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While high risk of failure is an inherent part of developing innovative therapies, it can be reduced by adherence to evidence-based rigorous research practices. Supported through the European Union's Innovative Medicines Initiative, the EQIPD consortium has developed a novel preclinical research quality system that can be applied in both public and private sectors and is free for anyone to use. The EQIPD Quality System was designed to be suited to boost innovation by ensuring the generation of robust and reliable preclinical data while being lean, effective and not becoming a burden that could negatively impact the freedom to explore scientific questions. EQIPD defines research quality as the extent to which research data are fit for their intended use. Fitness, in this context, is defined by the stakeholders, who are the scientists directly involved in the research, but also their funders, sponsors, publishers, research tool manufacturers, and collaboration partners such as peers in a multi-site research project. The essence of the EQIPD Quality System is the set of 18 core requirements that can be addressed flexibly, according to user-specific needs and following a user-defined trajectory. The EQIPD Quality System proposes guidance on expectations for quality-related measures, defines criteria for adequate processes (i.e. performance standards) and provides examples of how such measures can be developed and implemented. However, it does not prescribe any pre-determined solutions. EQIPD has also developed tools (for optional use) to support users in implementing the system and assessment services for those research units that successfully implement the quality system and seek formal accreditation. Building upon the feedback from users and continuous improvement, a sustainable EQIPD Quality System will ultimately serve the entire community of scientists conducting non-regulated preclinical research, by helping them generate reliable data that are fit for their intended use., Competing Interests: AB AB is an employee and/or shareholder at PAASP GmbH, PAASP US LLC, Exciva GmbH, Synventa LLC, Ritec Pharma, RB, MA, LB, Nd, EC, AD, RF, VG, SH, MH, MK, MP, PP, EP, LR, GR, MR, JS, MS, CS, VV, JV, KW No competing interests declared, AG AG are employees of Janssen / Johnson & Johnson and shareholders at Johnson & Johnson, BG, CE BG and CE are employees and shareholders at PAASP GmbH. JG JG is an employee of AAALAC International that is an EQIPD Associated Collaborator. VC, CF VC and CFC are employees of Porsolt. IL, FD IAL and FD are employees of Sanofi. LM LM is an employee and shareholder of UCB. SB SB is an employee of Novartis Pharma. BA BA is an employee and shareholder of Pfizer. The views and opinions expressed in this article are those of the individual author and should not be attributed to Pfizer, its directors, officers, employees, affiliates, or any organization with which the author is employed or affiliated. CF AB, BA, NdB, UD, CFB, PK, MK, MM, PM, PP, GR, JS, and TS are members of the Preclinical Data Forum (co-chairs - AB and TS), a network financially and organizationally supported by ECNP and Cohen Veterans Bioscience. PK PK is an employee and shareholder at PAASP US LLC. CK UD and CK receive funding from Volkswagen Foundation, PM PM is owner of Cerbascience Consulting, HP HP has received during the last three years consulting and speaking fees and/or funding for collaborative projects from Bayer, Roche, Zogenix, and Eisai. KW KW is a consultant of Avertim, Brussels, Belgium, support for this contribution was funded by Janssen Pharmaceutica NV. MM MM, UD and TS are members of the Advisory Board at PAASP. MM, UD and TS are members of the ARRIVE guidelines working group. UD UD and CK receive funding from Volkswagen Foundation. MM, UD and TS are members of the Advisory Board at PAASP. MM, UD and TS are members of the ARRIVE guidelines working group. TS MM, UD and TS are members of the Advisory Board at PAASP. MM, UD and TS are members of the ARRIVE guidelines working group. TS is an AAALAC ad-hoc specialist. TS and AG are employees of Janssen / Johnson & Johnson and shareholders at Johnson & Johnson., (© 2021, Bespalov et al.)

Objectives: The long-term safety of exposure to anti-tumor necrosis factor (anti-TNFα) drugs during pregnancy has received little attention. We aimed to compare the relative risk of severe infections in children of mothers with inflammatory bowel disease (IBD) who were exposed to anti-TNFα drugs in utero with that of children who were not exposed to the drugs., Methods: Retrospective multicenter cohort study. Exposed cohort: children from mothers with IBD receiving anti-TNFα medication (with or without thiopurines) at any time during pregnancy or during the 3 months before conception. Non-exposed cohort: children from mothers with IBD not treated with anti-TNFα agents or thiopurines at any time during pregnancy or the 3 months before conception. The cumulative incidence of severe infections after birth was estimated using Kaplan-Meier curves, which were compared using the log-rank test. Cox-regression analysis was performed to identify potential predictive factors for severe infections in the offspring., Results: The study population comprised 841 children, of whom 388 (46%) had been exposed to anti-TNFα agents. Median follow-up after delivery was 47 months in the exposed group and 68 months in the non-exposed group. Both univariate and multivariate analysis showed the incidence rate of severe infections to be similar in non-exposed and exposed children (1.6% vs. 2.8% per person-year, hazard ratio 1.2 (95% confidence interval 0.8-1.8)). In the multivariate analysis, preterm delivery was the only variable associated with a higher risk of severe infection (2.5% (1.5-4.3))., Conclusions: In utero exposure to anti-TNFα drugs does not seem to be associated with increased short-term or long-term risk of severe infections in children.

Background: While most studies have found a negative effect of smoking on Crohn's disease (CD) phenotype, more recent data have failed to reproduce this association, which might be due to a current wider use of thiopurines and biologic therapy. The TABACROHN study aimed at defining the impact of smoking on CD in the largest published series., Methods: This multicenter cross-sectional study included 1170 CD patients. Patients were classified as nonsmokers, current smokers, or former smokers according to their present smoking status. Clinical data regarding disease characteristics, treatment, and complications were collected., Results: Smokers were more frequently under maintenance treatment when compared to nonsmokers. In addition, current smokers presented higher use of biologic drugs compared to nonsmokers. Tobacco exposure and a higher tobacco load were independent predictors of need for maintenance treatment and stenosing phenotype, respectively., Conclusions: In the era of early and widespread use of immunosuppressants and biologics, tobacco exposure is an independent predictor of need for maintenance treatment, specifically biologic therapy. The wider use of biologics and immunosuppressants could account for the existence of no major differences in disease behavior and complications between nonsmokers and current smokers.

Allele frequency distributions of six short tandem repeat (STR) loci, HUMTH01, HUMFES/FPS, HUMTPOX, HUMVWF/A31, HUMF13B, and HUMLPL, were determined in a population (101 individuals) of the Vera-Jerte region in West Central Spain. Amplified products were electrophoresed on denaturing polyacrylamide gels and silver-stained. The exact test demonstrated that none of the six loci deviated from Hardy-Weinberg equilibrium. R-matrix analysis in relation to other European samples agrees well with genetic distance results of Reynolds et al. (1983). Comparisons show that our population comes reasonably well within the range of variation of other European samples, and that the representation of these samples on the genetic map indicates a close relation between geographical location and distribution in the diagram.