Sean Tunis is director of the Center for Medical Technology Policy and a leading advocate for comparative effectiveness research and evidence-based medicine. Formerly Director of the Office of Clinical Standards and Quality and CMO of the Centers for Medicare & Medicaid Services, he discusses the state of comparative effectiveness advocacy and his current work developing medical device protocols aimed at providing actionable information to physicians, patients, and payors.
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Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.
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The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.
From billion-dollar COVID antibody to a strategic reset, Marianne De Backer is navigating Vir's comeback through pipeline focus and disciplined leadership.
An interactive look at recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.
A Q&A with DeAnn Smith, partner and co-chair of the Patent Trial and Appeal Board Proceedings Practice Group at law firm Foley Hoag.
