Outsourcing Clinical Trial Materials - Pharmaceutical Technology

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Outsourcing Clinical Trial Materials
CROs and CMOs expand to gain a piece of the market for clinical trial materials.

Pharmaceutical Technology
Volume 33, Issue 6, pp. 48-52

Patricia Van Arnum
Supplying clinical trial materials (CTMs) is an important activity for contract research organizations (CROs), contract manufacturing organizations (CMOs), and other contract service providers. Several major CROs and CMOs are enhancing their CTM capabilities in an increasingly competitive market.

Crunching the numbers

A review of recent data shows that the number of drug candidates entering preclinical and clinical development has increased during the past several years, but the rate of attrition of drug candidates has increased. The data are based on a representative sample of public and private companies with developmental pipelines in multiple countries and in multiple indications from an analysis by Life Science Analytics, a biomedical database company whose product is MedTRACK. The number of drug candidates entering preclinical development increased nearly 19% in 2007 compared with 2006, but increased only 10% in 2008 compared with 2007 to reach 2224 in 2008. The number of drugs entering Phase I development increased 22% in 2007 compared with 2006, but increased only 12% in 2008 compared with 2007 to reach 1668 in 2008.

This trend of slowing growth continues in the later stages of development. The number of drug candidates entering Phase II development increased 18% in 2007 compared with 2006, but increased approximately 14% in 2008 compared with 2007 to reach 2754 in 2008. And in 2007, the number of drug candidates entering Phase III development increased 16% compared with 2006, but increased only 9.6% in 2008 compared with 2007 to reach 1050 in 2008.

Figure 1
As a separate measure of clinical drug development, Figure 1 identifies the number of original new investigational drug applications received by the US Food and Drug Administration's Center for Drug Evaluation and Research between 2004 and 2008.

Shifting market dynamics

The level of drug candidates, however, is not a full representation of the dynamics shaping the CTM market. "As the paradigm of drug development is under increasing pressure to improve time to market and to make better decisions earlier in the process, it has become a much larger puzzle to extract the variability out of the process and align expectations for more efficient and reliable on-time delivery of clinical trials materials," says John Bucksath, senior vice-president and general manager of the pharmaceutical division of Analytical Bio-Chemistry Laboratories (Columbia, MO). "The cost of making and releasing CTMs as compared to missing a clinical timeline start cannot only be calculated in hard costs, but [through] the realization of the incurred costs that are associated with missing contracted clinical start dates."

The pressure to advance clinical development and the reliance on external partners is particularly important as small and emerging pharmaceutical companies face increased financial pressures and Big Pharma restructures. "Small and emerging pharmaceutical companies typically do not have in-house resources to perform many drug-development activities or to coordinate those activities with other service providers such as clinical sites or formulators," says Bucksath. "But with recent restructuring activity, this is becoming a greater concern for large pharma as well. Regardless of size, many sponsors have lost some of their senior talent; consequently, their expectations for contract research organizations are very high."


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