· By Sanofi Admin

Drug Development 101: Phase 2 Clinical Trials

Author: Kristin Schuhwerk, VP, Global Head of Clinical Operations, Sanofi
This past November, my colleague Paul Deutsch shared some valuable information about Phase 1 clinical trials, as part of our Drug Development 101 series. Today, I’d like to build on this information by providing some insight on what comes after Phase 1 clinical trials – Phase […]

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 · By Sanofi Admin

Drug Development 101: Phase I Clinical Trials

Author: Paul Deutsch, VP, Head Translational Medicine and Early Development
Have you been following along with our Drug Development 101 series? If so, you’ll remember that last month, we provided some insight into preclinical research – an early but vital stage of testing that enables researchers to obtain foundational data about an investigational therapy. Today, we’re […]

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 · By Sanofi Admin

Drug Development 101: Preclinical Research

Author: Doug Keller, Global Head of Preclinical Safety Development Projects
How much do you know about the types of studies that researchers need to conduct before a new therapy can be approved for use in humans?
Many are familiar with clinical trials, since they involve human volunteers. But before clinical trials can take place, each experimental treatment […]

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 · By Sanofi Admin

Drug Development 101: FDA Responses to New Drug Applications

Authored by: Don Gieseker, Associate Vice President Regulatory Affairs
In the Drug Development 101 series here on Speaking of Sanofi, we have explored topics related to the FDA review process for new drugs, including the types of applications that can be submitted to the FDA and the meaning of a PDUFA date. Today, we shed some […]

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