Abstract
Summary
About $70 million (20%) of the total R&D costs per drug are spent on ADME/Tox failures.
Preclinical toxicity is one of the major bottlenecks in drug development. In
particular, the ability to predict the safety of a drug in the preclinical
stage, prior to human testing, has been one of the major bottlenecks in drug
development. Current approaches have serious limitations in their ability to
predict toxicity in humans, and thus invite substantial risk not only in terms
of patient welfare, but also in terms of the cost of late-stage clinical trial
failure. The integration of novel and traditional approaches to preclinical
toxicity assessment will have a major impact on the ability to predict
compound behavior in humans, reduce clinical trial failure, and cut both risk
and cost in drug development.
Scope
D&MD's Market Analysis Report, Managing Toxicology for the Future:
Improving Predictive Power Through Integrated Technologies, discusses the
critical challenges associated with ADME/Tox testing during pharmaceutical
R&D, including the requirements for:
- New strategies to minimize toxicity-related drug failures aimed at
improving R&D productivity and pharmaceutical risk management.
- Breath of expertise in multiple disciplines to deal with a complex and
fragmented technology landscape, such as "omics" technologies and in silico
approaches.
- Integrative activities that combine new and old approaches to assess drug
safety in a highly regulated and risk-aversive environment.
- Industry-wide collaborative efforts to build the necessary research
infrastructure for toxicology, including toxicology databases and
computational models.
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