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A quantitative method is presented to rank strengths, weaknesses, opportunities, and threats (SWOT) of modified vaccinia virus Ankara (MVA) as a platform for pre-pandemic and pandemic influenza vaccines. Analytic hierarchy process (AHP) was applied to achieve pairwise comparisons among SWOT factors in order to prioritize them. Key opinion leaders (KOLs) in the influenza vaccine field were interviewed to collect a unique dataset to evaluate the market potential of this platform. The purpose of this study, to evaluate commercial potential of the MVA platform for the development of novel generation pandemic influenza vaccines, is accomplished by using a SWOT and AHP combined analytic method. Application of the SWOT AHP model indicates that its strengths are considered more important by KOLs than its weaknesses, opportunities, and threats. Particularly, the inherent immunogenicity capability of MVA without the requirement of an adjuvant is the most important factor to increase commercial attractiveness of this platform. Concerns regarding vector vaccines and anti-vector immunity are considered its most important weakness, which might lower public health value of this.platform. Furthermore, evaluation of the results of this study emphasizes equally important role that threats and opportunities of this platform play. This study further highlights unmet needs in the influenza vaccine market, which could be addressed by the implementation of the MVA platform. Broad use of MVA in clinical trials shows great promise for this vector as vaccine platform for pre-pandemic and pandemic influenza and threats by other respiratory viruses. Moreover, from the results of the clinical trials seem that MVA is particularly attractive for development of vaccines against pathogens for which no, or only insufficiently effective vaccines, are available. (C) 2015 The Authors. Published by Elsevier Ltd.

This exploratory qualitative article analyzes the potentially rate-limiting factors affecting value chain dynamics during adjuvanted-vaccine development. Adjuvants are considered immunostimulating substances that can be added to a vaccine. Although adjuvants have the potential to elicit adverse reactions, they also offer certain benefits. After approximately 90 years of R&D, why have only four adjuvants been approved? Although ample literature is available describing the risks and benefits, it remains unclear as to how these potentially rate-limiting factors compare. Experts - representing knowledge institutes, industry and regulatory/public health authorities - were approached in order to collect a unique weighted-ranking dataset on rate limiting factors. Based on the principal-agent theory, there is a partial conflict of interests between the internal perceptions on the challenges faced. Additionally, content analysis reveals four underlying social constructs influencing this perception, namely: attitudes towards risk management, innovation strategy, valuation and funding. This study was designed to explore the topic of rate-limiting factors, and not intended to solve the issues. Moreover we offer previously unpublished and practical insights on the topic, and offer a validated starting point for further research. Ultimately, we would advocate more transparency on reasons for project discontinuation; sharing lessons learned from failed attempts could prove valuable for advancing the field of virosciences. © 2014 Elsevier Inc. All rights reserved.

Medical nutrition products are specific nutritional compositions for intervention in disease progression and symptom alleviation. This industry finds itself on the interface between the food and pharmaceutical industry and is still a relatively unknown industry. At present, insights concerning industry development and patenting in the European medical nutrition industry are limited. This research presents a systematic patent portfolio analysis of the industrial patenting trends and patenting strategy categorization of the 5 leading companies. Focusing on EU patent applications, we calculated company specific patent-, product- and market shares and average forward- and backward-citations. These indicators were combined to illustrate the European medical nutrition industry trends and company specific patent- and innovation-strategies. We found 222 European medical nutrition patent applications between 1990 and 2010. The analysis of the industry trends shows that the industry currently resides in the growth phase and is estimated to reach the stage of maturation within 2 years with approximately 400 patents. Predominantly neurological diseases, cancer and diabetes show opportunity for future MN innovations while gastrointestinal and infection related diseases may have already reached a market saturation stage. Three distinct patent strategies can be distinguished within this industry: the Prospector; the Analyzer; and the Reactor.

Innovation is a necessity for survival in dynamic and complex industries such as the medical nutrition industry. To remain competitive, medical nutrition companies must embrace innovation activities that improve productivity. Nevertheless, innovation is a difficult undertaking and companies must first overcome numerous barriers inhibiting innovation. Studying these barriers provides insight into the dynamics of innovation, which simultaneously is a first step in the process of overcoming them. This study investigates the exogenous barriers that inhibit medical nutrition innovation. Primary data was collected by qualitative interviews from 17 medical nutrition key opinion leaders (KOLs) through and quantitative data by means of a questionnaire from 77 KOLs. Medical nutrition innovation barriers were identified and ranked according to importance. This study shows that barriers impact all steps of the medical nutrition value chain. Nine main innovation barriers emerged from the research. The most significant barriers are associated with financial aspects and clinical research, whereas the least significant are associated with product barriers. Medical nutrition companies must realize that investment in innovation is and remains crucial within this industry.

As infectious diseases cause approximately 25% of the annual global mortality, vaccines are found to be a time proven and promising response to infectious disease need. However, like for pharmaceutical small molecules, vaccine development is lengthy, risky and resource demanding. Faced with an attrition rate estimated around 80%, key opinion leaders were interviewed with the question: is there a recipe for success?

ObjectiveBarriers to international Ebola preparedness may be elucidated by identifying heterogeneities in arguments to invest in countermeasures during “peace time.”MethodsFor each patent family (related patent documents that differed only by limited alterations to the same invention) concerning Ebola and published until the end of 2014 the oldest patent document was analyzed. Grounded theory coding identified 5 unmet needs for (1) vaccines and therapies, (2) control of outbreaks in endemic areas, (3) detection and control of outbreaks in nonendemic areas, (4) better understanding of filoviruses, and (5) protection against bioterrorism. Odds ratios for unmet needs by geographic regions and institution types were compared by using Pearson’s chi-square test.ResultsStatistically significant heterogeneities in unmet need profiles were found. US applicants combined self-centric and altruistic arguments, focusing on medical unmet needs and bioterrorism protection. Russian and Asian applicants emphasized self-centric motives, specifically, detection and control of nonendemic outbreaks. A clear, statistically significant mismatch between industry and academia was found: whereas industrial applicants focused on bioterrorism and neglected detection and control of nonendemic outbreaks, academic applicants did the opposite.ConclusionsThis research identified heterogeneities in articulated needs between geographic regions and stakeholder types. Structural articulation of unmet needs may form the basis for attuning stakeholder engagement strategies while progression across the demand-driven value chain might necessitate international concordance. (Disaster Med Public Health Preparedness. 2016;10:644–648)

Gold dimensions of pharmaceutical drug development indicate that it takes on average 11.9 years, with an investment around US$ 0.8 Billion, to launch one product on the market. Furthermore, approximately 22% of the drug candidates successfully complete clinical testing. These universally acknowledged proportions largely originate from one single, much cited publication: Dimasi et al. [5]. However an additional six articles describing new chemical entities (NCE) development were identified, which contain little, if any, information on vaccines. Published cumulative success rates range from 7% to 78% and investments calculations span US$ 0.8 to 1.7 Billion. Obviously this disserves further clarification? (C) 2011 Elsevier Ltd. All rights reserved.

Aim: The aim of this project was to investigate the magnitude of visual impairment and blindness in the rural population of Western Rajasthan and determine how best to address it. Setting: Jodhpur District of Western Rajasthan. Population 2.8 million. Rural population 67% spread over 860 villages. Method: An interventional “screen and treat” population based program of village outreach by holding Eye Camps--in remote areas of the District. Participants: Candidates –lined up for screening at Eye Camps. Results: Of the 49’ 518 screened; 32’ 615 men, women and children had refractory errors (mainly myopia and presbiopia). This is 66% of the total. 1’350 persons had cataract related blindness. This is 2.7% of the total population screened.

To date, vaccination is the most cost-effective strategy to combat infectious diseases. Recently, a productivity gap affects the pharmaceutical industry. The productivity gap describes the situation whereby the invested resources within an industry do not match the expected product turn-over. While risk profiles (combining research and development timelines and transition rates) have been published for new chemical entities (NCE), little is documented on vaccine development. The objective is to calculate risk profiles for vaccines targeting human infectious diseases. A database was actively compiled to include all vaccine projects in development from 1998 to 2009 in the pre-clinical development phase, clinical trials phase I, II and III up to Market Registration. The average vaccine, taken from the preclinical phase, requires a development timeline of 10.71 years and has a market entry probability of 6%. Stratification by disease area reveals pandemic influenza vaccine targets as lucrative. Furthermore, vaccines targeting acute infectious diseases and prophylactic vaccines have shown to have a lower risk profile when compared to vaccines targeting chronic infections and therapeutic applications. In conclusion; these statistics apply to vaccines targeting human infectious diseases. Vaccines targeting cancer, allergy and autoimmune diseases require further analysis. Additionally, this paper does not address orphan vaccines targeting unmet medical needs, whether projects are in-licensed or self-originated and firm size and experience. Therefore, it remains to be investigated how these - and other - variables influence the vaccine risk profile. Although we find huge differences between the risk profiles for vaccine and NCE; vaccines outperform NCE when it comes to development timelines.

De mens wordt voortdurend blootgesteld aan de bedreigingen van ziekmakende stoffen, levende ziekteverwekkers uit de buitenwereld en afwijkende cellen in het lichaam zelf. Om die te bestrijden is het immuunsysteem ontwikkeld. Immuniteit is gedefinieerd als de weerstand van het lichaam tegen specifieke infecterende bestanddelen (pathogenen). Het immuunsysteem kan worden onderverdeeld in twee interactieve systemen: aangeboren (niet-specifieke) en verworven (specifieke) afweermechanismen. Beide systemen maken ongewenste indringers onschadelijk door middel van een ontstekingsreactie. Er zijn vier fasen: herkenning, acute cellulaire respons, chronische cellulaire respons en resolutie. Het lichaam reageert echter niet altijd adequaat: er treedt een immuunrespons op terwijl dat niet nodig is of de immuunrespons is veel te sterk. Er is dan sprake van overgevoeligheid, allergie of auto-immuniteit. Het immuunsysteem ondergaat gedurende het leven allerlei veranderingen. Ook de leefstijl en verschillende aandoeningen zijn hierop van invloed. De samenstelling van de voeding is belangrijk voor het behoud van een actief en specifiek immuunsysteem. De vatbaarheid voor ziekten wordt door de algehele voedingstoestand van het individu beinvloed en een volwaardig dieet bevat alle benodigde macro- en micronutrienten. Variaties hierin beinvloeden de natuurlijke werking van de immuunrespons.

In the medical nutrition (MN) market, insights into the motives driving intellectual property (IP) protection strategies remain unclear. This emerging market has expressed the pressing need for clarity on the subject of applicable IP methods. The aim of this study is therefore to evaluate the role of patents and alternative IP instruments for the protection of innovations in the MN market, and to construct an IP decision framework facilitating IP selection. Data collection consists of a literature study on the topic of IP strategies, combined with a supplementary questionnaire sent out to MN companies.Although there are many different strategic motives to apply for a patent in the MN market, the classic protective motives prove to be most important. While our findings acknowledge that patenting is of paramount importance to this industry, different scenarios call for combining the various IP methods for the optimal protection of the MN innovation. One must therefore always carefully consider additional IP rights. Our IP decision framework provides both MN companies and academic R&D departments with a tool to assess the best applicable IP strategy for the protection of MN inventions. © 2013 .

At present, industries within the health and life science sector are moving towards one another resulting in new industries such as the medical nutrition industry. Medical nutrition products are specific nutritional compositions for intervention in disease progression and symptom alleviation. Industry convergence, described as the blurring of boundaries between industries, plays a crucial role in the shaping of new markets and industries. Assuming that the medical nutrition industry has emerged from the convergence between the food and pharma industries, it is crucial to research how and which distinct industry domains have contributed to establish this relatively new industry. The first two stages of industry convergence (knowledge diffusion and consolidation) are measured by means of patent analysis. First, the extent of knowledge diffusion within the medical nutrition industry is graphed in a patent citation interrelations network. Subsequently the consolidation based on technological convergence is determined by means of patent co-classification. Furthermore, the medical nutrition core domain and technology interrelations are measured by means of a cross impact analysis. This study proves that the medical nutrition industry is a result of food and pharma convergence. It is therefore crucial for medical nutrition companies to effectively monitor technological developments within as well as across industry boundaries. This study further reveals that although the medical nutrition industry's core technology domain is food, technological development is mainly driven by pharmaceutical/pharmacological technologies Additionally, the results indicate that the industry has surpassed the knowledge diffusion stage of convergence, and is currently in the consolidation phase of industry convergence. Nevertheless, while the medical nutrition can be classified as an industry in an advanced phase of convergence, one cannot predict that the pharma and food industry segments will completely converge or whether the medical industry will become an individual successful industry. © 2013 Weenen et al.

Background & aims: A quantitative systematic identification and prioritization of unmet needs and research opportunities in relation to enteral nutrition was conducted by means of a tailor-made health research prioritization process. Methods: The research objectives were reached by conducting qualitative interviews followed by quantitative questionnaires targeting enteral nutrition key opinion leaders (KOLs). (1) Define disease areas that deserve more research attention; (2) Rank importance of product characteristics of tube feeding (TF) and oral nutritional supplements (ONS); (3) Assess involvement of KOLs in enteral nutrition R&D process. KOLs ranked three product characteristics and three disease areas that deserve additional research attention. From these, overall priority scores were calculated by multiplying ranks for both product characteristics and disease areas. Results: 17 qualitative interviews were conducted and 77 questionnaires (response rate 35%) were completed and returned. (1) Disease areas in ONS and TF with highest priorities are: ONS: general malnutrition & geriatrics, TF: intensive care. (2) IF product characteristics with highest priorities are: composition and clinical evidence from a KOL perspective; tolerance and ease of use from a patient perspective. ONS product characteristics with highest priorities are: composition, clinical evidence and taste from a KOL perspective; taste from a patient perspective. We find a high discrepancy between product characteristic prioritization from a KOL and patient perspective. (3) Although 62% of all KOLs give advice to enteral nutrition companies on patient needs, they under-influence the setting of research priorities by enteral nutrition companies. Conclusions: This study provides a systematic approach to achieve research prioritization in enteral nutrition. In addition to providing new directions for enteral nutrition research and development, this study highlights the relevance of involving KOLs in the identification of research priorities as they have the ability to provide a balanced view of the unmet patient needs. (C) 2013 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

center dot Current knowledge is based on practical experience. This paper presents the first novel, quantitative and qualitative view on the efficacy of the sponsor query system widely applied in the pharmaceutical industry, used for quality control purposes by data management for clinical data. WHAT THIS STUDY ADDS center dot This study presents a structured view on the process of clinical data management and sponsor queries, the efficacy and cost effectiveness of sponsor queries and dual data entry and the conclusion to advocate a more evidence-based approach to clinical data validation. AIM Procedures for verification of data from clinical studies are intended to maintain reliability for clinical trial results. Guidelines or legislations relating to clinical data management are of limited value and no study has yet demonstrated its effectiveness. METHOD Sponsor queries and dual entry procedures from one CRO on three different phase I trials are analysed on content, impact and cost. RESULT In this study, sponsor queries and dual entry procedures proved time and cost inefficient in detecting data discrepancies. CONCLUSION We advocate a more evidence-based approach for enhancing data integrity throughout the process of clinical data management.