INTERNATIONAL PHARMACEUTICAL INDUSTRY
Author: Dr. Chitra Lele, Sciformix Corporation
Influenced by forces such as macroeconomics, politics, regulations, population growth and aging, there has been a major shift in the way biopharmaceutical companies conduct business. There is ever increasing pressure to comply with evolving regulations along with cost reductions in order to grow business. As companies expand their product portfolios into new geographies, regulatory scrutiny along the entire product lifecycle has seen a substantial increase, with all areas of the business being affected. The result of this is that the volume of outsourcing done by the biopharmaceutical companies has significantly increased.
This paper will outline the “The 3E Principle” of Effectiveness, Efficiency and Economics, which are key parameters organisations should consider when selecting an outsourcing partner to assist with knowledge-based activities in drug development and post-marketing stages of the product lifecycle. The 3E Principle will be considered for each of the following service areas: safety and risk management (SRM), scientific writing, regulatory affairs and statistics and programming.
The article will focus on the overall trends currently seen in outsourcing, and will demonstrate that the 3E Principle applies differently to each service area, and the drivers differ based on the size of the company, i.e., whether it is a mid to large or small business. It will conclude that those biopharmaceutical companies who outsource have a number of varying priorities, and the challenge that is of vital importance is for the outsourcing vendor to have the ability to deliver results effectively against the company’s strategic objectives.