Since 2004, when the US Food and Drug Administration (FDA) launched the Critical Path Initiative (CPI), a gap was filled that has aided research translation. The Critical Path Opportunities List addressed many of the specific priorities and identified needs, and was published for the Initiative in 2006.

Maxwell et al.'s “The Role of Public-Private Partnerships in Catalyzing Critical Path,” published in Clinical and Translational Science in August 2017, provides a detailed summary of the deliverables of the public-private partnerships, therapeutic areas, and needs addressed by public-private partnerships and critical path opportunities. The CPI aimed to accelerate product development and close the translational gap between basic science and development of medicinal products. To reach this goal, the CPI determined that public-private collaboration between the FDA scientists, research community, and industry was needed. Together with these stakeholders, the FDA identified specific research focus areas that were considered top priority. These included better evaluation tools, streamlining clinical trials, harnessing bioinformatics, moving manufacturing to the 21st century, and developing products to address urgent public health needs and an at-risk population: pediatrics.

The review and analysis published in CTS shows the specific deliverables, achieved and ongoing, in each of these areas, with detailed examples of the different deliverables. Perhaps not surprisingly, most deliverables (46%) are in the area of streamlining clinical trials, including development of new therapeutic area data standards. Clearly, this has been a highly successful area of public-private partnerships within the critical path. A large number of deliverables (23%) were in the area of better evaluation tools with a number of novel disease and drug safety biomarkers identified as part of this Initiative. The value of the CPI is clearly shown by the development and qualification of biomarkers for specific uses by several partnerships.

The article also shows that there is a surprisingly small number of deliverables in the areas or urgent public health needs (1%) and at-risk populations (3%), but ongoing partnerships in these areas show great promise for the next steps of the public-private partnerships. The experience shown in this review of the past 13 years clearly demonstrates that strategic partnerships between the research community, regulatory authorities, and industry can overcome the challenges of open data sharing and provide great advancements in accelerating product development from basic science discoveries to final approval and post market safety. The review is a delightful summary of the many successes reached as part of the critical path.

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