Making Medicine

Making Medicine is a story of big questions, breakthrough science, and a relentless desire to help people struggling with the world's most formidable diseases…
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How Clinical Trials Happen: Clinical Operations
http://gene.com/making - The clinical trial is central to understanding whether or not a molecule can ever become a medicine. It takes a tremendous amount of collaboration and dedication to make sure our medicines meet safety and efficacy standards.
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Scaling the Science: Technology Transfer
http://gene.com/making - To manufacture enough medicines for all our potential patients, we need to work globally. We also make sure that the quality is consistently the same no matter where a medicine is manufactured.
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Where Patients and Data Meet: Clinical Development
http://gene.com/making - We use data to understand how well the medicine works, for whom it's working and how it might further help people.
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Building a Body of Evidence: Translational Medicine
http://gene.com/making - Sometimes the science in the laboratory doesn't exactly play out as we predicted in clinical trials. So we spend time refining our approach in the lab and in the clinic.
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Targets, Mechanism, and Disease: Biomarker Development
http://gene.com/making - Biomarkers are measurable biological characteristics. We use them to deepen our understanding of disease and to create targeted medicines. Effectively using biomarkers is a collaborative effort that goes from early research to well after a medicine is approved.
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Understanding Assays: Bioanalytical Science
http://gene.com/making - As our medicines get more and more complex so do the methods we use to understand how they work. In particular, we study how the chemical composition of the medicine interacts with the body.
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Bringing Medicines to the Body: PK/PD & Clinical Pharmacology
http://gene.com/making - Before a potential medicine ever enters a human body, we develop simulations to test how it might behave. We need to understand where it goes, how long it will persist, and if it will reach its intended target.
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Keeping the Molecule Stable: Product Formulation and Delivery
http://gene.com/making - Medicines won't work unless they are stable and can be properly administered. We need to be clever to keep our biologics stable and intact after they leave Genentech.
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Managing Risk: Safety Assessment
http://gene.com/making - All medicines come with risk. It's important that we understand those risks sooner rather than later. We start with clinical development and continue to evaluate even after a medicine is approved.