Rationalizing ADME in the Current Regulatory and Business Environment

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May 1, 2012

Robert Guttendorf, Senior Consultant, DMPK Aclairo Pharmaceutical Development Group

Abstract
The development of new drugs is attended by high cost and even higher risk. Of the new chemical entities (NCE) that emerge from early screens as drug candidates, perhaps 1% may make it to an often highly competitive market. The cost of failure grows dramatically as candidates progress further in the development process. Tremendous savings in time, effort, and expense can be realized by only allowing those compounds with optimized ADME properties to advance into development. This presents various challenges to the ADME scientist. ADME property screening is now an integral component of the drug discovery effort. Failures due to poor pharmacokinetic behavior are decreasing. New challenges are emerging, however. More properties require characterization and in this age of budget constraints, company consolidation, and increased regulatory hurdles, efficiency of ADME modeling needs to improve. Different discovery approaches – high throughput vs. “rational discovery” - require different screening strategies, with experimental tools that are optimally aligned in throughput, accuracy, predictiveness, and resource intensiveness. We are challenged to find accurate in silico and in vitro systems, relevant animal models, and universal tools to predict human pharmacokinetics from preclinical data. As the tools evolve and knowledge is enriched, NCEs being put into development will increasingly have the greatest potential to succeed.

Drug Discovery

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