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Biogen, Amgen, Lilly and Genentech experts shared tales of impending stockouts, particularly for single-use assemblies, filters and resins, and some of the measures they took to prevent them from causing drug shortages.
The formulas for various COVID-19 vaccines remain shrouded in intellectual property protections – one of many factors preventing them from being manufactured in developing nations. Those in favor of upholding IP say that scrapping patents could stifle future innovation, but their opponents believe preserving COVID-19 related IP rights is limiting access to lifesaving medical tools.
Advanced Therapies have come a long way over the past decade. Some cell and gene therapies have already been approved and others have now entered the later stages of development and this is reflected in a shift towards later clinical trials. In consequence, manufacturing process consistency, GMP standards, etc., must now meet more formal requirements. This brings some challenges because the products, and their development and manufacturing processes, differ from traditional models.
HHS agencies look to build on COVID-19 experience by developing quicker public/private responses to pandemics and supply chain threats.
Pharmaceutical companies are ratcheting up voluntary efforts to control discharges of antimicrobials from their plants and those of their active pharmaceutical ingredient suppliers so they won’t contribute to antimicrobial resistance. But will it be enough to fend off regulation in countries like India?
Aside from a few high-profile exceptions, the biopharma industry supply chain has remained secure and resilient during the COVID-19 pandemic, outperforming retail and consumer goods. Chip Davis, Jr., head of the Healthcare Distribution Alliance, spoke with In Vivo about the need for a long-term industrial policy for drug manufacturing, real-time data-sharing and transparency in the supply chain, and minimizing disruptions.
Prescription psychedelic drugs in development, and supply for the growing recreational and medicinal use markets globally, are creating new business opportunities in mental health.
As the COVID-19 crisis recedes, industry leaders are placing a renewed emphasis on environmental sustainability, from API manufacturing and raw material sourcing to package inserts. As NHS England chair Lord Prior said at BIO Digital, “Climate change is going to make COVID look like a picnic in the park.”
Senior McKinsey executive shares insights on the potential contours of pharma’s 'reimagined' operations against the backdrop of COVID-19 and striking a balance between supply chain security and the cost component. A dramatic near-term shift to a “completely onshore model” in markets like the US would not realistically be possible, he indicated.
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