Vaccine innovation, translational research and the management of knowledge accumulation

What does it take to translate research into socially beneficial technologies like vaccines? Current policy that focuses on expanding research or strengthening incentives overlooks how the supply and demand of innovation is mediated by problem-solving processes that generate knowledge which is often fragmented and only locally valid. This paper details some of the conditions that allow fragmented, local knowledge to accumulate through a series of structured steps from the artificial simplicity of the laboratory to the complexity of real world application. Poliomyelitis is used as an illustrative case to highlight the importance of experimental animal models and the extent of co-ordination that can be required if they are missing. Implications for the governance and management of current attempts to produce vaccines for HIV, TB and Malaria are discussed. Article Outlin

Intellectual Property Management in Health and Agricultural Innovation: Executive Guide

Prepared by and for policy-makers, leaders of public sector research establishments, technology transfer professionals, licensing executives, and scientists, this online resource offers up-to-date information and strategies for utilizing the power of both intellectual property and the public domain. Emphasis is placed on advancing innovation in health and agriculture, though many of the principles outlined here are broadly applicable across technology fields. Eschewing ideological debates and general proclamations, the authors always keep their eye on the practical side of IP management. The site is based on a comprehensive Handbook and Executive Guide that provide substantive discussions and analysis of the opportunities awaiting anyone in the field who wants to put intellectual property to work. This multi-volume work contains 153 chapters on a full range of IP topics and over 50 case studies, composed by over 200 authors from North, South, East, and West. If you are a policymaker, a senior administrator, a technology transfer manager, or a scientist, we invite you to use the companion site guide available at http://www.iphandbook.org/index.html The site guide distills the key points of each IP topic covered by the Handbook into simple language and places it in the context of evolving best practices specific to your professional role within the overall picture of IP management

Emergence of the Biosimilar Sector and Opportunities of Developing Country Suppliers

As biologic products begin to come off-patent, a market is emerging for biosimilars (also known as biogenerics or follow-on biologics). Firms from emerging countries such as India and China have dominated the production of active ingredients in pharmaceutical industries all over the world and are now developing capabilities in biosimilar production. This emergence of a new market dynamic is disruptive to current key players as it has potential challenge their current dominant hold over the market, while for firms from developing countries it creates a sea of opportunities. This rise of biosimilars and capabilities for cheap production in developing country firms has potential to transform patient care in developing countries as well as advanced countries. This paper reviews study data collected at Innogen and the most recent literature to understand how the sector for biosimilars is evolving and the opportunities and challenges faced by emerging suppliers. The aim of the paper is to identify the gaps in the current literature and opportunities for further study in this area

The rise of companies from emerging markets in global health governance: opportunities and challenges

The article analyses the involvement of pharmaceutical companies from emerging markets in global health governance. It finds that they play a central role as low-cost suppliers of medicines and vaccines and, increasingly, new technologies. In so doing, pharmaceutical companies from emerging markets have facilitated the implementation of a key goal of global health policy: widening access to pharmaceutical treatment and prevention. Yet, looking closer at the political economy underlying their involvement, the article exposes a tension between this policy goal and the political economy of pharmaceutical development and production. By declaring access to pharmaceuticals a goal of global health policy, governments and global health partnerships have made themselves dependent on pharmaceutical companies to supply them. Moreover, to provide pharmaceutical treatment and prevention at the global level, they depend on companies to supply medicines and vaccines at extremely low prices. Yet, the development and production of pharmaceuticals is organized around commercial incentives that are at odds with the prices required. The increasing involvement of low-cost suppliers from emerging markets mitigates this tension in the short run. In the long run, this tension endangers the sustainability of global access policies and may even undermine some of the successes already achieved

2013 Annual Letter from Bill Gates

In previous annual letters, Gates focused on the power of innovation to reduce hunger, poverty, and disease. But any innovation -- whether it's a new vaccine or an improved seed -- can't have an impact unless it reaches the people who will benefit from it. That's why in this year's letter, Gates discusses how innovations in measurement are critical to finding new, effective ways to deliver these tools and services to the clinics, family farms, and classrooms that need them.The Foundation is supporting these efforts, but more needs to be done. Given how tight budgets are around the world, governments are rightfully demanding effectiveness in the programs they pay for. To address these demands, we need better measurement tools to determine which approaches work and which do not. In this letter, Gates highlights strong examples from the past year of how measurement is making a difference. In Colorado, Melinda and Bill learned how a school district is pioneering a new system to measure and promote teacher effectiveness. In Ethiopia, Gates witnessed how a poor country, pursuing goals set by the United Nations, delivered better health services to its people. In Nigeria, the digital revolution has allowed the foundation to improve the use of measurement in the campaign to eradicate polio. Thanks to cell phones, satellites, and cheap sensors, data can be gathered and organized with increasing speed and accuracy

Patent Landscape of Helminth Vaccines and Related Technologies

Executive Summary This report focuses on patent landscape analysis of technologies related to vaccines targeting parasitic worms, also known as helminths. These technologies include methods of formulating vaccines, methods of producing of subunits, the composition of complete vaccines, and other technologies that have the potential to aid in a global response to this pathogen. The purpose of this patent landscape study was to search, identify, and categorize patent documents that are relevant to the development of vaccines that can efficiently promote the development of protective immunity against helminths. The search strategy used keywords which the team felt would be general enough to capture (or “recall”) the majority of patent documents which were directed toward vaccines against helminths. After extensive searching of patent literature databases, approximately 2847 publications were identified and collapsed to about 446 INPADOC families. Relevant patent families, almost half of the total relevant families (210 being total number of relevant families), were then identified and sorted into the categories of trematodes, cestodes, nematodes or nonspecific helminth. The 210 patent families that were divided into these four major categories were then further divided into sub categories relating to common fields of technology (e.g. DNA vaccine, vaccine formulations, methods to produce subunits) This sorting process increased the precision of the result set. The four major categories (cestodes, nematodes, trematodes, and non specific applications) as well as the overall data set of the 210 relevant family members were subjected to a range of analytics in order to extract as much information as possible from the dataset. First, patent landscape maps were generated to assess the accuracy of the sorting procedure and to reveal the relationships between the various technologies that are involved in creating an effective vaccine. Then, filings trends are analyzed for the overall dataset of the 210 relevant families as well as by the categories of trematodes, cestodes, and nematodes. The country of origin each member of the 210 relevant families was determined, and the range of distribution to other jurisdictions was assessed. Filings were also analyzed by year, by assignee. Finally, the various patent classification systems were mapped to find which particular classes tend to hold helminth vaccine-related technologies. Besides the keywords developed during the searches and the landscape map generation, the classifications represent an alternate way for further researchers to identify emerging helminth vaccine technologies. The analysis included creation of a map of keywords describing the relationship of the various technologies involved in the development of helminth vaccines. The map has regions corresponding to plasmids and other gene based technologies used in DNA vaccines for Japonicum Schistosoma. Important technologies listed on the map include the use of reverse genetics to create reassorted viruses targeted for the use in veterinary applications. Additionally, the map suggests that numerous subunits exist for use in vaccines targeting cestodes, trematodes, and nematodes. Another major finding was that the number of patent documents related to helminths being published has been steadily increasing in the last decade, as shown in the figure below. Until the early-1990s, there were only a few helminth vaccine related patent documents being published each year. The number of publications increased noticeably when TRIPS took effect, resulting in publication of patent applications. However, since 2006 the number of vaccine publications has exploded. In the years 2011 and 2012, about 23 references disclosing parasitic worm vaccine technologies were published each year. Thus, interest in developing new and more efficacious helminth vaccines has been growing in recent years. The origin of the vaccine-related inventions was also analyzed. The team determined the country in which the priority application was filed, which was taken as an indication of the country where the invention was made or where the inventors intended to practice the invention. By far, most of the relevant families originated with patent applications filed in the United States and China. Other prominent priority countries were the United Kingdom, Japan, Brazil, Australia and France. Countries with the most filings were also analyzed. Countries that were heavily targeted for patent filings included the United States, Australia, Canada, and New Zealand. Top assignees for these families were mostly large pharmaceutical companies, with the majority of patent families coming from Heska, followed by Merck & Co., Institute Pasteur, AusBiotech Biotechnology, and Biological Sciences Research Council. Lastly, the jurisdictions were inventors have sought protection for their vaccine technologies were determined, and the number of patent families filing in a given country is plotted on the world map shown (Fig. 25). The United States, Canada, Australia, Japan, New Zealand and France have the highest level of filings, followed by Germany, Brazil, India, United Kingdom and Spain. However, although there are a significant number of filings in Brazil, the remainder of Central and South America has only sparse filings. Of concern, with the exception of South Africa, few other African nations have a significant number of filings. In summary, the goal of this report is to provide a knowledge resource for making informed policy decisions and for creating strategic plans concerning the assembly of vaccines targeting highly prevalent helminth infections. The ITTI team has defined the current state of the art of technologies involved in the manufacture of helminth vaccines, and the important assignees, inventors, and countries have been identified. This document should aid in evaluating the current state of vaccines technologies targeting helminths and the potential outgrows of these technological fields. Furthermore, as this report illustrates, the steady increase in helminth patenting, expanded diversity of assignees and greater global filings, indicates that intellectual property protection does not inhibit the development of crucial innovations for this class of neglected diseases, but, on the contrary, appears to be a driver of accelerated research and development

Global Public Goods and Global Health

The repair rate on electron beam welded diaphragm hasn’t been at the desired level at Siemens SIT for several years. An improvement program the past five years has reduce the repair rate from 60% to 12-15% but the goal of 5% repair rate hasn’t been met. Collection of diaphragm weld and repair data started in the fall 2011 and in this thesis the material composition of the materials used for the production will be analysed from a statistical perspective. The thesis includes a comprehensive research of the nonparametric statistical methods suitable for non normally distributed, highly kurtotic and skewed data. Unfortunately a lot of statistical tests loose their power to correctly reject a false hypothesis with this kind of data. All of the elements in the material composition and the mechanical properties were analysed individually. In some of the cases it was possible to use statistical methods but in other it was not possible to conclude anything with statistics. Every case of outliers was evaluated individually. The main conclusions are that in all of the four materials there are some elements and mechanical properties outside of the material specifications. A number of cases also had outliers inside of the material specification and in most cases those were causing the variability in the data and had higher repair rates than the overall repair rate. Some trends were found, for example the weld quality was better for lower yield strength in all materials and higher chromium content in material A produced better quality. The first steps to improvement for Siemens are to find out why materials outside of the material specifications are getting all the way to the production without anyone noticing. A simple material process control chart could visually notify if a material is outside of the specification limits or even just outside of the usual. Knowing exactly how the material is before starting the production will give time and space for preventive measures if they are necessary and could improve lead times and decrease costs.För några år har Siemens hatt kvalitetsproblem med Electron Beam svetsing av mellanväggar. Förbättringsprojekt har reducerat reparationer intensivt men fortfarande finns det problemer med svetsningen. Inga mellanväggar lämnar produktionen utan att ha bra kvalitet så att förbättringarna ska fokusera på att reducera produktionskostnader och ledtider. Hösten 2011 började Siemens att samla reparation data för mellanväggarna och i det examens arbetet blir materialsamansättningen analyserad med statistiska metoder. Arbetet innehåller övergripande analysis på non-parametriska statistiska metoder och hur dom funkerar på skevat data med hög kurtosis. Tyvärr finns det inte många metoder som har hög chans att förkasta falska hypoteser när man jobbar med sånt data. Alla elementer och mekaniska egenskaper av materialet blev analyserade, men tyvärr inte alltid med statistiska metoder. Alla extremvärden blev analyserade individuellt. I alla fyra materialer finns det elementer och mekaniska egenskaper utan förmaterialets specifikationer. I vissa fall finns det outliers inom materialets specifikationer men som har högre reparation procent än det vanliga och orsakar variationen i datat. Vissa tendenser kunne hittas, till exempel att det går bättre att svetsa materialer med lägre sträckgräns och högre kromhalt går bättre för material A. Simpelt processstyrningdiagram skulle kunna visa om material är utanför material specifikationen men också om materialet är utanför det ”vanliga”. Att veta exact hur materialet är innan produktion kan sjunka ledtider och produktionskostnader

Innovation With Impact: Financing 21st Century Development

Leadership from the G20 is critically important right now. The global economic situation is as fragile as it has been at any time in the past 50 years. As leaders of the G20, you face a difficult challenge: How do you resolve the immediate crisis while continuing to make smart investments in long-term growth and improved living conditions?During my lifetime, innovations in business, science, and technology have energized the global market economy in unprecedented ways. The world economy is 500 percent bigger than in 1960. Whole groups of countries that had been at the margins have become key drivers of growth. Their success is widely viewed as a miracle.This progress has benefited everyone, not just the richest. You can see progress in the rising Gross Domestic Product (GDP) of many countries around the world. You can also see it in falling poverty rates and other quality-of-life indicators captured in the Millennium Development Goals (MDGs), established by world leaders in 2000 and agreed to by all G20 nations

A Model of Regulatory Burden in Technology Diffusion: The Case of Plant-Derived Vaccines.

Plant-derived vaccines may soon displace conventional vaccines. Assuming there are no major technological barriers undermining the feasibility of this innovative technology, it is worthwhile to generate quantitative models of regulatory burden of producing and diffusing plant-derived vaccines in industrialized and developing countries. A dynamic simulation model of technology diffusion—and the data to populate it—has been generated for studying regulatory barriers in the diffusion of plant-derived vaccines. The role of regulatory burden is evaluated for a variety of scenarios in which plant-derived vaccines are produced and diffused. This model relates the innovative and conventional vaccine technologies and the effects of the impact of the uptake of the innovative technology on mortality and morbidity. This case study demonstrates how dynamic simulation models can be used to assess the long-term potential impact of novel technologies in terms of a variety of socio-economic indicators.dynamic simulation model; plant-derived vaccines; regulatory burden; technology transfer; vaccines;