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Conducting Clinical Trials with GMOs: Strategies to Overcome Regulatory, Operational, and Patient Enrollment Challenges
Session Chair(s)
Esther Mahillo, PhD
Customer Relationship Executive, Oncology and Hematology
Syneos Health, Spain
Global clinical trials conducted with GMOs pose unique regulatory, logistical and strategic challenges. This session will presents case studies addressing lessons learned and perspectives from regulatory authorities, investigators and patients.
Learning Objective : Describe strategies to optimize the conduct of clinical trials with GMOs, in order to facilitate approval across multiple layers and regulatory bodies; Discuss efforts among different stakeholders (Sponsor, CRO, vendors) to enable adequate IP management; Identify how to implement educational plans to overcome cultural barriers (patients, families and site staff) and facilitate enrolment completion.
Speaker(s)
Clinical Research with GMOs: Regulatory, Ethical, and Biosafety Challenges
Daniel Kavanagh, PhD, RAC
WCG, United States
Senior Scientific Advisor, Gene Therapy, Vaccines & Biologics
Operational and Logistical Aspects of Working with GMOs
Esther Mahillo, PhD
Syneos Health, Spain
Customer Relationship Executive, Oncology and Hematology
Patient Perspective
Kathleen Higgins
Li Fraumeni Syndrome Association, United States
Director of Community Outreach
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