Conversations Contributors - Andrew Emmett
Andrew Emmett, Managing Director for Science and Regulatory Affairs at the Biotechnology Industry Organization (BIO)
Andrew J. Emmett is Managing Director for Science and Regulatory Affairs at the Biotechnology Industry Organization (BIO). BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. In his role, Andrew develops and implements strategic BIO responses to scientific and regulatory issues that affect the ability of BIO's human healthcare focused companies to research and develop new medicines and biotechnology therapies, and to bring these products to market. Specifically, Andrew leads BIO’s efforts relating to the reauthorization and implementation of the Prescription Drug User Fee Act (PDUFA V) and the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA). In addition, he coordinates BIO activities regarding drug and biologic research and development, pharmacovigilance and benefit/risk management, regulatory science, pediatrics, manufacturing, biosimilars, anti-counterfeiting, health information technology, and FDA funding. He attended Cornell University and holds a Master’s of Public Health in healthcare policy from George Washington University.
Read Andrew Emmett's Conversations Responses
- On the one year anniversary of implementation of the Prescription Drug User Fee Act (PDUFA V), what element has shown the most promise?