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Knowledge

March 1, 2025

Preparation of an Investigational New Drug (IND) Application

Clinical, CMC, Knowledge, Pharmaceutical Development, Pharmaceutical Manufacturing, Planning, Pre-Clinical, Risk Management

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…

Stuart Gallant
February 20, 2025

The 4 Axes of Drug Development Readiness

Clinical, CMC, Finance, Knowledge, Oral Drugs, Parenteral Drugs, Patent, Pharmaceutical Development, Pharmaceutical Manufacturing, Planning, Pre-Clinical, Raw Materials, Risk Management

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…

Stuart Gallant
October 16, 2023

Project Management:  Creating a Timeline

CMC, Knowledge, Planning, Risk Management

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…

Stuart Gallant
November 9, 2022

Selecting and Working With a Contract Manufacturer

CMC, Knowledge, Logistics, Pharmaceutical Development, Pharmaceutical Manufacturing, Planning, Pre-Clinical, Raw Materials, Risk Management

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,”…

Stuart Gallant
June 22, 2022

The Design Process

CMC, Knowledge, Pharmaceutical Manufacturing, Planning

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…

Stuart Gallant
January 21, 2022

Knowledge Management and Knowledge Events (2 of 2)

CMC, Knowledge, Pharmaceutical Manufacturing

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…

Stuart Gallant
January 21, 2022

Knowledge Management and Knowledge Mapping (1 of 2)

CMC, Knowledge

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…

Stuart Gallant

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