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TUESDAY, MAY 13
7:30am – 5:45pm Registration Open
1:55pm Chairperson’s Remarks
2:00 Addressing Metabolic Bioactivation during Lead Optimization
Wei Tang, Ph.D., Department of Drug Metabolism and Pharmacokinetics, Merck Research Laboratories
Formation of reactive metabolites has been thought to represent a causative factor for drug-related adverse effects. This belief is supported by numerous case studies and has become a working hypothesis for industrial scientists whose ultimate goal is to provide the public with effective and safe medicines. The intention of this presentation is to discuss strategies of minimizing metabolic bioactivation in drug discovery.
2:30 Reactive Metabolites and Marketed Drugs: What Is the Evidence and What Are the Consequences?
John C. L. Erve, Ph.D., Principal Research Scientist, Wyeth Research
Among drugs that cause toxicity and have been withdrawn from the market for safety reasons, many have subsequently been shown to generate reactive metabolites. Such observations have associated reactive metabolites with drug toxicity and lead some firms to screen for their presence during early pre-clinical discovery. However, there remain drugs on the market, which also give rise to reactive metabolites. This presentation will examine some currently marketed drugs that generate reactive metabolites, including one with an excellent safety profile, and discuss the implications.
3:00
Drug-drug
Interactions of Human Cytochrome P450s by a New
Electrochemical Array
Gianfranco Gilardi, Ph.D., Research Director,
NanoBioDesign Ltd.
This group has developed a new electrochemical platform
where the main human P450 isoforms and their polymorphic
variants are immobilised on a derivatised gold working
electrode capable of driving catalysis and quantitatively
determine the extent of the turnover measuring Km, Ki, vmax
and their derived parameters such as IC50 and clearance. The
P450 array consists of a 8 well platform with the geometry
and dimensions of a row of a 96 well plate, fully compatible
with the available fluidic systems, with a 3 electrode
system capable of full control over the catalytic turnover
of human P450s. Electrons are injected into the enzyme via a
genetically fused reductase for refined coupling and contact
with the electrode. Validation is carried out with a number
of known targets.
3:30 Technology Watch
(Sponsorship Available)
3:45 Networking Refreshment Break in the Exhibit Hall
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PLENARY KEYNOTE
4:30 Pharmaceutical Research: From Productivity to Sustainability
Charles T. Gombar, Ph.D., Vice President, R&D Strategy & Business Improvement, Wyeth Research
The global pharmaceutical industry is facing new and unprecedented challenges that may alter the framework for how companies operate. For pharmaceutical companies to sustain research and development investments at traditional levels new products must succeed commercially, yet the evolution of the pharmaceutical environment is making commercial success increasingly difficult. Regulatory hurdles have never been higher, reimbursement is difficult to secure, and pressure from generic competition is eroding markets. In this session Charles Gombar, Ph.D., Vice President, R&D Strategy and Business Improvement, Wyeth Research, will present a perspective on the current industry challenges, and a panel of experts representing these major stakeholders will discuss the issues and potential solutions.
5:00 Panel
Discussion: Facing the Challenges in the Pharmaceutical Industry
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How
Pharmaceutical Companies Need to Evolve to Succeed
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Meeting the
Challenges in Licensing, Reimbursement, and Generic Competition
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Regulatory
Issues and Insights
Panelists:
Charles T. Gombar,
Ph.D., Vice President, R&D Strategy & Business Improvement, Wyeth Research
Susan S Allen, MD,MPH, Regulatory and Compliance Consultant, Regulatory and
Compliance Consultants, LLC
William D. Matthews, Ph.D., Vice President of R&D Management Operations,
Johnson and Johnson
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5:30pm End of Day
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