Bridging knowledge to the market: an innovative approach for an innovative development

We live in a world of constant development, growth, innovation and changing needs and nonetheless cultural habits. How to sustain this constant change and how to adapt to globalisation, technological change and constant creativity and innovativeness of key human resources inside larger corporations as well as knowledge institutions is answering the concept of corporate entrepreneurship, new ventures and academic spin-off creation. Article will show the trend in the field of new venture and academic spin-off creation, involving human and social capital as key success factors. Barriers and innovative solutions will be presented on how to overcome the issue of lacking cooperation between academia and industry. Relevant best practices and experiences will be presented to be discussed as opportunities that can find the place in the already existing strengths of Slovenia and its entrepreneurial development and regional growthAcademic spin-off, Early-Stage Financing, Knowledge-Intensive Regions, Knowledge-Intensive Companies, new venture

Scientific opinion on the evaluation of authorised ferric sodium EDTA as an ingredient in the context of Regulation (EC) 258/97 on novel foods and Regulation (EU) 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control

The present opinion deals with the evaluation of the proposed increase of the currently authorised maximum amounts of ferric sodium ethylenediaminetetraacetic acid (EDTA) as a novel food ingredient used as a source of iron, and its extension of use in processed cereal‐based foods and baby foods. The applicant also provided information on two forms of ferric sodium EDTA, one previously assessed by EFSA and a new one of finer consistency. To support the proposed changes to the uses of ferric sodium EDTA, the applicant proposed a revision of the current acceptable daily intake (ADI) for EDTA, derived from that set for the food additive calcium disodium EDTA (E 385). The Panel confirmed that ferric sodium EDTA is a source from which iron is bioavailable. In assessing the safety of the proposed revision to the existing specifications for the novel food ingredient ferric sodium EDTA, the Panel noted that this would not discriminate between the previously evaluated substance and the one of finer consistency. In particular, the Panel noted that particle size was not one of the proposed parameters for the revised specifications. The Panel noted that it was not possible to determine whether particles of ferric sodium EDTA in the nano range were present in the product with finer consistency in the solid form. The toxicological data submitted did not add any new relevant information to the database on which the current ADI for EDTA is based. Consequently, the Panel concluded that there was no sound scientific justification to increase the ADI for EDTA and hence increase the use levels of ferric sodium EDTA or introduce additional uses as proposed by the applicant. The Panel recommended that additional toxicological data should be provided to address the shortcomings in the available toxicity database prior to the re‐evaluation of calcium disodium EDTA (E 385)

Conference conclusions: shaping the future of food safety, together

The EFSA 2nd Scientific Conference 'Shaping the Future of Food Safety, Together' gathered an international audience composed of scientists, risk assessors, risk managers, as well as non-governmental organisations and industry representatives. This article summarises the final plenary session where a panel was asked to draw out overall impressions and conclusions for the EFSA to take away for its strategic planning into the future. The main conclusions of the conference are presented under five major themes. With new methodologies, technologies, big data and the increased societal demand for enhanced engagement in the risk assessment process, there is a clear need to maintain levels of expertise from traditional areas and to consider the inclusion of new areas and sources of expertise to perform scientific assessments. Academia, industry, research and regulatory science should work together to achieve this goal. As science progresses at pace, the continued development of assessment methodologies to deal with increasingly complex assessment questions is necessary, as is the need for applied research to underpin the support to policy development that EFSA provides. Greater collaboration is needed to reach agreement on best methods and practices for scientific assessment not just internationally, but also, equally importantly, across legislative areas and scientific disciplines, and in consultation with society at large. The communication of complex science, including important concepts such as uncertainty and risk perception, is not a trivial task, and must be integrated into the scientific process. As such, the relationship between risk assessment and risk management must continue to mature, remaining close, yet independent

Terminal half-life of FVIII and FIX according to age, blood group and concentrate type: data from the WAPPS database

Background Real-life data on pharmacokinetics of factor (F) VIII/IX concentrates, especially extended half-life (EHL), concentrates in large cohorts of persons with hemophilia are currently lacking. Objectives This cross-sectional study aimed to establish reference values for terminal half-life (THL) for FVIII/IX concentrates according to concentrate type, age, blood group and inhibitor history. Patients/Methods Data were extracted from the Web-Accessible Population Pharmacokinetics Service database. Groups were compared by nonparametric tests. THL was modelled according to patient characteristics and concentrate type. Results Infusion data (n = 8022) were collected from 4832 subjects (including 2222 children) with severe hemophilia (age: 1 month–85 years; 89% hemophilia A; 34% using EHL concentrates, 9.8% with history of inhibitors). THL of FVIII-EHL was longer than of FVIII standard half-life (SHL; median 15.1 vs. 11.1 h). FVIII-THL was dependent on age, concentrate type, blood group, and inhibitor history. THL of FIX-EHL was longer than of FIX-SHL (median 106.9 vs. 36.5 h). FIX-THL increased with age until 30 years and remained stable thereafter. FVIII-THL was shorter in subjects with blood group O. THL was decreased by 1.3 h for FVIII and 22 h for FIX in subjects with a positive inhibitor history. Conclusions We established reference values for FVIII/IX concentrates according to patient characteristics and concentrate type in a large database of hemophilia patients. These reference values may inform clinical practice (e.g., assessment of immune tolerance success), economic implications of procurement processes and value attribution of novel treatments (e.g., mimetics, gene therapy)

Predicting Individual Changes in Terminal Half-Life After Switching to Extended Half-Life Concentrates in Patients With Severe Hemophilia

Predicting individual effects of switching from standard half-life (SHL) to extended half-life (EHL) FVIII/FIX concentrates is pivotal in clinical care, but large-scale individual data are scarce. The aim of this study was to assess individual changes in terminal half-life (THL) after switching to EHL concentrates and identifying determinants of a clinically relevant THL extension in people with severe hemophilia. Data from participants with pharmacokinetic studies on both SHL and EHL were extracted from the Web-Accessible Population Pharmacokinetics Service (WAPPS) database and stratified according to hemophilia type and age groups (children/adults). A 30% increase in THL was considered clinically relevant. Predictors of a relevant increase were identified using logistic regression. Data from 688 persons with severe hemophilia (2174 infusions) were included: 89% hemophilia A; median age: 21.7 (interquartile range [IQR]: 11.5-37.7); positive inhibitor history: 11.7%. THL increased by 38% (IQR: 17%-67%) and 212% (139%-367%) for hemophilia A and B, respectively. All EHL-FIX concentrate users showed clinically relevant THL extension. However, 40% (242/612) of people with hemophilia A showed limited extension or decrease in THL after switching. Relevant FVIII-THL extension was predicted by short baseline THL and blood group non-O in both children and adults. In conclusion, clinically relevant THL extension was observed in all 75/76 participants switching to EHL-FIX, and in 60% of 612 switching to EHL-FVIII. Short THL on SHL-FVIII and blood group non-O were identified as predictors for a relevant THL increase after switching to EHL-FVIII. Individualized pharmacokinetic assessment may guide clinical decision-making when switching from SHL to EHL-FVIII

The safety assessment of microalgae-derived products as novel foods by the European Food Safety Authority

Recent advancements in food research alongside the growing interest in new sources with enhanced nutritional value have led to an increasing development of food products derived from microalgae. Some of these products fall under the category of novel foods (NFs) in the European Union (EU) and their safety must be evaluated by the European Food Safety Authority (EFSA) before being authorised on the EU market. By August 2024, EFSA had evaluated eleven NFs derived from microalgae, including oils rich in docosahexaenoic acid (DHA) from Schizochytrium spp., whole biomass of the microalga Euglena gracilis and its derivative beta-glucan polymer (paramylon), ethanolic extract from Phaeodactylum tricornutum and oleoresin rich in astaxanthin from Haematococcus pluvialis. One of the key scientific requirements for the safety assessment of these products is the characterisation of the microalga strain, including its unambiguous taxonomic identification at species level and pathogenicity. The “Qualified Presumption of Safety” (QPS) status of the microalgae also plays a significant role in determining the safety assessment approach to be applied. Other relevant requirements comprise a thorough chemical characterisation (e.g., biotoxins, undesirable substances, heavy metals) together with microbiological and nutritional characterisation of the product, description of the manufacturing process and a toxicological and allergenicity assessment. By illustrating examples of NF that consist of, are isolated from or are produced by microalgae we highlight the main requirements needed for their safety assessment alongside the challenges encountered. Taking into account the continuous evolution of the microalga sector leading to innovative products, we also extend these requirements to the safety assessment of microalgal proteins, considering potential future mandates to assess algae-derived proteins as NFs by EFSA.publishedVersio

Safety of iron hydroxide adipate tartrate as a novel food pursuant to Regulation (EU) 2015/2283 and as a source of iron in the context of Directive 2002/46/EC

[EN] Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on iron hydroxide adipate tartrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283 and as a source of iron in the context of Directive 2002/46/EC. The NF is intended to be used in food supplements up to a maximum dose of 100 mg per day, corresponding to a maximum daily intake of iron of 36 mg. The target population proposed by the applicant is the general population above 3 years of age. The NF which is the subject of the application is an engineered nanomaterial having primary particles, of almost spherical morphology, with a diameter typically smaller than 5 nm. The studies provided for absorption, distribution, metabolism and excretion (ADME) and bioavailability indicate that iron, once taken up into the epithelial cells of the gut, is subject to the same mechanisms of regulation and absorption as that of other forms of iron. Further studies provided in the context of the toxicological assessment indicate that the NF does not lead to iron bioaccumulation in tissues and organs at the doses tested. The Panel notes that the NF contains nickel at concentrations that may increase the risk of flare-up reactions in nickel-sensitised young individuals up to 10 years of age. In the 90-day toxicity study, findings related to haematology, clinical biochemistry and organ weights were observed and the Panel defined a no observed adverse effect level (NOAEL) of 231 mg/kg body weight (bw) per day, that is, the mid-dose used in the study. The Panel considers that the NF is a source from which iron is bioavailable and it is safe under the proposed conditions of useSIThe EFSA NDA Panel wishes to thank the members of the EFSA Cross-cutting WG nanotechnologies for the support provided to this scientific outpu

Safety of iron hydroxide adipate tartrate as a novel food pursuant to Regulation (EU) 2015/2283 and as a source of iron in the context of Directive 2002/46/EC

publishedVersio