Decision-making associated with drug candidates in the biotechnology research and development (R&D) pipeline

Abstract

This research investigated the issues and methods of analysis considered by executives when managing biotechnology drug candidates within the research and development (R&D) pipeline. A mail survey was developed to assess: (1) factors considered during clinical trials; (2) sources of funding for R&D; (3) analytic tools used in decision-making; and (4) the use and application of pharmacoeconomics, and targeted primarily Chief Financial Officers (CFO) within 396 biotechnology firms in the United States (US). Consistent with prior research on CFOs, a response rate of 7.5 per cent was achieved and respondents generally represented smaller biotechnology companies valued below US$100m. Findings indicated that regulatory and capital requirements as well as investor expectations were important factors throughout clinical phase trials. Venture capital and capital/securities markets were the most commonly used sources of R&D capital. The most frequently cited decision-making techniques used included prior experience/intuition/human judgment, net present value (NPV), and internal rate of return (IRR). Pharmacoeconomic methods were utilised at every stage of R&D and applied to the management of R&D pipelines in addition to aspects of product pricing and reimbursement. Overall, these results reflect the nature of risk and uncertainty associated with pharmaceutical and biotechnology R&D. Although the use of past experience/intuition/human judgment was most common for decision-making, methods based upon discounted cash flow (DCF) approaches were also employed frequently, as was the use of pharmacoeconomics. The implications of this work should seek to catalyse the development and utilisation of robust methods to manage drug pipelines such that senior executives are afforded optimal recommendations when attempting to hedge risk and maximise return.