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Tag: Intellectual Property

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
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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