In 2004 the FDA began the Critical Path Initiative (CPI). The Critical Path Initiative (CPI) is FDA’s national strategy to drive innovation in the scientific processes through which medical products are developed, evaluated, and manufactured. It is intended to stimulate and facilitate a national effort to modernize the scientific process through which a potential human drug or therapeutic biologic is transformed from a discovery or proof of concept into a medical product.
Despite advances in basic sciences that have increased discoveries of innovative new medical products, the technology development process has not advanced at the same pace. This has resulted in failure of the majority of investigational products that enter clinical trials. These failures have continued to increase the costs and time it takes to get new therapeutic products to market. The FDA is relying on the larger scientific and technological community for the infrastructure and new product development “toolkit” to improve the predictability and efficiency along the critical path of therapeutic development. This infrastructure includes: animal or computer-based predictive models; biomarkers for safety and effectiveness; new clinical evaluation techniques; and quality assessment technologies.
This new infrastructure that the FDA sees as critical to filling the gap between translational medicine and finished product relies on collecting, analyzing and evaluating, and making decisions on an enormous amount of transactional data. Fundamentally, SAP In-Memory Appliance (SAP HANA) software can play a critical role in almost every development process during clinical trial testing. SAP HANA combined with analytical applications like SAP ® BusinessObjects™can provide a real-time link to the data that investigators rely on to make the critical and timely decisions on which drugs or medical products to develop rather than relying on “trial and error” empirical testing. The FDA is responsible for continuously reviewing emerging data on safety, efficacy and product quality, during clinical trials testing. They make guidance and policy based on this information to ensure the public safety. Only SAP combines transactional and analytical applications enabled by in-memory. This would enable the FDA access to better, faster and more reliable insight into the data used for decision making.
To summarize, SAP ® HANA™ in combination with SAP ® BusinessObjects™ could be the game changing technology needed to advance the drug development process. More than ever, we need improved processes for getting more innovative and better treatments to patients. The FDA has identified the problem as slow technological innovation for the technology development process and launched the Critical Path Initiative to address the issue. SAP HANA’s ability to improve storage, search and ad-hoc analysis of real-time information may be the critical solution need for the CPI.