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By Robert E. Stratford, Jr.


Scientists are devising new ways that will enable physicians to sample healthy and diseased tissues in their patients, and then analyze those samples to diagnose and devise personalized medical treatment plans. A cornerstone of such efforts is the identification of biomarkers that signal a departure from healthy tissue behavior, preferably at the earliest stages. To support the discovery of these disease biomarkers and their use in the discovery and development of drugs, researchers are working with analytical techniques that will enable high spatial and temporal resolution sampling of endogenous substances produced at the site of disease. The development of exquisitely small, minimally invasive, tissue dialysis probes that capture endogenous chemicals, often proteins, is being pursued.

One of the leaders in the development of this technology is Robert Kennedy, Ph.D. at the University of Michigan. For over 20 years, Kennedy has developed elegant separation techniques to measure neurochemical from complex mixtures derived from in vivo sampling. Kennedy’s most recent work aims to identify peptide-based biomarkers in Alzheimer disease.

Frank Sinner, Ph.D., of the HEALTH – Institute for Biomedicine and Health Sciences, in Graz, Austria, focuses his work on human clinical trials to discover biomarkers associated with psoriasis. Sinner uses a technique known as open-flow microperfusion to sample subdermal fluids in patients; he then compares the analytical profiles of these samples to those observed in samples obtained from non-psoriasis affected subjects. His work is expected to lead to the identification of biomarkers that will provide insight into novel treatment strategies for psoriasis.

As we consider ways to accelerate findings using biomarkers, it’s essential to have government support. Shashi Amur, Ph.D., of the U.S. Food and Drug Administration has developed expertise in the field of biomarkers and leverages that experience to support the application of biomarkers in drug development and drug licensing applications. Amur’s research leads her to provide pragmatic insight regarding the all-important application of biomarkers in the development of drugs into the forseeable future.

At the American Association of Pharmaceutical Scientists National Biotechnology Conference, to be held in Boston from May 15–18, scientists will convene from around the world to present and discuss their work, the ultimate aim of which is to advance medical therapies to treat the myriad of diseases that continue to threaten human health. The three scientists noted above will present the latest findings from their research to identify biomarkers that hope to fuel the discovery of more effective treatments for these diseases. I developed this symposium because of my desire to participate in research that deepens our understanding of the causes of CNS disorders, and uses that knowledge as a basis for the design of new drugs.

Robert E. Stratford, Jr. Ph.D., has worked in drug discovery and development for over 23 years at Eli Lilly and Company before moving to the academic enviroment in 2010. He is currently an associate professor at the Mylan School of Pharmacy at Duquesne University.