Former Speaker Newt Gingrich at the “Promoting Biomedical Innovation and Economic Value” event co-sponsored by the Engelberg Center for Health Care Reform at Brookings and the Leonard D. Schaeffer Center for Health Policy and Economics at USC said, “The human race is on the edge of the greatest explosion in scientific knowledge in history.” As he sees it, there will be four to seven times new knowledge discovered in the next quarter century as was discovered in the entire last century.
For example in the future, regenerative medicine will enable individuals to use their own cells to grow solutions totally compatible with their bodies. In kidney dialysis alone, the federal government spends $27 billion a year. Kidney dialysis will soon be a larger cost than the entire NIH—yet regenerative medicine stands at the edge of making kidney dialysis an obsolete therapy. In addition, regenerative medicine is creating the potential for revolutionary breakthroughs for spinal cord injuries, cancer patients, and heart disease.
Brain science stands on the edge of an even greater revolution in knowledge and capabilities than regenerative medicine. Because of breakthroughs in instrumentation and computation, brain science will be one of the most exciting and explosive areas for new knowledge in this lifetime.
To make it possible to address the critical health issues that will take place in this century, it is essential to have the FDA provide for the free flow of information and make it accessible to all scientists across bureaucratic lines. As Gingrich stated, “This country needs to develop a FDA that is able to function effectively from the laboratory all the way to the individual’s medicine cabinet.”
One of the issues that Gingrich feels needs to be addressed is to develop a new system so that information can easily be obtained from clinical trials. When we have electronic communications in place, it will be possible to monitor clinical trials on a daily basis/real-time to obtain data on side effects and any unexpected developments if they occur.
According to the FDA report on “Strategic Priorities 2011-2015”, the agency is now developing a clinical trials repository and collects clinical trial submissions from many sources. So far, valuable information has been obtained on safety, effectiveness and performance of drugs, biologics, and devices both before and after approval.
FDA finds it difficult to analyze all of the data since the information is submitted in various non-standardized structures in formats that are sometimes paper-based. FDA needs to be able to convert all of the data into an electronic uniform standard structure in a common language or format.
According to the FDA report, in the next five years, the agency plans to develop innovative strategies to help in the development of new biomedical products and emerging technologies. The agency plans on playing an important regulatory role in systems biology, wireless healthcare devices, nanotechnology, medical imaging, robotics, cell and tissue-based products, regenerative medicine, and combination products.
FDA’s goal is to build their CER clinical data and standards infrastructure, tools, skills, and capacity by forming large study data repositories containing information applicable to CER. In the future, comparative effectiveness pilots and other complex research projects will use FDA’s vast but untapped stores of patient safety and clinical efficacy data.
In many other ways, the electronic transmission of data is going to play an important role in the coming years. Looking to the future, FDA will need to make new investments in informatics hardware and software to effectively be able to review multiple studies and perform analytical studies.
To view the FDA report “Strategic Priorities 2011-2015, go to www.fda.gov.
