Title: Fixing the paradigm for biopharmaceutical R&D: Where to start?

Authors: Christopher-Paul Milne

Addresses: Tufts Center for the Study of Drug Development, Tufts University, 75 Kneeland Street, Suite 1100, Boston, MA 02111, USA

Abstract: The basic thesis of this paper is that the R&D sector of the new medicines| business is experiencing evolutionary stress. Due to the failure of the regulatory framework and applied sciences to keep pace with advances in discovery, there is a bottleneck in the development phase of R&D. While improved process may help, there are still problems related to the products themselves, such as the need to move from a population-based model of product development, in which one size fits all, to a more targeted approach based on specialty drugs for patient subpopulations. The old paradigm dominated by big pharma and blockbusters must evolve, in order for a new bio-pharmaceutical paradigm to emerge. Despite the challenge that the fates of the pharmaceutical and biotech sectors are currently intertwined, it may be the dark before the dawn that betokens real change.

Keywords: biopharmaceutical R&D; drug development costs; product lifecycles; regulation; personalised medicines; research and development; specialty drugs; product development; pharmaceuticals.

DOI: 10.1504/IJBT.2008.021307

International Journal of Biotechnology, 2008 Vol.10 No.5, pp.404 - 415

Published online: 18 Nov 2008 *

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