I have worked in the industry for 22 years as a Coordinator, CRA and Manager. I have worked for both CROs and Pharmaceutical companies. I have worked at Cephalon since 1998 in both Medical Affairs and Clinical Operations and Resourcing. Currently, I am the Global Clinical Operations Lead in CII.
Ian Birks is a VP, Global Functional Resourcing (GFR). He positions Quintiles as a strategic ally in designing and delivering functional models (FSPs) which facilitate transformational change. These FSP models vary in intent, but all are highly integrated and tailored to each partner.
Jennifer Charron, RPS (ReSearch Pharmaceutical Services, Inc), United States
Jennifer Charron has 18 years of Clinical Research experience. She has held positions as a data manager, CRA, Lead CRA and Manager. She has experience building and growing Alliance Programs. She is currently a RPS Director of Clinical Programs and oversees a partnership with a BioPharma company.
Since receiving her PhD in Pharmacology from the Univ of Pennsylvania in 1995, Dr. Inglis has worked for GlaxoSmithKline. She spent 10 years working in Clin Pharm and moved to the US Vaccines Clin Ops Group in 2006. She is currently Director of Monitoring and Outsourcing for the US Group.
Description
There are many ways to partner with a functional service provider (FSP). This symposium will provide case studies of how several of these models have worked and how the appropriate model was selected, as well as discuss performance metrics/key performance indicators (KPIs) and governance and infrastructure of the various models. Pricing strategies including unit costing, cost savings and risk sharing, will also be explored.
Learning Objectives: Define the vendor and client core competencies to develop clinical development strategies activities and timelines Develop key performance indicators (KPIs) and define requirements to manage long-term, highly integrated partnerships Define the processes and success factors in developing unit pricing in FSP partnerships.