Cambridge Healthtech Associates™ Announces Results of Survey on Trends in Safety Biomarkers

NEEDHAM, Massachusetts  – July 30, 2012– Cambridge Healthtech Associates™ (CHA™), today announced results of industry survey of biotech and pharmaceutical companies on the use of safety biomarkers in the development of new medications. 

Recently, Cambridge Healthtech Associates, through the Drug Safety Executive Council™ (DSEC™), completed interviews with preclinical safety experts from large and small biotech and pharmaceutical companies, focusing on middle and senior level managers in preclinical safety and toxicology groups.    

The goal of the research was to identify trends in biomarkers and their utilization in these top tier companies. The survey builds on CHA’s seven year history of technology evaluation projects in the life sciences.    

Ernie Bush, Ph.D., Scientific Director in drug safety and development, for DSEC and CHA, led this research project.  Dr. Ernie Bush has nearly 30 years of biomedical research, focused on:  

• Preclinical safety assessment; and the   
• Navigation, evaluation and prioritization of biopharmaceutical research initiatives.  

Some of the key findings of the safety biomarkers research include the following:  

• Biomarkers of organ toxicity are consistently rated as one of the most desired new tools by this industry segment. In this current study, most interviewees found the inclusion of systems or pathway modeling into the selection and interpretation of safety biomarkers to be an attractive new element. We have also seen this pattern emerge in CHA’s annual New Technology Adoption surveys. 

• In theory, knowing the levels and profiles of various safety biomarkers will improve the understanding of the mechanism and relevance of the animal studies relative to human clinical safety prediction.   

• The following trends emerged in ’early’ safety tests in drug discovery (tests that companies use more than 50% of the time):  
• Small companies are far less aggressive than larger companies in terms of the volume of tests conducted, and how early those tests are administered.    
• Most companies are running 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.    
• Surprisingly, 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 early safety tests run at large and small pharmas was from about 20% to over 90%, but the average was about 60%.  
•   

“We are always interested in trends in the life sciences industry and our recent surveys indicate a growing interest in the use of biomarkers in early drug safety testing. We believe this is one of several areas of growth for the future,” said Dawn Van Dam, General Manager for Cambridge Healthtech Associates and the Drug Safety Executive Council.  

About Cambridge Healthtech Associates Cambridge Healthtech Associates™ (CHA™) uses its unique collaborative model to improve the speed, economics and effectiveness of life science research and development, leveraging its consulting, technology evaluations and communities to help clients in the industry penetrate the marketplace and increase revenue. Read more at www.chacorporate.com.
  
About the Drug Safety Executive Council
The Drug Safety Executive Council™ (DSEC™) is an online community focused on the development of better and safer medicines. DSEC is a platform for biopharmaceutical companies, contract research organizations and academics to share knowledge and exchange ideas on improving the drug pipeline. DSEC™ is managed by Cambridge Healthtech Associates™ (CHA™). Read more at  www.drugsafetycouncil.org.