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

The business case for early adoption of product lifecycle management The business case for new drug development is both difficult and risky, but the effective use of product lifecycle management strategies can reduce risk and increase opportunities for innovator companies of all sizes. For product lifecycle management  to be most successful, the groundwork must be integrated early in the drug development process, as opposed to added on a few years before a patent expires. A diverse, cross-functional team working at the clinical stage enables companies to: select the optimal therapeutic indication; develop effective formulation strategies; manage intellectual property; gather competitive intelligence; understand payer policies; develop marketing messages; develop proactive regulatory strategies; use lifecycle management tactics to expand beyond the base indication of the initial product launch (2, 7). Because all pharmaceutical brands are not equal, companies often use strategic models to predict the decline rate of brand revenues resulting from generic competition or they use multi-attribute models to determine the intrinsic potential for brand expansion. Seasoned innovators have learned through bitter experience that the best candidates for lifecycle management have strong barriers to entry built into the product design (product or class attributes), which makes prescribers or consumers less likely to switch brands (8). This increased complexity reinforces the need for CRO expertise. Although established pharmaceutical companies will likely have access to a wide array of in-house resources, small and medium specialty pharmaceutical companies and biopharmaceutical companies must increasingly look outside company walls to gain access to the requisite expertise for optimal execution of a product lifecycle management strategy. CRO strategies for accelerating drug development Understanding that many pharmaceutical companies face aggressive drug development timelines, intelligent CROs have aligned their expertise, service offerings, and technology to accelerate the drug development process. An expedited formulation strategy is one example of a collaborative CRO–sponsor project to meet aggressive clinical development timelines through the alignment or dedication of critical formulation, analytical, and manufacturing contract resources. CROs have been able to reduce hard-capsule formulation development to 10.5 weeks to match shortened client timelines and deliver quicker first-in-human study results. Similarly, pharmaceutical companies may seek strategic relationships with CROs to gain access to technologies for accelerating drug development. Partnering with a CRO can provide access to precision microdosing equipment that enables sponsors to move efficiently toward clinical proof-of-concept (e.g., chemical-in-capsule supplies for exploratory investigational new drug studies) or to achieve greater speed to first-in-human studies (e.g., API microdosing or over encapsulation). A recent US Food and Drug Administration guidance cites several advantages associated with exploratory investigational new drug studies, including the ability to identify promising drug development candidates earlier in the process, thereby reducing the time and resources devoted to drug development candidates that are unlikely to succeed. Direct encapsulation of API provides an expedited strategy to first-in-human studies and can be substantially more efficient than development efforts that result in a full formulation (9). (continued)