Critical Path Initiative

In the current health care environment, dominated by increasing expenses associated with drug development programs, rapidly changing technologies, generic competition, and therapeutic substitution, there is increased pressure to develop new therapies using effective drug development programs. The escalating costs and low productivity of drug development have been well documented over the past several years. In March 2004, the FDA recognized that drug development has become increasingly challenging, inefficient, and costly - 16]. The agency concluded that the major contributor to the inefficiency in development was the absence of innovative new methods for pre-clinical and clinical testing of drugs. In its critical path initiative, the agency called upon new, publicly available scientific and technical tools to improve drug development programs. These include the use of biomarkers and clinical trial endpoints as well as PK/PD modeling to improve decision making and make the development process more effective and more likely to result in safe products to benefit patients [17-20].

The agency recommended reviewing the body of collective biomarker information to build a new framework for biomarker and surrogate endpoint use in drug development [16]. Part of this initiative is to complete an inventory of surrogate endpoints that have been used for past drug approvals and to evaluate how the decision was made to accept the respective surrogates. As part of this process there will be an attempt to identify widely used, disease-specific biomarkers and determine the gap that exists to elevate these bio-markers to surrogate endpoints. The acceptance of CD4 cell counts and HIV plasma RNA as mechanism-based surrogate endpoints are probably the best examples. The elevation of a biomarker to a surrogate endpoint is particularly attractive because biomarkers can be measured more quickly and easily and at lower cost than can true clinical endpoints, or when clinical endpoints are excessively invasive or when their use would be considered unethical.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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