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The Value of Domestic and International Outsourcing
Tuesday, November 13
2:00 pm – 4:00 pm
Roundtable
ACPE #073-999-07-518-L04
The importance of bioanalysis is evident in virtually every stage of pharmaceutical development. The focus of many pharmaceutical research organizations, however, is often on the interpretation of bioanalytical data rather than on the process of bioanalysis itself. Ensuring the resources and expertise necessary to generate quality bioanalytical results should be a high priority in pharmaceutical development considering the critical nature of bioanalytical results. Minimization of the impact of bioanalysis on the success of research organizations may result in the bioanalytical process being treated as somewhat of an assembly line commodity and could compromise critical drug development studies. One of the first areas of preclinical and clinical research often considered for outsourcing in many pharmaceutical companies is bioanalysis. Because this is the case, it becomes very important for the bioanalytical chemist to become aware of the relevant facts that will help them communicate with other individuals within their organizations and to maintain an appropriate balance between internal bioanalytical capabilities and that which is outsourced to subcontractors. The purpose of this roundtable will be to explore and debate the appropriate balance between the maintenance of in-house bioanalytical capabilities and the degree to which critical studies can be outsourced. Presentations will be given by various bioanalytical thought leaders as a means to stimulate a debate on the value of maintaining internal bioanalytical capabilities versus potential benefits and risks associated with outsourcing. Presentations will focus on a clear demonstration of the benefits in quality, time and money when using these two approaches to generation of bioanalytical data.
Moderator
Mark Rose, Ph.D.
Amgen, Inc.
Collaborations with Academic Institutions as a Means of Outsourcing
H. Thomas T. Karnes, Ph.D.
Virginia Commonwealth University
Experiences with Global Outsourcing: A Sponsor's Perspective
Ajai K. Chaudhary, Ph.D.
Lilly Research Laboratory
Factors Affecting Outsourcing Decisions in an R&D Environment
Anthony DeStefano, Ph.D.
Proctor and Gamble Pharmaceuticals