Integrated approach to improving the value potential of biopharmaceutical R&D portfolios while mitigating risk

Effective prioritisation of R&D portfolios under resource constraints is critical for biopharmaceutical companies to gain competitive advantage. This paper presents an application of a prototype software tool to assess the reward and risk associated with different drug portfolios in development. The tool adopts a hierarchical framework to incorporate the interactions between drug development activities, the available resources and databases. The valuation approach highlights the cash flow implications of diverse portfolios under uncertainty and uses efficient frontier analysis to prioritise portfolios for given constraints. A case study is presented to illustrate the application of this method where Monte Carlo simulations are used to capture the inherent uncertainties in drug development. The example addresses the portfolio management question of which antibody drug candidates to select for clinical development given finite levels of resources. The analysis highlighted the impact of different drug combinations on the expected portfolio profitability and risk. The simulation studies were used to generate efficient frontiers so as to identify the optimal portfolios at different levels of risk and budgetary constraint. This valuation method helps decision-makers to identify clearly where a company portfolio is positioned with regard to the risk-return characteristics of alternative product portfolios and hence facilitates investment decisions. Copyright © 2006 Society of Chemical Industry

[1]  Bernard W. Taylor,et al.  Multiple criteria R&D project selection and scheduling using fuzzy logic , 1996, Comput. Oper. Res..

[2]  A. Stuart,et al.  Portfolio Selection: Efficient Diversification of Investments , 1959 .

[3]  R. W. Hansen,et al.  The price of innovation: new estimates of drug development costs. , 2003, Journal of health economics.

[4]  Gintaras V. Reklaitis,et al.  A simulation—optimization framework for addressing combinatorial and stochastic aspects of an R&D pipeline management problem , 2000 .

[5]  Alan W. Pearson,et al.  Managing uncertainty in research and development , 2001 .

[6]  Rolf F. Tiggemann,et al.  Project Portfolio Management: A Powerful Strategic Weapon in Pharmaceutical Drug Development , 1998 .

[7]  Suzanne S. Farid,et al.  Modelling of the biopharmaceutical drug development pathway and portfolio management , 2005, Comput. Chem. Eng..

[8]  Ignacio E. Grossmann,et al.  Optimization Models for the Scheduling of Testing Tasks in New Product Development , 1996 .

[9]  Jeffrey S. Stonebraker How Bayer Makes Decisions to Develop New Drugs , 2002, Interfaces.

[10]  Nilay Shah,et al.  Pharmaceutical supply chains: key issues and strategies for optimisation , 2004, Comput. Chem. Eng..

[11]  Robert G. Cooper,et al.  Portfolio Management in New Product Development: Lessons from the Leaders-I , 1997 .

[12]  Gary Blau,et al.  Risk management in the development of new products in highly regulated industries , 2000 .

[13]  Suzanne S Farid,et al.  Decision‐Support Tool for Assessing Biomanufacturing Strategies under Uncertainty: Stainless Steel versus Disposable Equipment for Clinical Trial Material Preparation , 2008, Biotechnology progress.

[14]  Janice M. Reichert,et al.  Monoclonal antibodies in the clinic , 2001, Nature Biotechnology.

[15]  Janice M Reichert,et al.  Monoclonal antibody successes in the clinic , 2005, Nature Biotechnology.

[16]  Michael R. Walls,et al.  Combining decision analysis and portfolio management to improve project selection in the exploration and production firm , 2004 .