (UK) Stevenage (UK) Verona (ITA) RTP (USA) Tokyo (JPN)

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1 GSK R&D Greenford (UK) Harlow (UK) Stevenage (UK) Verona (ITA) RTP (USA) Upper Providence (USA) Upper Merion (USA) Tokyo (JPN) Dr Ashley Bates Discovery GlaxoSmithKline Australia

2 GlaxoSmithKline at a Glance Sales of almost $30B - In Pharmaceuticals, Vaccines, Consumer Healthcare Over 100,000 employees. - R&D: 15,000 employees, 20 sites, 8 countries, US$3.5B annual investment 5000 Clinical, Regulatory staff in over 50 Countries - An integrated organisation focused on rapid, efficient commercialisation Manufacturing: 35,000 employees, over 100 manufacturing sites in 40 countries - Supplies over 1,100 brands to 140 markets In Treated over 75,000 patients in clinical trials, - filed over 700 Regulatory submissions (NCE + PLEs)

3 R&D Roadmap - an aide memoire Target Selection Find/Create it Make Technical it Candidate Selection Product Development 15 Safety Medical Regulatory Commercial Test it (pre-clinical) Test it (man) Register it Sell it

4 Discovery Safety Medical Commercial R&D Roadmap Full Development Approval III B peri-marketing studies Launch Proof of concept Continuing research into the disease Patents Chemical diversity Packaging and distribution Assessment of and biological assay Transfer to primary and to markets developability Genetics (DGE) secondary manufacture Drug candidate selection Developm,ent of synthesis, formulation Disease target identified and means of production New formulations Chemical and biotechnology research, Quality assurance analytical methods and Technical preliminary formulation Product evelopment Plan TIME Short term toxicology Absorption, distribution, metabolism and elimination Oncogenicity and teratogenicity tests Longer term toxicology IV post-marketing surveillance III New indications efficacy,safety Surrogate II and quality of life markers I patient safetystudies in patients volunteer studies Further registrations studies in new markets Marketing Authorisation Draft Summary of Clinical Trials Applications Applications Product Characteristics Market Communications with customers - Product optimisation Target Product Profile investigators and markets and transfer to market Health Outcomes Pricing and reimbursement Regulatory 10 to 14 Years Some of the many activities undertaken during development of a new medicine

5 Geneticists 15 Biochemists Safety Medical Medicinal Chemists Financial Computational Technical Commercial Target Selection Regulatory Pharmaceutical R&D Mathematicians Biologists Veterinarians Toxicologists lawyers Candidate Selection Physicists Microbiologists Material Engineers Pharmacists Nurses Robotics Pharmacologists Product Development Statisticians Physicians All of the above and more Rocket Scientists Industrial Chemists

6 Ashley Bates B.Sc. Chem: Heriot-Watt U, Edinburgh Ph.D. Physical Chemistry: - Heriot-Watt U, Edinburgh Formulation Scientist: Upjohn England (1 year) Scientist: Upjohn MI USA (6 yrs) R&D Mgt (Pharmacia & Upjohn Perth): Perth, WA - 3 yrs Project Mgr Pharmaceutical Development (GlaxoWellcome): 1 year Head Pharmaceutical Development (GlaxoWellcome) 1year Head Discovery (5 years).

7 The role of Discovery Contribute to GSK R&D by partnership with Australian researchers and innovation Leverage GSKA DR efforts to maximise direct and indirect benefits to the local business Support and encourage a sustainable Australian environment

8 GSK Australia s s involvement in the R&D Process Target Lead Candidate I GlaxoSmithKline Corporate II III File & approval Launch IV GSKA JLMRU Clinical Regulatory Clinical Affairs GSKA Discovery Genetics Drug Discovery Drug Discovery Business Partnering Business Partnering Next Gen Academia Biotech Academia

9 Discovery Australia Activities: Partner of choice activities Brokerage - Proactively seek new research opportunities Local management of existing projects Maximise financial leverage of R&D activity Over 35 projects in 2005 Griffith University University of NSW University of Sydney Garvan Inst of Medical Murdoch University University of WA Woolcock Inst of Med Nat Centre for Immun Evogenix Vic College of Pharmacy CSIRO Baker Heart Institute International Diabetes Institute University of Tasmania Monash Medical Centre Peter MacCallum Cancer Institute Austin Endocrine Centre of Excellence University of Melbourne Alfred Hospital Target Lead Candidate I II III File & approval Launch IV