The last 10-15 years have seen the great emergence of drug development efforts in the rare disease space. Contributing factors include increased public awareness, encouraging drug regulation changes, scientific advancement in cellular/molecular biology and genetics, development of innovative trial designs, large influx of capital investment, availability of scientific talent through decades of cultivation, etc.
As a result, a great number of regulators, academicians, and industry statisticians now work to bring these orphan drugs to patients, facing unique technical issues and challenges. However, at least in the US, there is no statistical conference dedicated to such unique issues and challenges. Given the large unmet need, the New England Statistical Society (NESS) proposes this unique conference so that statisticians across the entire rare disease drug development spectrum have a common “home” to exchange ideas and share experiences, and also to network.
NERDS Workshop aims to be a one-day workshop with detailed presentations and discussions. Speakers from industry, academia, and government are invited. Topics will cover technical issues, regulation interpretation, industry trends, and case studies of both success and failure stories.
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