Kevin Barber, Ph.D.

Vice President, Regulatory Strategy & Submissions

Kevin Barber

Kevin Barber, Ph.D.

Vice President, Regulatory Strategy & Submissions

Combining extensive strategic leadership, scientific knowledge, and regulatory expertise, Dr. Kevin Barber supports Rho’s clientele in the development and execution of integrated regulatory strategies and clinical development plans for drugs, biologics, and medical devices.

With close to 25 years of experience in regulatory affairs and product development, Dr. Barber is a regulatory expert across all phases from preclinical through product launch and post-approval life cycle management. His significant experience moderating regulatory authority meetings and preparing and filing regulatory submissions includes more than 45 US INDs and more than 40 global marketing applications.

Throughout his career, Dr. Barber has participated in development programs for the treatment of infectious diseases across a range of products including new chemical entities, IVIG products, peptides, botanicals, and reformulations of existing chemical entities. His contributions for various antiviral, antifungal, and antibacterial indications have included the development of integrated regulatory strategies and clinical programs, facilitating regulatory agency interactions, and leading the preparation and submission of 8 INDs and 3 marketing applications.

Dr. Barber has participated in development programs for more than 20 therapies to treat rare diseases, including 7 approved marketing applications for orphan products across various infectious diseases, neurologic, pulmonary, metabolic, gastrointestinal, and oncology indications. For these products, his contributions have included developing integrated regulatory strategies and clinical programs, facilitating regulatory agency interactions, and leading the preparation and submission of clinical trial applications and marketing applications.

Prior to joining Rho, he served in leadership positions including Senior Director of Regulatory Affairs and Project Management at a midsize global CRO, Vice President of Regulatory Affairs at a biotech startup, and Vice President of Global Brand Regulatory Affairs at a midsize pharmaceutical company.

Dr. Barber holds a Ph.D. in Biomedical Engineering from Duke University.

Why infectious and rare disease?

“These can be extremely challenging development programs, often with regulatory and clinical pathways that are unclear. This means that interactions with the FDA and other regulators become very interesting because we’re educating ourselves as well as the regulators on the disease and the most appropriate ways to assess the therapy. We need to learn as much as we can about the natural history of the disease, and how to move the therapy forward from a clinical and regulatory perspective, but more importantly from a patient perspective, focusing on what is clinically meaningful for the doctor as well as what makes a difference in the lives of the patients.”

This is what drives Kevin:

“I’ve been working in this industry for more than 25 years, and what drives me today is what drove me at the start of my career – getting products approved and into the hands of patients and healthcare providers to improve the lives of patients. I started my career in basic research, but with my engineering background, I felt like I could contribute more by moving away from the benchtop and into product development – focusing on regulatory strategy, integrated development, and project management. Whether I’m helping a client by facilitating the development of key benefit and risk messages for a New Drug Application, creating a regulatory strategy for a combination product in early phase development, or authoring an End-of-Phase 2 meeting package, I’m passionate about driving products to approval and commercialization.”