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Proceedings
Day 1 - Tuesday, October 19, 2004
Overview
Objectives/Format/Opening Remarks
Program Co-Chairs:Steven A. Hofstadler, Ibis Therapeutics;
Mark Sanders, Brisol-Myers Squibb
Plenary
Quantitative and Ultra-sensitive High Throughput Proteomics
Richard D. Smith, Pacific Northwest National Laboratory
Biomarkers - Initiatives, Perspectives & Approaches
Discussion Leaders: Bradley Ackermann, Eli Lilly and Company;
Sushmita M. Roy, SurroMed
This session will initiate a dialogue on biomarker discovery and evaluation,
setting the stage for two subsequent sessions which explore these topics in
greater detail. Two distinguished speakers will share their experience and
vision for how biomarker strategies and current technology can be deployed to
optimize the discovery and development of novel therapeutic agents.
An Industrial Perspective on Biomarker Research: One Approach Taken
Stanley Hefta, Bristol-Myers Squibb
Biomarkers of Oxidative Stress
Ian Blair, University of Pennsylvania
Roundtables - How Do We Set Priorities in Drug Discovery and Development?
Discussion Leader: Mike S. Lee, Milestone Development Services
Setting priorities is critical for successful research and the accomplishment
of specific goals. Increased workloads and aggressive timelines make the task
of prioritization both challenging and difficult. This informal session will
highlight current industry perspectives and practices for setting priorities
within drug discovery and development. Recent experiences with “how” actual
priorities are set will be discussed from an analytical perspective. The goal
will be to identify and recommend key elements that are necessary to achieve
goals and foster successful collaborations.
Bradley Ackermann, Eli Lilly and Company
Edward Brewer, Tandem Labs
Chandra Natarajan, Sanofi Aventis
Steve Unger, Bristol-Myers Squibb
Outsourcing Trends - Emerging Business Models & Overseas Partners
Discussion Leader: Roger Hayes, Schering Plough Research Institute
The industry for the outsourcing of bioanalytical analysis from the pharmaceutical
sector has been an arena of considerable change in recent years. Riding the
crests and troughs of its R&D partners, the 1990s were a time of great growth
for the outsourcing sector, but in a climate of weak pipelines, uncertain future
of blockbuster drug candidates, and reduced pharmaceutical R&D budgets this sector
has been required to reassess its operational strategies. This session will
initiate a dialogue on outsourcing strategies and explore this topic from two
perspectives - "Big Pharma" and Contract Research Organizations.
The Impact of Value Enhancement Initiatives to Outsourcing Strategies
Roger Hayes, Schering Plough Research Institute
Outsourcing and Offshoring DMPK Studies - The Pros and Cons
Zamas Lam, Quest Pharmaceutical Services
Cost Benefit Analysis
Mickey O'Brien, Tandem Labs
High Throughput Analysis & Information Management Strategies
Discussion Leader: Eric A. Milgram, Advanced Chemistry Development
The purpose of this session will be to examine the challenges that arise
due to operating in a high-throughput mode and to look at some solutions
that have been developed to meet those challenges. For example, all
high-throughput groups must develop solutions for keeping track of the
large numbers of samples coming through the laboratory, developing generic
sample treatment and analysis methods, and automating data collection and
processing. Also, data quality standards have to be implemented with a
tradeoff between minimizing the number of data items that a human must
examine and maximizing the confidence of the results for the purpose of making
a business decision. Most groups use a combination of both commercial and
in-house developed hardware and software.
Flexible Automation Tools for Drug Metabolism: Workstation and Fully Automated
Approaches for in vitro and PK Studies
Tom Lloyd, H. Kandoussi and R. Talaat, Wyeth
Automatic Reduction of Analytical Data System
Kenneth Lewis, Eli Lilly and Company
High-Throughput LC-MS – A Total Package
Manish Soni, Aventis Pharmaceuticals
Vendor Session:
Discussion Leader: Kathleen Anderson, Novatia
The vendor sessions provided a unique opportunity for the exhibitors to directly
respond to industry updates on specific issues and needs that were delineated in
the symposia sessions. This year, the issues and needs highlighted the balance
between standardization and flexibility with regard to high throughput analysis.
The Tuesday Vendor Session featured presentations on specific areas that deal with
sample preparation, chromatography, analysis, informatics, and specialized
services. Many thanks go to all of the participants for informative and stimulating
presentations!
Asha Oroskar, Orachem Technologies
Jeremy Kenseth, CombiSep, Inc.
Mark Hail, Novatia
Becky Wittrig, Restek Corporation
Kevin Mansfield, Ionalytics
Michael Sabatino, LEAP Technologies
Paul Corcoran, McKinley Scientific
Donna duPont, Eksigent Technologies
Terry Sheehan, Dionex Cooperation
Roy Martin, Waters Corporation
Dragon Vuckovic, IONICS Mass Spectrometry Group, Inc.
Elaine Fukuda, Applied Biosystems
Sau Lan Tang Staats, Phoenix S&T, Inc.
Steve Hobbs, Nanostream
James Jernee, Shimadzu Biotech
Jerry Pappas, Thermo Electron
Gary Valaskovic, New Objective
Poster Session/Social Hour
Chairs: Praveen Balimane, Bristol-Myers Squibb
Manish Soni, Aventis Pharmaceuticals
James Stephenson, Research Triangle Institute
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