Meet Kara Shah, MD, PhD, Medical Monitor
Medpace is pleased to announce that Dr. Kara Shah has joined Medpace’s Dermatology medical leadership team. Dr. Kara Shah is a board-certified dermatologist with over 15 years of experience in clinical practice, academic medicine, and clinical trial execution. Her areas of expertise include psoriasis, atopic dermatitis, and other inflammatory skin diseases; hidradenitis suppurativa; genodermatoses, including epidermolysis bullosa and congenital ichthyoses; skin and soft tissue infections, including onychomycosis and impetigo; and bullous pemphigoid, pemphigus vulgaris, alopecia areata, vitiligo, and other autoimmune skin diseases. She is a diplomate of the American Board of Pediatrics, and the American Board of Dermatology and holds board-certification in general pediatrics, general dermatology, and pediatric dermatology.
Unique to Medpace is our emphasis on scientific and medical expertise. In her role as a medical monitor, Dr. Kara Shah will facilitate the development of a strategic plan that provides expert medical leadership and guidance to ensure the successful development and execution of your clinical trial.
In this brief interview, we learn more about her background and the expertise that Dr. Shah brings to Medpace.
Tell us about your background: what expertise do you bring to Medpace?
In addition to training in general pediatrics as well as in general and pediatric dermatology, I have a doctorate in molecular and cellular biology. While in academic and private practice, I had the opportunity to diagnose and manage a wide range of dermatologic conditions in both children and adults. I was also able to participate in many clinical trials in indications such as psoriasis and atopic dermatitis as an investigator. These experiences solidified my interest in drug and device development. Through my work at Medpace, I am well-situated to leverage these experiences and interests by working closely with colleagues and sponsors to advance the development of novel and effective therapeutics.
How does your prior experience translate into the work you do with Medpace?
As a medical monitor at Medpace, I am able to utilize the knowledge gained from my experiences in clinical trials and in clinical practice to better assist sponsors with the design and execution of their clinical trials. I have a thorough understanding of disease pathophysiology, standards of care, outcome measures, and patient quality of life concerns in addition to a thorough understanding of the pathway from drug development to marketing approval.
What drew you to Medpace?
One of the distinctions between Medpace and other CROs was the emphasis that Medpace places on full integration of the medical monitor into each clinical trial from the earliest point of contact through regulatory approval. In addition, the depth and diversity of therapeutic expertise of the medical monitors is unparalleled and is an important component of the success of Medpace. It is very exciting to work with such innovative small- and mid-sized biotechnology and pharmaceutical companies.
What are some challenges, considerations, or risks that are specific to dermatology clinical development?
Dermatology is such an exciting therapeutic area with regards to new drug development for both common skin conditions such as atopic dermatitis and for rare diseases such as congenital ichthyoses. Some of the challenges in clinical trial execution in dermatology include access to patients with the indication of interest, whether with regards to rare disease status or to competing trials for common indications; the subjectivity of assessments that rely on skin examination; and specific challenges with regards to the inclusion of pediatric patients in clinical trials given the high prevalence of some skin diseases in children and the large unmet need for approved therapeutics in children.
How does imaging play a key role in dermatology research?
Given that the skin is readily accessible from a visual perspective, skin imaging can be an important component of various assessments. Advances in skin imaging techniques and standardization of image capture allow for reproducible, high-quality images that can be used to quantify outcome measures and to address some of the issues that arise due to the subjective nature of many standard skin disease assessments that rely on physical examination.
What motivates you and your interest in clinical research – specifically in dermatology?
I was drawn to dermatology due to the complexity and breadth of skin diseases; over 3000 distinct skin diseases have been described! In addition, there is a tremendous need for more effective, safer treatments for so many skin diseases, in particular for many chronic inflammatory skin diseases. Many skin diseases are very stigmatizing and can be associated with symptoms such as chronic pain or itching, which can result in a significant negative impact on quality of life. Through my work at Medpace, I am fortunate to be able to use my extensive medical and basic science training to contribute to the development of better therapeutics for a variety of skin conditions, which is very rewarding. In addition, I have a special interest in pediatric dermatology and in advancing therapeutic options for children with both common, chronic skin diseases such as psoriasis and for those with rare and/or potentially life-threatening skin conditions such as epidermolysis bullosa.
Learn more about Medpace’s dermatology expertise.