Stuart R. Gallant, MD, PhD PharmaTopo is a strong advocate of higher education. College and graduate school improve our thinking processes, help us build career…
Knowledge
Getting The Most From AI
Stuart R. Gallant, MD, PhD All of us have had the experience of working with a good colleague who helps us be productive and who…
Small Molecule and Antibody Release Specifications—Lessons Learned
Stuart R. Gallant, MD, PhD Drug substance and drug product release specifications have numerous uses throughout the product lifecycle. They guide process development and provide…
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…
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,”…
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…
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…