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Tag: Risk Management

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
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
October 1, 2023

Tactics for Managing the Unforeseen

CMC, Pharmaceutical Development, Pharmaceutical Manufacturing, Risk Management

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…

Stuart Gallant
January 18, 2023

Solving Drug Shortages

CMC, Finance, Marketed Products, Pharma Economics, Pharmaceutical Manufacturing, Pharmacy, Planning, Portfolio Management, Risk Management

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…

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
September 20, 2022

Pharmaceutical Patent Strategy

Clinical, CMC, Marketed Products, Patent, Pharmaceutical Development, Pharmacy, Planning, Portfolio Management, Risk Management

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. …

Stuart Gallant
August 9, 2022

Pharmaceutical Supply Chain Risk Management

CMC, Finance, Logistics, Pharmaceutical Development, Pharmaceutical Manufacturing, Planning, 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…

Stuart Gallant
August 6, 2022

Pharmaceutical Decision Making and Fundraising

Clinical, Finance, Pharma Economics, Pharmaceutical Development, Planning, Portfolio Management, Pre-Clinical, Risk Management, Uncategorized

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…

Stuart Gallant
July 29, 2022

Why and Where You Should Still Be Wearing a Mask

Covid-19, Medical

Stuart R. Gallant, MD, PhD I am sure many of you are so done with Covid 19 that you could not imagine wearing a mask…

Stuart Gallant

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