Case Study

How COVID-19 Is Making Operationalizing Gene Therapy Trials Even Tougher – And How We Handled It

By Naomi Kautz

T-cell

Though gene therapy has been around for decades, it continues to pose extraordinary challenges in the areas of R&D, clinical development, and operation of clinical trials. Sponsors and CROs face shifting operational and regulatory demands amid rapid advances in the science of precision medicine.

In our previous blog post, we discussed site selection, manufacturing, long-term follow-up, and other critical considerations for gene therapy trials at the study design phase. In this follow-up, we’ll continue our case study of a rescue Phase 1/2 gene therapy trial involving localized administration of gene therapy using specialized equipment with a look at the operational challenges of these trials during COVID-19.

VIEW THE CASE STUDY!
Signing up provides unlimited access to:
Signing up provides unlimited access to:
  • Trend and Leadership Articles
  • Case Studies
  • Extensive Product Database
  • Premium Content
HELLO. PLEASE LOG IN. X

Not yet a member of Clinical Leader? Register today.

ACCOUNT SIGN UP X
Please fill in your account details
Login Information
I'm interested in newsletter subscriptions.
ACCOUNT SIGN UP

Subscriptions

Sign up for the newsletter that brings you the industry's latest news, technologies, trends and products.

You might also want to: