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

Speakers

Lisa Dilworth

Executive Director, Program Strategy, Rare Disease & Pediatrics

Lisa Dilworth, Executive Director Program Strategy Rare Disease and Pediatrics, regularly consults with clients on key factors such as study design, eligibility criteria, appropriate patient populations, end point selection and program strategy in order to develop global therapeutic product strategies for rare and pediatric trials.  Ms. Dilworth’s expertise and experience includes multiple gene therapy trials in subjects ranging from neonates to adults around the globe.

Ms. Dilworth holds a master’s degree in Clinical Research from the University of California, San Diego and a Bachelor’s in Biology from the University of California, Berkeley.  Her prior work as a study coordinator and various clinical operations roles enable her to work closely with clients, physicians and patients with a variety of disorders.

Nadia Zeini

Senior Regulatory Start-up Manager

Nadia Zeini is currently working as Sr. Regulatory Study Start Up Manager at Premier Research since December 2016. She is responsible for all regulatory and start up activities in EU and non-EU countries, as applicable. Nadia Zeini has a solid regulatory background where she grew from local start up associate to Global Regulatory lead for ten years

Ms. Zeini holds a Chemistry-Major in Biochemistry from Complutense University in Spain as well as a Master’s degree in Clinical Trials from Universidad of Seville in Spain.

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