Bernard Ilson, MD, FACP, is a Therapeutic Medical Director at Medpace, providing expert support for nephrology development programs. He is a
nephrologist with over 24 years of experience in clinical drug development and carried several drugs through from early phase development to regulatory approval and product launch.
He has been Principal Investigator for more than 200 clinical trials. Dr.
Ilson is board certified in Internal Medicine, Nephrology/Hypertension, and Clinical Pharmacology.
US Medical Device Regulations and Regulatory Landscape
Vice President Regulatory Affairs, Medpace Medical Device MORE
Medpace has the experience to conduct trials in renally-impaired patients, including patients currently undergoing dialysis, and in patients
suffering from diabetic nephropathy as well as other chronic kidney diseases (CKD).
Our expertise in nephrology drug development enables us to collaborate closely with sponsors on clinical and regulatory aspects of their
drug development programs. Our multinational network of investigative sites specialized in the nephrology therapy area, and collegial
relationships with these sites provides sponsors with confidence that programs are completed on time and within budget.
Medical and Regulatory Expertise
Medpace has long been considered an industry leader in drug development for diabetes, obesity, and metabolic disorders. More recently,
Medpace has conducted several large trials in diabetic nephropathy patients and CKD patients and, as a result, has developed the
relationships and therapeutic expertise for development projects dealing with renal disorders. Medpace understands the complex metabolic
conditions that cause CKD and, perhaps more importantly, understands the medical complications experienced by patients with CKD and
Early Stage Renal Disease (ESRD). In addition, Medpace has a working knowledge of the international landscape of nephrology investigative sites which regularly
participate and successfully enroll in nephrology studies.
Recent examples of Medpace experience in Nephrology studies
- Full conduct of two large international Phase III diabetic nephropathy studies.
- Phase II-III Overt nephropathy study, involving 272 Investigative sites in 23
countries (including the US) and approximately 2,400 randomized patients.
- Several CKD studies evaluating novel phosphate-binding agents in patients with
severely impaired renal function.
- Study in patients with diabetic nephropathy and stage 4 CKD, evaluating safety
and tolerability of a novel anti-diabetic compound.
>> Click here to learn more about
Medpace's capabilities and therapeutic focus on nephrology.