October 3, 2013 Comments Off on Protecting the U.S Medicine Supply: Integrating Approaches to Promote Safety Posted in: General Biotechnology The safety and efficacy of America’s medicine supply has long been considered the “gold standard” by which other countries are measured. Our “closed system” comprised of strict regulations for the approval, manufacture and distribution of prescription drugs served us well in an era when those regulations could be enforced. Today, however, a global economy through which goods and services flow virtually unimpeded, and the ever-increasing demand for more accessible and affordable prescription drugs are threatening to overwhelm our regulatory systems and place the medicine supply at risk. The growing presence of substandard, adulterated and counterfeit medicine in the U. S. market is a warning sign that responsible parties need to act promptly to restore the overall integrity of the nation’s prescription drug supply. This will require a holistic approach that employs advanced technology within a comprehensive strategy that includes stakeholder awareness, regulatory enforcement, legal change, and a sustained policy commitment to patient safety and global health.
October 3, 2013 Comments Off on An Agile, Cross-Discipline Model for Developing Bio-Enterprise Professionals Posted in: General Biotechnology In meeting bio-enterprise needs, university education often revolves around introducing students in the sciences to business, managerial and other professional expertise. This paper introduces the Bio-Enterprise Innovation Expertise Model, an alternative driver for bio-enterprise-relevant education that includes science-focused students, but also draws students from non-scientific fields, which are essential to the success of any bio-enterprise. Students are grounded in the global biotechnology industry and the dynamic of expertise required throughout the innovation process – from science to product. Against a backdrop of current approaches, the experience of the Business of Biotechnology (BoB) Program at the University of San Francisco (USF) is described. It utilizes the model to cohesively integrate multiple degree programs (business, law, information systems and biotechnology.) With a complement of three lecture courses and four study tours to differing global bioclusters, 95 graduate students from four degree programs undertook 170 BoB courses over five semesters. In terms of extensibility, previously unpublished Council of Graduate Schools research data is presented that shows master’s focused institutions out-performing doctoral institutions at the master’s level, establishing relevance of the model to all universities. The experience further demonstrates how such programs can evolve incrementally with strategic use of the model, opening numerous options for implementation, and increasing the potential to better serve bio-enterprise.