IQ Survey Results on Current Industry Practices-Part 1: Immunogenicity Risk Assessment.

An immunogenicity risk assessment (IRA) is a relatively new expectation of health authorities that is increasingly incorporated into the drug development process across the pharmaceutical/biotech industry. The guiding principle for an IRA includes a comprehensive evaluation of product- and patient-related factors that may influence the immunogenic potential of a biotherapeutic drug and a potential action plan. The Immunogenicity Working Group from the IQ Consortium (Clinical Pharmacology Leadership Group) has conducted a survey to understand the current practices for conducting IRAs and relevant aspects of bioanalysis.

2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA ( - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation).

The 18th Workshop on Recent Issues in Bioanalysis (18th WRIB) took place in San Antonio, TX, USA on May 6-10, 2024. Over 1100 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 18th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.

Effect of lactation feeder design on sow and litter performance, feeder cleaning criteria, and economic return.

A total of 557 mixed parity sows (PIC 1050) were used to evaluate the effect of lactation feeder design on sow farrowing performance, litter growth performance, feeder cleaning criteria, and economics. The experiment was conducted during the summer of 2023 at a commercial sow farm located in northwest Texas. The study used two sequential farrowing groups with approximately 279 sows per group.

The effects of dacitic (rhyolitic) tuff breccia and corn distillers' dried grains with solubles (DDGS) inclusion on pellet mill electrical efficiency, production rate, and subsequent pellet quality.

Two experiments were conducted to evaluate the effect of Azomite (AZO) and 30% distillers' dried grains with solubles (DDGS) on pellet mill (PM) electrical consumption (kWh/MT), production rate, and pellet quality. Experiment 1 was conducted as a 2 × 2 × 2 factorial with main effects of diet formulation (0% or 30% DDGS), PM (1 or 2), and AZO (0% or 0.25%) with 4 replications per treatment.

The Provision and Utilization of Telehealth within Academic Mental Health Clinics in North America during the COVID-19 Pandemic.

Objective: To document the experience of 14 academic child and adolescent psychiatry programs in transitioning to and managing telehealth services during the COVID-19 pandemic. The goal was to understand how programs adopted and sustained telehealth during the pandemic. Telehealth was defined as services delivered via videoconferencing and telephony.

2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization).

The 17 Workshop on Recent Issues in Bioanalysis (17 WRIB) took place in Orlando, FL, USA on June 19-23, 2023. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 17 WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week to allow an exhaustive and thorough coverage of all major issues in bioanalysis of biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.

Risk-based approach of bioanalytical methods for clinical immunogenicity assessment of multidomain biotherapeutics.

Tweetable abstract Risk-based bioanalytical method development for clinical antidrug antibody detection and characterization of multidomain biotherapeutics.

Evaluation of a based dried fermentation product administered through drinking water on nursery pig growth performance, fecal virulence genes and pathotypes, antibiotic usage, and mortality.

A total of 34,749 pigs were used in two experiments to evaluate the effects of a postbiotic dried fermentation product () administered through drinking water on nursery pig growth performance, antibiotic injection frequency, morbidity, mortality, fecal consistency, and characterization of fecal . The DFP is composed of bioactive molecules derived from In Exp. 1, 350 barrows (DNA Line 200 × 400; initial body weight [] 6.

2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.

The 16 Workshop on Recent Issues in Bioanalysis (16 WRIB) took place in Atlanta, GA, USA on September 26-30, 2022. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 16 WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.

2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays ( - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach).

The 2022 16th Workshop on Recent Issues in Bioanalysis (WRIB) took place in Atlanta, GA, USA on September 26-30, 2022. Over 1000 professionals representing pharma/biotech companies, CROs, and multiple regulatory agencies convened to actively discuss the most current topics of interest in bioanalysis. The 16th WRIB included 3 Main Workshops and 7 Specialized Workshops that together spanned 1 week in order to allow exhaustive and thorough coverage of all major issues in bioanalysis, biomarkers, immunogenicity, gene therapy, cell therapy and vaccines.

Comparing tryptophan:lysine ratios in dried distillers grains with solubles-based diets with and without a dried distillers grains with solubles withdrawal strategy on growth, carcass characteristics, and carcass fat iodine value of growing-finishing pigs.

A total of 6,240 finishing pigs (DNA 600 × PIC 1050; initially 22.5 ± 1.00 kg), divided into two groups, were used in a 119 or 120 d study comparing increasing Trp:Lys ratio in diets containing dried distillers grains with solubles (DDGS) or a DDGS withdrawal strategy (removing all DDGS from the last phase before marketing) on growth performance and carcass fat iodine value (IV).

Effect of different sow lactation feeder types and drip cooling on sow bodyweight, litter performance, and feeder cleaning criteria.

A total of 600 sows (line 3; PIC, Hendersonville, TN) were used to evaluate the effect of different lactation feeder types and drip cooling on sow farrowing performance and litter growth performance during the summer. For the feeder evaluation, the trial was conducted in two sequential groups with 300 sows per group. Five 60-farrowing-stall rooms with tunnel ventilation were used for each group.

When Adverse Childhood Experiences Present to a Statewide Child Psychiatry Access Program.

Many children experience adversity, yet few receive needed psychiatric services. Pediatric primary care providers (PCPs) are uniquely positioned to intervene but often lack training and resources to provide patients with adverse childhood experiences (ACEs) the psychiatric support they need. The current study examines characteristics of youth with and without ACEs who were the focus of PCP contacts with a statewide child psychiatry access program (CPAP).

Cultivating cultural capitals in introductory algebra-based physics through reflective journaling.

At a large, diverse, hispanic-serving, master's-granting university, the Alma Project was created to support the rich connections of life experiences of science, technology, engineering, and mathematics (STEM) students that come from racially diverse backgrounds through reflective journaling. Utilizing frameworks in ethnic studies and social psychology, the Alma Project aims to make learning STEM inclusive by affirming the intersectional identities and cultural wealth that students bring into STEM classrooms. Approximately once per month students who participate in the Alma Project spend 5-10 min at the beginning of class responding to questions designed to affirm their values and purpose for studying STEM in college.

Characteristics of Patients Served by a Statewide Child Psychiatry Access Program.

Objective: Maryland's Behavioral Health Integration in Pediatric Primary Care (BHIPP) is a child psychiatry access program offering child-adolescent psychiatry consultation, resource and referral networking, and direct-to-patient mental health intervention. This study investigated characteristics of patients for whom primary care providers sought BHIPP services.

Methods: Data from 6,939 unique patient contacts between October 2012 and March 2020 were collected on service type, demographic characteristics, presenting concerns, clinical severity, clinicians' diagnostic impressions, current treatments, and BHIPP recommendations.

Anti-drug Antibody Sample Testing and Reporting Harmonization.

A clear scientific and operational need exists for harmonized bioanalytical immunogenicity study reporting to facilitate communication of immunogenicity findings and expedient review by industry and health authorities. To address these key bioanalytical reporting gaps and provide a report structure for documenting immunogenicity results, this cross-industry group was formed to establish harmonized recommendations and a develop a submission template to facilitate agency filings. Provided here are recommendations for reporting clinical anti-drug antibody (ADA) assay results using ligand-binding assay technologies.

Characteristics of Primary Care Providers' Consultations With a Statewide Child Psychiatry Access Program Regarding Autism Spectrum Disorder.

Background: Child Psychiatry Access Programs (CPAPs) provide consultative support for pediatric primary care providers (PCPs) to treat co-morbid mental health (MH) symptoms among patients with Autism Spectrum Disorder (ASD).

Objectives: We examined differences in illness severity, comorbidity, and psychotropic medication use between patients with and without ASD for whom primary care providers sought consultation from Maryland's CPAP.

Methods: We examined N = 3641 Maryland's CPAP consultations from 2012 to 2019; n = 311 were consultations for ASD.

Trends in Mental Health Concerns Reported to Two Pediatric Mental Health Care Access Programs During the COVID-19 Pandemic.

Objective: Pediatric Mental Health Care Access (PMHCA) programs increase access to mental health care by providing training, consultation, and resource-referral support to primary care providers (PCPs). The authors compared trends in services provided by two PMHCA programs during the COVID-19 pandemic.

Methods: Maryland and Mississippi PMHCA programs had 2,840 contacts with PCPs from January 2019 to March 2021.

Buprenorphine Induction in a Rural Maryland Detention Center During COVID-19: Implementation and Preliminary Outcomes of a Novel Telemedicine Treatment Program for Incarcerated Individuals With Opioid Use Disorder.

Over 10 million individuals pass through U.S. detention centers on an annual basis, with nearly two-thirds meeting criteria for drug dependence/abuse.

Mobile Telemedicine for Buprenorphine Treatment in Rural Populations With Opioid Use Disorder.

Importance: The demand for medications for opioid use disorder (MOUD) in rural US counties far outweighs their availability. Novel approaches to extend treatment capacity include telemedicine (TM) and mobile treatment on demand; however, their combined use has not been reported or evaluated.

Objective: To evaluate the use of a TM mobile treatment unit (TM-MTU) to improve access to MOUD for individuals living in an underserved rural area.

Pediatric Primary Care Provider Comfort with Mental Health Practices: A Needs Assessment of Regions with Shortages of Treatment Access.

Objectives: Nearly 50% of children with a mental health concern do not receive treatment. Child Psychiatry Access Programs like Behavioral Health Integration in Pediatric Primary Care (BHIPP) address regional shortages of mental health treatment access by providing training and consultation to primary care providers (PCPs) in managing mental health concerns. This study assessed PCPs' comfort with mental health practices to inform expansion of BHIPP services.

Using multiple platforms for critical reagents selection process to support pharmacokinetic ligand-binding assay development.

We have evaluated the utility of epitope binning on biolayer interferometry (BLI) as a strategy to funnel the selection of candidate pairs suitable for pharmacokinetic assay development. Totally, 8 anti-Idiotypic monoclonal antibodies in 64 possible combinations were tested by BLI, ELISA and Gyrolab. Two epitope binning approaches were utilized, in-tandem and classic sandwich.