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.
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 In terms of extensibility, previously unpublished Council of Graduate Schools research data is presented that shows master's focused institutions out-performing doctoral institutions at the master's level,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.
Road traffic related fatalities account for over 50% of the global deaths for individuals between ages 15 and 44 and ranks 11th in the cause of death for all age groups. It’s future impact is equally dismal: within the next decade road traffic related morbidity is projected to be the 6th leading contributor global fatalities and 3rd leading contributor to global Disability-Adjusted Life Years, disproportionately impacting the overall global burden of disease. However, national-level traffic safety intervention by global health organizations lacks programmed efforts to include vehicle simulation-based technologies as a key element of comprehensive national traffic safety programs. This is particularly true for two wheel vehicles in low and middle income countries (LMICs). Importantly, US resources in diplomacy settings are also subject to loss because of deployment into these risky settings, lack of adaptability to traffic cultures and systems locally, and limited skills training. The United States Marine Corps has utilized two wheel motorcycle simulation based technologies as part of a comprehensive education and training strategy to reduce fatalities and injuries amongst military personnel operating motorcycles off-duty. Positive experiences with motorcycle vehicle-simulator training program indicate further potential to validate impact on injury rates and efficacy of motorcycle simulator technology both for those assigned abroad and for relevant LMICs personnel. Other international professional and charitable organizations contending with similar risks abroad would also benefit from shared advances in traffic safety training utilizing motorcycle simulators. By improving traffic safety in these environments, health care resources can be shifted from expensive reactive, acute care trauma settings to investments in longer term public health infrastructures, medicines, and outreach.
New anti-tampering technologies and security features along with coding of individual medicine packages can aid in identifying and then reducing harm associated with counterfeiting of medicines. Equally important, however, is effective communication between public sector and private sector actors; this has occurred in the past as evidenced in a joint effort to address a global criminal network. The Pharmaceutical Security Institute is participating in ongoing international efforts to promote the concept of a Single Point of Contact (SPOC) system to further enhance communication amongst the stakeholders. Using this approach, technology and human engagement can promote safety of the global drug supply.
Stem cell-based therapies represent a potential pathway for a new era of 21st century regenerative medicine. In support of this new form of treatment, a global multibillion-dollar research endeavor is currently underway in an effort to establish a scientific evidence base for safe and effective clinical use of stem cells. At present, due to its early stages, only a few stem cell therapies are approved for use. Yet despite very limited evidence-based data, a proliferation of questionable and often illegal stem cell providers around the world are now offering unfettered access to largely experimental stem cell treatment claiming cures for virtually any disease or condition. These stem cell clinics promote their services globally to patients using unregulated Internet and forms of direct-to-consumer advertising. In this paper we examine marketing characteristics of these questionable stem cell clinics and discuss pathways of access through the globalization of medical tourism. We conclude with an examination of the similarities between unproven stem cell therapy access and illicit online pharmacies and explore possible lessons that can be learned to inform future global regulation and policymaking in this arena.
Technology has promoted global health. Yet advancing technology has also allowed physicians and trainees to cheat, and inappropriate experimentation with medical technology has resulted in study patient deaths. Further, journal editors have not made significant inroads in employing technology to identify dishonesty. Unfortunately, this continues to be strongly within the culture of the profession. Due to corruption of medicine, global health promotion will be severely retarded by falsified and suspect data that lower-and-middle income countries cannot afford to reproducethemselves and must rely upon for clinical decisionmaking. Further, clinical environments that facilitate dishonesty will result in poorer patient care. In addition, emerging markets rely on research to produce advanced therapeutics such as biosimilars that will be used by developed and developing economies, compounding the potential risks of dishonesty globally. By employing relevant antiplagiarism technology and accessing funding sources for all parties including authors, reviewers, and journal editors; “honesty” accreditation that includes mandated participation by journals; and external audits and whistleblowing of dishonesty, medical culture globally can move toward honesty and take advantage of technological evolution to promote global health.
Human Genome Science (HGS) aspired to dominate the emergent field of genomics by discovering expressed gene sequences and developing therapeutic and diagnostic products based on proprietary genes. While HGS’ accomplishments fell short of their own lofty expectations, by the time HGS was acquired by GlaxoSmithKline, the company had extensive intellectual property and had launched a product with >$1 billion market potential. Nevertheless, HGS’ acquisition price was less than the total capital investments in the company. This work examines HGS’ history and accomplishments in the context of the business plan described by the company at their IPO. We focus specifically on the company’s valuation over time, which was highly correlated with general market indices, but negatively correlated with metrics of technical or clinical progress. The history of HGS points to the challenge of accounting for the value created by a science-based business plan. Earnings-based metrics, present value calculations, and “fair value” assessments did not account for HGS’ progress in executing their stated business plan. This work highlights the critical need for accounting practices that credit value to the progress of translational science and enable investors to profit from such investments.
The recombinant drug industry is growing at almost 20% rate in India. The long term growth of this sector depends upon the innovation as well as competition and market. The structure, conduct and performance of firms in market plays a very important role in predicting the future of innovation and competition in market. The present paper analyses the structure-conduct-performance paradigm in the context of recombinant drug sector in India. The analysis reveals that R&D, distribution chains and advertisement has significant effect on the profits of firms in the recombinant drug sector. If your reader cannot render the information below, go to
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