Stuart R. Gallant, MD, PhD With around 25,000 drugs in clinical development globally at any given moment, deals to purchase and to sell developmental molecules…
Portfolio Management
Product Recalls
Stuart R. Gallant, MD, PhD There are 20,000 to 25,000 prescription and OTC medications licensed in the United States, and every year there are about…
Pharmaceutical Process Scale-Up
Stuart R. Gallant, MD, PhD A friend of mine who has been employed in pharmaceutical manufacturing for decades has a saying regarding process scale up. …
AI in Pharma R&D and Manufacturing
Stuart R. Gallant, MD, PhD Artificial intelligence is being widely adopted in fields like law, accounting, banking, customer service, marketing, and human resources. These early…
Approval Rate and Development Cost by Drug Category
Stuart R. Gallant, MD, PhD Takeda just announced that it would exit cell-based treatment research [1]. Last year, Takeda had ended development of its non-Hodgkin…
Solving Drug Shortages
Stuart R. Gallant, MD, PhD Imagine that you have an infection, and you need a common antibiotic, but you cannot find a drugstore that is…
Pharmaceutical Patent Strategy
Stuart R. Gallant, MD, PhD When I think of patent law, I am reminded of a line from the play A Man for All Seasons. …
Pharmaceutical Design Focus: Clot Busters (2 of 2)
Stuart R. Gallant, MD, PhD In the first part of this post, we looked at urokinase. In the second part, we will look at tissue…
Pharmaceutical Design Focus: Clot Busters (1 of 2)
Stuart R. Gallant, MD, PhD This November will be the 35th anniversary of the approval of tissue plasminogen activator (tPA, alteplase) a leading treatment for…
Pharmaceutical Decision Making and Fundraising
Stuart R. Gallant, MD, PhD Within pharmaceutical development, there are two types of go-no-go decisions: 1) clinical and 2) financial. These decisions are linked together…