Area Sits At Drawing Board To Craft Rules For Industry

March 31, 2008
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Why would an international consortium consisting of the U.S. Food and Drug Administration, the European Medicines Agency, and the world's largest pharmaceutical companies choose West Michigan's ClinXus to not only facilitate clinical trials for new drug discoveries, but also assist with overhauling the entire system by which drugs are discovered and, ultimately, delivered to patients?

The answer is simple. Unlike other communities that have chosen to invest in the creation of a life sciences corridor, West Michigan has made an intangible investment against which few others can compete. Our secret recipe? Collaboration.

On Jan. 9, ClinXus — a West Michigan alliance of local life science and health care organizations — announced that it had become the first organization of its kind to join the Critical Path Institute's Predictive Safety Testing Consortium.

This news may have profound implications both for the development of the local life science and biotech industries and for patient access to cutting-edge clinical trials and treatments, as well as for the future of drug discovery and development.

ClinXus formed in July 2006 with the assistance of a $1.5 million grant from the Michigan 21st Century Jobs Fund. Its focus is to develop innovative clinical trials involving new medicines that are primarily biomarker-driven. In other words, ClinXus works to advance the implementation of molecular techniques to introduce a more personalized, molecular-based era of medicine — one in which patients and their diseases are evaluated at the molecular level to optimize the delivery of safe and effective medicines.

ClinXus' members include Spectrum Health, Saint Mary's Health Care, Jasper Clinical Research & Development, Grand Valley State University, Grand Valley Medical Specialists and Van Andel Institute. ClinXus serves as the single point-of-contact for patients and physicians, leveraging the resources of its member organizations, which include expertise in basic and translational research, state-of-the art clinical capabilities, and the latest in molecular biological and computational technologies.

In March 2004, the FDA launched a landmark study called the Critical Path Initiative to identify problems and delays in medical product development and opportunities for improvement. The study found that it can take upward of a decade at a cost of $1 billion to bring a single drug to market. In response to this study, the Critical Path Institute was established in 2005 as an independent nonprofit research and education institute to facilitate collaboration between scientists in government, industry and academia.

In March 2006, Department of Health and Human Services Secretary Mike Leavitt announced the formation of the PSTC, involving scientists from the FDA, Critical Path Institute and some of the United States' largest pharmaceutical companies to share internally developed laboratory methods to predict the safety of new treatments before they are tested in humans. The initial PSTC members include Bristol-Myers Squibb Co., GlaxoSmithKline, Johnson & Johnson Pharmaceutical Research & Development LLC, Merck and Co. Inc., Novartis Pharmaceutical Corp., Pfizer Inc., Roche Palo Alto LLC, and Schering Plough Research Institute. Since that time, the PSTC has added seven pharmaceutical industry members and invited the FDA's equivalent in Europe, the European Medicines Agency, to serve in a similar advisory role.

Notice the names on this list: They include the world's two most important drug regulatory organizations, the international giants of the pharmaceutical industry — and one nonprofit community alliance: ClinXus. How did West Michigan gain a seat at such a table? Independently developing a model very similar to that of the Critical Path Institute, ClinXus had the foresight to develop a translational infrastructure that cooperatively utilizes the expertise and services of each member organization to the benefit of the alliance and the region — something that few other communities are doing effectively.

It's a great way for a region that is building a life sciences industry to leverage community resources. Although not one of the partners in the ClinXus alliance is a giant in the industry, together — with the same spirit of cooperation and collaboration that has been a hallmark of the region — ClinXus found a way to move mountains.

What does this mean for West Michigan? The PSTC is crafting the rules of drug-safety testing for the coming century. Sitting at this table means that ClinXus, and by extension, West Michigan, will have a hand in crafting the drug safety and development rules for the foreseeable future.

Because of ClinXus' expertise in designing and conducting innovative clinical trials and because of its association with the giants of drug discovery and development, West Michigan could become a national destination for innovative clinical research. It is conceivable to imagine satellite offices of the major pharmaceutical companies opening in Grand Rapids, giving area patients readily available access to state-of-the-art treatments prior to their general availability — access that can mean the difference between life and death.

Finally, what this all means in terms of job creation and economic development to the region should be fairly obvious. The recognition of the progressive qualities of the region by a prestigious international consortium helps position West Michigan as a national model in the development of the life sciences.

In my January "Vital Signs" column, I sent out a challenge to the visionaries in the region to "get in the game, identify a niche, meet a need and become a partner in the growth of the life sciences industry in West Michigan." We now have a tangible example of that challenge being met. Many more challenges and innovations await. HQX

David Van Andel is chairman and CEO of Van Andel Institute.

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