Unexpected toxicity is the single greatest cause of pipeline attrition. Despite the fact that a typical preclinical safety program will consume about 1,300 rats and 90 dogs, there is no guarantee that the compound will not present safety problems serious enough to warrant termination.
Outlook for Predictive Safety
Technologies, a CHI Insight Pharma report, surveys the latest developments in discovery-stage and preclinical predictive safety assessment
tools — from in silico methods for lead selection and optimization to high-content cell-based screens, toxicogenomics, tissue proteomics, and advanced animal models. It provides the information and analysis you need to get the best
return — in terms of confidence, cost-benefit, and ease of maintenance and
use — on your preclinical safety technology investments. Specifically, the report delivers:
A comparative assessment of the leading predictive safety technologies, with an emphasis on performance, specific applications in non-clinical testing, and total cost of ownership
Estimates of potential savings in research costs and animal
use — including a case study scenario of cost savings for a mid-sized biopharma company
Adoption rates by
industry — which technologies are attracting resources, and why?
roundtable" where 10 leading safety experts in industry and FDA provide their extended views on key scientific and business issues around predictive safety technologies
A quantitative survey (n=46) of the views, practices, and plans of ADME/Tox researchers in industry and academia presented in easy-to-scan charts
Expert insight into critical issues such as safety challenges presented by large molecule drugs, the implications of
FDA's Exploratory IND Guideline, and timelines to reduced FDA emphasis on animal safety studies
The Relative Predictive Value of Early-Stage Safety Assessment Methods
Source: CHI Insight Pharma Reports © 2006
Nearly half of the respondents to our survey used some sort of predictive safety technology. Other noteworthy trends revealed in our research:
Large companies were more likely to use equipment-intense safety solutions that are easily scalable to the degree of throughput required in large library-based drug development.
The vast majority of respondents believed that early-stage predictive safety testing would result in significant savings, but were skeptical that it would result in reduced animal use.
The pharmaceutical industry is responding to the challenge of moving safety assessments upstream to the discovery and early preclinical stages. However, to fully embrace predictive safety testing in drug development, the industry must understand the
"total cost of ownership," a term that encompasses all the costs involved in acquiring, implementing, maintaining, and using such procedures.
Outlook for Predictive Safety Technologies is designed to help managers understand the range of technologies available, their pros and cons, and to decide on the one best suited to their organization.
About the Author
Hermann A.M. Mucke,
PhD, spent 17 years in academia and industry before he founded H.M. Pharma Consultancy (www.hmpharmacon.com) in 2000 to become an independent pharmaceutical consultant, analyst, and science author. His last industry position was Vice President R&D in a European pharmaceutical company that he helped to take public on the Frankfurt Stock Exchange in 1999. Since then, Dr. Mucke, who holds a PhD in biochemistry from the University of Vienna (Austria), became a consultant and advisory board member for several European and US pharmaceutical companies and a regular reviewer of drugs and patents for Thomson Current Drugs and Ashley Publications. He has served as an outside expert author for CHI since 2004. Dr. Mucke is based in Vienna and can be reached at email@example.com or by fax at +43 1 494 9989.