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Tag Archives: biotech regulatory issues
“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 >
People With Rare Diseases Face a Host of Unique Challenges
By Dennis Jackman, Senior Vice President, Public Affairs, CSL Behring People with rare and serious medical disorders encounter a host of unique challenges–from obtaining a correct diagnosis, to identifying an appropriate course of treatment and gaining affordable access to the care they need. They and their families, caretakers and health care providers face a constant struggle to identify and access available resources, away from the attention of traditional media that focuses on more common disorders Read More >
How to grow the economy and feed the world
By Barbara Wells, President and CEO, ArborGen Chair, BIO Food and Agriculture Section Governing Board For the past two decades, the United States has led the world in crop biotechnology innovation. Under this leadership, American growers have produced most of the world’s food, fiber and energy, while the U.S. agricultural sector experienced sustained economic growth and a positive trade balance. But an increasingly complicated regulatory system and threats of litigation from opponents of technology have Read More >
Biologics & Biosimilars: What is the Science Telling Us?
Panelists from the varied backgrounds of academia, business and regulation agreed on the highest scientific standards of biosimilar regulation. Each panelist emphasized the need for the most stringent of standards in order to ensure patient safety and efficacy within the emerging biosimilars market. As Brian Liang, Executive Director of the Institute of Health Law Studies at California Western School of Law, summed it up, “the need in biosimilars is to focus on science, not cost. These are Read More >
