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…
Author: Stuart Gallant
Lipid Nanoparticles for Covid-19 Vaccines
Stuart R. Gallant, MD, PhD Hopefully, you have received your Covid-19 vaccine. If you did, there’s a pretty good chance it was delivered in lipid…
Payment for Pharmaceuticals
Stuart R. Gallant, MD, PhD The United States has a mixed public and private insurance system for health care. Payments for pharmaceuticals are provided through…
Pharmaceutical Design Focus: Factor VIII (2 of 2)
Stuart R. Gallant, MD, PhD In the first part of this two-part post, we looked at the biochemistry of clotting factor Factor VIII and the…
Pharmaceutical Design Focus: Factor VIII (1 of 2)
Stuart R. Gallant, MD, PhD Today’s post is a big story involving genetic engineering, pharmaceuticals, intellectual property, and economics. You will recall from the first…
Technology Focus: Supercritical Fluid Chromatography
Stuart R. Gallant, MD, PhD This post is the first in an occasional PharmaTopoTM series called “Technology Focus.” Today, we look at supercritical fluid chromatography…
Financial Metrics of Pharmaceutical Companies (2 of 2)
Stuart R. Gallant, MD, PhD In the second part of this two-part post, the topic of valuation will be discussed, followed by how some of…
Financial Metrics of Pharmaceutical Companies (1 of 2)
Stuart R. Gallant, MD, PhD This two-part post looks at pharmaceutical companies and how they are financially structured to survive in a competitive market, to…
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,…
Pharmaceutical Design Focus: Insulin
Stuart R. Gallant, MD, PhD Insulin is a subject on a lot of people’s minds—C&E News just came out with a cover story on insulin…
Knowledge Management and Knowledge Events (2 of 2)
Stuart R. Gallant, MD, PhD The first part of this two-post series addressed knowledge management and knowledge mapping. In this second part, the use of…
Knowledge Management and Knowledge Mapping (1 of 2)
Stuart R. Gallant, MD, PhD Any successful drug development program generates a massive amount of information. Just the NDA can run to more than 100,000…
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…
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…