De-Risking Cell & Gene Therapy Development With Integrated MRL Expertise

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 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.
A 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 examine the importance of integrating 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 cell and gene therapy 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 integrated medical, laboratory and clinical operations expertise can help reduce risks and improve the execution of cell and gene therapy trials.

Who Should Attend
This webinar will appeal to VPs, Directors, Managers and Department Heads working within:
Clinical Affairs
Clinical Research
Clinical Pharmacology
Clinical Outsourcing
Project Management
Regulatory Affairs
Medical Affairs

What You Will Learn
Attendees will:
Connect laboratory strategy to clinical objectives from the beginning. Collaborating early with scientific and laboratory experts can assist sponsors in selecting suitable biomarkers, assays and testing strategies, while minimizing later adjustments that may impact timelines or data interpretation
Anticipate operational challenges before they become trial risks. CGT studies can involve specialized sample handling, product logistics, chain of identity and custody, site requirements and complex workflows; aligning these considerations early can support more consistent execution
Bring medical, laboratory and clinical operations perspectives together. Integrating expertise across functions helps translate scientific goals into executable trial strategies and allows potential issues to be identified and addressed before they impact study conduct
Use integrated expertise to make complex development more predictable. A coordinated approach can help sponsors navigate the scientific, clinical and operational complexities of CGT development while maintaining focus on data quality, patient safety and development timelines

Register free on Xtalks:
https://xtalks.com/webinars/de-risking-cell-gene-therapy-development-with-integrated-mrl-expertise/