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…
Planning
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. …
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]. …
Selecting an Analytical Laboratory
Stuart R. Gallant, MD, PhD Analytical testing is required to verify the identity, strength, quality, purity, and potency of investigational and commercial products. The precise…
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…
So, You Want to Consult
Stuart R. Gallant, MD, PhD Consultation—offering your professional services to companies on a time-limited basis—can be a rewarding type of work. It is gratifying to…
Trends in Pharmaceutical Autoinjector Design and Use
Stuart R. Gallant, MD, PhD In today’s post, some important aspects of development and manufacture of combination products with pharmaceutical autoinjectors are considered. Pharmaceutical autoinjectors…
Leased Lab Space
Stuart R. Gallant, MD, PhD In the last two decades, startup pharmaceutical companies have become increasingly frugal with investment capital. One of the ways to…
Investing in Pharmaceutical Startups
Stuart R. Gallant, MD, PhD PharmaTopo recently posted on the topic of founding a pharmaceutical startup. Today’s post looks at pharmaceutical startups from the investor’s…
Founding a Pharma Startup
Stuart R. Gallant, MD, PhD In the late 1950s, electronics scientists and engineers like Robert Noyce, Gordon Moore, and Eugene Kleiner invented the idea that…
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 Product Launch
Stuart R. Gallant, MD, PhD Above is a photo from the 1947 launch of the M.V. St. Essylt at J.L. Thompson and Sons was a…
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…
The Design Process
Stuart R. Gallant, MD, PhD In Pharmaceutical manufacturing, frequently process development uses designed plays—just like in American football. In football, the play caller looks at…
Logistics: So, You Want To Move Your Drug?
Stuart R. Gallant, MD, PhD Okay, here’s the premise of today’s post: you have contracted with a company outside the US (maybe in Germany, China,…
Raw Materials Testing, Starting Materials, and Contact Materials (2 of 2)
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,…
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…
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)…