Arena Outsourcing in Clinical Trials New England
September 07, 2016 - September 08, 2016
Sheraton Boston Hotel
39 Dalton St
Boston, MA (USA) 02199
Thursday September 8, 2016
11:30am - 12:15pm PAREXEL session (Therapeutic)
Speaker: Dr John Lambert
Vice President Chief Medical Officer PAREXEL Early Phase
Bio: Global head PAREXEL Early Phase Medical Sciences and Chief Medical Officer. Over 30 years early clinical drug development experience as medically trained Clinical Pharmacologist working as a clinician, principal investigator, Medical Director and industry consultant. Published extensively and member of several Colleges of Physicians and industry bodies.
Presentation “Considering Safety Risk Management in Early Clinical Trials – A CRO perspective”
- Considerations for combined first-in-human studies (SAD/MAD)
- Key regulatory guidances around risk management, risk mitigation in early-phase studies
- Starting dose considerations: NOAEL-based versus MABEL-based assessments.
- Practical Safety Considerations: Facility capabilities and protocol design.
- Shaping of the Early phase regulatory landscape, lessons from the BioTrials and Tegenero studies.
- An Early Phase Safety Risk Assessment and Risk Mitigation process based on the 2007 EMA Guidance