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Patient Experience Data is the systematic collection of meaningful data related to the experiences, perspectives, needs, and priorities of patients. Below you will find a graphic that outlines types of patient experience data, how that data might be used in different phases of drug development and review.
Over the last five years, there has been a dramatic increase in the global development of transformative gene therapies. Given this increase and the global development, there is a clear need for harmonization across global regulatory authorities to ensure that these therapies can be delivered to the patients that need them as quickly as possible. Such harmonization efforts may include regulatory terminology and definitions, and nonclinical, quality, and clinical considerations.
The Rare Pediatric Disease Priority Review Program (RPD PRV) was established to incentivize the development of therapies to treat rare pediatric diseases. The RPD PRV achieves this goal by granting a priority review voucher to a drug developer who develops and gains approval for a therapy that treats a rare pediatric disease.
In recent years, America’s position as the global leader in new technologies has come under attack. As countries race to secure access to these technologies, governments are working to weaken global rules and international organizations, instead of investing in innovation. BIO recommends several foreign policy actions that will restore our standing as a global leader on biotechnology, enhance economic growth and job creation, and lay the groundwork for leveraging science and American innovation to solve society’s biggest and most pressing challenges.
Because of the integration of the North American economies, enabled by the North American Free Trade Agreement (NAFTA) and recently confirmed through the United States-Mexico-Canada Agreement (USMCA), the agricultural markets of U.S. and Mexico are inseparably linked. Unfortunately, Mexico’s treatment of innovative biotech products is undermining the development and deployment of technologies critical to sustainably feeding the world and addressing climate change.
Innovations in animal biotechnology can improve human and animal health, make our farming and food systems more sustainable, and boost our bioeconomy. But these breakthroughs are dependent on a clear, timely, and science based regulatory approval process that provides a viable path to market.
Animal biotechnology has enormous potential to address several agricultural, environmental, humanitarian, and public health challenges. In order for these solutions to be realized, the U.S. must act now and develop a sensible, science-based regulatory approval process that provides these technologies with a viable path to market.
Gene Therapy. Immunotherapy. Precision Medicine. We’ve come too far to let government mandates, even harmless sounding ones, threaten progress in biomedical research.
The Power of Innovation in Addressing the Opioid Epidemic