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Tag: Planning

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
September 27, 2023

So, You Want to Consult

CMC, Marketed Products, Pharmaceutical Development, Pharmaceutical Manufacturing, Planning

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…

Stuart Gallant
September 11, 2023

Trends in Pharmaceutical Autoinjector Design and Use

Clinical, CMC, Parenteral Drugs, Patent, Pharma Economics, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmacy, Planning, Pre-Clinical

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…

Stuart Gallant
June 19, 2023

Leased Lab Space

Finance, Logistics, Pharma Economics, Pharmaceutical Development, Planning

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…

Stuart Gallant
March 26, 2023

Investing in Pharmaceutical Startups

Finance, Patent, Pharmaceutical Development, Pharmacy, Planning, Pre-Clinical

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…

Stuart Gallant
March 11, 2023

Founding a Pharma Startup

Finance, Patent, Pharmaceutical Development, Pharmacy, Planning, Pre-Clinical

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…

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 29, 2022

Pharmaceutical Product Launch

CMC, Insurance, Marketed Products, Medical, Patent, Pharma Economics, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmacy, Planning

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…

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
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
February 12, 2022

Logistics:  So, You Want To Move Your Drug?

Logistics, Planning

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,…

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 17, 2022

Raw Materials Testing, Starting Materials, and Contact Materials (2 of 2)

CMC, Pharmaceutical Manufacturing, Planning, Pre-Clinical, Raw Materials, Uncategorized

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,…

Stuart Gallant
January 17, 2022

Risk Assessment of Raw Materials and Contact Materials (1 of 2)

CMC, Pharmaceutical Manufacturing, Planning, Raw Materials

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…

Stuart Gallant
December 31, 2021

Drug Development Plan

Clinical, CMC, Patent, Planning, Pre-Clinical

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)…

Stuart Gallant

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