Karen Kesler, Ph.D.

Associate Vice President, Federal Research Science

Karen Kesler, Ph.D.

Associate Vice President, Federal Research Science

Conducting pediatric and rare disease studies at Rho for more than 20 years, Karen Kesler has provided oversight and full management support for over 10 rare disease studies. She has also directed several studies requiring the oversight of data safety monitoring boards and data monitoring committees.

Beginning as a Statistician and later a Lead Investigator, Dr. Kesler climbed the ranks to lead the Coordinating Center for the Comprehensive Sickle Cell Centers as the Primary Investigator, where she helped design highly complex trials, including multi-therapeutic, adaptive design, and registry studies. Funded by the National Heart Lung and Blood Institute, this group has provided seminal research studies in the area of sickle cell and essentially laid the groundwork for much of the current research.

In addition to rare disease-focused research, Dr. Kesler is deeply interested in methods for designing more efficient Phase 2 and 3 trials and is an industry expert in adaptive design. She has written protocols, statistical analysis plans, and performed the analyses for many adaptive studies, including sample size recalculations, pruning designs, Bayesian dose escalation studies, and adaptive randomizations. She has given numerous professional presentations and has over 15 publications and manuscripts to her credit.

Dr. Kesler earned a doctorate degree in biostatistics from the University of North Carolina at Chapel Hill.

Why sickle cell?

“Back in the 1920s, sickle cell was one of the very first diseases where its genetics were described. But even with straightforward Mendelian genetics, we still don’t understand why some children have multiple strokes by age 5, and others have relatively mild symptoms. We also have only identified three treatments, two of which are toxic. There is so much to be discovered in this area and patients need help fighting this incredibly debilitating disease with so many comorbid conditions. Good research and new treatment options are desperately needed in sickle cell, and if I can help design and run solid studies that get new therapies approved quickly, I’ll feel like I’ve actually done something to help those suffering from this disease.”

This is what drives Dr. Kesler:

“I’ve always been attracted to the ability to use science and quantitative measures to help people. As I got older, I’ve realized it’s much more complex. Not only do we need to do research, we need to do good research, quickly and safely. This continues to be the driving force in my career.”

Content by Karen Kesler, Ph.D.


Protocol Design: What You Need to Know to Ensure a Successful Study

Solid protocol design is critical to clinical development.  No matter how well executed a clinical study is, if the underlying design is flawed, it wasn’t worth doing.  In this webinar, Dr. Shoemaker and Dr. Kesler will walk through the process of developing a protocol, explain the major considerations, and point out common mistakes and challenges.