In Episode Three of the Syneos Health Dedicated Dialogue podcast series, we uncover how the proliferation of new digital health technologies, telemedicine and mobile nursing services are helping fuel novel clinical trials. These range from community-based studies, which are administered through PCPs, local health centers and outpatient facilities in lieu of academic research centers, to hybrid and fully virtual trials designed around patients in their homes, with or without a synthetic control arm replacing patients on placebos. Additionally, we share new insights about how trial sponsors discovering new ways to engage participants, enhance data capture and devise pathways to put patients at the center of clinical trials across the biopharmaceutical product development continuum.
Treasury proposes adding biotechnology to its Outbound Investment Security Program, a pharma funding roundup covers Gilead’s $1.275 billion acquisition of an oral IL-23R inhibitor from PepStar and Zymeworks’ licensing deal with Roche, and Incubate’s John Stanford on why MFN is an offer pharma can’t refuse.
Dave Maraldo, Ph.D., president of manufacturing at Merck, explains how flexible capacity, earlier input from manufacturing in R&D, and digital tools are helping the organization keep up with a faster, more varied portfolio.
FDA grants Ultomiris accelerated approval for primary immunoglobulin A nephropathy, a pharma funding roundup covers Alcon’s $550 million acquisition of Neurotech and AI Proteins’ collaboration with Astellas, and Incubate’s John Stanford on which therapeutic areas MFN deals might hit hardest.
Alcon is acquiring Neurotech Pharmaceuticals to add the only FDA-approved MacTel cell therapy to its retina portfolio, while AI Proteins has enters a collaboration with Astellas to design novel miniprotein therapeutics.