Pharmaceutical R&D Productivity Forum 2008

20th - 21st October 2008

Hyatt San Diego, California

Optimizing R&D pipelines

day one | day two | biomarkers focus day

Day OneOctober 20, 2008
Registration, Coffee & Breakfast
Chairperson's Opening Remarks

Bill Guo, CEO & Chairman , Venturepharm Group
Unveiling new high impact technologies for drug discovery
  • Recent progress in small molecule discovery at Roche
  • Real-life examples of the impact of new computational and high throughput screening tools on discovery development
  • The impact of novel early safety approaches
  • Successful application of increased 3D structural information and novel bioinformatics tools

Dr Hans-Joachim Böhm , Global Head of Chemistry &Center Manager Pharma Research Basel, F. Hoffmann-La Roche Ltd Basel, Switzerland
Achieving Breakthroughs in Therapeutic Research
Next generation biologics: beyond the antibody
  • Brief market overview to update you on current biological R&D activity
  • Explaining key advances in development and production to display the therapeutic potential of biologics for the pharmaceutical industry
  • Forecasting where the next generation of biologics are coming from: indications to reveal the next areas to be targeted

Dr Katherine Call, Global Head, Biotherapeutics Initiative, Sanofi-Aventis
Optimizing the Benefits of Technology & IT Innovation
Comparing and selecting pre-clinical safety and technology strategies
  • Different approaches taken to pre-clinical cardiac safety at Abbott
  • Overview of the role of technology; where it was best suited and where it was misused
  • Revelations from the translation of in vivo through to first "in human" trials

Dr Gary Gintant, Senior Group Leader, Dept of Integrative Pharmacology, Abbott Laboratories
Antibody therapeutics: gaining tactical insights beyond the traditional technologies
  • Revealing how ImmunoGen's focus on a sub-type of "Antibody-Drug Conjugate" [ADC, called "antibody-maytansinoid conjugate" - has resulted in successful delivery of a potent anti-mitotic cytotoxic agent specifically to the cancer cells
  • Review their most high-profiled candidate to date (trastuzumab-DM1); Learn how they "supercharged" Genentech's trastuzumab (Herceptin) with non-traditional technologies
  • Increase your conception of protein therapeutics as this innovative biotech shares knowledge about their emerging approaches and technology

Dr Peter Park, Senior Director, Discovery Research, ImmunoGen, Inc.
Allocating limited resources: leveraging an enterprise wide project and human resources capacity planning methodology.
  • Illustrate how the analysis of schedule variance and resource constraints facilitates well informed and deliberate prioritization decisions
  • Review the steps to build a capability that provides timely and actionable information without over burdening the organization.
  • Discuss specific examples and lessons learned regarding technology, process and change management.

Christopher Beck, Vice President, Global Strategic Planning and Program Management, Shire Pharmaceuticals
Morning Coffee
Panel discussion: is there really such a thing as a generic biologic?
Clarifying, evaluating and forecasting the impact of generic biologics through expert discussion
  • Can different cell lines produce equivalent products? Do biologics need to be evaluated on a product-by-product basis , due to factors such as the potential immunogenicity?
  • Will the interest from Congress toward examining the possibility of establishing new regulations for the approval of generic biologics make them a reality in the near future?
  • If every biologic has to go through such rigorous testing, can we ever see the price reductions associated with traditional generic products?

Steve Swanson, Director of Clinical Immunology, Amgen Inc.
Dr Peter Park, Senior Director, Discovery Research, ImmunoGen, Inc.
Dr Katherine Call, Global Head, Biotherapeutics Initiative, Sanofi-Aventis
The Role of Small-Animal SPECT/CT in Drug Development
  • Detailed discussion of image system performance, SPECT imaging agents & resolution; direct & indirect comparisons to other imaging modalities & results from multiple pre-clinical case studies
  • Examples of practical applications with quantifiable, longitudinal evaluation. Case studies & applications in oncology, cardiology, neurology plus multi-purpose imaging agents
  • A recently developed, on-line SPECT radiopharmaceutical database to expedite the dissemination of commercial and novel imaging agents

Dr Jeffrey P Norenberg, Executive Director, National Association of Nuclear Pharmacies, Associate Director, New Mexico Center for Isotopes in Medicine
Optimizing the Benefits of Technology & IT Innovation
Reliably facilitating information connectivity at a previously unprecedented level of data sharing
  • Establishing an information flow from the research lab that identifies biomarkers, to the clinical care setting where biomarkers are validated, to the clinical research setting where new targeted therapies are evaluated
  • Unveiling a standardized infrastructure of interoperable open-source software tools, databases and grid-enabled computing with wide applicability to many therapeutic areas within drug discovery

Dr Kenneth H Buetow, Chief, Laboratory of Population Genetics, National Cancer Institute, Director, NCI Center for Biomedical Informatics and Information Technology
Hosted Luncheon
Unveiling innovation in RNA therapeutics
  • Gaining a deeper understanding of RNA therapeutics in practice through the practical experiences of an innovative Biotech
  • Benefiting from the real-life "lessons learned" shared in this case study to inform your own RNA therapeutic R&D efforts
  • Learning how this technology may lead to gene based therapies of genetic, inflammatory and metabolic disorders and cancer

Ryszard Kole, Senior Vice President of Discovery Research, AVI Biopharma
Pre-arranged One-to-One meetings
Currently-used assay and screening methodologies and their status in improving the productivity and quality of lead discovery
  • Critical considerations for automated cell culture, assays and screening to eliminate bottle necks and achieve higher efficiency rates
  • Fostering a principle of selective target choice to enable a more pragmatic approach and improve your success rate
  • Strategically progressing platform technologies, such as high-content screening of cellular assays, further into the drug discovery process, to aid productivity

Dr Thomas D Meek, Worldwide Vice-President, Biological Reagents & Assay Development , GlaxoSmithKline
Experts’ pharmacokinetics and toxicology panel: are current technology and investigative toxicology efforts up to the challenge of making a difference to the overall process?
Safety is often the make or break of a new drug or therapeutic – recent media reports into drug safety highlight how vital this aspect of R&D is, but in light of the frequency of these reports, are pre-clinical efforts really impacting positively on success and efficacy?
  • Learn from the experiences and tactics of toxicology R&D experts and pioneers in this leaders panel session on the best practice approaches taken in early toxicity screening
  • Gain knowledge from their ideas of strategies to approach toxicity considerations within R&D stages – working with CROs; different approaches and technologies; vital issues to be addressed
  • Get to grips with best practice ideas for the timing of tox-testing R&D processes to reduce levels of failure
  • Discover the experts thoughts on where the next breakthroughs will come from

Dr Gary Gintant, Senior Group Leader, Dept of Integrative Pharmacology, Abbott Laboratories
Dr Stefan Platz, Vice President and Head of Non-Clinical Safety, Roche Palo Alto LLC
Close of Day One and Networking Drinks Reception

day one | day two | biomarkers focus day

Day TwoOctober 21, 2008
Coffee & Breakfast
Chairman's opening remarks and recap of Day One

Bill Guo, CEO & Chairman , Venturepharm Group
Innovating management strategies to revolutionize R&D: The Eli Lilly Chorus Solution – A rational approach to new product development
  • Hear how the success of Chorus represents the ideal match of an innovation-management problem with development solution
  • Learn why the model is well suited to drug development by reducing risk in an environment where development costs and failure rates are extremely high
  • Understand how Chorus uses just one-tenth of Lilly’s investment in early-stage development, but has recently delivered a substantially greater fraction of the molecules slated for late Phase II trials
  • —at almost twice the speed and less than a third of the cost of the standard process, in some cases shaving 12 to 24 months off the usual development time

Joel C Scherer, MD, Managing Director, Chorus , Eli Lilly & Company
Pre-arranged One-to-One meetings
RNA therapeutics – preparing for unheralded changes on the horizon
  • Informative overview of how RNA is being used as a research tool to understand the complex networks that drive common diseases and to discover new targets and biomarkers to develop novel therapies
  • Insights into both molecular profiling and RNA interference (RNAi) through the utilization of molecular technologies
  • Developing RNAi-based therapeutics to treat diseases in a new way
  • Predictions for the future

Dr Alan Sachs, Vice President, RNA Therapeutics and Molecular Profiling, Merck & Co.
Themed lunch discussions
  • Multi-Plexed Biomarker Solutions: Hosted by BioRad
  • Analyzing next generation multiplex, biomarker driven drug discovery and screening methodologies: Hosted by High Throughput Genomics Inc
  • Important Issues to Consider When Selecting a Chemistry Outsourcing Partner: Hosted by PharmaAgra Labs
  • Integrated drug discovery services: Hosted by Syncom
Cancer stem cells: strategic implications for advancing cancer therapeutics
  • Revealing the need for unique CSC (Cancer Stem Cells) target identification and a deeper understanding of both the biology of normal stem cells and tumor progression in order to meet the challenge
  • Are there any current indications that this targeted approach could be successful?
  • An overview of possibilities including: generating novel targets that could overcome issues of drug resistance, toxicity and improving therapeutic efficacy

Dr Catriona Jamieson, Director, Stem Cell Research Program, Moores UCSD Cancer Center
Personalized medicine strategy panel discussion session
Industry experts discuss key questions and raise examples and experiences to inform your views on the future of personalized medicine
  • Does personalized medicine have a worthwhile ROI for large Pharma?
  • What does the revolution in the personalized space mean for Pharma?
  • The long awaited promise of personalized medicine still hasn’t matured, so can it realistically help drive a more productive pipeline?

Dr Scott D Patterson, Executive Director, Medical Sciences, Amgen Inc.
Dr Bahija Jallal, Vice President, Translational Sciences , MedImmune, Inc.,
Cell-PLoc: a web-server package for predicting protein subcellular localization and its application to drug development
  • Using protein subcellular localization to help understand intricate parthways that regulate biological processes at the cellular level
  • Bridging the gap between the avalanche of protein sequences generated in the Post Genomics Age and the knowledge of their subcellular localization
  • Cell-PLoc is a computational tool developed recently with high expected accuracy and will be presented for many location-unknown proteins with the corresponding results observed

Professor Kuo-Chen Chou, President and Chief Scientist , Gordon Life Science Institute
Chairpersons closing remarks & close of conference

Bill Guo, CEO & Chairman , Venturepharm Group

day one | day two | biomarkers focus day

Day ThreeOctober 22, 2008
An in-depth focus day highlighting the continued importance of biomarker R&D and the realities and potential they hold for R&D productivity improvement: discussing business critical issues and scientific innovation
Delegate Registration, Coffee & Breakfast
Chariman's opening remarks

Bill Guo, CEO & Chairman , Venturepharm Group
Applying new data and improved models to change the industry approach to biomarkers in depression
  • Verifying treatment effects – including safety markers during preclinical and early clinical development
  • Finding an industry consensus – what, how and when we measure to help our understanding of the diseases, and eventually develop more specific treatments
  • Ramifications for R&D strategy in this field

Dr Irina Antonijevic, Director, Translational Research, Lundbeck Research USA
The realities of stratified / personalized medicine: application of a biomarker strategy from Phase 1 to patient selection in a marketed product
  • The application of biomarkers from FIH through to late-stage development and even post-marketing, enables better decisions to be made on the progression of candidate therapeutics. This can be achieved through analysis of direct effects of the candidates on biochemical pathways
  • Knowledge of the pathways that could influence response may also enable the development of patient stratification approaches
  • Application of these approaches and the range of different tools required to execute on this strategy from multiplexed protein arrays, flow cytometric analyses, to sensitive mutational analysis methods will be discussed

Dr Scott D Patterson, Executive Director, Medical Sciences, Amgen Inc.
Networking Coffee Break
Dynamic translation of biomarkers from discovery to clinic: Surmounting validation and safety obstacles
From this case study learn how
  • Creation of a smooth transition from discovery through development and into early clinical trials was achieved
  • Motivational leadership of the process stages was carried out
  • Overcoming practical obstacles and regulatory challenges

Dr Stephen M Hewitt, Clinical Investigator and Chief, Tissue Array Research Program (TARP), Advanced Technology Center, NCI/NIH
Interactive panel discussion: Sharing insights and perspectives on current and emerging biomarker strategy
  • Strategize: predicting how patients will respond to treatment and whether the drug is hitting the target
  • Validate: share perspectives on how this is progressing, what makes a valuable biomarker and what is expected from the FDA
  • Streamline: discuss approaches to streamlining the process of narrowing down hundreds of candidates to the select few and determine viewpoints on when to stop investing
  • Innovate: learn how different companies are approaching their biomarker strategy

Dr Irina Antonijevic, Director, Translational Research, Lundbeck Research USA
Dr Scott D Patterson, Executive Director, Medical Sciences, Amgen Inc.
Dr Stephen M Hewitt, Clinical Investigator and Chief, Tissue Array Research Program (TARP), Advanced Technology Center, NCI/NIH
Buffett Lunch
Afternoon site visit: tour of The Genomics Institute of the Novartis Research Foundation (GNF)

Dr Avi D Spier, Director of Business Development, Novartis Research Foundation (GNF), San Diego, CA

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