The Center for Biomarker Research is dedicated to education and applied research activities that expand knowledge and development of biomarkers as a tool for diagnostics, drug development, and the practice of medicine in the 21st century.
Collaborating with academic, corporate, and not-for-profit partners, the Center for Biomarker Research seeks to spur innovation in approaches to the discovery and commercialization of new biomarkers that address unmet diagnostic needs. The Center is investigating new biomarkers for rare and other diseases that are difficult to diagnose with existing in vitro diagnostic tests. Currently utilizing flow cytometry to investigate cellular biomarkers,a the Center intends to expand its applied research efforts to genomic and proteomic biomarkers as well.
By partnering with the government agencies, foundations, and industry partners, the Center explores biomarkers in rare disease populations. These activities will facilitate biomarker discovery and provide a means of classifying and stratifying disease populations. From this research, a new database of rare disease biomarkers is being created which will be accessible to academic and corporate communities for their own research.
Biomarkers are molecular indicators used to measure a range of physiological conditions. They hold great promise in the fight against disease and the development of personalized medicine because they reveal the physiological state of an individual. Biomarkers can be used to diagnose disease, monitor disease progression and response to therapy, and are targets for development of new drugs.
The Center for Biomarker Research educates graduate students at KGI and undergraduate engineering students at Harvey Mudd College in the development of diagnostic tools for biomarker discovery. Students learn to operate in a Good Laboratory Practice facility that handles human samples, and they gain valuable hands-on experience in quality assurance, assay validation and regulatory compliance, areas that are not commonly addressed in an academic setting.
The Center for Biomarker Research’s laboratory contains an array of equipment to support its research efforts:
We have initiated a translational and collaborative National Science Foundation PFI project involving industry (Beckman Coulter, Inc.), a non-profit organization (National Organization of Rare Disorders), and academia (Harvey Mudd College and KGI) to educate translational scientists and to discover and commercialize new disease-specific biomarkers.
Our initial effort is focused on Inclusion Body Myopathies (IBM). These rare diseases are a diverse group of muscle-wasting disorders that share similar histopathology with sporadic Inclusion Body Myositis and senile plaques found in Alzheimer’s brain disease. The autosomal recessive form, IBM2, is the most common and is due to a mutation in the rate limiting enzyme for sialic acid synthesis. It usually affects young adults, between the age of 20-35 years, and often leads to severe disability and confinement to a wheelchair within 10-15 years. IBM2 is a recessive genetic disorder, which means it can happen to anyone, even without family history of the disease. Most of the patients have healthy parents who were carriers of the disease without knowing – the patients and their families had never heard of IBM2 prior to their devastating diagnosis.
The Center works with the HIBM Research Group (HRG), a California non-profit public benefit corporation founded by Dr. Daniel Darvish engaging in medical research on HIBM. Over the past few years, HRG has established a depository center for maintaining and distributing reagents and resources necessary for research on IBM2. As with many rare disorders, there is a significant need to develop biomarkers for IBM2 that can be useful in clinical and molecular evaluation of the disease. Such biomarkers will allow us to monitor progression of the disease and determine the effectiveness of therapy early in clinical trials, which may translate to significant cost and time savings. KGI and HRG have begun a team-oriented effort to develop and validate IBM2 specific biomarkers.