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Pronker E.,Vacceleron | Geerts B.F.,Leiden University | Cohen A.,Center for Human Drug Research | Pieterse H.,Profess Medical Consultancy BV
British Journal of Clinical Pharmacology | Year: 2011

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. © 2011 The Authors. British Journal of Clinical Pharmacology © 2011 The British Pharmacological Society.

Pronker E.S.,Vacceleron | Weenen T.C.,Erasmus University Rotterdam | Commandeur H.R.,Erasmus University Rotterdam | Osterhaus A.D.M.E.,Erasmus University Rotterdam | And 2 more authors.
Vaccine | Year: 2011

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? © 2011 Elsevier Ltd.

Pronker E.S.,Vacceleron | Pronker E.S.,Erasmus University Rotterdam | Weenen T.C.,Erasmus University Rotterdam | Commandeur H.,Erasmus University Rotterdam | And 3 more authors.
PLoS ONE | Year: 2013

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. © 2013 Pronker et al.

Weenen T.C.,Erasmus University Rotterdam | Weenen T.C.,Erasmus Medical Center | Pronker E.S.,Vacceleron | Commandeur H.R.,Erasmus University Rotterdam | And 2 more authors.
PharmaNutrition | Year: 2013

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. © 2013.

Weenen T.C.,Erasmus University Rotterdam | Weenen T.C.,Erasmus Medical Center | Pronker E.S.,Vacceleron | Commandeur H.R.,Erasmus University Rotterdam | And 2 more authors.
PharmaNutrition | Year: 2013

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. © 2013 Elsevier B.V.

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