Cell and Gene Therapy Expert Dr. Kenneth Ndugga-Kabuye to Lead Clinical Strategy With Collaboration From Operations, CMC and Regulatory Experts

MORRISVILLE, N.C., April 17, 2023 — 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,” Ndugga-Kabuye said. “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. Premier Research’s CGT experts include:

• Kenneth Ndugga-Kabuye, D., FACMG, VP, Cell & Gene Therapy, who has extensive experience in the management and clinical development of CGT assets in both biotech and CRO environments. He is particularly focused in gene therapies (inclusive of gene-modified cell therapies), RNA therapies, synthetic biotics and enzyme replacement therapies. Ndugga-Kabuye is an ABMGG board-certified clinical geneticist and holds medical licenses in California and Washington. Previously, he was Medical Director, Metabolic Diseases at a biotech focused on the development of novel biotherapeutics.
• Jessica Merryfield, Executive Director, Cell & Gene Therapy, who has more than 20 years of clinical research experience, including more than 10 years specializing in CGT. Merryfield leads the design and operational strategy for prospective and ongoing CGT studies. She specializes in coordinating cross-functional teams to deliver complex programs, complete with operational proficiency, regulatory and statistical consulting, medical expertise, patient engagement and strategic development plans. Her extensive background spans all phases of clinical development and numerous therapeutic areas, including pediatrics, rare/ultra-rare disease, cardiology, immunology/autoimmune disorders, dermatology and central nervous system (CNS).
• Olu Aloba, Ph.D., VP, CMC Services, who has more than 35 years in pharmaceutical research and development, pharmaceutical technology and regulatory strategy. He leads the CMC service offerings of Premier Consulting — a Premier Research business unit. These CMC services focus on pharmaceutical development strategizing, planning, execution, and documentation. A registered pharmacist, he is an expert in drug product development, with special expertise in the application of Quality by Design (QbD) to formulation and process development, analytical development and development strategy. Aloba is a co-inventor on several pharmaceutical patents and has authored scientific articles and presented his work at numerous conferences.
• Greg Meyer, VP, Regulatory Affairs, who has been in the pharma, biopharma and medical device industry for more than 30 years. Meyer has gained regulatory approvals in more than 20 countries. With specialty areas that include biologics and drug-device combination products, he has had numerous interactions with FDA, European national and EU regulators and the Australian TGA. He has also worked in the development, submission and commercialization of neuromuscular electrical stimulation (NMES) devices and 505(b)(2) products across oncology, neurology and dermatology.

About Premier Research

Premier Research, a clinical research, product development, and consulting company, is dedicated to helping biotech, specialty pharma, and device innovators transform life-changing ideas and breakthrough science into new medical treatments.

As a global company, Premier Research specializes in the use of innovative technologies for smart study design and trial management to deliver clean, conclusive data to sponsors.

Whether it’s developing product lifecycle strategies, reducing clinical development cycle times, securing access to patients, navigating global regulations, maximizing the impact of limited rare disease data, or providing expertise in specific therapeutic areas, Premier Research is committed to helping its customers answer the unmet needs of patients across a broad range of medical conditions. Visit premier-research.com.

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Premier Research
Joe Lindroos
Vice President, Marketing
Joe.Lindroos@premier-research.com
+1 450 577 1036