Application of a risk-management framework for integration of stromal tumor-infiltrating lymphocytes in clinical trials

Stromal tumor-infiltrating lymphocytes (sTILs) are a potential predictive biomarker for immunotherapy response in metastatic triple-negative breast cancer (TNBC). To incorporate sTILs into clinical trials and diagnostics, reliable assessment is essential. In this review, we propose a new concept, namely the implementation of a risk-management framework that enables the use of sTILs as a stratification factor in clinical trials. We present the design of a biomarker risk-mitigation workflow that can be applied to any biomarker incorporation in clinical trials. We demonstrate the implementation of this concept using sTILs as an integral biomarker in a single-center phase II immunotherapy trial for metastatic TNBC (TONIC trial, NCT02499367), using this workflow to mitigate risks of suboptimal inclusion of sTILs in this specific trial. In this review, we demonstrate that a web-based scoring platform can mitigate potential risk factors when including sTILs in clinical trials, and we argue that this framework can be applied for any future biomarker-driven clinical trial setting

Reduced growth performance in gilt progeny is not improved by segregation from sow progeny in the grower–finisher phase

Gilt progeny (GP) are born and weaned lighter than sow progeny (SP) and tend to have higher rates of mortality and morbidity. This study quantified the lifetime growth performance differences between GP and SP and, additionally, evaluated whether segregating GP and SP in the grower-finisher period compared to mixing them within common pens reduced this variation. It was hypothesised that GP would be lighter than SP at every stage and segregation would improve growth performance of both GP and SP. All piglets born to 61 gilts (parity 1) and 47 sows (parities 2 to 7; mean 3.5 ± 0.2) were allocated to four treatments at 10 weeks of age: (i) GP housed together (GG), (ii) GP mixed (M) with SP (GM), (iii) SP housed together (SS) and (iv) SP mixed with GP (SM). The GM and SM pigs were housed together in common pens after movement into the grower-finisher facility. Individual live weight of all progeny was recorded at birth, weaning (WWT), 10 weeks of age (10WT) and sale (SWT). Individual hot carcass weight (HCW), fat depth at the head of the last rib (P2) and dressing percentage were measured at slaughter. Gilt progeny were lighter at birth (P = 0.038), weaning (P 0.10) in female SP, or in males. In conclusion, GP were lighter at every stage than SP and differences after weaning were highly related to the lighter WWT of GP. Under the conditions of this study, overall segregation of GP and SP showed no consistent advantages in growth performance for both groups and differed significantly between males and females

The synergistic effects of ractopamine and porcine somatotropin on finisher gilt performance

Ractopamine hydrochloride (Paylean®, RAC, Elanco Animal Health Pty Ltd, Macquarie Park, NSW) is an approved ingredient for pigs used to increase lean tissue growth and improve production efficiency (Dunshea et al., 2005). Porcine somatotropin (Reporcin®, pST, OzBioPharm Pty Ltd, Knoxfield, VIC) is a protein naturally produced by the pig that induces the redirection of nutrients towards increased muscle growth and decreased fat growth (Dunshea et al., 2005). Recent research (Rikard-Bell et al., 2009) has shown that combining RAC and pST in the last two weeks of production improves feed efficiency. The aim of this experiment was to evaluate changes in production efficiency obtained by combining RAC and pST in the last four weeks of growth

NIMPIS: An information system for marine introductions in Australia

The National Introduced Marine Pest Information System (NIMPIS) was developed to provide managers, researchers, students and the general public with access to accurate and up to date information on the biology, ecology and distribution of introduced marine species, and potential control options for those designated as pests. Included within this system are (i) species that are known to be introduced to Australian waters and (ii) those species that are considered to be likely future introductions ('next pests'). The information provided by this web site is held in a structured form that is also used by the biological risk assessment module of the AQIS ballast water management decision support system. As a result some of the descriptive text has been compiled from a number of fields and may be a little cryptic. Most however remains in the native form and is well documented

Narrating, writing, reading: life story work as an aid to (self) advocacy

This article is about life story work with people with learning disabilities. It talks about reading and writing stories, and listening to them. Telling your life story, writing it down and talking about it with others can be an important part of self-advocacy for people with learning disabilities. Life stories are helpful when they are told or written in a way that brings back memories that tell you about the real person. They should be written in a clear and honest way. These stories are very important, and other people need to listen to or read them in a careful and respectful way. Life stories show how each person is special and an individual in their own right, with their own history. This is not the case in the files and records of most service organizations. Life story work can help people with learning disabilities to feel good about themselves and to understand themselves better. It also helps sup port workers and others to see each person with learning disabilities as an individual, to understand important relationships, and the ways in which the person they are working with makes sense of his or her life. © 2006 BILD Publications

Factorization of Block Triangular Matrix Functions with Off-diagonal Binomials

... framework of Wiener algebras of matrix-valued functions on connected compact abelian groups, with a non-archimedean linear order on the dual group. A criterion for factorizability is established for 2 × 2 block triangular matrix functions with elementary functions on the main diagonal and a binomial expression in the off-diagonal block