day one | day two

Day One2 December 2008 08:30 Delegate registration 08:55 Chairman's introduction Professor Ian Wilson, Senior Principal Scientist, AstraZeneca UK 09:00 DRUG REPOSITIONING STRATEGIES THROUGHOUT THE PRODUCT PORTFOLIO Fully exploiting potential from development candidates and reviving old compounds for new indications Identifying and validating new indications for compounds in the Pfizer development pipeline Systematically exploring the biology of compounds in disease models across multiple indications Maximising chances of success in clinical trials Opportunities, challenges, and lessons learned in the first year of the Indications Discovery Unit Dr. Dean Welsch, Research Fellow, Indications Discovery Unit, Pfizer Global Research and Development USA 09:30 DEVELOPING AN IMPROVED IN VITRO SYSTEM TO PREDICT DRUG-INDUCED LIVER INJURY IN MAN Why are preclinical models often not predictive of chronic liver pathologies in man? Idiosyncratic vs. iatrogenic liver injury Identifying susceptible populations - gender and ethnicity as risk factors for DILI Need for biomarkers of safety and efficacy Encompassing multiple mechanisms of DILI in an in vitro system Professor Jürgen Borlak, Director, Fraunhofer Institute of Toxicology and Experimental Medicine Germany 10:00 Pre-scheduled one-to-one meetings 11:20 MOVING TOWARDS COLLABORATIVE PHARMA INDUSTRY - ACADEMIC COLLABORATIONS: BRIDGING TWO WORLDS FOR MUTUAL BENEFIT Capitalising on complementary research strengths to address differing needs Understanding the different drivers between industry and academia, capitalising on the synergies to build mutually beneficial alliances Doing the deal - where are the hurdles? How we can move beyond these to maintain a vibrant research base? Effectively managing alliances to make the most of your investments Samantha O' Connor, Director, Worldwide Business Development, Pfizer Ltd UK   TOXICITY NEW STRATEGIES TO IDENTIFY SAFETY LIABILITIES EARLY Complementing in vivo studies with in vitro and in silico toxicity analysis Building a testing strategy from target assessment to lead compound optimisation and long-term exposure studies Devising testing paradigms to support science-based decisions, targeted to the molecule under consideration Assessing compounds with in silico and in vitro studies to refine required in vivo studies Focusing in vivo evaluations to the relevant questions - reducing in vivo animal and human testing Professor Theodor W. Guentert , Senior Vice President Global Non-Clinical Safety , F. Hoffmann-La Roche Ltd Switzerland   12:00 CREATING A COLLABORATIVE PHARMA MODEL - BENEFITING FROM A NETWORK OF MINDS Collaboration for innovation Developing business through collaboration Benefiting from internal knowledge and external expertise A collaborative approach to expanding pipelines and improving the chances for business success From collaboration to mergers & acquisitions - exploring the spectrum Dr. Bruce Pratt, VP, Science Development, Genzyme Corporation USA   IDENTIFYING HUMAN DRUG METABOLITES FOR TOXICITY TESTING - METABOLITES IN THE MIST Understanding and responding to FDA guidance on safety testing of drug metabolites Implementing identification of human drug metabolites earlier in development Generating critical metabolite data from in vitro human models and in vivo studies Which situations require further toxicity testing of drug metabolites? Performing early clinical studies to identify disproportionate drug metabolites - avoiding development and marketing delays Professor Ian Wilson, Senior Principal Scientist, AstraZeneca UK   12:40 Networking luncheon 13:50 OUTSOURCING MEDICINAL CHEMISTRY TO ASIA Developing strategic research partnerships Tapping in to the chemistry talent pool in Asia Increasing capacity by working globally Identifying a partner to complement in house expertise Moving towards fully integrated drug discovery services Dr. Frederik Deroose, Head, External Collaborations & Outsourcing Services, Johnson & Johnson Pharmaceutical Research & Development Belgium   PREDICTING DRUG PROMISCUITY In vitro Safety Pharmacology Profiling: an essential tool to reduce late attrition Broad-scale in vitro pharmacology profiling of NCE's to predict clinical adverse effects Implementing a large number of assays based on modern, inexpensive technologies and rapidly expanding knowledge In vitro assays and in silico tools focusing on toxicology and bioavailability provide a powerful tool to aid drug development Dr. Jacques Hamon, Head, In Vitro Safety Pharmacology Profiling, Novartis Institutes for BioMedical Research Switzerland   14:30 Pre-scheduled one-to-one meetings 16:15 COLLABORATION WORKSHOP CHALLENGES FOR MEDICINAL CHEMISTS IN SUCCESSFUL AND EFFECTIVE COLLABORATIONS AND PARTNERSHIPS IN DRUG DISCOVERY Creating a "one-stop-shop": keeping a "speciality-focused" provider competence whilst enlarging the technology platform Anticipating potential liabilities by using a complete package of ADMET/PK profiling capabilities The "NiKem-hybrid" business model: a viable alternative to decrease costs and avoid leakage of confidential information, while maintaining high quality and productivity Dr. Giuseppe Giardina, Chief Executive Officer, NiKem Research Italy   TOXICITY WORKSHOP ALTERNATIVE MODELS FOR TOXICITY TESTING: ZEBRAFISH Developing Cardiotoxicity screening in zebrafish Implementing the 3R’s – refining, replacing and reducing animal use in toxicity screening Benefiting from genetic and structural similarities of zebrafish and humans Designing and conducting in vivo studies to allow evaluation of parent substance and metabolites, and enable estimation of safety margins Dr. Carles Callol, Scientific Director, Biobide SL Spain   17:15 BIO-IMAGING WORKSHOP MOLECULAR IMAGING IN DRUG DEVELOPMENT USING HIGH RESOLUTION NanoSPECT/CT Fundamentals of high resolution, high sensitivity pre-clinical imaging Fundamental differences between SPECT and PET Benefits and complimentary nature of SPECT and PET Infrastructural requirements for the use of SPECT and PET Preferential phases and tasks for the use of SPECT and PET in the drug development process Challenges and solutions in data analysis Professor Jeffrey Norenberg, Director Radiopharmaceutical Sciences, University of New Mexico USA   DRUG DESIGN DESIGNING MULTI-TARGET DRUGS TO IMPROVE SPECIFICITY AND EFFICACY A superior antipsychotic: rational design or irrational dream? Case study: Rational design of antipsychotic drugs Analysis of existing antipsychotic drugs and highlighting their complex receptor profiles Proposing which receptors are important for efficacy and which contribute only to side effects Highlighting the complexity of multi-target drug discovery Discussion of approach around one chemical series culminating in a compound with the desired receptor profile and activity in vivo Dr. Andrew Payne, Senior Medicinal Chemist, Neurosciences Centre of Excellence for Drug Discovery, GlaxoSmithKline UK   18:15 DRUG PRICING AND REIMBURSEMENT When should companies start considering whether their drug will be reimbursed? Implications of the current reimbursement environment for drug discovery and development Differentiating drugs for the same indication Ensuring drug cost-effectiveness for success in the market Professor Mondher Toumi, Chief Scientific Officer, Creativ-Ceutical SA France 18:45 Chairman's closing remarks and drinks reception

day one | day two

Day Two3 December 2008 08:30 Delegate registration 08:55 Chairman's introduction Dr. Jinghai Xu, Director, Automated Biotechnology, Merck & Co. USA 09:00 BRINGING SPEED AND SURVIVAL TO DRUG DISCOVERY AND DEVELOPMENT THROUGH CONTINUOUS IMPROVEMENT Encouraging innovation throughout the discovery and development process Implementing a sustainable culture change to improve efficiency in R&D Motivating scientists through champions who see a need to change Remodelling the R&D process – benefiting from increased data generated early in the process for efficient decision making Dr. Andrew Seddon, Senior Director, Strategic Management Group, Pfizer Global Research & Development USA 09:30 APPLICATIONS OF SYSTEMS BIOLOGY IN TARGET IDENTIFICATION AND TOXICITY SCREENING Using a new perspective to study complex interactions in biological systems Integrated analysis of Mining, Modelling, Manipulation, and Measurements Addressing major issues in drug efficacy and safety Case-study: applications of systems biology in atherosclerosis and drug-induced liver injury Dr. Jinghai Xu, Director, Automated Biotechnology, Merck & Co. USA 10:00 IS THE FUTURE OF PHARMA IN PERSONALISED MEDICINE? Companion diagnostics and biomarkers Developing companion diagnostics alongside therapeutics Improving the chances of drug success through targeting of patients most likely to derive benefit Implications for the future of pharmaceutical and diagnostic strategies Dr. Thomas Metcalfe, Global Head, Personalized Healthcare Portfolio , F. Hoffmann-La Roche Ltd Switzerland 10:30 Morning refreshments 11:00 SCREENING HCS VS HTS – DEVELOPING A COMPLEMENTARY DRUG DISCOVERY MODEL Combining the strengths of HTS with HCS – maximising the use of data Phenotypic screening: a complementary drug discovery paradigm Interrogating complex biological systems with cell based assays Direct identification of cell active compounds with phenotypic drug discovery Setting up strategic phenotypic drug discovery assays at Eli Lilly & Co. Dr. Jonathan Lee, Senior Research Advisor, Quantitative Biology, Eli Lilly & Co. USA   EXPLOITING NEW MODALITIES BEYOND MONOCLONAL ANTIBODIES A future in fragments? Therapeutic potential of Fabs, scFvs, engineered variants and alternative scaffolds Clinical development of antibody fragments Advantages and disadvantages of fragments vs. whole antibodies Future perspectives Dr. Andy Popplewell, Director, V-Region Discovery & Engineering, UCB Celltech UK   11:40 THE INDUSTRIALISATION OF CELLULAR SCREENING Case-study: Aequorin assays for high-throughput screening and structure–activity relationship Improving assay consistency and reducing the costs associated with cell-based screening Adoption of automated methods of cell culture or the use of cryopreserved cells to reduce biological variability Transfer of knowledge from the manufacturing industry to the research environment to mimimise assay failure Dr Michael Allen , Screening and Compound Profiling Department, GlaxoSmithKline UK   STREAMLINING BIOPRODUCTION R&D Optimising development steps to speed proteins to market Optimising resources and capacities to accommodate high-throughput development Integrating in-licensed early projects towards fast clinical proof-of-concept and beyond Achieving successful technology transfers within the organisation Insourcing and outsourcing strategies Dr. Berthold Bödeker, Head, Cell Culture and Pilot Plants, Global Drug Discovery - Biotech Development , Bayer HealthCare AG Germany   12:20 Themed luncheon discussions 13:50 MEDICINAL CHEMISTRY STRUCTURE-BASED DRUG DISCOVERY: FROM FRAGMENT TO CLINICAL CANDIDATE Case study - building success from fragments Utilising high-throughput x-ray crystallography and NMR screening for fragment identification Growing mM fragments into nM leads using structure based design Overview of the technology and its application within the industry Successful development of a novel kinase inhibitor for oncology and progression into clinical trials Dr. Andrew Woodhead, Associate Director, Chemistry, Astex Therapeutics UK   INFORMATICS HIT EXPLOSION POST HIGH THROUGHPUT SCREENING Capitalising on HTS output within a resource limited environment Computational approaches to aid lead generation Compound selection for generating SAR data Searching for back up series to promote success in discovery Dr. Nicola Richmond, Principal Scientist, Computational Chemistry and Informatics, GlaxoSmithKline UK   14:30 TACKLING THE THREAT OF COMPOUND-RELATED TOXICOLOGICAL ATTRITION IN MEDICINAL CHEMISTRY Drug properties and attrition Analysis of drugs and compounds that have attrited/shown tox. effects Property trends - for target class activity & toxicity Use of biological fingerprints as a better descriptor than structure/chemotype Dr. Jonathan Mason, Chief Scientist, Predictive Technologies & Drug Design, Lundbeck Research Denmark 15:00 STREAMLINING PROCESSES IN DISCOVERY AND DEVELOPMENT Case study – A novel application of Lean Six Sigma (LSS) to rat PK processes in the discovery DMPK department at AstraZeneca Identifying and resolving process blockers in DMPK to speed progression into lead optimisation projects Simplifying decision making in lead optimisation projects to generate candidate drugs of higher quality more quickly Accelerating drugs through development by preventing hold ups due to lack of PK data Immediate and sustainable improvements in PK process times following LSS implementation Clare Hammond, Senior Scientist, AstraZeneca UK 15:30 Chairman's closing remarks and close of conference