Stuart R. Gallant, MD, PhD In the first post of this series, raw materials risk analysis was discussed. In the second post of this series,…
Author: Stuart Gallant
Risk Assessment of Raw Materials and Contact Materials (1 of 2)
Stuart R. Gallant, MD, PhD One of the first steps in a pharmaceutical development project is selection of chemicals. For the development team, it may…
The Value of Medications (2 of 2)
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…
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…