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…
Risk Management
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. …
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…
Contract Manufacturing in the Age Tariffs
Stuart R. Gallant, MD, PhD Almost three years ago, PharmaTopo carried a post describing the process of selecting and working with a contract manufacturer [1]. …
Preparation of an Investigational New Drug (IND) Application
Stuart R. Gallant, MD, PhD A pharmaceutical company begins development of a new drug by screening dozens or even thousands of molecules to find the…
The 4 Axes of Drug Development Readiness
Stuart R. Gallant, MD, PhD In the earliest stages of drug research, scientists conduct bench experiments at a university or in a corporate pharmaceutical research…
Project Management: Creating a Timeline
Stuart R. Gallant, MD, PhD I was talking with one of my nieces recently. In her school, she and several of her friends have a…
Tactics for Managing the Unforeseen
Stuart R. Gallant, MD, PhD Sooner or later, something goes wrong in our work lives. In pharmaceutical manufacturing, errors or “deviations” are common events, and…
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…
Selecting and Working With a Contract Manufacturer
Stuart R. Gallant, MD, PhD The Convention on Pharmaceutical Ingredients (CPhI) was just held in Frankfurt. As the self-described “leading networking event for pharmaceutical industry,”…
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 Supply Chain Risk Management
Stuart R. Gallant, MD, PhD As pharmaceutical supply chains have become global, the risk management of drug supply has become increasingly complex. Recently, I was…
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…