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Early-stage therapeutic development can falter without proper medical and scientific data coupled with complete documentation elucidating the path from preclinical to FIH. Good science does not always get to the clinic, as documentation and repeatability are paramount to the therapeutic journey. By aligning preclinical research, translational medicine, and clinical development with regulatory expectations; differentiating therapeutic assets early and on an ongoing basis; and leveraging external expertise, companies can avoid costly missteps and possibly accelerate their entry into the highly competitive U.S. market.
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