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Biomarkers are a beacon of hope in the current tumultuous pharmaceutical industry climate. They have the potential to encourage innovation, improve efficiency, save costs, and gain research organizations a valuable advantage over their competitors. However research organizations face a number of hurdles in realizing and passing on these benefits.

The pharmaceutical industry is facing significant challenges, in 2006 only 22 new molecular entities (NMEs) were approved for use by the US Food and Drug Administration (FDA), down from 53 in 1996. Of greater concern is the fact that R&D spend by US companies in Pharma research has increased from USD 17m to USD 43m alongside this decrease in productivity (Ref 1). In conjunction with this there have been some high profile drug withdrawals due to safety concerns, for example Vioxx.

These factors, along with increased generic competition and patent expiration have contributed to the increased cost of developing a drug. The major stakeholders – the patients, payors, pharmaceutical industry, clinicians and regulatory agencies are all facing a period of change as they seek to address these challenges. How their reactions play out over the next few years could well set the course of drug discovery for years to come. In this article we will select one beacon of hope in the current tumultuous climate, looking at how the pharmaceutical industry is using Biomarkers in an attempt to begin to address these issues.

The potential impact of Biomarkers
There seems little doubt that Biomarkers will be one of the major drivers of pharmaceutical research and drug development in the 21st Century. Biomarkers have the potential to encourage innovation, improve efficiency, save costs, and gain research organizations a valuable advantage over their competitors. However, at the present time research organizations face a number of hurdles in realizing and passing on these benefits. Regulatory agencies are reluctant to accept biomarker-based evidence to support a drug approval without reliable standards of biomarker documentation. The information provided by a biomarker must be absolutely trustworthy if it is to be used to support a key decision. And biomarkers must become established enough that they shift the research paradigm away from the ‘blockbuster’ model to smaller-market but more carefully targeted products.

At the recent Pharmavision meetings hosted by Thomson Reuters, Dr. Jeffrey Ross, Albany Medical College, a renowned researcher in Oncology presented his view on Biomarkers

The regulatory authorities
The bodies who regulate the approval of new drugs are looking across the whole of drug R&D for how to address these issues. The FDA released their first Critical Path Initiative in 2004 and has continued to expand and refine its initial premise. The basic idea is to reduce uncertainty about a product’s performance throughout the product life cycle through scientific research. There are all-round benefits with this approach

• to the patient through increased efficacy and improved safety
• the payors through cost effective therapies
• the pharmaceutical industry through increased return on investment.

One of the key opportunities identified by the FDA is a greater use of Biomarkers throughout the drug R&D process.

The role of Biomarkers in the drug development process
Biomarkers can provide their discoverers with tangible benefits by speeding up and focusing the development of associated treatments for the disease they indicate. Therefore most biomarker research is proprietary, and biomarkers are themselves commodities just like the drugs they help to bring to market. Biomarker research, too, follows a similar pipeline to drug research: from discovery, through initial documentation, exploratory use in pre-clinical and clinical development, to publication and regulatory approval, and ideally onward into widespread adoption in the clinics. There is undoubtedly as high an attrition rate in biomarker development as in drug development. The end point for a biomarker researcher may not simply be to support drug development, but to establish and manufacture diagnosis kits and software, with all the licensing opportunities that suggests.

Hurdles in Biomarker research
As with all emerging fields of research, identifying the useful information and then applying it to the benefit of your research can be a challenge. Biomarkers are no exception here:

What is the best Biomarker to use for my research?
How does it differ if I want to diagnose a disease or select a patient cohort for treatment?
How can I measure it effectively?

These are just some of the questions asked by researchers who are employing biomarkers. It doesn’t stop there, the needs of the discovery scientist differ from those of the clinical scientist. The transition of a biomarker from discovery and development into a clinical setting is a real bottleneck, the use of translational research can help to minimize this but until clinical and discovery groups have complete alignment, Biomarker selection will continue to be a challenge.

One of the issues here is finding the information, Biomarker information is exploding at a huge rate, and it can be found in academic literature, patents, clinical trial documents and websites, press releases and presented at congresses. For a researcher wanting to use a Biomarker in their research, the challenge in finding the information they need can be daunting. Their task is made even more difficult by the non-standardized terminology applied in Biology, particularly Gene and Protein synonyms. Because of this it is difficult to ensure comprehensive searching. Searching patent documents and congress information can prove difficult. While it may not be difficult to find information on well-researched Biomarkers, such as Her2, it can be difficult to be sure you have identified all the uses for the Biomarker. It can be almost impossible to find those new, emerging Biomarkers without significant resource investment

BIOMARKERcenter
At Thomson Reuters, with our history of creating high quality, comprehensive value added scientific databases, we feel we are suited to helping Biomarker researchers and have created BIOMARKERcenter. Using a unique lifecycle approach to indicate the stage of a given biomarker, BIOMARKERcenter covers individual biomarker usage as identified in literature, patents, conferences, clinical trial information, and other sources for all major therapeutic areas.

For each therapy area, BIOMARKERcenter includes not only biomarkers with established clinical usage, but also emerging uses for the biomarker. Each record is manually created and expertly indexed to enable searching by fields such as name, type, biological process, indication, population, role, measurement technique, substrate, lifecycle stage, and development status of diagnostic kits. Each record is further enriched with links to all supporting source documents, throughout the history of the biomarker.

The future
It seems likely that Biomarkers will continue to play an increasingly important role in improving the effectiveness of drug R&D. This, coupled with the rapidly progressing understanding of the molecular basis of disease processes, would seem to hold the greatest promise in addressing the challenges found in drug R&D. We are seeing the emergence of Personalized Medicine, and the opportunities are tantalizing. It seems the pieces of the jigsaw are beginning to appear: decreased costs of high volume genomic sequencing, development and marketing of consumer diagnostic tests, improved pre-therapy screening of patients. How far away the real era of personalized medicine is will depend on the appetite of the pharmaceutical industry

A number of organizations are already benefiting from the data found in BIOMARKERcenter, including the National Cancer Institute.

Learn more about BIOMARKERcenter

Ref 1: US FDA, CDER approval times for priority and standard NMEs and new BLAs Calender Years 1993-2006, January 29, 2007.

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