On-Demand Webinar: Preparing for Pivotal: Solving Challenges in Scale for Cell and Gene Therapy Clinical Trials

Event Overview: 

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 medical research, 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 may often lead to accelerated status and pressure to scale rapidly. With more than 1,220 advanced therapy clinical trials operating world-wide, the need for solutions that simplify and scale cell and gene therapy studies is urgent.

Key Learning Objectives: 

  • Understand some of the unique operational aspects of advanced therapy clinical trials, including combined study phases and accelerated timelines.
  • Analyze the importance of pivotal trials for cell and gene therapies, and how the unique features of advanced therapy clinical studies affect preparations for pivotal trials.
  • Evaluate solutions that simplify and optimize preparations for pivotal trials in cell and gene therapies.

Expert speakers:

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