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. Survey results were provided by 19 IQ member companies participating in the Clinical Pharmacology Leadership Group (CPLG) and the Translational and ADME Sciences Leadership Group (TALG). Nearly all the respondents reported experience with monoclonal antibodies (mAb), with 10 other drug modalities including bioengineered protein therapeutics such as fusion and multi-domain proteins, peptides, oligonucleotides as well as gene and cell therapies. The survey results demonstrate that most companies have a defined IRA process, and there was a common understanding that the IRA may need to be revised as more information becomes available or the drug development strategy changes. Some differences found across the respondents are related to the time frame for implementation of IRA document, the types of preclinical data and computational methods used to assess risk, and how the IRA informs clinical plans and documentation practices. These results highlight that while there have been widespread insights gained with performing IRA for mAbs, more experience is needed to perform IRAs for the novel modalities.
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http://dx.doi.org/10.1002/cpt.3568 | DOI Listing |
BMJ Open
January 2025
Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
Objective: To identify physician perspectives on factors associated with physician burnout, protective factors against burnout, and to seek potential solutions for this pervasive problem.
Design: A qualitative study with semistructured focus group interviews using a systematic framework analysis.
Setting And Participants: Physicians from general internal medicine (GIM) and the emergency department (ED) at two urban tertiary care hospitals in Vancouver, Canada, were recruited.
J Mol Diagn
February 2025
Infectious Disease Subdivision Leadership of the Association for Molecular Pathology, Rockville, Maryland; Department of Laboratory Medicine and Pathology, Mayo Clinic, Phoenix, Arizona.
Dermatol Ther (Heidelb)
January 2025
Department of Dermatology, University of Tsukuba, Tsukuba, Japan.
Introduction: Patients with moderate-to-severe atopic dermatitis (AD), a body surface area (BSA) of ≤ 40%, and an itch numerical rating scale (NRS) score of ≥ 7 ("BARI itch dominant") have been characterized as an important group to consider for the oral janus kinase (JAK) 1/2 inhibitor baricitinib (BARI). Herein we aim to evaluate quality of life (QoL) and functioning outcomes in adult patients with BSA ≤ 40% and itch NRS ≥ 7 at baseline (BL) who received BARI 4 mg in the topical corticosteroid (TCS) combination trial BREEZE-AD7.
Materials: BREEZE-AD7 was a randomized, double-blind, placebo-controlled, parallel-group outpatient study involving adult patients with moderate-to-severe AD who received once-daily placebo or 2-mg or 4-mg BARI in combination with TCS for 16 weeks.
Clin Infect Dis
January 2025
Department of Cellular Therapy and Allogeneic Stem Cell Transplantation, Karolinska University Hospital Huddinge, Karolinska Comprehensive Cancer Center, Stockholm, Sweden.
Herpes simplex virus (HSV) infection is one of the most prevalent viral infections worldwide. In general, host immunity is sufficient to clear viral shedding and recurrences, although it is insufficient to prevent subsequent virologic reactivations. In immunocompromised patients, prolonged and difficult-to-treat HSV infections may develop.
View Article and Find Full Text PDFGlob Adv Integr Med Health
January 2025
Alameda County Health, San Leandro, CA, USA.
Background: Food as Medicine is a rapidly developing area of health care in the United States, aimed at concurrently addressing nutrition-sensitive chronic conditions and food and nutrition insecurity. Recipe4Health (R4H) is a Food as Medicine program with an integrative health equity focus. It provides prescriptions for locally grown produce ('Food Farmacy') with or without integrative group medical visits, alongside training for clinic staff.
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