Strategic Program Champion

Originally hailing from Long Island, New York, Scott, made the journey southward to obtain his degree in biology from Virginia Tech.  After completing a clinical trial-based dissertation for his doctorate at Wake Forest University, Scott combined these two experiences to enter the world of pharmaceutical development with a focus on CMC. He found that CMC provides the foundation for conducting a successful clinical trial. As he likes to say, “No matter how well the protocol may be written, a subject cannot be dosed without a viable drug product.”

Scott’s career encompasses extensive CMC regulatory affairs experience with U.S. and internationally based pharmaceutical companies and CROs. He is well-versed in small molecules, biologics, cell and gene therapies, drug-and device combination products. He has authored numerous FDA submissions, including meetings packages, INDs, and successful marketing applications, and has guided pharmaceutical products from early-stage development to commercialization.

For Scott, the variety of products encountered while consulting is one of the most enjoyable aspects of the job, and he relishes helping new, innovative technologies make their way to patients.  Scott prides himself on his collaborative approach, communication skills, and dedication to creative regulatory strategies to drive meaningful business outcomes for clients.

While growing up on the beaches of Long Island, Scott developed a love for the sea and the outdoors.  From scuba diving in Australia, kayaking in Alaska, skiing in Colorado, to camping trips with his children’s scout troop, he strives to maintain a healthy work-life balance.  Scott now resides in Chapel Hill, NC with his wife and two children.