Stuart R. Gallant, MD, PhD With around 25,000 drugs in clinical development globally at any given moment, deals to purchase and to sell developmental molecules…
Marketed Products
Product Recalls
Stuart R. Gallant, MD, PhD There are 20,000 to 25,000 prescription and OTC medications licensed in the United States, and every year there are about…
Pharmaceutical Process Scale-Up
Stuart R. Gallant, MD, PhD A friend of mine who has been employed in pharmaceutical manufacturing for decades has a saying regarding process scale up. …
Contract Manufacturing in the Age Tariffs
Stuart R. Gallant, MD, PhD Almost three years ago, PharmaTopo carried a post describing the process of selecting and working with a contract manufacturer [1]. …
Pharmaceutical Shelf-Life Determination
Stuart R. Gallant, MD, PhD Pharmaceutical shelf-life determination affects patient safety by assuring that the strength, quality, purity, and potency of an investigational or commercial…
Nicotine and Vapes
Stuart R. Gallant, MD, PhD Humans have been smoking tobacco for more than 10,000 years, but e-cigarettes (“vapes”) have only existed for less than two…
So, You Want to Consult
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…
Solving Drug Shortages
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…
Vaccines for Lyme Disease
Stuart R. Gallant, MD, PhD In 1991, Helmut and Erika Simon, two German tourists hiking in the Alps near the Austrian/Italian border when they saw…
Pharmaceutical Product Launch
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…
Anti-TNF Medications
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…
Pharmaceutical Patent Strategy
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. …
Moderna’s Bivalent Booster
Stuart R. Gallant, MD, PhD Back in April, PharmaTopo posted on lipid nanoparticle formulations for Covid-19 vaccines [1]. Because the Moderna bivalent vaccine recently arrived…
Pharmaceutical Design Focus: Clot Busters (2 of 2)
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…
Pharmaceutical Design Focus: Clot Busters (1 of 2)
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…
Lipid Nanoparticles for Covid-19 Vaccines
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…
Payment for Pharmaceuticals
Stuart R. Gallant, MD, PhD The United States has a mixed public and private insurance system for health care. Payments for pharmaceuticals are provided through…
Pharmaceutical Design Focus: Factor VIII (2 of 2)
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…
Pharmaceutical Design Focus: Factor VIII (1 of 2)
Stuart R. Gallant, MD, PhD Today’s post is a big story involving genetic engineering, pharmaceuticals, intellectual property, and economics. You will recall from the first…
Pharmaceutical Design Focus: Insulin
Stuart R. Gallant, MD, PhD Insulin is a subject on a lot of people’s minds—C&E News just came out with a cover story on insulin…