The current SARS-Cov-2 pandemic has brought the world to a standstill. Research groups and drug developers all over the world are scrambling to develop antivirals and vaccines to treat or prevent COVID-19. Longer term, better modeling will be required to test compounds in a controlled clinical setting once the pandemic has abated. Such a model could be a human challenge trial, commonly known as a controlled human infection model, or CHIM.
A coronavirus CHIM could be an ideal tool to support endeavors to develop effective COVID-19 interventions and provide a longer-term platform to support preparations against the emergence of new or novel coronaviruses.
This webinar will highlight the regulatory considerations to implement such a model and speed up the development pathway of much needed drugs and antiviral products.
- Introduction to controlled human infection modeling (CHIM)
- SARS-CoV-2: an introduction
- Regulatory considerations surrounding COVID-19 modeling
- Working with regulators on COVID-19 CHIM design and development
- How a COVID-19 CHIM trial could accelerate your pipeline development
Bruno Speder: Head Regulatory Affairs & Consultancy, Bruno has played a pivotal role in the establishment of several CHIM models, and has led interactions with global regulators on their use. He is currently advising a broad range of organizations (non-profits, biotechs, large pharma) on the regulatory aspects of challenge studies and how they need to be implemented in development plans.
Robin Rogiers: M.D. and principal investigator at SGS’s clinical pharmacology unit, Robin specializes in early phase clinical trials. She focuses on the conduct of infectious disease trials such as vaccine trials and controlled human infection models, from first in human to proof on concept.
Adrian Wildfire: An infectious disease specialist for over 30 years, Adrian has specialized in Human Challenge Models for nearly 10 years and is currently leading a multidisciplinary team manufacturing Challenge Agents for use in clinical trials. He has authored and published papers and articles relating to HIV, Ethics and Viral Challenge amongst others.
The COVID-19 pandemic is unprecedented in the modern era, posing unforeseen challenges to business continuity. At SGS, we are working hard to meet those challenges and support international efforts to beat COVID-19.