Lesson's Learned Onboarding Cell and Gene Therapy Vendors and Clients in the 21st Century

Program Chair(s)

• KL

  Kevin Land, MD

  VP Clinical Services
  Vitalant
  Tempe, Arizona, United States

  Disclosure(s): No financial relationships to disclose

  PDF

Speaker(s)

• 

  Melissa Marlowe, CHS, MBA

  VP Clinical Services Adminstration
  Vitalant, Arizona, United States

  Disclosure(s): No financial relationships to disclose
• 

  Kate Brown, PhD (she/they)

  Senior Director of Science
  CooperSurgical, Inc.
  Tucson, Arizona, United States

  Disclosure(s): CooperSurgical, Inc: Full-time/Part-time Employee or Owner (Ongoing)

  PDF
• LS

  Laura Staller, MHA, MLS(ASCP)

  Manager
  Customer Ready Products
  NMDP

  Disclosure(s): No financial relationships to disclose
• RM

  Robert Marriott

  Vice President
  Clinical & Research Quality Services
  Vitalant

  Disclosure(s): No financial relationships to disclose

37 cell and gene therapy (CGT) products licensed in the US with a steady pipeline of anticipated approvals moving forward. Each one of these has a unique contracting and onboarding process. During the onboarding process, it is important to create processes and SOPs which mitigate complexity in order to address the vendor-specific requirements for collection, processing, training, labeling, quality audits, and certificate of analysis required for each new product. We will look at this issue from the standpoint of an individual customer and explore where we have further opportunities to streamline activity across customers. This session will discuss common contracting issues, operational strategies for successfully onboarding CGT vendors, and emerging best practices from experts across the industry including AABB Cellular Therapy Standards, a third-party contract processing laboratory, and an industry partner (NMDP).

CABP CE Eligible