Operational Excellence in Immuno-Oncology Clinical Trials

As cancer treatments become more focused on personalized care for the patient, understanding the intricacies of immuno-oncology becomes increasingly important. Join our speakers who will outline how to manage the complexity of these studies and ways to maintain a successful partnership with your CRO.

In this webinar, the speakers will:

Examine the complexity of CAR-T studies including:

•  The general therapeutic process from patient identification to post-infusion
•  Startup considerations
•  Biovigilance

Explore logistics management in a successful CAR-T study including:

• Identifying key departments and staff for the study
• Defining the role of the logistical coordinator
• Other best practices

Review the process for a successful partnership between CRO and investigative site including:

•  Mitigating risk through proper planning
•  Training site staff
•  Meeting monitoring requirements

Speakers

Megan Liles, Director, Project Management, Chiltern

Megan Liles has over 19 years’ clinical research experience including project management, monitoring and study coordination across multiple therapeutic areas including oncology, infectious disease (adult and pediatric), respiratory (adult and pediatric), and pain. Liles has extensive experience in developing, managing and monitoring all aspects of complex, adaptive design, cohort-driven Phase 1 and 2 studies from start-up through submission of the Clinical Study Report.

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Lynn Donald, Project Director, Chiltern

Lynn Donald has over 15 years’ experience in the CRO industry from pre-clinical to managing full service global clinical studies. Donald is now project director with Chiltern early phase oncology currently managing and overseeing the start-up of CAR-T study with sites in the United States and Europe. Donald’s interests and expertise lie in oncology and has worked with both small biotechs and large Pharma on some exciting new treatments.

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