Predictive ADME and Toxicology Strategies

Summary

Researchers in the pharmaceutical and biotech industry have been developing tools over the years to maximize the efficacy of drugs while minimizing toxicity, and advances have been made. A decade ago, the number of drugs failing preclinically due to poor pharmacokinetics was upwards of 40%, but improved in vitro and animal models have reduced that rate to about 10%. Failures due to ADME and toxicology, however, are still in the 50% to 60% range, making it the number one reason for preclinical attrition. That disparity is likely due to outdated tools, says 'Innovation and Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products,' a white paper published last year by FDA: 'Despite some efforts to develop better methods, most of the tools used for toxicology and human safety testing are decades old. Although traditional animal toxicology has a good track record for ensuring the safety of clinical trial volunteers, it is laborious, time-consuming, requires large quantities of product, and may fail to predict the specific safety problem that ultimately halts development.' The white paper noted that one pharmaceutical company estimated that clinical failures based on liver toxicity cost them more than $2 billion over the last decade. Measuring the ADME/Tox properties early can be one method of minimizing failure. The process of drug discovery and development requires that a drug's behavior in the human body is modelled in other systems before being actually tested in humans. When considering the drug discovery process backwards, certain toxicities must be determined before long-term use is allowed. Prior to this, the correct starting dose for human tests must be estimated. This over simplification illustrates some of the reasons for the processes being analysed with ADME and toxicology for most drugs. This report provides an in-depth analysis of emerging and rapidly growing ADME/Tox screening technologies. The report focuses on emerging technologies, market drivers, restraints, challenges, and provides in-depth company profiles and key market engineering parameters for in vitro and in silico ADME/Tox screening markets.

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