Kevin Barber, Ph.D.

Senior Vice President, Regulatory Strategy & Submissions

Kevin Barber, Ph.D.

Senior 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.”

Content by Kevin Barber, Ph.D.


Mapping Out Oncology Development: Filling Gaps and Avoiding Pitfalls

Nine out of 10 clinical trials for new drugs fail; Oncology drugs have a 3.4 percent probability of succeeding. Still, cancer drugs can and are being commercialized. From 2003 to 2020, 124 oncology therapies were approved by FDA. What makes this possible? Knowing the key factors to consider at each juncture of development is critical to build the right roadmap for your product. In this webinar, you will learn how examining each step of drug development helps sponsors find success for cancer therapies. Topics include: 1. How to fill gaps and avoid pitfalls of oncology drug development. 2. The importance of early phase planning, from optimum dosage to formulation, 3. The role of end-of-phase planning, such as regulatory feedback.


Clinical Studies Required for a 505(b)(2) Development Program

A very common yet very critical question for a 505(b)(2) development program is “What clinical studies are needed to support the marketing application?” The clinical program required is very dependent upon the specifics of the new drug product and indication, and the studies necessary to gain approval can range from a single bioequivalence study to a more comprehensive Phase 2 and Phase 3 clinical program.

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Blog Post

FDA COVID-19 Treatment Development Update

With the recent emergency authorizations of the Pfizer-BioNTech COVID-19 vaccine by the regulatory authorities in the United Kingdom, Canada, and United States, we are on the verge of a significant breakthrough in coping with the COVID-19 global pandemic.


Implications of Historical Control Studies for Rare Disease Products

Development programs in rare diseases are becoming a major focus for small biotech and pharmaceutical companies. A crucial consideration is the choice of control group used to assess efficacy. Through recent case studies, we will discuss factors to consider, appropriate analysis, and the critical role that externally controlled studies play in supporting marketing applications for orphan/rare disease products.


Potential COVID-19 Products: Choosing the Right Path with FDA

If you are considering development of a product for treatment of COVID-19 or COVID-19-related indications, ensuring no time is wasted between idea and engaging FDA via the appropriate pathway with all the required information is essential. In this webinar, we’ll review the pathways you might consider, based on the development phase and overall goals for your product, and discuss the information and data necessary to help FDA expeditiously review your proposal and move it forward.