Steve Smith is moderating this panel at the BIO Conference
June 9th 2016 at 10:30 in San Francisco.
Come see leaders of biotech and patient groups discuss these opportunities for your innovation.
Abstract
New tools of drug development
New tools of drug development hold the potential for increasing the success rate of clinical trials and the development of treatments for serious diseases, including, but not limited to, rare diseases. New regulatory policy and new science converge to highlight the potential value of new tools of drug development including biomarkers, cross-functional protocol teams, patient engagement strategies, patient reported experience data, patient communities’ risk vs. benefit statements, natural history studies, genomics, imaging, clinical data, and data sharing. Major legislative change in the U.S. called 21st Century Cures is having positive impact on global collaboration and consensus about what needs to be done to improve drug development that is both safe and fast. Cross-stakeholder discussions including patients, biotechs, FDA, NIH and academia are considering new ways to validate biomarkers as surrogate endpoints for personalized targeting of medicine. Challenges remain as models are emerging for structuring patient reported information for use as evidence in clinical trial design and approvals. There is parallel progress in Europe and increasing harmonization of approaches. What's the roadmap to fulfilling the promise these new tools of drug development will hold for patients? How can we do more with data we already have, engage patients, and dramatically accelerate the development of safe, effective medicine while reducing drug prices?