Vice President, Regulatory Strategy & Biometrics
Vice President, Regulatory Strategy & Biometrics
Joining the team in 2007, Rob Woolson brings 20 years of experience as an applied statistician to his current role as Rho’s Vice President of Regulatory Strategy & Biometrics.
Mr. Woolson has an extensive background working with small biotech and pharmaceutical companies to successfully bridge and navigate the biometrics, CDISC data standards, and regulatory requirements of drug and biologics development. He has advised and supported sponsor companies through 12 marketing applications in several therapeutic areas, including playing a vital role in numerous FDA and Advisory Committee meetings.
Much of Mr. Woolson’s work has focused on psychiatry-related product development, with an emphasis on therapies related to pediatric and adult ADHD. He has led the study design, analytical planning, regulatory data standards compliance, and ISS and ISE analysis design and execution in numerous pediatric and adult ADHD development programs, including 4 products approved by the Division of Psychiatry Products (DPP).
He supports regulatory agency interactions in the ADHD setting, including representing sponsors on multiple occasions at FDA DPP meetings and teleconferences, as well as authoring numerous responses to FDA queries.
Mr. Woolson’s educational background includes a Bachelor’s degree in mathematics from Northwestern University, a Juris Doctor degree from DePaul University, and a Master’s degree in applied statistics from DePaul University.
This is what drives Rob:
“Moving a product from early development through a regulatory marketing application rarely progresses in a straight line, and helping sponsors overcome regulatory, analytical, and other challenges is very rewarding to me. However, the impact that our work has on patients’ lives really makes the work we do worth it. On more than one occasion, I have been supporting a sponsor through an FDA Advisory Committee and have been struck by the public patient testimonials during these meetings. These testimonials remind me how much what we do really matters to public health and to individual patients.
And I have been fortunate to have been a part of numerous successful and impactful development programs throughout my career. Many of my engagements with sponsors have lasted years, through numerous studies and phases of development. Those phone calls I’ve received from sponsors on the day a product approval letter arrived have been some of the most rewarding days of my career. Knowing that I contributed, in some way, to bringing a safe and effective therapy to patients … that’s all the drive I need.”
Content by Rob Woolson
Decentralized clinical trials (DCTs) are playing a role in an increasing number of drug and biologics development programs. While much has been written about the potential benefits that these trials can bring, our experience in this space has taught us that there are several questions that sponsors should be asking as they consider the end-to-end execution of a DCT.
CROs: The Tip of the Spear in Maximizing the Value of Hybrid, Virtual, and Synthetic Clinical Trials
Hybrid, Virtual, and Synthetic clinical trials are becoming a part of an increasing number of drug and biologics development programs. In this webinar, Rho experts discuss how their approach to maximizing the benefits of decentralized trials helps sponsors get the most out of their trials through offering solutions that bridge the gap across an ever-increasing number of data collection systems and
leverage the information real-time.
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.
The COVID-19 pandemic is having a substantial impact on many ongoing clinical studies in all phases of product development. Numerous difficult decisions are being made and steps are actively being taken to ensure the safe execution, or future resumption, of ongoing studies. While patient safety is paramount and should drive all study conduct related decisions, many of these decisions can impact the interpretability of estimates of efficacy at study conclusion.
Marketing application submissions, including NDAs, BLAs, and PMAs in the US, are the culmination of years of research and the final hurdle before a product makes it to market. This webinar will share tips on regulatory strategy, data integration and readiness, and electronic publishing that can help you avoid common pitfalls in the submissions process.
Keys to Success for Your Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)
The integrated summary of safety (ISS) and the integrated summary of efficacy (ISE) are critical components of your new drug application (NDA) submission. Presenting the FDA with a coherent and clear integration of the data from your product development program is imperative and requires a sound strategy and a skillful approach.