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…
Author: Stuart Gallant
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. …
AI in Pharma R&D and Manufacturing
Stuart R. Gallant, MD, PhD Artificial intelligence is being widely adopted in fields like law, accounting, banking, customer service, marketing, and human resources. These early…
Approval Rate and Development Cost by Drug Category
Stuart R. Gallant, MD, PhD Takeda just announced that it would exit cell-based treatment research [1]. Last year, Takeda had ended development of its non-Hodgkin…
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]. …
Practical Tips to Limit Kid’s Screen Time
Stuart R. Gallant, MD, PhD Parents are facing challenges limiting children’s screen time, including TVs, smart phones, and tablets. Today’s post on PharmaTopo looks at…
Challenges in Sterile Filling
Stuart R. Gallant, MD, PhD Parenteral products require sterility whether they are liquid vials, lyophilized vials, or prefilled syringes. This week’s post on Pharmatopo addresses…
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…
3 Dimensions of Early Pharmaceutical Formulation
Stuart R. Gallant, MD, PhD In the pre-clinical phase of pharmaceutical development, the project team wants to demonstrate drug efficacy in animal models, as well…
Selecting an Analytical Laboratory
Stuart R. Gallant, MD, PhD Analytical testing is required to verify the identity, strength, quality, purity, and potency of investigational and commercial products. The precise…
Small Molecule and Antibody Release Specifications—Lessons Learned
Stuart R. Gallant, MD, PhD Drug substance and drug product release specifications have numerous uses throughout the product lifecycle. They guide process development and provide…
Preparation of an Investigational New Drug (IND) Application
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…
The 4 Axes of Drug Development Readiness
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…
Vaccine Hesitancy
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. …
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…