Category: Regulatory
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AI: Everything, Everywhere, All at Once; FDA: now, wait a second!
Artificial Intelligence is no longer just a fancy tool for predicting protein structures with AlphaFold. The FDA’s new draft guidelines outline a vision where AI permeates every stage of drug and biologics development. Whether it’s identifying drug targets, optimizing manufacturing, or—yes—even drafting Standard Operating Procedures (SOPs), AI is now under the regulatory spotlight. And here’s… Read more
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Biotech dreams & Startup nightmares
Let me take you back to a time when Avatar was breaking box office records, everyone was pretending to love quinoa, and I was an eager Master’s student interning at a small biotech startup. Let’s call it…BioHopeful Inc. (to spare feelings). The Product That Could Have Been a StarAt the core of BioHopeful’s ambitions was… Read more
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Three Big Questions for Canada’s Innovation Ecosystem
A Reality Check on Our Productivity Crisis Canada’s innovation ecosystem feels like a group project where everyone’s working hard, but nobody’s quite sure who’s in charge. We’ve got the brains, the ambition, and a few gold stars on the global stage, but productivity numbers tell a different story. According to Stats Canada, labour productivity in… Read more
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Promise and Challenges of Cell Therapy
Cell therapy isn’t as new as many believe. The concept of using cells as a therapeutic tool has been around for centuries. Blood transfusions, for instance, have been saving lives for centuries, and xenotransplantation, like using pig heart valves in humans, has been performed since the 1960s. These are early forms of ‘cell-based’ therapies that… Read more