ASK US series: Phase 1 clinical trials (part 2)

Question: What are the critical factors associated with the planning and conduct of Phase 1 clinical trials?

British Columbia has been conducting Phase 1 trials in the area of cancer for decades but there has been limited Phase 1 trials in other areas. There is now growing local activity and interest in Phase 1 clinical trials in BC to evaluate the safety of a wide range of health products. The development of a Phase 1 clinical trials unit in BC puts this topic in our spotlight.  

Join us in part two of the ASK US broadcast on Phase 1 clinical trials with special guest speaker, Stephane Lamouche, senior director, early clinical development at Syneos Health. Stephane will provide understanding of the current landscape, areas of trials, safety considerations, potential risks and benefits, regulations and general considerations for optimal designs to initiate a Phase 1 trial. 

Speaker:

Stephane Lamouche, PhD  

Senior director, early clinical development 

Syneos Health 

• Part of Syneos Clinical Pharmacology and Bioanalytical Division (FKA Early Phase division), has a clinical pharmacology, drug development, and regulatory science background 
• Active role in engaging very early with sponsors to assist in their early clinical strategy and study design support for clinical pharmacology studies (both for pharmaceutical and biological drugs) 
• Involved in assessing regulatory feasibility as well as occasional non-clinical/CMC data gap analysis in support of early clinical trials to ensure best path forward to study approval  
• Participates in the critical review and due diligence of clinical pharmacology development plans for novel or already approved repurposed/repositioned drugs (i.e. FDA 505(b)(2)), as well as biosimilars 
• Former head of the Regulatory and Scientific Affairs team for Early Phases, leading a multidisciplinary team of Clinical Research Scientists as well as Regulatory Affairs professionals liaising with the Canadian Health Authority 
• 20 years of experience in the CRO industry 
• Holds a Ph.D. in Pharmaceutical Sciences from the University of Montreal where he’s a guest lecturer on numerous occasions

Hosts:

Tatiana Kawakami

Senior manager, Clinical Trials BC

Jean Smart, PhD

Regulatory affairs & quality officer, Clinical Trials BC

Privacy officer, Michael Smith Health Research BC