With the recent changes in drug discovery and clinical models, collaborations between key stakeholders are critical for generating efficient development programs. This session will present several considerations from an early stage clinical CRO & Biotechnology perspectives which are used for developing new drugs and efficient trials. Design factors include sponsor objectives, regulations, type of compounds and timelines. However, additional factors such as study population, medical expertise, safety events and communication can have a significant impact on study conduct. A case study analysis will be used to discuss the development of efficient programs while accounting for key stakeholder collaborations and design considerations.
Presented at the 2014 CSPS Conference by: Marc Lefebvre, Vice-President, Scientific & Regulatory Affairs, Algorithme Pharma, and Patrick Colin, Chief Development Officer, GI Care