By: Meenakshi L --
23 April, 2015
Toxicology the study of poisons, determines whether a drug can be used on humans. Almost 30% of clinical trial attritions are attributed to the toxicological profile of a molecule. The patent cliff's drying pipelines are driving the fail early and are failing safe practices in the drug development process. One such measure is discovery toxicology, also referred to as exploratory toxicology. Discovery toxicology involves determining the toxicology, as well as safety pharmacology profiles of the molecule, during the discovery stage (before lead optimization). It involves both in vitro as well as in vivo testing, and predictive modeling. Discovery toxicology, hitherto considered core, is being outsourced by the large pharma in bits and pieces owing to lack of efficiency in-house. Service providers, on the other hand, are preparing themselves in both capabilities and capacities to meet this demand. The process of drug development is a prolonged and strenuous affair; and is not just capital, but risk intensive as well. The industry benchmarks cost of drug development at USD 1 billion. The patent cliff and drying pipelines have placed a deep scrutiny into the productivity of R&D. This resulted in a spate of rescue measures from large pharma companies to increase cost efficiencies through major restructuring, increased focus on late stage assets and reliance on external sources for innovation, among others. An analysis shows that almost 30% of clinical stage attritions are due to toxicology profile. The recent recall of Omontys for anaphylactic reactions serves a sad reminder of this fact. Additionally, pharma companies are adopting an early fail strategy to weed out molecules that might have high risk to benefit ratio. This has fuelled demand for investigative discovery toxicology services.