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Leaping the Valley of Death: Keys to Successfully Going from the Lab to the Clinic for Pharmaceutical Products
Session Chair(s)
Michael Swit, JD
Senior Director, Legal, Regulatory Affairs
Varian, United States
Going from the lab to the clinic is the first huge leap in drug development. In this session, we will examine that process and explore how to ensure the jump over the “valley of death” avoids the sponsor falling into an abyss of bad decisions and poor results.
Learning Objective : Describe the panoply of decisions faced in the jump from the lab to the clinic including how those decisions can speed or derail drug development; Develop strategies to analyze unexpected challenges and minimize their impact on the drug development pathway; Explain how to maximize use of both internal and external resources to address the challenges faced in leaping from beaker to bedside.
Speaker(s)
That Valley Is a Big One! Who/What Will Help Me Cross?
Gerald J Yakatan, PhD
IriSys, Inc., United States
Chairman, Chief Executive Officer, and Founder
Indiana Jones’ Regulatory Toolbox: Crossing the Valley in Today’s World
Michele Yelmene
Ambit Biosciences, United States
Consultant
Key Intellectual Property Considerations When Going from the Lab to Clinical Development
Leslie Overman, JD, PhD
The Law Office of Leslie B. Overman, United States
Attorney
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