Navigating Your Way to Successful Cell & Gene Therapy Development

Overview

JLABS @ LabCentral
700 Main St.
Cambridge, MA 02139
United States

Tuesday, 7 May 2019 - 10:00am to 1:00pm

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Details

Cell and gene therapies hold huge promise for addressing unmet medical needs but developing safe and effective therapies come with unique challenges. Come hear from a panel of experts on topics critical to achieving long-term success.

 

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