http://www.workcast.com/register?pak=7359547145219988

Ensuring high-quality data from the Human Challenge Model – Regulatory and Clinical considerations & solutions

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Abstract:

Viral-challenge studies are used as proof-of-concept trials after initial activity assessments, Phase I human pharmacokinetic, tolerability studies and must comply with specific clinical trial and regulatory conditions. Moreover, the selection, isolation and manufacture of Challenge Agents for use in the Human Challenge Model (Phase 2a/b) must also meet stringent criteria at all stages if the eventual product is to both comply with regulatory advice and provide pertinent data.

What this webinar will cover:

  • Provide an overview of the use of viral-challenge studies in drug development and the regulatory requirements for this type of studies.
  • Discuss the regulatory requirements for challenge viruses.
  • Review Best Practice for the identification of potential challenge strains and the pilot testing required prior to manufacture to ensure high titres of active agent are achieved.
  • Evaluate the value of various agents with the relative merits of each, as documented in commercial clinical trials, laid out for consideration.

Registration link:   http://www.workcast.com/register?pak=7359547145219988

SPEAKERS BIOGRAPHY

Adrian Wildfire: Project Director – Infectious Diseases & Viral Challenge Unit – SGS Life Science

Services – Belgium

Adrian Wildfire has over 30 years experience in infectious diseases, working on early and late phase clinical trials (Phase I to IV) as a researcher, laboratory scientist and senior department manager. Assisting KoLs with healthy volunteer (FIM, SAD, MAD and HCT) and patient population studies (in hepatitis, HIV, tuberculosis and sexual health), he has gained experience with a wide range of IMPs including antivirals, antibiotics, antihelminthics and biologicals. He has advised on various study designs including interventional analyses, testing regimens and endpoints.Recently he has specialised in URTIs and more especially in the field of viral or Human Challenge modelling.

 

Bruno Speder: Head Clinical Regulatory Affairs – Clinical Research – SGS Life Science Services -
Belgium

Bruno Speder holds a degree in Bio-engineering and a degree in Business Economics from the University of Ghent, and has an additional degree in Health Economics from the EHSAL Management School. He joined SGS Life Science Services in 2008 and has held several positions in the regulatory group since. He is currently Head Clinical Regulatory Affairs where he is involved in all the regulatory aspects of drug development, focusing on regulatory support to sponsors in early development phase.

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