Cell and gene therapy programs bring together scientific innovation and clinical complexity unlike many traditional drug development programs. From selecting meaningful biomarkers and designing fit-for-purpose laboratory strategies to managing patient safety, site execution, sample logistics, and evolving clinical considerations, decisions made early in development can have significant downstream implications.
In this webinar, Medpace experts from medical, laboratory, and clinical operations will explore how an integrated approach to cell and gene therapy development can help Sponsors identify and address potential risks before they affect study timelines, data quality, or clinical execution.
- A Medpace Medical Director will provide a clinical perspective on the unique considerations associated with developing cell and gene therapies, including translating the underlying science and therapeutic goals into practical clinical trial strategies.
- One of our very own Medpace Reference Laboratories (MRL) scientist will examine how integrated MRL expertise can support complex cell and gene therapy programs through specialized molecular, biomarker, flow cytometry, and bioanalytical capabilities helping generate actionable data, anticipate challenges, and keep development moving forward.
- Two Clinical Operations experts will then bring the discussion into the realities of trial execution, addressing how complex laboratory requirements, patient and site considerations, sample handling, product logistics, and study-specific processes must work together across the clinical development program. The panel will highlight where disconnects between scientific intent and operational execution can introduce avoidable challenges, and how cross-functional collaboration can help mitigate them.
Drawing on Medpace’s experience supporting complex cell and gene therapy programs, the discussion will demonstrate the value of bringing medical, laboratory, and clinical operations expertise together rather than treating each function as a separate component of development. Medpace’s integrated model combines specialized laboratory capabilities with therapeutic, medical, regulatory, and operational expertise to support complex CGT studies globally.
Attendees will gain practical perspectives on building an integrated development strategy, anticipating challenges earlier, and connecting laboratory insights with clinical decision-making and operational execution. The goal is not simply to manage complexity once it arises, but to use cross-functional expertise proactively to reduce risk and create a more coordinated path from development strategy to clinical execution.
Register for this webinar to learn how cross-functional clinical expertise can strengthen the design and execution of cell and gene therapy clinical trials.
Advancing Cell and Gene Therapy Clinical Research
Medpace, a full-service clinical research organization (CRO), has conducted over 160 cell and gene therapy trials, and applies this experience to help Sponsors advance their CGT therapies. We provide Sponsors with comprehensive strategies that address the rapidly evolving clinical, operational, and regulatory challenges, as well as the unique set of hurdles presented in crossover therapies. Additionally, our patient-centric approach enables our team to keep patients engaged throughout the entirety of the study.
Leverage Medpace’s cross-functional cell and gene therapy clinical development services for your next trial. Learn more by visiting our website or contacting our team of experts, and a member of our team will contact you shortly.