Accelerating Time to Data in Cell and Gene Therapy Trials

Cell and gene therapy (CGT) development relies on speed, yet scientific complexity and operational bottlenecks can delay the moment that matters most: access to meaningful data. In today’s high-cost, high-stakes environment, sponsors must generate early insights to inform critical go or no-go decisions, strengthen investor confidence and sustain program momentum.

In this webinar, the featured experts will explore the most common barriers slowing the speed-to-data in CGT trials, including protocol complexity and amendments, site selection, patient identification and enrollment, manufacturing & logistics challenges, and data review processes. Attendees will learn practical strategies to streamline study start-up, reduce operational friction and improve coordination across stakeholders without compromising quality. They will also learn how faster access to meaningful data can support stronger trial execution and more confident decision-making in CGT.

Register for this webinar to gain practical insights that can help accelerate timelines, enhance trial execution, and bring you closer to the data that drives confident decision-making.

Speakers

Kenneth Ndugga-Kabuye, MD, FACMG, Vice President, Cell & Gene Therapy, Premier Research

Dr. Ken Ndugga-Kabuye is Vice President, Cell & Gene Therapy at Premier Research. He brings direct experience supporting drug development candidates for clinical studies leveraging innovative approaches in the treatment of disease, inclusive of cell and gene therapies, synthetic biotics, RNA therapies and enzyme replacement therapies.

In previous roles, Dr. Ndugga-Kabuye has supported CRO and biotechnology clients in the ATMP space. Dr. Ndugga-Kabuye is a Clinical Geneticist with residency and fellowship training in Medical Genetics and Genomics from the University of Washington in Seattle, WA, US. He is board-certified by the American Board of Medical Genetics and Genomics in Clinical Genetics and Genomics. He holds a Medical License in Washington State and California. He is a Diplomate of the American Board of Medical Genetics and Genomics. He is a Member of the American Society of Human Genetics (ASHG), the European Society of Human Genetics (ESHG), the American College of Medical Genetics (ACMG), the African Society of Human Genetics (AfSHG), the American Medical Association (AMA) and the American Academy of Pediatrics (AAP).

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Leslie Amos, Executive Director, Program Delivery, Cell & Gene Therapy, Premier Research

Leslie Amos is an Executive Director, Program Delivery in Cell & Gene Therapy (CGT) at Premier Research. She provides strategic support for complex cell and gene therapy programs through key stakeholder engagement and cross-functional program management. Leslie brings over 20 years of experience in global study and portfolio oversight, with a specific focus in the past 10 years on Rare Disease and CGT programs. Her experience spans autologous and allogeneic cell products, gene therapies with complex administrations, procedures and safety follow-ups, as well as other important logistical considerations that impact project delivery.

In her role, she directs and empowers an experienced team of Project Managers and Project Directors that lead global CGT project teams. Through this exceptional leadership and operational expertise, she consistently drives deliverables and project success with her global cross-functional teams and client partners.

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