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Day One26 October 2010 08:25 Chairman's introduction 08:30 Creative Ways to Address Unmet Medical Needs and Business Demands Addressing unmet clinical needs through collaboration, speed and understanding Success and challenges in the indications discovery effort Developing an indications discovery effort Making a commercially attractive business case Orphan drug development - opportunities for wider indications Dean Welsch, Research Fellow, Indications Discovery, Pfizer Global Research & Development USA 09:00 Personalised Health Care Strategies Improving decision making with biomarker discovery and assay development tools Improved decision making with R&D tools for profiling targets, compounds Understanding pathways and mechanisms for patient subpopulations and optimised patient stratification Implementation pharmacodiagnostic development early for increased benefit/risk ratio Companion diagnostics Dr. Gerd Maass, Global Head of Biomarker and Pathway Analysis, Roche Pharma Research and Early Development 09:30 Target Identification and Validation Target validation – the key factor for future success in pharma R&D Translating and establishing operational excellence from the target validation point of view to increase efficacy and profitability during drug discovery Adopting multi layer approaches to discharge any unexpected challenges Exploring new tools and gaining control on gene expression to successfully accomplish a multi disciplinary approach Dr. Lorenz Mayr, Executive Director Unit Head Biology, Protease Platform, Novartis Pharma AG / NIBR Switzerland   Lead Identification and Optimisation Influence of drug like concepts in early decision making Which drug like properties can better influence early decision making to ensure success? Evaluating early portfolios and application of drug discovery processes Probabilistic approaches to filter out poor players and reduce pipeline attrition - extending Lipinksi’s rule of 5 Using ligand efficiency metrics Compound management strategies - reducing lipophilicity and improving safety profiles Dr. Paul Leeson, Director of Medicinal Chemistry, Astra Zeneca UK   Research Alliances and Collaborations Successful lead generation with lucrative research alliances - setting up lean collaborations with biotech and small molecule players Agreeing early licensing deals - sharing risks and rewards Offering free capacity to partners to develop pre-clinical candidate status and developing early alliances Harnessing complementary skills Taking over lead candidates in and at a later stage develop in return for milestone royalties Expanding therapeutic focus and smarter combination for drugs increase likelihood for Dr. Mathias Schmidt., Associate Principal, Head of Early Alliance Team, Nycomed GmbH   Informatics, Data and Knowledge Management Managing the world’s largest Medicine cabinet - enabling technologies to drive the efficiency and effectiveness of the drug discovery process Maximising the value of the Pfizer’s investment in the compound file Effective technologies to store and provision the compound file Making effective changes and investments improve our utilization of the compound file Overcome to implementation challenges Successfully applying continuous Improvement methodologies in this domain Jerry Lanfear, Head of Materials and Data Management World-Wide Research and Development , Pfizer Ltd UK   10:10 New Targets in Inflammation and Metabolic Disorders and Cancer Validating the target for a specific indication How to handle the selection of a specific indication when you have the benefit of working with one of the best examples of a multi-diseases target How to advance few compounds in different indications linked to the same target Dr.Giuseppe Biondi , R&D Director , Angelini-Santa Palomba Research Center Italy   Candidate Development Strategies Targeting transcription factors with small molecules: from the druggable to the undruggable Have we fully explored the chemical space and utilities for small molecules? Exploring new and promising avenues Directing explorations of chemical space towards compounds with the greatest biological relevance Exploring novel chemical space with computational and structural biology Expanding druggable chemical landscapes including target space historically perceived as undruggable Virtual screening partnered with structural biology - X-ray crystallography, nuclear magnetic resonance (NMR) spectroscopy and/or rigorous homology modeling Cheaper, streamlined ways to identify hits and validating leads prior to preclinical and clinical evaluation Dr. Alan C Rigby, Director Program in Drug Discovery and Target Validation,Center for Vascular Biology Research , Harvard Medical School USA   Achieving Clinical Advancement Faster pre-clinical development of a lead compound -achieving clinical advancement Resolving issues quickly for clinical advancement Achieving early decision making Reducing time to clinic Dr. Ming Wang, Director Research, Amgen USA   Lead Discovery Informatics Virtual screening strategies Implementing a lead discovery informatics programme Dr Andreas Bender, Lecturer for Molecular Informatics, University of Cambridge, Unilever Centre for Molecular Science Informatics   10:50 Pre-scheduled one-to-one meetings 12:10 Spectacular Targets for Orphan Diseases and Larger Patient Populations Identifying spectacular targets for orphan disease and larger patient populations Understanding how a chain of genes may be the root of several diseases Ensuring rock solid biochemical rationale at the onset - maximising opportunities for extra indications Identifying molecular similarities and pathways between different diseases Quicker, cheaper innovative new drugs - presenting a commercially attractive business case for parallel drug development Developing valuable antibodies and small molecule drugs Risk reward ratio's - achieving cheaper regulatory filings and extra revenue through repositioning strategies Dr. Georg C. Terstappen PhD, adj. Prof., , University of Siena Italy   Small Molecules and Biologics vs. Sirna, Stem Cells and Gene Therapy Which approach will lead to increased productivities? How can the industry further develop new therapeutic approaches? Balancing between pure outright disruptive technologies and novelty vs. sticking to well proven strategies Exploring the chemical space and utilities for small molecules Dr. Barry Morgan, Vice President, Molecular Discovery Research, GlaxoSmithKline USA Dr. Ron Swanson, Senior Director, Johnson & Johnson USA Dr. Denise Karaoglu , Senior Principle Scientist and Research Fellow, Abbott Laboratories USA Prof. Andreas Baumann, Global Early Development, Bayer Schering Pharma AG, Germany   Understanding Better Pathophysiological Disease Models to Improve Tox Studies Increasing predictivity in toxicological studies Understanding the pathophsiology of human disease states and translating this to animal models Improving the relevance of animal models in pre-clincial toxicology studies Enhancing the chances of successfully predicting clinical adverse effects during pre-clinical development Dr. Josef Scheiber, In Silico Sciences - Bioinformatics, Pharma Research Penzberg , Roche Diagnostics GmbH   Novel Computational Approaches to Biomolecular Knowledge Mining Using new methods to integrate and mine molecular data for translational systems research Combining information from genome-scale experiments Developing visualisation tools for integrative data analysis Leveraging functional annotations and network data Prioritising potential disease and drug targets Dr. Mario Albrecht, Group Leader for Molecular Networks in Medical Bioinformatics , Max Planck Institute for Informatics Germany   12:50 Disease Systems Chemical Biology A way to link drug action and disease susceptibility Prof. Olivier Taboureau, Center for Biological Sequence Analysis, DTU Systems Biology , Technical University of Denmark Denmark   Strategies for Shaping a Screening File for Lead Discovery Dr. Jeremy Everett, Director Medicinal Chemistry,   External Collaboration for Pre-Clinical Development Creating smaller decision making groups and network alliances Breaking down decision making groups Creating different skills and tensions Establishing a network of alliances - emulating small, innovative biotech companies Building and establishing networks Dr. Andrew Parsons, VP Pre-clinical Development, CEED, GSK UK   Using Informatics to Enable Decision Making Cutting and slicing data and delivering consolidated reports throughout the business (Thompson Reuters client case study) Enabling better decision making Dr. Andreas Mattern, ,   13:25 Networking lunch 14:25 Virtual Screening Workshop Virtual high throughput screening to accelerate lead identification and optimisation Optimising the compound library for HTS through in silico modelling - reducing time and resources needed for HTS Improving docking and in silico screening models to improve accuracy of HTS Can virtual screening replace HTS as the standard method of candidate selection? Virtual screening, structural biology, X-ray crystallography, nuclear magnetic resonance (NMR) spectroscopy and rigorous homology modeling   Interactive Workshop Led by Nuevolution Fragment based lead discovery using millions to billions of screening compounds Nuevolution’s proprietary Chemetics® technology brings Fragment Based Lead Discovery to the billion compound library scale using standard laboratory equipment. Tens of thousands of diverse fragments, which are made to react with tens of thousands of fragments provides access to truly diverse libraries that makes the difference for lead discovery. Each compound within a Chemetics® library is linked to a strand of DNA encoding the synthetic history and the chemical structure of the small-molecule. DNA offers a unique opportunity for storage of information and single-molecule detection. In few days, screening libraries comprising hundreds of millions of synthetic molecules may be screened by one person using micrograms of target material and nanograms of library material. The Chemetics® approach to small molecule lead discovery has proved to be successful for multiple types of targets including protein-protein interactions. Alex Haahr Gouliaev, Chief Executive Officer, Nuevolution A/S Denmark   Drug Development Decisions Workshop FDA drug approval packages and drug development decisions: New Avenues for supporting strategic decision-making Albert van der Wal, Senior Product Sales Manager, Elsevier   15:05 Pre-scheduled one-to-one meetings 16:35 Lead Identification: Generating Value, Addressing Attrition Design, synthesis and selection of DNA-encoded small-molecule libraries Using DNA encoding to select hundreds of millions of discrete molecules in a single container with minimal amounts of protein HT sequencing techniques to deconvolute selection output to yield families of ligands and emerging trends of SAR and selectivity before biochemical assay Using rapid and inexpensive routes to the discovery of small-molecule drug leads How does DNA encoding compare to conventional high throughput screening? Achieving favourable process economics Dr. Barry Morgan, Vice President, Molecular Discovery Research, GlaxoSmithKline USA   Transforming Discovery & Development of Human Monoclonal Antibodies SIMPLE ANTIBODY™ technology exploits active immunization of Camelids V regions of conventional Camelid antibodies have high human sequence homology CDRs of these V regions show perfect human structural homology Outbred nature of Camelids provides high diversity of functional antibodies upon immunization with a human disease target Active immunization yields very high affinity antibodies (10E-4 to 10E-5 off rates translating into picomolar affinities / potencies) Dr. Prof. Hans de Haard, Chief Scientific Officer, arGEN-X BV Belgium   Novel Models of Idiosyncratic Toxicity Drug-induced mitochondrial dysfunction yields a novel model of idiosyncratic toxicity Dr. Jim Dykens, Associate Research Fellow, Drug Safety R&D, Pfizer   17:15 Keynote session: Continuous Improvement and Systems Biology Dr. Andrew Seddon, Senior Director Strategic Managment Group, Pfizer Global Research & Development USA 17:50 Chairman's closing remarks and drinks reception

day one | day two

Day Two27 October 2010 08:55 Chairman's opening remarks 09:00 Strategic Portfolios - Balancing Between Small Molecules and Biologics Wisely balancing drug portfolios - evaluating small molecules vs biologics Creating smarter, strategic porfolios Is the grass greener on the biologics side? Have we fully explored the chemical space and the utilities for small molecules? Process improvement in small molecules and biologics New therapeutic approaches Sirna, stem cells and gene therapy Which approaches will lead to an increased productivity? Dr. Neil Weir, Senior Vice President, Global Research, UCB UK 09:30 Stimulating Drug Innovation Dr. Youseff Bennani, VP Drug Innovation, Vertex Pharmaceuticals USA 10:05 Target Identification and Validation Lean gene as a novel target for obesity and type II diabetes treatment How to identify genes associated with a "lean phenotype" · Mutated enteropeptidase – A "twiggy gene" Why mutation within enteropeptidase genes are extremely rare Inactivation of enteropeptidase in mice Inhibitors of enteropeptidase Dr. Itzik Harosh, Founder and CSO, Obe Therapy France   Biologic Drug Discovery Strategies Protein optimisation strategies for biopharmaceuticals Using genetic recombination protein evolution technology Identifying mutations to improve protein properties Generating large DNA libraries expressed in protein libraries and screening assays to detect protein properties Optimised screening in HTS Optimising many types of protein properties including target affinity and selectivity, enzymatic activity and stability Developing strategic collaborations Dr. Eva Dahlen, Discovery Team Leader, Alligator Bioscience Sweden   Pre-Clinical Development Pre-clinical development of biopharmaceuticals - developing custom prepared programmes based on individual compounds Study design and types of non-clinical safety studies -defining an appropriate programs Avoiding non relevant studies with limited predictive value and successful estimating safety risks of biologics in non-clinical development Successful species selection for non-clinical studies with biologics Immunogenicity studies of biologics within nonclinical drug safety Special study types for PK/PD approaches and comparability exercise Bioanalytics of biologics in nonclinical and clinical development Prof. Andreas Baumann, Global Early Development, Bayer Schering Pharma AG, Germany   Informatics and Data Managment Computer-aided drug repurposing - new targets for old drugs Mapping drug-target (D-T) interactions Pairing D-T with desired and unexpected clinical outcomes (DTCOs) Semantic web DTCO data mining - toward computer-aided drug repurposing Dr. Tudor I. Oprea, Professor Biochemistry and Molecular Biology , University of New Mexico School of Medicine USA   10:45 Morning refreshements 11:15 Using PK/PD to Improve the Understanding of Target Engagement Integration of PK/PD modeling and PK prediction in discovery and development Designing target validation studies Design and interpretation of PK/PD studies in lead optimisation Making PK/PD awareness a vital component in relating preclinical results to humans Dr. Jens Sydor, Head of DMPK, Abbott Germany   Fine Tuning Therapeutic Antibodies Improving antibody target competitiveness via isotype and Fc sequence selection design Moving away from the standard IgG1 isotype to develop more “fit for purpose” antibodies and Fc fusion proteins Surrogate antibodies for non-clinical pharmacology and safety studies, isotype selection and functionality Dr. Ron Swanson, Senior Director, Johnson & Johnson USA   Genotox Impurities Addressing the scrutiny on potentially mutagenic impurities Overcoming regulatory constraints Understanding European and US regulations Dr. Andrew Teasdale , Senior QA Executive, Chair of the AZ Genotoxic Impurities Advisory Group , Astra Zeneca UK   Bench to Bedside Informatics as the Foundation for Delivering Tomorrow’s Medicines Using data management and analytics suites to provide domain specific solutions to transform drug discovery, development and clinical trials Biomarker validation and diagnostics development Preclinical development including PK, BioAnalysis and formulation Large molecule scale up and pilot manufacturing Clinical decision support Dr. Paul Denny-Gouldson, Product Manager, IDBS UK   11:55 Target validation for mono - and bi - specific antibodies Case study: Validating IL-18 and other target pairs for bi - specific antibodies Selection of IL-18 as a therapeutic target · Converting the anti-IL-18 mAb into a dual-targeting therapeutic Selection and validation of target pairs for bi-specific antibodies In vitro assays and in vivo models to demonstrate efficacy of bi-specific antibodies Dr. Denise Karaoglu , Senior Principle Scientist and Research Fellow, Abbott Laboratories USA   Next Generation Antibody Therapeutics IgG4 Fab-arm exchange strategies IgG4 antibodies are often used for immunotherapeutic applications in which recruitment of host effector functions is undesired Understanding the dynamic antibody biology behind Fab-arm exchange Showing IgG4 Fab-arm exchange in humans, using the therapeutic antibody natalizumab Discussing consequences for pharmacokinetics and pharmacodynamics of wild-type IgG4 therapeutic antibodies Dr. Janine Schuurman, Associate Director Research, Genmab b.v The Netherlands   Lead Generation and Drug Discovery Platforms Establishing a productive drug discovery engine to generate many lead drugs Using Antisence technology as an efficient tool in drug discovery Rationally design and discover potent and safe RNA targeted drugs Dr. Troels Koch, VP Drug Discovery, Santaris Pharma Denmark   12:35 Themed luncheon discussions 14:05 Valuation of Non-Surrogate Biomarkers The uses of biomarkers in drug development Return on investment for "non-surrogate" biomarkers" Specific biomarkers to answer specific questions Dose selection biomarkers Biormarkers of efficacy Dr. Orest Hurko , Senior Clinical Consultant, Biologics Consulting Group USA   Natural Products Based Discovery Discovering natural products to mimick the functions of AK-1 for cancer & AK-2 for protection against new viral infection Dr. Grace Wong , CEO, ActoKine Therapeutics USA   14:45 Genome Wide Association Studies with Metabolomics. Discovery of genetic determined metabotypes - determining the implications in individualised medicine Development of targeted drugs for steroid-related diseases like breast/prostate-cancer or osteoporosis Prof. Jerzy Adamski, Head of Department Genome Analysis Centre, Institute of Experimental Genetics Germany 15:30 Drug Repositioning Strategies Harnessing new and exising opportunities for successful drug repositioning Concept of drug repositioning –rationale and leading methododologies Opportunities for geographic repositioning - why Russia is an opportunity now? Repositioning examples from Russia and France Challenges, future developments in repositioning and its role within pharmaceutical innovation Prof. Mondher Toumi, CEO, Marco Polo Pharmaceutica France 16:05 Chairman's closing remarks