Premier Research Fortifies Cell and Gene Therapy Leadership Team

Premier Research announced today the addition of Kenneth Ndugga-Kabuye, M.D., FACMG, as VP, Cell & Gene Therapy to the strategic Cell & Gene Therapy (CGT) Leadership Team. Ndugga-Kabuye joins experts Jessica Merryfield, Executive Director, Cell & Gene Therapy, Olu Aloba, Ph.D., VP, CMC Services and Greg Meyer, VP, Regulatory Affairs in addressing the complexities of CGT development, as evolving regulatory receptivity creates a supportive environment for innovation.

“The speed at which agency guidance is changing, coupled with complicated cell and gene therapy study logistics, is creating demand for early, in-depth strategic planning,” Premier Research Chief Operating Officer Michael Arlotto, Ph.D., said. “With the addition of Dr. Ndugga-Kabuye, our team is purpose-built to minimize development risks through strategic regulatory support, expert-led chemistry, manufacturing and controls (CMC) strategies and data-driven clinical execution.”

The fluid nature of guidance and backlog of CGT agency work is creating a high-stakes regulatory landscape. In addition, lack of CMC expertise among sponsors is causing many to experience otherwise avoidable issues related to product quality, safety, consistency and timely delivery. Establishing a clear and cohesive regulatory strategy early on, complete with CMC strategies and objectives, is critical for sponsors. Forging the right partnerships to support both planning and execution saves sponsors significant time and money and ensures a seamless transition from concept to submission to clinic.

“Cell and gene therapy approval pathways are highly variable among regulatory agencies globally,” said Ndugga-Kabuye. “We develop integrated strategies from knowledge gathered in frequent agency engagements. We have a complete team of regulatory affairs, CMC, medical and clinical operations experts who are focused on scalable solutions. From safety considerations to complex vein-to-vein logistics, the breadth of our experience across molecule types and therapeutic areas is what differentiates us in the CGT space.”

Premier Research has conducted over 60 CGT studies since 2015, spanning disease areas that include oncology, hematology, rare disease, neurology and metabolic disorders.