Operationalizing Gene Therapy Trials

Even measured against the vast scientific mystery that defines the biotech industry, gene therapy poses extraordinary challenges. It’s still a young field, the science is stunningly complex, and the regulatory terrain is still evolving.

Sponsors and CROs have an understandably challenging time operationalizing clinical trials for new gene therapy treatments. In this webcast, we’ll examine the history and current state of gene therapy research and investigate the obstacles in both patient recruitment and retention, study start-up regulations, and types of gene therapy vectors and vector delivery strategies.

Overview

Title:
Operationalizing Gene Therapy Trials: Webcast
Date:
Tuesday, May 8, 2018
Time:
11:00AM EDT | 4:00PM BST | 5:00PM CEST
Duration:
1 hour

Topics Covered

  • Types of gene therapy vectors and vector delivery strategies
  • Site selection and start-up regulations
  • Patient recruiting: the usual rare disease challenges plus the need to manage patient and family expectations when using a single-dose therapeutic
  • Patient retention obstacles

Speaker

Juliet Moritz

Executive Director, Patient Engagement & Program Strategy, Rare Disease

Juliet Moritz has worked in clinical research for more than 25 years, and her extensive background covers the spectrum from single-site studies to large, multinational trials. She joined Premier Research in 2016 to specialize in rare diseases, supporting the strategic development of products that address unmet medical needs associated with rare and orphan afflictions.

Prior to joining Premier Research, Ms. Moritz was Associate Director of Global Project Management at PPD Inc., overseeing infectious and respiratory disease research, and prior to that was Associate Director of Clinical Research at Knopp Biosciences. She held senior positions at Wyeth, Theravance, and PPD and began her career as a clinical research associate.

Ms. Moritz holds a Master of Public Health degree from the Drexel University School of Public Health and a bachelor’s degree in biology from the University of Pennsylvania. She is a member of the National Organization for Rare Disorders and the Drug Information Association.

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