Non-Clinical Safety Evaluation for Drugs and Medical Devices – talk at www.bio2devicegroup.org by Michael Taylor, January 17, 2012


Dr. Michael Taylor discussed the interactive nature of drug and device development and the role played by pharmaceutical toxicology.  Drug development process takes new chemical compounds through considerations regarding formulations, safety of materials used, effects of molecules inside the body, toxic effects etc. Toxicology is the most time and resource consuming component.  Goal of pharmacological toxicology is often to minimize spend and kill a molecule sooner, rather than later.  However, that is not the only goal.  Sometimes the goal is to understand and identify things like, safe dose, impact of harmful interactions, identifying potential target organs and so on.  In the end, it is about balancing risk and benefit.

What needs due consideration is what exactly is being developed. Is it small molecule, biologic, device, combination product, approval of drug device material, new usage, new indications, change in delivery route, new manufacturing process, new impurities, target population?  Each of these considerations will have its own unique parameters.  For instance, if the drug in development is an end of life drug then different considerations will go into effect compared to a drug that is targeting relatively mild condition.  Early considerations must begin with solid review of literature, review of FDA approved summaries and screening data, and receptor profiling.  The presentation ended with Q&A.

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