Accelerating Gene & Cell Therapy Trials With Real-World Evidence

Place
Free Webinar
Site visit
Dates
In-house Available
22 June 2020, 14:00 CET
Who should attend?

Summary

With several hundred clinical programs in gene and cell therapies ongoing, there is enormous potential to address the unmet needs of patients with rare and complex conditions, which currently have inadequate or no satisfactory treatment options. But not all of these programs will advance to the commercial stage, given the substantial challenges in meeting the regulatory requirements for clinical evidence as well as manufacturing.

This webinar will concentrate on the newest strategies to successfully design and execute gene and cell therapy clinical trials. We will hold the webinar in two parts, with a presentation of the above topics followed by an extensive Q&A session.

Hosted by: Marek Babusiak PhD., Training & Development Specialist, Symmetric

Learning Objectives

Key Topics

  • Accelerating development from early phase to scale up and regulatory approval
  • Reducing the time and cost of clinical development programs and thoughts on de-risking
  • Designing Phase I/II studies that are robust enough for marketing application
  • Developing endpoints for gene and cell therapy trials -  the crucial role of natural history studies
  • Successfully identifying and recruiting patients and conducting trials in small populations
  • Leveraging real-world evidence to enrich populations and enable faster, shorter trials
  • The long-term follow-up of patients and post-authorisation clinical and value evidence generation

Trainers

David Schwicker (MA)

David Schwicker, CEO, ORPHA Strategy Consulting

A sought-after expert for accelerating time to launch and patient access for orphan drugs and advanced therapies, author and co-author of numerous peer-reviewed publications, David is a regular speaker at international meetings as well as a Symmetric Trainer. Detailed biography: https://www.orphastrategy.com/biography/

David Schwicker (MA)

David Schwicker, CEO, ORPHA Strategy Consulting

A sought-after expert for accelerating time to launch and patient access for orphan drugs and advanced therapies, author and co-author of numerous peer-reviewed publications, David is a regular speaker at international meetings as well as a Symmetric Trainer. Detailed biography: https://www.orphastrategy.com/biography/

Tour info

Price per Delegate (EUR)

Public Training

Online Training

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Testimonials

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Contact us

Lydia Makori

l.makori@symmetric.events
+421 222 200 543