Dr. Thomas Laage, Director, Product Development Consulting and Regulatory Medical Writing Support tells us about his experience with MIT’s Hacking Medicine Grand Hack Weekend. It started with an email from Dan Morden, a young biotech entrepreneur in Cambridge whom I had met during a business call several months ago. “MIT’s Hacking Medicine is holding a...
While there is currently no cure for atopic dermatitis (AD) — commonly called eczema — this prevalent condition can often be well managed through conventional drug therapies. Current AD strategies used by dermatologists include symptom relief, patient/parent education, and the prevention of secondary complications. The “Gold Standard” for Mild to Moderate Atopic Dermatitis The most frequently used therapies...
Biologics have revolutionized psoriasis treatment over the last two decades. These targeted immunomodulatory therapies act directly on the cytokine pathways that are upregulated in psoriasis and other autoimmune diseases. Two major classes make up biologics in psoriasis treatment: tumor necrosis factor (TNF) inhibitors and interleukin (IL) inhibitors. TNF Inhibitors TNF inhibitors became the first available biologic...
A little less than five percent of the world’s population are estimated to suffer from more than 7,000 different types of known rare diseases. There are even more medical conditions where those who have them are too embarrassed to talk about what’s wrong or simply don’t know exactly what ails them. Yet, these individuals are...
The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) is a major group providing guidance for design considerations of acute pain clinical trials. IMMPACT is made up of a team consisting of some of the most respected researchers and clinicians in the field of pain medicine. As of 2016, IMMPACT recommends these ten best practices...
Atopic dermatitis (AD), also known as atopic eczema, is a common skin disorder affecting millions of people worldwide. While many cases are mild, AD can take a significant financial and emotional toll on patients and their loved ones. What are the symptoms of atopic dermatitis? AD is characterized by skin barrier function abnormalities and skin...
Psoriasis is an autoimmune disease that affects 7.5 million people in the United States and roughly 100 million worldwide. While its main manifestation is in unsightly, often irritating skin lesions, many patients also experience painful psoriatic arthritis. Additionally, psoriasis often comes with a wide range of other chronic conditions, including Type 2 diabetes, cardiovascular disease and...
Short-duration acute pain management trials involve a variety of complex factors that must be taken into account for successfully evaluating the safety and efficacy of a new analgesic product. These five considerations are key. 1. Choosing the Right Model There are a number of established pain models for clinical research, each with its own type, intensity,...
Knowledge of a disease’s natural history is essential to building the scientific foundation for an effective clinical development program. That’s especially the case when developing drugs to treat rare diseases, which by their very nature are poorly understood. Natural history studies don’t just track the course of diseases over time, but identify demographic, genetic, environmental,...
Designing and conducting psoriasis clinical trials is tricky. After all, psoriasis is a highly variable group of conditions that produce a range of debilitating and often subjective symptoms. So how do researchers assess efficacy in novel psoriasis treatments? Read on for the answer. Considerations for Psoriasis Trials In clinical practice, broad global assessments are used...