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Monthly Archives: September 2012

Biosimilars, also known as follow on biologics, are complex biotechnology drugs that are similar, but not identical, to original biologic drug forms, and represent potential lower cost versions that may improve access. Yet biologics and their biosimilar forms have a key safety concern: unwanted immunogenicity. Emerging markets have tremendous interest in biosimilars, but are at a tipping point: they are moving from developing country concerns (e.g., communicable disease) to developed country needs (e.g., cancer therapies) that require biologic drugs. Production, however, is at lower than current Good Manufacturing Practice levels standard in highly-regulated markets. Emerging market public-private partnerships between public agencies, local producers, and global pharmaceutical firms, can incentivize biosimilar production at higher quality levels than required for local markets as well as position themselves for entry into developed markets. Public health goals can be reached while increasing economic opportunities in these markets to benefit global health.

Full details at the Journal of Commercial Biotechnology

There has been a trend of worldwide harmonization of patent laws. Due to the continuing harmonization, examination of patents in Europe and the United States are very similar.  However, examination standards between the two patent offices can differ. Thus, applicants should be aware of the differences between examination standards since both standards need to be addressed in the single patent application.  This paper will review some of these differences, both major and subtle, that should be considered when drafting a biotech patent for filing in both the U.S. and Europe.

Full details at the Journal of Commercial Biotechnology

While medicines are always expected to be a safe remedy for human ailments, unfortunately, there is also the phenomenon of ‘unsafe medicines’ due to unscrupulous elements in society manufacturing and marketing fake, spurious, mislabeled medicines, as well as medicines with sub-standard ingredients. As more and more consumers are adversely affected by these drugs, and global health concerns grow, efforts were needed to bring stakeholders together to address this public health problem. This was the genesis of the Partnership for Safe Medicines-India. Strategic efforts were required integrating a wide array of stakeholders and early and intensive planning. Lessons learned from this experience may be useful for other emerging markets.

Full details at the Journal of Commercial Biotechnology

UC Davis and its partners are addressing the need for innovation and entrepreneurship in graduate education and training. This paper will showcase the Designated Emphasis in Biotechnology graduate education program, cross-disciplinary partnerships and technology brokering. These interactions can bring diverse groups of individuals together to translate ideas into real world applications. The creation of intellectual and human capital at universities must be linked to financial capital and social capital. This can be accomplished by creating dense social networks. PhD programs in science and engineering must be transformed in order to stay relevant in the 21st century. UC Davis has been addressing these issues for close to 20 years and is now seeing significant outcomes.

Full details at the Journal of Commercial Biotechnology

UC Davis and its partners are addressing the need for innovation and entrepreneurship in graduate education and training. This paper will showcase the Designated Emphasis in Biotechnology graduate education program, cross-disciplinary partnerships and technology brokering. These interactions can bring diverse groups of individuals together to translate ideas into real world applications. The creation of intellectual and human capital at universities must be linked to financial capital and social capital. This can be accomplished by creating dense social networks. PhD programs in science and engineering must be transformed in order to stay relevant in the 21st century. UC Davis has been addressing these issues for close to 20 years and is now seeing significant outcomes.

Full details at the Journal of Commercial Biotechnology

China is the largest emerging market in the world. It is also on the front lines of health diplomacy, where the tools of diplomatic statecraft are being employed by public health professions of both the US and China to help improve the practice of public health. This article examines the US Department of Health and Human Services’ (HHS) and the US Centers for Control and Prevention (US CDC) in China, describes critical features of the Chinese health system, presents two examples of US-China collaborations, and describes common management mechanisms and strategies supporting both. This examination will help inform other global health collaborations between the US and China as well as lessons for supporting global health collaborations in other middle income countries.

Full details at the Journal of Commercial Biotechnology

China is the largest emerging market in the world. It is also on the front lines of health diplomacy, where the tools of diplomatic statecraft are being employed by public health professions of both the US and China to help improve the practice of public health. This article examines the US Department of Health and Human Services’ (HHS) and the US Centers for Control and Prevention (US CDC) in China, describes critical features of the Chinese health system, presents two examples of US-China collaborations, and describes common management mechanisms and strategies supporting both. This examination will help inform other global health collaborations between the US and China as well as lessons for supporting global health collaborations in other middle income countries.

Full details at the Journal of Commercial Biotechnology

Assuring a safe and adequate blood supply in developing nations such as emerging markets is a daunting challenge that directly affects fundamental health metrics of a country. Numerous mortalities can be reduced when an effective national blood transfusion system is in place including leading causes of death such as maternal hemorrhage, sickle cell anemia, and malaria. There exists a circular relationship between blood supply and safety: efforts to ensure donor and recipient safety reduce the population of eligible voluntary blood donors, which in turn restricts blood supply. In this article we describe the main issues for blood supply in developing nations and emerging markets, identify the major causes and impact of transfusion transmitted infections, present a safety model that describes the relationship between defensive barriers in depth to assure safe blood, its effectiveness, and the impact it has on safe blood supply. We use twenty two nations in sub-Sahara Africa to present the safety model. Finally, we discuss strategies for blood safety and supply in developing nations.

Full details at the Journal of Commercial Biotechnology

Assuring a safe and adequate blood supply in developing nations such as emerging markets is a daunting challenge that directly affects fundamental health metrics of a country. Numerous mortalities can be reduced when an effective national blood transfusion system is in place including leading causes of death such as maternal hemorrhage, sickle cell anemia, and malaria. There exists a circular relationship between blood supply and safety: efforts to ensure donor and recipient safety reduce the population of eligible voluntary blood donors, which in turn restricts blood supply. In this article we describe the main issues for blood supply in developing nations and emerging markets, identify the major causes and impact of transfusion transmitted infections, present a safety model that describes the relationship between defensive barriers in depth to assure safe blood, its effectiveness, and the impact it has on safe blood supply. We use twenty two nations in sub-Sahara Africa to present the safety model. Finally, we discuss strategies for blood safety and supply in developing nations.

Full details at the Journal of Commercial Biotechnology