The pharma and biotech industries have reached significant R&D milestones in the past decade, including the broad adoption of immunotherapy and the advent of gene therapies. Despite these breakthroughs, the productivity of research and development efforts among large pharma/biotech remains low. As novel methods of development become more commonplace and the areas of focus shift from larger disease areas to more niche diseases, pharma companies will need to expand on existing capabilities across the product lifecycle. In this paper Emre Vural, Kishore Gangangari, and Joanna Lee look at how R&D has evolved from a focus on primary care to specialty medicine for rare disease as well as innovation in R&D sourcing models.
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Evidence requirements for orphan drugs
CRA’s Life Sciences Practice focuses on global policy, commercialization, and market access issues dedicated to orphan drug issues, including orphan evidence...