Preparing for pivotal: solving challenges in scale for cell and gene therapy clinical trials

White Paper

Advanced therapies—such as cell therapies, gene therapies, and personalized cancer vaccines—emerge from uniquely advanced science. The clinical studies behind these therapeutics are some of the most complex in the history of medicine, and must overcome the operational challenges inherent in their patient-centric paradigm. In addition, the transformative nature of these treatments means that a promising early result often leads to accelerated status and pressure to scale rapidly.


This article is a follow-up to a past webinar and will provide a valuable and insightful discussion with industry experts.

Panelists and Co-authors:

  • Richard Gaeto, Independent Technical Operations Consultant – SupplyLinc
  • Erin Goodhue Meyer, M.D., Attending Physician, Transfusion Service and Apheresis Clinic – Nationwide Children’s Hospital and Director of Clinical Research and Development – Terumo BCT
  • Chris Greenberg, Associate Director Supply Chain Systems – The Janssen Pharmaceutical Companies of Johnson & Johnson
  • Jim Wise, Vice President, Head of Center for Immuno-Oncology, Cellular & Gene Therapy – PRA Health Sciences, an ICON plc company
  • Moderator: Subbu Viswanathan – Compliance Officer and SVP of Quality, Security, and Compliance, Vineti