Virginia BIO and BIO Praise 21st Century Cures Initiative Discussion Draft Release
Friday, May 1, 2015
The Committee on Energy and Commerce released its 21st Century Cures Initiative discussion draft intended to accelerate the discovery, development and delivery of next generation modern medicine.
BIO, along with Virginia Bio, applaud the release of this discussion draft. Some welcome areas include: prioritizing placing patients at the center of the drug development process, spurring the development of therapies for the most prevalent conditions and encouraging the development of treatments focused on unmet medical needs. Support is also given in establishing a structured and transparent way to incorporate patient views into the development and regulatory review processes, both with respect to the patient input for benefit-risk assessments and use of patient experience data in regulatory decision-making.
In a statement attributed to Jim Greenwood, BIO President and CEO, he said, “Further, we support modernizing clinical trials to expedite and accelerate drug development through the use of alternative clinical trial designs, biomarkers and surrogate endpoints, and modern scientific approaches and greater utilization of post-market validation and other confirmatory techniques, including the use of real-world data. We applaud the Committee’s recognition, in this draft, of the need for the Food and Drug Administration’s (FDA) involvement in validating and facilitating the use of cutting-edge drug development tools, while also taking account of the agency’s limited resources.”
Jeff Gallagher, President of Virginia Bio, summarizes the release stating, “These changes will have a pervasive impact on our industry.”