By Ernie Bush
May 24, 2010 | The Bush Doctrine | The Drug Safety Executive Council (DSEC) is a professional community of approximately 1,900 members representing various disciplines within drug safety and over 100 biopharmaceutical companies. DSEC is organized and managed by Cambridge Healthtech Associates (CHA). Each January and February for the past few years, CHA has surveyed DSEC discovery toxicology and preclinical safety members (about 40% of the community) to get the pulse on the industry trends and progression of novel technologies in predictive drug safety. The 2010 survey participants were mainly from Western pharma companies, with the largest percentages from North America (54%) and Europe (31%). Of the participants, 44% represented the Top 20 Pharma companies and over 85% described themselves as either Senior Managers/Directors and/or Senior Scientists/Lab Managers.
Results of the survey show that the most popular types of technologies biopharmaceutical companies are already spending resources to evaluate are:
* High content tox assays or high throughput cell health profiles
* Alternative in vitro assessments of cardiovascular risk
* Toxicity biomarkers
The most common new technologies on which pharmaceutical companies are planning to start their evaluations over next 12 months include:
* Screens that estimate the risk for idiosyncratic liver toxicity
* Platforms that identify toxicity biomarkers
* Technologies for exploring systems toxicology or modeling toxic pathways
* New in vitro assessments of cardiovascular risk
Trending into the future, DSEC members are indicating a potential increase in investment in the following areas:
* Stem or induced pluripotent stem (iPS) cells in human safety prediction
* 3-D matrix of human metabolite forming cells
* Modeling of toxic pathways, toxicity biomarkers
* Developing a database of toxic outcomes from failed compounds
Not surprisingly, DSEC members report that time and money are, by far, the largest barriers to assessing new technologies and platforms. However, they also state that too often the assessment or qualification process lacks “actionable insights” and this negatively impacts their companies’ willingness to invest in evaluation assessments. It is also worth noting that there is a perception that technology vendors as a sector are, at best, inconsistent in supporting new technology evaluations by potential customers, and quite often do this very poorly.
Key Insights
20–30% Increase in Consortia Participation
As biopharmaceutical companies look to leverage resources and derive insights that are actionable from the assessment process, there will be changes both internally and externally in their evaluation approaches. Many biopharmaceutical companies will work toward formalizing their evaluation processes of new predictive toxicology technologies. As such, they predict there will be a 20-30% increase in biopharmaceutical companies’ participation in consortia as a means to better leverage new technology assessment resources, as well as a slower-moving trend toward formalizing the review processes.
15-20% Increase in Spending on New Technologies
Based on the survey responses, the pharma industry will increase its spending on new technologies in 2010 relative to 2009, or at the very least will increase the resources committed to assessment of the new technologies. Again, they predict an increase of 15-20% in the number of technology assessments (of predictive toxicology tools) per company per year, potentially raising the average of 5.5 to 6 or 7 assessments. Most of the survey participants believe discovery toxicology would be the major functional area to benefit from new technologies (~60%) however they thought that these advances in safety assessment would significantly benefit all pharma R&D phases from discovery through to GLP and clinical testing.
Toxicity Biomarkers, Database of Failed Compounds and Profiles of In Vitro Screens
The survey results confirm with confidence that biopharmaceutical companies will continue to focus much of their attention on toxicity biomarkers and promising high content in vitro screens with an emphasis on hepatoxicity, cardiotoxicity, and toxic pathway assessment. In addition, companies are spending resources on developing or applying systems toxicology tools. The data also suggest there could be a future increase in investment toward the evaluation of new types of technologies such as stem and iPS cells, 3-D matrices of human metabolite forming cells, and further development of databases of failed compounds.
Ernie Bush is VP and scientific director of Cambridge Health Associates. He can be reached at: ebush@chacorporate.com.
This article also appeared in the May-June 2010 issue of Bio-IT World Magazine. Subscriptions are free for qualifying individuals. Apply today.