omation mbers - Society for Laboratory Automation and Screening
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omation mbers - Society for Laboratory Automation and Screening

omation mbers - Society for Laboratory Automation and Screening omation mbers - Society for Laboratory Automation and Screening

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11:30 am Thursday, February 5 High Throughput Screening — ADME – Tox Room A2 Alexandra Heinloth NIEHS, 111 Alexander Drive Research Triangle Park, North Carolina 27709 heinloth@niehs.nih.gov The Role of Genomics in Toxicology 56 Co-Author(s) Richard D. Irwin, Gary A. Boorman Paul Nettesheim, Leping Li, Raymond W. Tennant Michael L. Cunningham, Richard S. Paules Traditional toxicology deals with measuring endpoints of toxicity, evaluating one compound at a time in a very time consuming manner. The classic parameters of toxicity evaluated in such efforts are dose and time dependent and rarely allow for predictions of toxicity. One of the main challenges for toxicologists in the 21st century is the identification of highly sensitive and accurate predictive biomarkers for exposure, pharmacological effect and toxicity of environmental hazards. An extremely promising tool to aid in this effort is the genome-wide analysis of gene expression, from which scientists may extrapolate predictive signatures of exposure and effects. This would allow scientists to rapidly classify unknown compounds as being similar to groups of known compounds, thus potentially predicting their beneficial and adverse effects. In order to accomplish this goal we are creating a knowledge base of gene expression patterns. One model substance examined within this enterprise is acetaminophen as a representative compound inducing acute hepatotoxicity. We exposed rats to a wide doserange of acetaminophen (from non-toxic to severely toxic) and examined gene expression responses. We were able to extrapolate gene signatures identified following exposures to non-toxic doses which indicated the potential toxicity of this substance and which were observed to increase in magnitude in progression with increasingly toxic doses. The goal is to develop signatures that can serve as predictive biomarkers in the screening process of unknown compounds for hepatotoxicity. 1:30 pm Thursday, February 5 Drug Discovery Case Studies Room B1 Alexander Alanine F. Hoffmann-La Roche Ltd Grenzacherstrasse 124 Basel, CH-4070 Switzerland alexander.alanine@roche.com Hit and Lead Generation Beyond High Throughput Screening The identification of small molecule modulators of protein function and the process of transforming these into high content lead series are critical activities in modern drug discovery. The key decisions made during this process have far reaching effects down-stream for success in lead optimization and even more critically in clinical development. Recent focus on these activities has been driven by the increasing costs resulting from the high clinical failure rates as well as untapped opportunities emerging from the efforts in functional genomics.

2:00 pm Thursday, February 5 Drug Discovery Case Studies Room B1 Esteban Pombo-Villar Novartis Pharma Ltd. WSJ-386.07.15 Basel, CH-4002 Switzerland esteban.pombo@pharma.novartis.com Alliances in Technology Developments in technology are often the result of formal or informal alliances. Formal alliances to develop a specific technology, such as collaborations, licensing agreements, joint ventures and consortia, can be successful in providing a useful product and some competitive advantage to the parties. These alliances are common in the pharmaceutical industry, for example, where the exclusivity of the product is one of the main drivers of competitive advantage. Another type of process however can be successful in delivering a generally useful technology – this is the case of informal partnerships between potential users and developers. The model used by the software industry, of having a user group to test the beta version of an eventual commercial package. In this case, the needs of a specific market are incorporated into the product design, and together with the commercial motivation of the developer, the final product may be more practical, and in the end deliver more value to the customers. 2:30 pm Thursday, February 5 Drug Discovery Case Studies Room B1 Fred Pritchard MDS Pharma Services 3504 Proprietor Way Raleigh, North Carolina 27612 fred.pritchard@mdsps.com Understanding Risk and Value: Decision Gates in Drug Development Automation has changed the process of drug discovery from managed serendipidy to engineered selection. Nevertheless, the promise of more drugs with high specificity and selectivity, low toxicity and optimal delivery achieving clinical success has not yet met the expections of the pharmaceutical, medical and investment communities. Predicting how a drug will behave in humans prior to clinical testing requires a battery of sophisticated in vitro tests that complement traditional in vivo animal safety assessments. This presentation will describe how to strategically identify which non-clinical studies should be performed to provide the required guidance and comfort to stakeholders involved in clinical drug testing. In addition, key factors that can influence risk and value in the decision process will be addressed. 57 PODIUM ABSTRACTS

2:00 pm Thursday, February 5 Drug Discovery Case Studies Room B1<br />

Esteban Pombo-Villar<br />

Novartis Pharma Ltd.<br />

WSJ-386.07.15<br />

Basel, CH-4002 Switzerl<strong>and</strong><br />

esteban.pombo@pharma.novartis.com<br />

Alliances in Technology<br />

Developments in technology are often the result of <strong>for</strong>mal or in<strong>for</strong>mal alliances. Formal alliances to develop a<br />

specific technology, such as collaborations, licensing agreements, joint ventures <strong>and</strong> consortia, can be successful<br />

in providing a useful product <strong>and</strong> some competitive advantage to the parties. These alliances are common in the<br />

pharmaceutical industry, <strong>for</strong> example, where the exclusivity of the product is one of the main drivers of competitive<br />

advantage. Another type of process however can be successful in delivering a generally useful technology – this<br />

is the case of in<strong>for</strong>mal partnerships between potential users <strong>and</strong> developers. The model used by the software<br />

industry, of having a user group to test the beta version of an eventual commercial package. In this case, the<br />

needs of a specific market are incorporated into the product design, <strong>and</strong> together with the commercial motivation<br />

of the developer, the final product may be more practical, <strong>and</strong> in the end deliver more value to the customers.<br />

2:30 pm Thursday, February 5 Drug Discovery Case Studies Room B1<br />

Fred Pritchard<br />

MDS Pharma Services<br />

3504 Proprietor Way<br />

Raleigh, North Carolina 27612<br />

fred.pritchard@mdsps.com<br />

Underst<strong>and</strong>ing Risk <strong>and</strong> Value: Decision Gates in Drug Development<br />

Aut<strong>omation</strong> has changed the process of drug discovery from managed serendipidy to engineered selection.<br />

Nevertheless, the promise of more drugs with high specificity <strong>and</strong> selectivity, low toxicity <strong>and</strong> optimal delivery<br />

achieving clinical success has not yet met the expections of the pharmaceutical, medical <strong>and</strong> investment<br />

communities. Predicting how a drug will behave in humans prior to clinical testing requires a battery of<br />

sophisticated in vitro tests that complement traditional in vivo animal safety assessments. This presentation will<br />

describe how to strategically identify which non-clinical studies should be per<strong>for</strong>med to provide the required<br />

guidance <strong>and</strong> com<strong>for</strong>t to stakeholders involved in clinical drug testing. In addition, key factors that can influence<br />

risk <strong>and</strong> value in the decision process will be addressed.<br />

57<br />

PODIUM ABSTRACTS

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