Kevin Barber, Ph.D.
Senior Vice President, Regulatory Strategy & Submissions
Kevin Barber, Ph.D.
Senior Vice President, Regulatory Strategy & Submissions
Kevin Barber, PhD, RAC, PMP, serves as Rho’s Senior Vice President of Regulatory Strategy & Submissions, providing extensive strategic leadership, scientific knowledge, and regulatory expertise to support Rho’s clientele in the development and execution of integrated regulatory strategies and clinical development plans for drugs, biologics, and medical devices. Dr. Barber has close to 25 years of experience in regulatory affairs and product development across all phases, from preclinical through product launch and post-approval life cycle management. Dr. Barber holds a PhD in Biomedical Engineering from Duke University and 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. He has significant experience moderating regulatory authority meetings and preparing and filing regulatory submissions, including more than 45 US INDs and more than 40 marketing applications in the US, Canada, Europe, and other regions.
Content by Kevin Barber, Ph.D.
Webinar
Regulatory Agency Meetings – Your guide to EOP2 meeting preparation
The end-of-phase 2 (EOP2) meeting with FDA is a critical milestone in your development program and likely the most important interaction you will have with the Agency. Getting the most from this meeting can help successfully launch your phase 3 program and help you begin preparing for your marketing application (NDA/BLA) submission. Companies nearing completion of their phase 2 studies or who are planning phase 3 programs will benefit from this webinar.
Blog Post
Development of COVID-19 Therapies: FDA Pathways
At a high level, there are basically 3 (inter-related) programs that FDA has in place to make drug product available for COVID-19 patients in an expedited manner or under an “emergency” use status for products that are ready to initiate clinical studies, are already undergoing clinical development prior to approval of a new drug application, or are already approved in other indications: CTAP, EUA and Expanded Access.
Webinar
Right-to-Try or Right-to-Ask? Understanding Right-to-Try and FDA’s Expanded Access
This webinar explores both Right-to-Try legislation and existing FDA Expanded Access Programs, including understanding sponsor responsibilities under these programs and when products may be eligible for these programs, evaluating options such as treatment protocols, treatment INDs, and emergency use, and discussing development risks associated with participation in these programs.
Blog Post
Master Protocols and the New FDA Guidance
In September of 2018, FDA released a new FDA guidance on master protocols. So, what are master protocols, how can they benefit sponsors and patients, and what are the challenges? Kevin Barber shares his thoughts and expertise on the topic.
