In evaluating patient response to treatment of solid tumors, the nearly decade-old RECIST 1.1 guideline remains the gold standard. But the implementation earlier this year of the iRECIST guidance is focusing attention on how the many wide-ranging approaches to tumor assessment interrelate, and how they rank in relevance — today and looking forward. It all...
The most prevalent gauge of efficacy in the study of fibromyalgia drugs is — no surprise here — pain relief. But analgesic effect alone is not a sufficient measure in the eyes of the FDA, which seeks evidence of overall benefit and improvement in patient function when evaluating treatments for a condition commonly associated with...
Dr. Thomas Laage, Director, Product Development Consulting and Regulatory Medical Writing Support shares more about his participation in MIT’s Hacking Medicine Grand Hack Weekend. As I mentioned in my last post, I was excited to participate in MIT’s Hacking Medicine Grand Hack. I paired up with two other attendees to develop and pitch our idea to the...
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...