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JLABS Presents: Navigating Your Way to Successful Cell & Gene Therapy Development

Time: 10 AM - 1 PM
Location: Lobby
Residents can email Eliza for a ticket discount code.

JLABS is bringing another not-to-be-missed panel event to LabCentral! Hear from a panel of experts on topics critical to achieving long-term success in developing cell & gene therapy. 

The discussion will include: 

  • Pre-phase I
  • CMC strategy
  • Pharm/tox requirements
  • Working with the FDA and other regulatory agencies
    • Expanded access strategies
    • Accelerated development designations
    • “Right to try” considerations
  • Site selection
    • Site infrastructure
    • Investigator and staff experience
  • Planning for breakthrough designation
    • Impact on monitoring team
    • TMF readiness
    • Getting sites ready for inspection
    • Integrated and synchronized clinical supply chain management
    • Chain of custody
    • Cell processing plan
    • Import/export requirements
  • FDA Bioresearch Monitoring Program (BIMO)
    • Accuracy and reliability of clinical trial data
    • Compliance with regulations
    • Protection of Study Subjects

Speakers include:

  • Alliso Bowen, Managing Project Director, Early Phase Development, PAREXEL
  • Laurie McRae, Director Solutions Consulting - Clinical Trial Supplies and Logistics, PAREXEL
  • Todd Shuster, M.D., VP, Global Therapeutic Area Lead, Oncology/Hematology, PAREXEL
  • Kathy Tsokas, Sr. Director, Global Regulatory Affairs, Janssen R&D