Improving Predictive Power Through Integrated Technologies

By Mike Silver, PhD and Brigitta Tadmor, PhD

Published: January, 2003

294 Pages, 68 Exhibits, 24 Company Profiles 

About $70 million (20%) of the total R&D costs per drug are spent on ADME/Tox failures.  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. 

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.

> Breadth 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-averse environment.

> Industry-wide collaborative efforts to build the necessary research infrastructure for toxicology, including toxicology databases and computational models. 

This Report will help you:

> Understand the challenges ahead to overcoming the ADME/Tox bottleneck through a clear analysis of the short and long-term opportunities and their impact on pharmaceutical R&D.

> Recognize the need to integrate new and existing ADME/Tox models and testing strategies through a comprehensive review of currently accepted and emerging approaches to toxicology, from traditional animal studies to in vitro and in silico methods.

> Appreciate the imperative for radically new tools and paradigms to improve the predictive power of toxicology models through a detailed discussion of research activities aimed at developing, validating, and applying novel approaches.

> Gain insights into the issues and benefits associated with consortia approaches to toxicology via case studies of those already sharing data, technologies, expertise, and resources.

> Learn about ADME/Tox-related technology and business strategies through a thorough discussion of approaches taken by technology platform and pharmaceutical companies.

Publisher: Drug and Market Development 

To order go to this URL: http://www.bioportfolio.com/cgi-bin/acatalog/DMD_2003.html#a94