Stuart R. Gallant, MD, PhD In Danielle Ofri’s recent column in The New York Times “My Patients Used to Be Enthusiastic About the Covid Vaccine. …
Author: Stuart Gallant
Plant-Based Drug Discovery—Nature’s Pharmacy
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…
Wound Care and Healing
Stuart R. Gallant, MD, PhD CAVEAT: THIS POST INCLUDES PHOTOGRAPHS OF TISSUE INJURIES AND MAY CAUSE SOME READERS DISCOMFORT. An 81-year-old, retired accountant is on…
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…
Project Management: Creating a Timeline
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…
Travelers’ Diarrhea
Stuart R. Gallant, MD, PhD Twenty to fifty percent of international travelers develop travelers’ diarrhea—sudden onset of loose stools while traveling. While some of these…
Tactics for Managing the Unforeseen
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…
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…
Trends in Pharmaceutical Autoinjector Design and Use
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…
Subcutaneous Suspensions for Challenging Formulations
Stuart R. Gallant, MD, PhD In today’s post, we will look at subcutaneous suspensions as a way of meeting difficult drug delivery challenges. To decide…
What The Washington Post Got Wrong About Doctors
Stuart R. Gallant, MD, PhD The Washington Post just published an article by Andrew Van Dam, “How much money do doctors really make and why…
Leased Lab Space
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…
Dietary Choices to Support Weight Control
Stuart R. Gallant, MD, PhD People reach a peak bone mass and muscle mass in their early 20s. After that, any increase in weight typically…
Investing in Pharmaceutical Startups
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…
Founding a Pharma Startup
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…
Steroid Hormone Replacement Therapy (Part 2 of 2)
Stuart R. Gallant, MD, PhD Steroid hormone replacement therapy (HRT) is a topic that has been in the scientific and popular press a lot recently. …
Male (Androgen) and Female (Estrogen) Hormone Pharmacology (Part 1 of 2)
Stuart R. Gallant, MD, PhD Steroid hormones are frequently in the news—sometimes in infamy, as in the case of sports doping, but also in many…
Skin pH, Water Content, and Water Loss
Stuart R. Gallant, MD, PhD Our skin does so much for us. Skin protects us against infection and dehydration. Skin allows us to be in…
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…
Oral Delivery of Protein Drugs
Stuart R. Gallant, MD, PhD Proteins and peptides are commonly delivered subcutaneously and by infusion; however, these approaches have disadvantages. Among the chief problems are:…
Immediate, Delayed, and Extended-Release Drug Products
Stuart R. Gallant, MD, PhD The focus of today’s post is oral drug release—immediate, delayed, and extended. Many technologies exist for controlling drug release—the focus…
Selecting and Working With a Contract Manufacturer
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,”…
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…
Amazon’s Push Into Healthcare
Stuart R. Gallant, MD, PhD I was intrigued by Amazon’s recent purchase of One Medical for $3.9B in cash. Amazon is implementing a strategy to…
Pharmaceutical Supply Chain 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…
Pharmaceutical Decision Making and Fundraising
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…
Why and Where You Should Still Be Wearing a Mask
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…
Treatments for Alzheimer’s Disease (2 of 2)
Stuart R. Gallant, MD, PhD Having discussed the pathological processes of Alzheimer’s disease in the first part of this post, the current status of Alzheimer’s…
Treatments for Alzheimer’s Disease (1 of 2)
Stuart R. Gallant, MD, PhD One of the most useful words in medicine is “multifactorial.” Commonly, in science and medicine, we struggle to find a…
Improving the Patient-Doctor Conversation
Stuart R. Gallant, MD, PhD Eventually, all of us need to talk to a doctor or a nurse, maybe about a headache, flu symptoms, or…
The Design Process
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…
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…
Technology Focus: Supercritical Fluid Chromatography
Stuart R. Gallant, MD, PhD This post is the first in an occasional PharmaTopoTM series called “Technology Focus.” Today, we look at supercritical fluid chromatography…
Financial Metrics of Pharmaceutical Companies (2 of 2)
Stuart R. Gallant, MD, PhD In the second part of this two-part post, the topic of valuation will be discussed, followed by how some of…
Financial Metrics of Pharmaceutical Companies (1 of 2)
Stuart R. Gallant, MD, PhD This two-part post looks at pharmaceutical companies and how they are financially structured to survive in a competitive market, to…
Logistics: So, You Want To Move Your Drug?
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,…
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…
Knowledge Management and Knowledge Events (2 of 2)
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…
Knowledge Management and Knowledge Mapping (1 of 2)
Stuart R. Gallant, MD, PhD Any successful drug development program generates a massive amount of information. Just the NDA can run to more than 100,000…
Raw Materials Testing, Starting Materials, and Contact Materials (2 of 2)
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,…
Risk Assessment of Raw Materials and Contact Materials (1 of 2)
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…