E Claassen

Erasmus University Rotterdam, Rotterdam, South Holland, Netherlands

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Publications (143)407.13 Total impact

  • Kenneth Fernald · Eric Claassen

    No preview · Article · Dec 2015 · Nature Biotechnology
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    ABSTRACT: Immunization is considered the most effective strategy for infectious disease control and maintaining global health. Conventional vaccines have successfully targeted a broad spectrum of pathogens. However, a large number of untargeted diseases still remain. Introduction of novel Genetically Modified (GM) vaccines allow development of new improved vaccines and immunotherapeutics. Moreover, GM vaccines can also target non-communicable diseases outside the range of infectious diseases, including cancer, autoimmune diseases, and allergies. Methods: We compiled novel and unique datasets encompassing data from literature, patent documents, clinical trials, and vaccine registers in order to provide a thorough overview of the GM market.Results: Based on patent data, we found that most patent applications were filed in North America, Asia, and Europe, which coincides with the locations of the largest companies and institutes. Looking at clinical trial data we forecast marketing of two next generation GM vaccines, targeting cancer and malaria. In addition, we calculated phase transition success rates of 82% (phase 1-2) and 76% (phase 2-3).Conclusions: These findings indicate viable regions for GM vaccine research and development. Phase transition success rates of 82% (phase 1-2) and 76% (phase 2-3) predict a relatively high chance of marketing approval. Increased registrations of GM vaccines complemented by rising numbers of patent applications suggest global growth of the GM vaccine market, which currently holds a proportion of nearly 20% of the total vaccine market.
    Preview · Article · Nov 2015
  • M.van den Nieuwboer · P.D. Browne · E. Claassen
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    ABSTRACT: Due to broad application of probiotics, research efforts are diluted, thus contributing to rejection of health claims. This study aimed to systematically prioritize the unmet needs and research opportunities in infants, children, adults and elderly for probiotics according to their relative importance from a key-opinion-leader (KOL) perspective. In addition, it reveals potential probiotic product characteristics that need improvement from both a patient or consumer and a KOL perspective. Moreover, KOL involvement in the probiotic research & development (R&D) process was assessed. Data was collected by conducting semi-structured interviews and subsequent online questionnaires. The three clinical indications requiring the highest research attention for infants were (infectious) diarrhoea, antibiotic-associated diarrhoea (AAD) and necrotizing enterocolitis (NEC); for children, obesity, AAD and diarrhoea and for adults, AAD, irritable bowel syndrome (IBS) and Alzheimer’s disease. From both a KOL as well as a patient or consumer perspective, clinical evidence needs to be improved for probiotic products. Although the majority of the KOLs consult for and perform research with probiotic companies, they are (surprisingly) not able to sufficiently influence industry research agendas. This study incorporates the insights of KOLs and provides direction in the R&D of probiotics to fulfil unmet medical needs in patients.
    No preview · Article · Sep 2015 · PharmaNutrition
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    ABSTRACT: The field of probiotics has great innovative potential, addressing several unmet medical needs. However, despite mounting evidence and opportunities in the field, relatively few strains are commercially available and probiotics are seldom in routine use in clinical practice. Innovation in the field of probiotics seems hampered. Using the barrier approach, this study identified the main barriers in the probiotic innovation process, as experienced by key-opinion-leaders (KOLs). These innovation barriers are visualised and their underlying causes revealed by means of qualitative root cause analysis. The root causes were placed in an academic-industrial valorisation cycle. Furthermore, a quantitative ranking of the barriers was used to demonstrate their relative importance. This study demonstrates that the probiotic research cycle is faulty due to specific barriers and bypasses, and that innovation is hampered in all domains of the valorisation cycle. Eleven main barriers were identified, with “difficulty in demonstrating clinical efficacy” being the most significant inhibiting factor. Other barriers could be classified as fundamental research barriers, clinical research barriers, financial barriers, regulatory barriers, collaboration barriers, marketing barriers and product barriers. Using this barrier approach, inhibiting factors are identified which allows subsequent action to be taken to re-establish the natural cycle of innovation.
    No preview · Article · Sep 2015 · PharmaNutrition
  • Kenneth Fernald · Ruud Hoeben · Eric Claassen
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    ABSTRACT: Venture capitalists (VCs) aim at trade sales as a preferred exit-strategy for biotechnology companies they invest in. Therefore, VCs pay close attention to the wishes of larger (bio)pharmaceutical acquirers. In this paper we explore VCs’ behavior and strategies by analyzing the technology fields and therapeutic areas in which they are invested most and which yield the highest relative returns by means of trade sales. The data show that VCs are by far most invested in oncology and this is also an area in which relatively high returns are realized. Regarding other areas, VCs could balance their average investment valuations more in correspondence with what acquirers are willing to pay. In addition, VCs have predictive insight in the types of technologies that do well and they seem to employ a strategy focused on both short-term and long-term success. They are investing most in small molecule drugs and protein/peptide therapeutics, which both yield high returns, followed by DNA/RNA technologies which underlie the possibilities of personalized medicine. We conclude that VCs act as technological gatekeepers because they are predicting long-term cure and care macro-trends.
    No preview · Article · Jul 2015 · Journal of Commercial Biotechnology
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    ABSTRACT: 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. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.
    Preview · Article · Jun 2015 · Vaccine
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    ABSTRACT: Societal unmet needs for enhancing historical consciousness (HC) and democratic citizenship (DC) may be fulfilled by integrating popular culture initiatives with formal education. Focusing on the heritage of wars in the 20th century (modern war heritage), this pilot study identified and prioritised such unmet needs and the perceived advantages / disadvantages of integrating popular initiatives with formal education. Furthermore, some research priorities were determined. The aims were reached by consulting key opinion leaders and professionals from several European countries in the fields of popular culture, modern war heritage and education. Their insights were evaluated in an online survey by means of a prioritisation process. Participants in the survey prioritised: for HC and DC unmet needs in terms of importance and improvement; the advantages / disadvantages of integrating popular initiatives with formal education. Seventeen semi-structured interviews were conducted (response rate 46%); 49 surveys were returned (response rate 37%). Most important unmet needs were: ‘Enhancing insights, skills and capacities’ (HC / DC) and ‘Making the past relevant in the present’ (HC). Most important integration advantages were: ‘Increased opportunities for multiperspective understanding’ and ‘Increased possibilities to make the past relevant in the present’ (HC); ‘Inspires curiosity and personal development’ and ‘Inspires critical thinking and reflection’ (HC/DC). The ‘Risk of inaccuracy and inhibition of critical thinking and further exploration’ was the most important integration disadvantage for HC and DC.
    Full-text · Article · Jun 2015
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    ABSTRACT: This study aimed to systematically evaluate safety of probiotics and synbiotics in children ageing 0-18 years. This study is the third and final part in a safety trilogy and an update is provided using the most recent available clinical data (2008-2013) by means of the Common Terminology Clinical Adverse Events (CTCAE version 4.0) classification. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. Analysis of 74 clinical studies indicated that probiotic and/or synbiotic administration in children is safe with regard to the specific evaluated strains, dosages and duration. The population of children include healthy, immune compromised and obese subjects, as well as subjects with intestinal disorders, infections and inflammatory disorders. This study revealed no major safety concerns, as the adverse events (AEs) were unrelated, or not suspected to be related, to the probiotic or synbiotic product. In general the study products were well tolerated. Overall, AEs occurred more frequent in the control arm compared to children receiving probiotics and/or synbiotics. Furthermore, the results indicate inadequate reporting and classification of AEs in the majority of the studies. In addition, generalizability of conclusions are greatly limited by the inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes.
    No preview · Article · Mar 2015 · Beneficial Microbes
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    ABSTRACT: Our aim was to determine whether a fermented milk drink containing probiotics could improve the bowel habits of frail elderly individuals living in a nursing home. A total of 135 participants were enrolled in this pilot study. The bowel habits (stool quality and bowel movements) were recorded by nursing staff during a baseline period of 3 weeks. After this period participants received daily a fermented milk drink containing minimally 6.5×109 colony forming units of i>Lactobacillus casei Shirota (LcS) for 6 weeks. During this period, bowel habits were recorded and compared to baseline period. Forty-four participants (74'99 years old) were compliant and used for analysis. Consummation of fermented milk containing LcS significantly increased the percentage of ideal stool types per week (P<0.01), lowered the percentage of constipation stool types per week (P<0.01) and significantly lowered the percentage of diarrhoea stool types per week (P=0.016) as compared to the baseline period. The study product had no significant effect on bowel movements. During the study, no changes in laxative usage or adverse events associated with the study product were reported. Our results suggest that a fermented milk containing LcS significantly improves the bowel habits of frail elderly residents in a nursing home. These promising results should be further substantiated by a confirmatory study.
    Preview · Article · Feb 2015 · Beneficial Microbes
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    ABSTRACT: ACCORDING TO THE World Health Organization, the current Ebola epidemic is unlikely to be controlled in the coming months (1). With the exception of the com- passionate use of unregistered compounds (2), no specific medical interventions, including the use of antiviral drugs, anti- bodies, or vaccines, are available. Some candidate compounds and vaccines have entered into limited clinical trials for safety and immunogenicity in healthy individu- als. Most of these trials have been carried out by governmental organizations, such as the National Institute of Allergy and Infectious Diseases (NIAID), or by small or medium-size biotechnology companies with public funding. Private-sector investment has been very limited because past filovirus outbreaks were largely self-limiting and therefore believed to provide insufficient financial return on investment. We argue that this is a misconception of the very nature of emerging viruses.
    Full-text · Article · Oct 2014 · Science
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    ABSTRACT: This study aimed to systematically evaluate safety of probiotics and synbiotics in immune compromised adults (≥18 years). Safety was analysed using the Common Terminology Clinical Adverse Events (CTCAE version 4.0) classification, thereby providing an update on previous reports using the most recent available clinical data (2008- 2013). Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. Analysis of 57 clinical studies indicates that probiotic and/or synbiotic administration in immune compromised adults is safe with regard to the current evaluated probiotic strains, dosages and duration. Individuals were considered immune compromised if HIV-infected, critically ill, underwent surgery or had an organ- or an autoimmune disease. There were no major safety concerns in the study, as none of the serious adverse events (AE)s were related, or suspected to be related, to the probiotic or synbiotic product and the study products were well tolerated. Overall, AEs occurred less frequent in immune compromised subjects receiving probiotics and/or synbiotics compared to the control group. In addition, the results demonstrated a flaw in precise reporting and classification of AE in most studies. Furthermore, generalisability of conclusions are greatly limited by the inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes. We argue that standardised reporting on adverse events (CTCAE) in 'food' studies should be obligatory, thereby improving reliability of data and re-enforcing the safety profile of probiotics.
    Full-text · Article · Oct 2014 · Beneficial Microbes
  • Kenneth Fernald · Enrico Pennings · Eric Claassen
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    ABSTRACT: The management and exploitation of biotechnological product innovation have proven to be more difficult than initially expected because the number of currently marketed biotechnological products is far from sufficient to counter deficits in pharmaceutical innovation. This study provides insight into the role of governance structures in interfirm cooperation and their effects on biotechnological product innovation and company success. Most of the existing literature regarding alliances and mergers and acquisitions (M&A) examines their effects on technology recipients' innovation performance. Here, the effects of alliances and M&A on both the innovation success and financial performance of technology suppliers (i.e., sources) are examined. Drawing from a sample of 220 human therapeutic biotechnology and biopharmaceutical firms over a period of 32 years (1980–2011), an analysis of the effects of biotechnology clusters, strategic alliances, and acquisitions is provided. This study reveals the existence of a risk-return trade-off for strategic alliances between biotech companies and larger, more established firms. Increased biotech company involvement in product development alliances decreases risk by increasing the likelihood of future product introductions. The trade-off, however, is that biotech companies earn lower returns when their products are developed through such alliances. A similar risk-return trade-off effect is found for clusters. However, acquisitions generally affect both product introductions and product returns in a negative way. These findings have strategic implications not only for managing the development of biotechnological product innovations and technology platforms but also for commercialization strategies with respect to interfirm cooperation and risk reduction. http://onlinelibrary.wiley.com/doi/10.1111/jpim.12218/full
    No preview · Article · Oct 2014 · Journal of Product Innovation Management

  • No preview · Article · Jul 2014 · PharmaNutrition
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    T.C. Weenen · E. Pronker · H.R. Commandeur · E. Claassen

    Preview · Article · Jul 2014 · PharmaNutrition
  • Tamar C. Weenen · Harry Commandeur · Eric Claassen
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    ABSTRACT: A plethora of terms and definitions for medical nutrition has resulted in an ambiguity in the way “medical nutrition” is termed and defined across various societal levels. The terms medical nutrition, clinical nutrition, enteral nutrition, parenteral nutrition, oral nutritional supplements, medical foods, foods for special medical purposes, nutritional support, nutritional intervention and nutritional therapy are used interchangeably. To date consistent terminology/nomenclature and definitions have not emerged from the US and European medical nutrition community. The current absence of clear medical nutrition product category boundaries makes it necessary to introduce medical nutrition terminology conformance in order to reduce widespread confusion at policy; industry; healthcare; and patient level. In order to end discussion, this literature review attempts to put quantitative and qualitative clarity and continuity to the use of these terms and definitions by: (1) addressing the terminology used; (2) discussing the distinguishing features of medical nutrition in various definitions and (3) proposing a single medical nutrition term and a clear pragmatic operational definition. A scientific literature-based comparison was conducted resulting in the selection of 22 publications, describing 8 different terms with 19 definitions.
    No preview · Article · Jul 2014 · Trends in Food Science & Technology
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    ABSTRACT: 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.
    No preview · Article · May 2014 · Technological Forecasting and Social Change
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    Eric Claassen

    Preview · Article · Feb 2014 · Frontiers in Pharmacology
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    ABSTRACT: In this study, we systematically evaluated safety aspects in clinical trials with probiotics and synbiotics in young infants (0-2 years of age). This study is an update of earlier reports and covers the recent literature from 2008-2013. The safety evaluation is performed along the Common Terminology Clinical Adverse Events (CTCAE) version 4.0 scale, hereby also providing guidance for future studies. Safety aspects are represented and related to number of participants per probiotic strain/culture, study duration, dosage, clinical condition and selected afflictions. The results show a deficiency in the precise reporting and classification of adverse events in most studies. Analysis of 57 clinical trials with probiotics and synbiotics in combination with eight follow-up studies indicate that probiotic administration to infants between 0 and 24 months is safe with regard to the evaluated strains in infants with a particular health status or susceptibility. Most adverse events and serious adverse events were considered unrelated to the study product, and there were no major safety concerns. Almost all studies concluded that none of the adverse effects were related to the study product; the study products are generally well tolerated. Finally, inconsistent, imprecise and potentially incomplete reporting as well as the variation in probiotic strains, dosages, administration regimes, study populations and reported outcomes, greatly limit the generalizability of conclusions and argue convincingly for obligatory and standardised behaviour on adverse events (CTCAE) reporting in 'food' studies.
    Full-text · Article · Jan 2014 · Beneficial Microbes
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    ABSTRACT: 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.
    Full-text · Article · Dec 2013 · PLoS ONE
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    ABSTRACT: 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. 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. 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) TF 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. 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.
    No preview · Article · Dec 2013 · Clinical nutrition (Edinburgh, Scotland)

Publication Stats

4k Citations
407.13 Total Impact Points

Institutions

  • 1995-2015
    • Erasmus University Rotterdam
      • Department of Immunology
      Rotterdam, South Holland, Netherlands
    • Uniformed Services University of the Health Sciences
      • Department of Microbiology & Immunology
      Bethesda, MD, United States
    • National Institute for Public Health and the Environment (RIVM)
      Utrecht, Utrecht, Netherlands
  • 1991-2015
    • VU University Amsterdam
      Amsterdamo, North Holland, Netherlands
  • 2013
    • Erasmus MC
      Rotterdam, South Holland, Netherlands
  • 1994-2002
    • Utrecht University
      • Department of Infectious Diseases and Immunology
      Utrecht, Utrecht, Netherlands
  • 2000
    • Merck Animal Health Netherlands
      Boksmeer, North Brabant, Netherlands
  • 1996
    • University of Liège
      • Department of Pathology
      Luik, Walloon Region, Belgium
  • 1989-1995
    • Geisel School of Medicine at Dartmouth
      Hanover, New Hampshire, United States
  • 1993
    • Bristol-Myers Squibb
      • Department of Molecular Immunology
      New York City, NY, United States
  • 1985-1989
    • University of Amsterdam
      • Department of Histology
      Amsterdamo, North Holland, Netherlands
  • 1987
    • St. Jude Children's Research Hospital
      • Department of Immunology
      Memphis, TN, United States