Vala enables drug developers to identify which lead candidates will cause side effects before in vivo animal testing, virtually eliminating a major cause of wasted time, money and resources.
“Fail Fast” to mitigate the Strain of Attrition Costs
Through our KIC® technology and CyteSeer® software, Vala can achieve in vitro screening predictivity unmatched by other in vitro methods. In fact, Vala’s methods have been demonstrated to be equivalent to in vivo animal testing in some cases.
The objective of Vala’s predictive screening services is to help drug developers statistically rank order their portfolios early in the game, well before they get to the clinic.
Candidates with observed cardiotoxicity or neurotoxicity can be demoted while candidates with excellent safety profiles can move to the top of the list for further screening. In some areas, Vala can also screen for drug efficacy, enabling the industry to remove ineffective candidates before they fruitlessly consume precious resources.
Arrhythmia and Cardiomyopathy are Leading Causes of Post-Approval Drug Withdrawals
Causes of 65 Drugs Withdrawn for Cardiosafety Reasons
Of the 353 medicinal products withdrawn from sale in 1950-2015, cardiovascular, hepatic, and nervous system toxicities accounted for 60% of post-marketing failure. Attrition due to cardiovascular problems (22%) was reported to exceed those of hepatotoxicity (21%) throughout the drug development process (preclinical to marketing/post-approval). Adverse drug reactions from Phase I clinical trials through post-approval due to cardiovascular side effects (16%) exceeded those due to hepatotoxicity (1%).
Recent studies of post-approval drug withdrawals due to cardiovascular safety issues report 74% of such withdrawals were due to primary cardiac toxicities, with 35% caused by arrhythmias, 38% caused by cardiac injury (cardiomyopathy) and 22% due to cardiovascular events (see pie chart).
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