Now more than ever, companies may need to consider agile and novel evidence generating study designs to streamline development. How do we balance the need to pursue more rapid but unconventional research approaches to identify treatments for Covid with the risk of generating erroneous results? This webinar analyzes the role that Real-World Evidence (RWE) is playing in supporting the urgent need for evidence on emerging therapies for COVID-19.

This webinar will cover:

  • Early experience with CTAP and other regulatory mechanisms
  • How EMR and other data providers are responding to the need for real-time data on patient treatment and outcomes in COVID-19 and how to navigate them
  • The value and challenges of synthetic control arms in COVID-19 research
  • How COVID-19 is going to shape RWE’s role in drug development going forward

Featured Speakers

Leanne Larson

Corporate Vice President & WW Head Real-World Evidence
Parexel

Leanne brings over 25 years’ experience in healthcare, featuring extensive work in pharmaceutical product development and commercialization, and in healthcare technology and operational consulting. Leanne is an industry leader in designing and leading observational / non-interventional studies and in advancing the science of outcomes research, and publishes and speaks widely on a variety of topics in this area.

Michelle Hoiseth

Senior Vice President & Chief Data Officer
Parexel

Michelle leads Parexel’s data sciences division, working in a multi-disciplinary environment to solve the challenges using real-world data in clinical research. Michelle is committed to leading inclusive, invested, innovative teams to move our industry into the future of clinical product development. Michelle has over 29 years’ experience in the drug and medical device industry, with experience of product development plan creation, designing of novel regulatory pathways to approval, writing strategic and tactical business development plans, and supporting product commercialization objectives and life cycle management.

Register now for this webinar