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Outsourcing Reformulation and Life Cycle Management: The Expanding Role of CROs (continued)

Conclusion Contract research organizations that understand the increasing complexity in today's pharmaceutical industry have positioned themselves to become more than a traditional capacity supplier. By closely aligning internal capabilities to client needs, these firms can provide a true competitive advantage in accelerating the drug development process, thereby maximizing product marketability within the exclusivity period and extending patent exclusivity for maximum profitability. References M. Rios, "The Outsourcing Advantage in Formulation Development," Pharm. Technol. 29 (1), 38–44 (2005). R. Daly and M. Kolassa, "Start Earlier, Sell More, Sell Longer," Pharm. Exec. 24 (1), 8–20 (2004). I. Kola and J. Landis, "Can the Pharmaceutical Industry Reduce Attrition Rates?" Nat. Rev. Drug Discov. 3 (8), 711–715 (2004). J. Ho, "Extending the Product Lifeline," Pharm. Exec. 23 (7), 70–76 (2003). Defending Brand Revenue: Pharmaceutical Lifecycle Management Planning (Cutting Edge Information, Durhan, NC, 2005). S. Viswanathan, "Life Cycle Management: Pharma Gimmick or True Innovation?" Pharm. Form. Qual. 6 (4), 22–26 (2004). Patent Protection Strategies; Maximizing Market Exclusivity (Business Insights Ltd., London, UK, 2003). E. Tuttle, A. Parece, and A. Hector, "Your Patent Is About To Expire: What Now?" Pharm. Exec. 24 (11), 88–98 (2004). Draft Guidance for Exploratory IND Studies (FDA, Rockville, MD, Apr. 7, 2005). M. Agrawal and N. Thakkar, "Surviving Patent Expiration: Strategies for Marketing Pharmaceutical Products," J. Product and Brand Management 6 (5), 305–309 (1997). T. Atkinson, Achieving Market Dominance Through Reformulation (Business Insights Report, London, UK, 2001). PT