Jules Petit
Project Manager, Companion Diagnostics GenDx
Jules Petit holds a PhD in Molecular Immunology and has multiple years of experience in Diagnostic Services in the pharma industry. He joined GenDx 3 years ago, where he leads the companion diagnostics department.
At GenDx, Jules has established GenDx’s internal processes for CDx development and is responsible for developing and aligning clinical validation and regulatory affairs strategy for the CDx co-development programs. Through multiple CDx co-development programs, Jules has gained hands-on experience with development and validation of Companion Diagnostics and global clinical validation studies in multiple EU and North American countries. Moreover, Jules experienced first-hand the regulatory and operational challenges in Pharma-IVD partnerships and possible solutions to navigate these challenges.
Seminars
- At what stage should the diagnostic partner ideally be involved to ensure technical and regulatory alignment without slowing drug development?
- What does an ideal collaboration model look like under IVDR, balancing innovation speed with compliance?
- Can pharma use any IVD within its drug trial framework?
- Who should take the lead, and the regulatory accountability, in a combined study?
