Affimers as anti-idiotypic affinity reagents for pharmacokinetic analysis of biotherapeutics.

Therapeutic antibodies are the fastest growing class of drugs in the treatment of cancer, and autoimmune and inflammatory diseases that require the concomitant development of assays to monitor therapeutic antibody levels. Here, we demonstrate that the use of Affimer nonantibody binding proteins provides an advantage over current antibody-based detection systems. For four therapeutic antibodies, we used phage display to isolate highly specific anti-idiotypic Affimer reagents, which selectively bind to the therapeutic antibody idiotype. For each antibody target the calibration curves met US Food and Drug Administration criteria and the dynamic range compared favorably with commercially available reagents. Affimer proteins therefore represent promising anti-idiotypic reagents that are simple to select and manufacture, and that offer the sensitivity, specificity and consistency required for pharmacokinetic assays.

Engaging pregnant women in observational research: a qualitative exploratory study.

BACKGROUND: Recruitment of pregnant women to population health research can be challenging, especially if the research topic is sensitive. While many pregnant women may be inherently interested in research about pregnancy, there is the possibility that the nature and timing of the project may give rise to anxiety in some women, especially if the topic is sensitive or it brings about new awareness of potential pregnancy complications. Research staff undertaking recruitment need to be skilled at strategies to manage the environment, and have well developed communication and interpersonal skills to explain and promote the study and facilitate each woman's informed decision-making regarding participation. However, the skills needed by recruitment staff to successfully engage pregnant women with a research topic are not well understood. This study aimed to address this evidence gap by providing insight into the dynamics between a pregnant woman and recruitment staff at the time of the offer to participate in an observational study about alcohol use in pregnancy. METHODS: Naturalistic inquiry guided a qualitative exploratory descriptive approach. Experienced recruitment staff from the Asking Questions about Alcohol in Pregnancy (AQUA) study (Muggli et al., BMC Pregnancy Childbirth 14:302, 2014) participated in individual semi-structured interviews and were asked about their experiences and approaches to engaging pregnant women. Interviews were transcribed verbatim and analysed using inductive content analysis. RESULTS: Pregnant women brought with them an inherent interest or disinterest in alcohol research, or in research in general, which formed the basis for engagement. Women responded favourably to the invitation to participate being delivered without pressure, and as part of a two-way conversation. Engagement with a sensitive topic such as alcohol use in pregnancy was facilitated by a non-judgmental and non-targeted approach. Influences such as privacy, distractions, partner's opinion, time factors and level of clinical support either facilitated or hindered a woman's engagement with the research. CONCLUSIONS: These results provide an in-depth explanation of barriers and enablers to recruitment of pregnant women in antenatal clinics to studies that may inform strategies and the training of recruitment staff.

High school Tay-Sachs disease carrier screening: 5 to 11-year follow-up.

The Melbourne high school Tay-Sachs disease (TSD) carrier screening program began in 1997. The aim of this study was to assess the outcomes of this screening program among those who had testing more than 5 years ago, to evaluate the long-term impact of screening. A questionnaire was used for data collection and consisted of validated scales and purposively designed questions. Questionnaires were sent to all carriers and two non-carriers for each carrier who were screened in the program between 1999 and 2005. Twenty-four out of 69 (34.8 %) carriers and 30/138 (21.7 %) non-carriers completed the questionnaire. Most participants (82 %) retained good knowledge of TSD and there was no evidence of a difference in knowledge between carriers and non-carriers. Most participants (83 %) were happy with the timing and setting of screening and thought that education and screening for TSD should be offered during high school. There was no difference between carriers and non-carriers in mean scores for the State Trait Anxiety Inventory and Decision Regret Scale. This evaluation indicated that 5-11 years post high school screening, those who were screened are supportive of the program and that negative consequences are rare.