July 17, 2012
Dawn Van Dam, General Manager, Cambridge Healthtech Associates : Recently, Cambridge Healthtech Associates™ (CHA) completed interviews with preclinical safety experts from large and small biopharmaceutical companies, focusing on middle and senior management levels of preclinical safety/toxicology groups. CHA specializes in conducting evaluations of new technologies in the marketplace and we have completed many technology evaluation projects over the last seven years. We were able to apply our expertise to identify trends in safety biomarker utilization within these top-tier companies.
Ernie Bush, PhD, our Scientific Director in drug safety and development, led this ground-breaking research project. Dr Bush has nearly 30 years of biomedical research, focused on preclinical safety assessment and the navigation, evaluation and prioritization of biopharmaceutical research initiatives. Dr Bush's experience in several senior decision-making roles at big pharma was critical for recommendations made as an outcome of this consulting and market research initiative.
One key conclusion from the research was that knowing the levels and profiles of various safety biomarkers helps to improve understanding of the mechanism and relevance of the animal studies relative to human clinical safety prediction. Most interviewees found the inclusion of systems or pathway modeling into the selection and interpretation of safety biomarkers to be an attractive new element.
As expected, there were considerable differences among companies in which tests they routinely run, and at what stage in the early safety-testing process they run the tests. Despite these differences, in attempting to benchmark current ‘early’ safety tests in drug discovery - those used routinely by companies (>50% of the time) - we found the following trends:
- Large companies are far more aggressive than smaller companies in terms of the number of tests run, and how early they are run (this trend also reappears below)
- Most companies are using physical chemical prediction software, and about half are using DEREK or other forms of gene or DART prediction software. Most companies conduct HCA cell health parameter screening of some form, with the exception of small companies.
- Most companies, large and small, did a form of off-target screening (usually CEREP), with smaller companies performing the screens later in the process. - The range of tests run at large and small pharmas was from about 20% of the tests considered, to over 90%, but the average was about 60%.
In a future article, we will discuss additional findings from our safety biomarkers research. In the meantime, if you have questions or would like more information on our research projects, please contact me.
We have scientific experts in many areas, including drug safety, next-gen sequencing, genomics, bioinformatics, diagnostics, biomarkers, protein engineering, drug discovery, preclinical safety, high-content analysis, biologics, and more.