Fellow Focus in Four: Joshua Skydel, MD, Rheumatology, Allergy, and Immunology

Yale holds an important place in the history of rheumatology. Many people know that Lyme disease was first described at Yale, but the section has also included leaders from across our field, from bench researchers who have made foundational discoveries in basic immunology, to clinical researchers who lead U.S. Food and Drug Administration (FDA) advisory panels and write the guidelines we use every day to treat countless rheumatic diseases.

I was excited to have the opportunity to come to Yale as a fellow, to learn from such experts at the bedside, and to collaborate with old and new mentors to identify and answer policy questions relevant to the practice of rheumatology.

I'm also from the New Haven area, so I was thrilled at the chance to come home and practice in the community where I grew up!

My research background is in regulatory science, and much of my work to date has evaluated the evidence generated for new drugs and biologics after they are approved by the FDA.

Traditionally, post-approval research about drugs has not received the same attention as the clinical trials that lead to FDA approval, but these studies are incredibly important for understanding the risks and benefits of therapeutics when they are used for new indications, or for patient populations that were not enrolled in pre-approval trials. The FDA has stated its interest in using real-world data as another means of evaluating how therapeutics perform after approval, but our systems for collecting and analyzing the necessary data from electronic medical records are in their earliest stages.

One of my goals as an academic rheumatologist is to develop methods for using real-world data to evaluate the safety and effectiveness of disease-modifying antirheumatic drugs (DMARDs). The last 25 years have seen dozens of DMARDs approved by the FDA, but there is still uncertainty over which patients are most likely to benefit from specific therapies.

Using computational methods, I hope to develop clinical prediction tools to help guide treatment decisions for conditions like rheumatoid arthritis and to answer questions relevant to patients, clinicians, and policymakers. Advocacy is another important outcome of this work. I hope to draw attention to issues affecting patients with rheumatic diseases, such as in a recent Commentary advocating for improving biosimilar access that I published in the BMJ with colleagues at the Yale Collaboration for Regulatory Rigor, Integrity and Transparency (CRRIT).

As an undergraduate, I had opportunities to intern with my congresswoman one summer, and at a pharmaceutical company the next. While I didn't end up pursuing either of these career paths directly, the experiences left me fascinated by the laws and regulations that influence everything from reimbursement to our fundamental trust in the safety and efficacy of our medicines.

I later came to Yale as a visiting medical student to work with Dr. Joseph Ross, who is a health services researcher and a leading expert on U.S. pharmaceutical policy. Dr. Ross mentored me through my first research project and taught me to think critically about interactions between the FDA and the pharmaceutical industry that shape the clinical evidence generated for new therapies, and what they mean for our patients. To this day, he is one of my closest mentors, and I've carried his lessons in patient-oriented policy research into the world of rheumatology!

I love the local music scene in New Haven, and I'm working up the courage to one day play guitar at an open mic night!

Rheumatology, Allergy and Immunology, one of 10 sections in the Yale Department of Internal Medicine, is dedicated to providing care for patients with rheumatic, allergic and immunologic disorders; educating future generations of thought leaders in the field; and researching fundamental questions of autoimmunity and immunology. To learn more, visit Rheumatology, Allergy and Immunology.