Stuart R. Gallant, MD, PhD This is the second post in a two-part series on the value of medications. In this post, we bite the…
Author: Stuart Gallant
The Value of Medications (1 of 2)
Stuart R. Gallant, MD, PhD This post is the first in a two-part series on the value medications. “The Value of Medications” is a bit…
Lessons Learned: Documenting Your Intellectual Property and Defending It
Stuart R. Gallant, MD, PhD Some readers may not have had the opportunity to be deposed by the opposing counsel from a pharmaceutical company. Here…
Drug Development Plan
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)…
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…
Parenterals and Covid-19
Stuart R. Gallant, MD, PhD The Biden administration has announced that it plans to invest billions of dollars in Covid-19 vaccine manufacturing capacity [1]. What’s…