Human Genetics and Biomarkers to Guide Drug Development and Treatment
 

As opposed to single gene disorders such as fragile X, autism and many other disorders of brain development likely result from complex and multivariate neurobiological dysfunctions. Consequently, Seaside plans to collaborate with genetic and molecular diagnostic groups to accelerate human clinical development of potential drugs and maximize probability of success in clinical trials. Once compounds are judged to be safe, we intend to extensively characterize efficacy in a broad range of patient populations. As we anticipate significant variability in response to our drugs among individuals with developmental delay and disorders, we believe it will be necessary to extensively characterize each individual and intend to supplement behavioral observations with objective data. In addition to traditional behavioral and clinical assessments, we will employ sophisticated genetic testing and biomarker analyses to further characterize subjects in our clinical trials. The complex interactions of genetics, cellular pathways, environment, behavioral and non-drug therapies will be assessed and resulting insights incorporated in our development plans. To assure that we have the capabilities to generate and analyze these robust databases, we will establish strategic relationships with scientists and diagnostic companies who possess expertise in these fields. We expect this integrated approach to guide drug development and to facilitate identification of new drug targets and new medications.

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