New FDA Commissioner Scott Gottlieb intends to release a far-reaching plan aimed at modernizing regulatory processes and speeding approvals for new drugs and devices, which could allow greater patient access to new medicines through unprecedented scientific and technological advancements. Key elements of the plan, called the Innovation Initiative, include using computer models and virtual patients to develop and evaluate new drugs or devices, particularly those targeting personalized medicine and rare disease populations, and creating new regulatory standards to apply expedited pathways for regenerative medicine products. The FDA will also move forward with guidance in areas including novel clinical trial design and use of real-world evidence in drug approvals, which has been made possible through recently developed digital technologies.
IndieBio, Science Exchange partnership aims to accelerate R&D science
In a move sure to make scientists happier at the prospect of less administrative burden, two companies—one that accelerates pharma and biotech research and another that figures out the research details—are joining forces. Science Exchange and IndieBio last week announced a strategic partnership. The joint effort plans to bring new disease cures to market faster, cheaper and most certainly with less operating aggravation for pharma and biotech startups. IndieBio-backed startups plan to access Science Exchange’s network of 2,500 pre-contracted CROs to more quickly outsource much of the “nuts and bolts” research key to an innovation launch.
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