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Tag Archives: biotech regulation
“When Genetic Engineering Came Of Age”
October 29 was the 30th anniversary of the approval by the Food and Drug Administration (FDA) of human insulin synthesized in genetically engineered bacteria. In an article for Forbes, Henry Miller, the founding director of the FDA’s Office of Biotechnology, marked the anniversary and commented on today’s regulatory environment: “Regulators have adopted a highly risk-averse and even adversarial mindset, few new drugs are approved without convening extramural advisory committees, and decisions are sometimes hijacked by Read More >
How to Become a Global Biotech Leader: Innovation and the Worldview Report
What are the BRICS of the future? Latin America, Korea, North Africa, Thailand, Turkey? Scientific American’s 2012 Worldview contains a special section on Emerging Markets 2.0 and an exploration of countries that are showing promise for future development and an on-the-ground look at some of the science parks, incubators, research centers, or other hot spots of innovation that are coming into their own. With the release of Worldview Report and Scorecard at the 2012 BIO Read More >
Americans, Biotech Execs, Convention Attendees Optimistic About Biotech
What does the future hold for biotechnology? After surveying American voters, biotech executives, and attendees here the 2012 BIO International Convention, we learned that the future is indeed bright. More than three quarters of American voters, nearly all the biotech execs, and 1,400 of the attendees we spoke to are optimistic that science and technology will find cures to help patients suffering from serious diseases, such as cancer, diabetes, Alzheimer’s, Parkinson’s and HIV/AIDS. Tempering that Read More >
Industry Regulatory Issues to be Highlighted at 2012 BIO International Convention
In the words of BIO’s Andrew Emmett, Managing Director, Science & Regulatory Affairs, ‘2012 is shaping up to be a momentous year for FDA reform.’ From the reauthorization of the Prescription Drug User Fee Act (PDUFA V) to modernizing and expediting the approval of new drugs and biologics, implementing the new biosimilars pathways and addressing the growing global drug shortage crisis, all eyes are on the current regulatory environment and its role in supporting innovation. Read More >
2012: A Critical Year for Biotechnology
In 2012, we must continue to look for ways to reduce risk; enhance reward; reduce uncertainty; and reinforce the position of the industry as a major contributor resolving society’s most pressing needs. Policies to encourage investment in innovation and to speed discovery to scientific breakthroughs simply must be the priority in 2012. The industry relies on a policy and regulatory environment that encourages innovation for much needed treatments and cures for some of the most Read More >
