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Tag: Patent

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
January 4, 2024

Plant-Based Drug Discovery—Nature’s Pharmacy

Analytical, Antibiotics, CMC, Patent, Pharmaceutical Development, Pharmacy, Pre-Clinical

Stuart R. Gallant, MD, PhD Before there was a pharmaceutical industry, humans looked to plants as source of medicines.  Today’s post focuses on medicines derived…

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
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
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 24, 2022

Anti-TNF Medications

Clinical, Finance, Marketed Products, Medical, Parenteral Drugs, Patent, Pharma Economics, Pharmaceutical Development, Pharmacy

Stuart R. Gallant, MD, PhD I have a weakness for old Hollywood movies.  The movie still that appears above this paragraph depicts John Carradine in…

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 25, 2022

Pharmaceutical Design Focus:  Clot Busters (2 of 2)

Clinical, CMC, Finance, Marketed Products, Medical, Parenteral Drugs, Patent, Pharma Economics, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmacy, Portfolio Management, Raw Materials

Stuart R. Gallant, MD, PhD In the first part of this post, we looked at urokinase.  In the second part, we will look at tissue…

Stuart Gallant
August 25, 2022

Pharmaceutical Design Focus:  Clot Busters (1 of 2)

Clinical, CMC, Finance, Marketed Products, Medical, Parenteral Drugs, Patent, Pharma Economics, Pharmaceutical Development, Pharmaceutical Manufacturing, Pharmacy, Portfolio Management, Raw Materials

Stuart R. Gallant, MD, PhD This November will be the 35th anniversary of the approval of tissue plasminogen activator (tPA, alteplase) a leading treatment for…

Stuart Gallant
April 3, 2022

Lipid Nanoparticles for Covid-19 Vaccines

CMC, Covid-19, Marketed Products, Parenteral Drugs, Patent, Pharmaceutical Manufacturing, Pharmacy, Raw Materials

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…

Stuart Gallant
March 22, 2022

Pharmaceutical Design Focus:  Factor VIII (2 of 2)

Clinical, CMC, Finance, Marketed Products, Parenteral Drugs, Patent, Pharma Economics, Pharmaceutical Manufacturing

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…

Stuart Gallant
January 1, 2022

Lessons Learned: Documenting Your Intellectual Property and Defending It

Patent

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…

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
December 18, 2021

Intellectual Property (2 of 3)

Clinical, Patent, Pharma Economics, Pharmaceutical Manufacturing, Royalty

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…

Stuart Gallant

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