Stuart R. Gallant, MD, PhD How A Drug Development Plan Originates Keller and Schnell suggest that there are five challenges to a pharmaceutical startup: 1)…
Month: December 2021
Nonclinical and CMC (3 of 3)
Stuart R. Gallant, MD, PhD Non-clinical development has two chief goals: 1) to develop safety data enabling the entry of the medicine into human clinical…
Intellectual Property (2 of 3)
Stuart R. Gallant, MD, PhD Licensors and Licensees As discussed in Part 1 of this three-part series, drug development and licensing has taken on the…
Cost of Pre-Clinical Development (1 of 3)
Stuart R. Gallant, MD, PhD In the last three decades, how pharmaceutical drug development occurs has changed dramatically. Prior to this change, a significant share…