Drug Safety Executive Council Blog

September 18, 2012 

Dawn Van Dam, General Manager, Cambridge Healthtech Associates :  After interviewing numerous professionals in the life science industry over the past six months, I've seen a common theme emerge: in an ideal world, sharing data with other companies and institutions would allow the development of better technologies and faster solutions. Words like "synergy" and "ecosystem" were used by interviewees to paint a picture of an idealized healthcare landscape in which breakthroughs are accomplished through collaborative efforts - where researchers share both their successes and failures.

In reality, however, the industry provides scientists with incentives that understandably keep them from sharing their findings with other industry leaders. Pharma researchers must protect their IP in order to preserve company integrity and maintain job security, and academics need to keep their findings quiet as they vie for the chance to publish. Therefore redundancies are common in research and those coveted breakthrough results don’t come along as often as they could!

It seems that professionals across the healthcare spectrum - scientists to CEOs - believe that collaboration in research through sharing data and findings is the solution to translate research to the clinic faster. Could increased collaboration in research really help push the industry forward, or is it simply too idealistic for a cut-throat, business-oriented world?

Many of the industry professionals who support collaboration in research suggest creating an incentive system that encourages data-sharing. One, a CTO and Head of R&D for a small organization focused in bioinformatics, believes strongly in combining efforts for more efficient research. In an interview for our study, he highlighted the cost/time benefits of collaboration: "I have an impression that many people do the same thing in a slightly different way, and each one with different funding in a different place in the world. So, I have the impression that a lot of energy is actually redundant." Sharing data can ensure that those vital funds aren’t being used up by redundant experiments and, instead, are put toward achieving new breakthroughs.

Sharing data has benefits for research, but could also have serious implications for the business side of the industry. While redundant research depletes resources throughout the industry, competition within the industry forces researchers to work harder and faster towards making breakthroughs. If collaboration in research and data sharing eliminated the threat of a competitor making an important discovery first, would scientists work more slowly toward scientific discoveries?

Perhaps one solution to increase industry efficiency is to develop public-private partnerships, as a CEO and founder of a small European bioinformatics company described. "The [private enterprises] find it difficult to access these data and make use of them to ultimately push forward and develop the best drugs. I think that when you read about good public-private partnerships, where there are these collaborative efforts between the academic world and the private world, that’s when it becomes most effective."

Industry and academic partnerships allow for data sharing and collaboration in research on a smaller and more manageable scale, while maintaining that competitive edge necessary to drive industry forward at a fast pace. With shared resources and combined funding sources, these partnerships can make greater strides in research and avoid repeating the same mistakes as others in the industry, or drawing redundant conclusions.

A contained and organized system, like the public-private partnership, or a consortium, is a small-scale initiative that can encourage collaboration in research and could ultimately help the entire industry function more efficiently.

We would like to acknowledge and thank all of those who provided their thoughts for this six-month study.

If you would like more information about how Cambridge Healthtech Associates™ help you form, implement or manage a collaborative project in life sciences research and development, please contact me. We have completed many collaborative projects over the last seven years; consequently, our expertise and experience are unparalleled in the industry. 

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.   

March 26, 2012 

Dawn Van Dam, General Manager, Cambridge Healthtech Associates : If you are finding us for the first time… welcome. Our vision is for the Drug Safety Executive Council online community to become the platform to both network with peers and exchange ideas related to advancing drug safety solutions. Up until now, membership in the DSEC community has been limited to bio-pharma company employees. To engage a wider audience in the drug safety space, the new DSEC will include members from bio-pharma, along with governmental agencies, academia, CROs and technology providers. 

I invite you to take a look around the new site, and we welcome your feedback.