Science of Medical Products Review and Evaluation Must Keep Pace with Rapid Advances in Research
]The process of translating biomedical discoveries into novel therapies continues to increase in complexity as science and technology rapidly evolve.
To ensure timely patient access to safe and effective innovative medical products, it is critical that the science of drug review and evaluation keeps up with rapid advances in drug discovery and development, so that experts across the ecosystem are able to understand, adopt and apply new scientific tools, standards, and approaches in evidence-based decision making processes.
Growing and maintaining a pool of professionals properly trained in regulatory science is therefore essential to sustain biopharmaceutical innovation, and requires collaboration across the ecosystem as well as rigorous, forward-thinking education.
It is with this mindset that PhRMA and the Georgetown University Program for Regulatory Science & Medicine (PRSM) recently established a postgraduate Fellowship in Regulatory Science to provide interdisciplinary expert training needed to modernize and improve the way medical products are reviewed and evaluated.
This program will offer fellows opportunities to engage expert faculty and scientists from academia, the pharmaceutical industry and the U.S. Food and Drug Administration (FDA). Through this program, fellows will learn about current challenges facing drug discovery and development, and develop a comprehensive understanding of regulatory science and its applications to drug evaluation. Applications for the fellowship are due June 30, 2014, with the first year-long term beginning September 1, 2014.
Advancing regulatory science was identified as a priority for PhRMA’s science advocacy by the Biomedical Advisory Council (BMAC). It should be a priority across the entire scientific ecosystem, including research and academic institutions as well as government and regulatory bodies. Though the field is early in its evolution, it holds great promise to enhance the safety and effectiveness of medical products and improve public health.
This fellowship program signifies PhRMA’s desire to promote and enable the extraordinary value that encompasses regulatory science, and the biopharmaceutical industry’s commitment to supporting and sustaining training and education in this specialized field.