Regulatory Affairs

Andrew Emmett, Managing Director, Science & Regulatory Affairs, speaks about the important regulatory issues facing the industry, specifically PDUFA reauthorization, the FDA and regulation. Also, hear his programming highlights from the Achieving Regulatory Approval and Compliance Track at the upcoming 2012 BIO International Convention.

State governments in 2011 continued to see regional economic growth in the life sciences industry and in 2012 will increasingly focus attention on technology transfer and venture funding as mechanisms to increase private sector innovation related activities within their jurisdictions. Realizing that entrepreneurship is a key ingredient in economic development, states and localities are undertaking the support of programs that assist high technology businesses, and that capitalize on state regional presence of universities and federal laboratories.

Biotechnology continues to hold the greatest promise to address many of the most critical issues facing our world.

While the U.S. leads in the area of biotechnology, there is no guarantee this competitive edge will continue.

The biotech industry has shrunk dramatically in recent years based primarily on the continued tight capital markets and increased aversion to risk on the part of investors.

Society has tapped just a small fraction of the many potential uses and benefits of biotechnology.