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.
Blog Post
Diversity Action Plans: A New Requirement for Phase 3 Clinical Trials. Are You Ready?
Diversity Action Plans will soon be required for phase 3 clinical trials and other pivotal studies of drugs and biological products conducted in the US. Are you ready for this requirement?
Webinar
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.
Webinar
Accelerating Clinical Development with Expanded Access
Expanded Access can be leveraged to advance and even accelerate clinical development of treatments for serious or life-threatening conditions. This webinar examin
Article
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.
Blog Post
How to Determine the Appropriate Listed Drug for Your 505(b)(2) Product Development Program and NDA
To obtain approval for a new product via the 505(b)(2) pathway relying upon the Agency’s findings of safety and efficacy for a previously-approved drug, the applicant must explicitly identify at least one “listed drug” for which FDA has made a finding of safety and effectiveness, containing the same active ingredient as the applicant’s new product.
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.
Blog Post
505(b)(2) Regulatory Pathway: What are the Advantages and Does Your Product Qualify?
The advantages afforded the 505(b)(2) applicant are significant in that the applicant is able to reference safety and efficacy data in the marketing application of the innovator product rather than conduct costly preclinical and clinical studies. Find out if your product qualifies.
Webinar
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.
Webinar
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.
