| Day One2 December
2008 |
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| 08:30 |
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| 08:55 |
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| 09:00 |
DRUG REPOSITIONING STRATEGIES THROUGHOUT THE PRODUCT PORTFOLIO
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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
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| 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
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| 10:00 |
Pre-scheduled one-to-one meetings |
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| 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
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| 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
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| 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
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| 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
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| 12:40 |
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| 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
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| 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
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| 14:30 |
Pre-scheduled one-to-one meetings |
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| 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
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| 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
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| 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
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| DRUG DESIGN |
| DESIGNING MULTI-TARGET DRUGS TO IMPROVE SPECIFICITY AND EFFICACY
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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
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| 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
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| 18:45 |
Chairman's closing remarks and drinks reception |
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