Review
Pharmacology & Pharmacy
Ciska Verbaanderd, Ana Trullas Jimeno, Joerg Engelbergs, Hilke Zander, Ilona Reischl, Ana Moreno Oliver, Spiros Vamvakas, Camille Vleminckx, Christelle Bouygues, Thomas Girard, Francesca Day, Zaide Frias
Summary: The new In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) brings significant changes to the EU legal framework for companion diagnostics (CDx), including a risk-based classification system for in vitro diagnostic tests (IVDs) and enhanced involvement of notified bodies in the certification process. It also establishes a link between CDx assessment and medicinal products, requiring scientific opinions from medicines regulators. However, challenges like insufficient capacity of notified bodies and manufacturer readiness exist. The progressive roll-out and increased collaboration among stakeholders will ensure timely access to essential IVDs.
CLINICAL PHARMACOLOGY & THERAPEUTICS
(2023)
Review
Pharmacology & Pharmacy
Julianne D. Twomey, Baolin Zhang
Summary: ICIs, targeting PD-1 or PD-L1, have become a new standard-of-care for many cancer indications, approved by the FDA. This review focuses on their clinical indications, companion diagnostics, and strategies for identifying predictive biomarkers for guiding their clinical use.
Article
Pharmacology & Pharmacy
Faiza Naimat, Mathumalar Loganathan Fahrni, Shankar Purushothaman, Mohamad Nizam Abdul Ghani, Supatat Chumnumwat, Zaheer-Ud-Din Babar
Summary: Community pharmacists are receptive to and value precision medicine. A relatively high number of pharmacists have been exposed to the concept of precision medicine through their pharmacy education and are willing to adopt it in their daily practice. With appropriate training and education, community pharmacists will be prepared to provide precision medicine services in the future.
FRONTIERS IN PHARMACOLOGY
(2022)
Article
Pharmacology & Pharmacy
Blandine De La Gastine, Soizic Percevault, Laurent Varin, Nicolas Richard, Fabienne Fobe, Benoit Plaud, Georges Daccache, Vincent Compere, Jean-Jacques Parienti, Antoine Coquerel, Magalie Loilier, Nathalie Bleyzac, Laurent Bourguignon, Sylvain Goutelle, Veronique Lelong-Boulouard
Summary: This study investigated the relationship between tramadol and CYP2D6 phenotype and found that tramadol is not suitable as a probe drug for CYP2D6 phenotyping.
Article
Health Care Sciences & Services
Jeeyun A. Kim, Rachel Ceccarelli, Christine Y. Lu
Summary: Pharmacogenomics (PGx) is a key component of precision medicine that analyzes genetic variations to tailor drug therapies. This study found that the proportion of new drugs approved by the US FDA with PGx information has been increasing, especially in the field of cancer therapies. Results show that PGx information in cancer drugs is more clinically actionable compared to other therapeutic areas, indicating the need for more evidence to support the clinical adoption of pharmacogenomics in non-cancer treatments.
JOURNAL OF PERSONALIZED MEDICINE
(2021)
Article
Psychiatry
Beatriz Cantieri Almeida, Emanuella Dutra Goncalves, Maria Helena de Sousa, Maria Jose Martins Duarte Osis, Marilia Jesus Batista de Brito Mota, Aline Cristiane Planello
Summary: Brazilian psychiatrists have some familiarity with PGx but express concerns regarding education, test requests and interpretation, cost-effectiveness, and ethical issues. Age, practice setting, and gender are associated with varying perceptions and competency in PGx. Education and training resources are needed to improve the clinical implementation of PGx in psychiatry.
PSYCHIATRY RESEARCH
(2021)
Review
Medicine, General & Internal
John H. McDermott, Stuart Wright, Videha Sharma, William G. G. Newman, Katherine Payne, Paul Wilson
Summary: This review examines the barriers and facilitators of pre-emptive pharmacogenetic testing programs in healthcare organizations. Through data synthesis using the CFIR, it was found that these programs varied in design and scale. Positive institutional culture, leadership engagement, stakeholder involvement, and the use of clinical champions were identified as facilitators, while clinician self-efficacy, lack of stakeholder knowledge, and intervention costs were commonly cited barriers.
FRONTIERS IN MEDICINE
(2022)
Article
Oncology
Jan Trost Jorgensen
Summary: Predictive biomarkers play a key role in precision medicine, especially in the development of companion diagnostics for hematological and oncological drugs. The FDA has approved 44 CDx assays by the end of 2020, with diverse analytical platforms requiring rigorous regulatory pathways for approval.
TRANSLATIONAL ONCOLOGY
(2021)
Article
Biochemistry & Molecular Biology
Maria Laura Idda, Magdalena Zoledziewska, Silvana Anna Maria Urru, Gregory McInnes, Alice Bilotta, Viola Nuvoli, Valeria Lodde, Sandro Orru, David Schlessinger, Francesco Cucca, Matteo Floris
Summary: Pharmacogenetics aims to identify the genetic factors that determine individual differences in drug response. This study investigated the pharmacogenetic variation in a sample set of Sardinians and found a high likelihood of atypical responses to multiple drugs in this population. Additionally, Sardinians showed a higher number of pharmacogenetic variants compared to other European populations, which may contribute to interpopulation variability in drug response phenotypes.
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES
(2022)
Review
Biochemistry & Molecular Biology
Claudia Pisanu, Anna Meloni, Giovanni Severino, Alessio Squassina
Summary: This article provides an overview of the most relevant findings regarding the pharmacogenomics and pharmacoepigenomics of lithium response in bipolar disorder. It discusses the candidate gene studies, genome-wide association studies, and post-GWAS approaches that support an association between genetic load for various psychiatric disorders and poor response to lithium. The article also explores the role of epigenetic mechanisms, such as changes in methylation or noncoding RNA levels, in regulating gene expression.
INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES
(2022)
Article
Chemistry, Multidisciplinary
Brian E. Harvey
Summary: Nonalcoholic fatty liver disease is a growing public health crisis, with no approved drugs or biological treatments for NASH or related liver diseases. The regulatory pathway for product approval is unclear due to extra-hepatic factors and the organizational structure of FDA.
ACTA PHARMACOLOGICA SINICA
(2022)
Review
Pharmacology & Pharmacy
Danya Kabbani, Reem Akika, Ahmed Wahid, Ann K. Daly, Ingolf Cascorbi, Nathalie Khoueiry Zgheib
Summary: Considerable efforts have been made to implement Pharmacogenomics (PGx) into routine clinical practice. The article proposes an approach for initiating clinical PGx in hospitals, including evaluating available evidence, selecting relevant drugs and gene pairs, deciding on genotyping strategy, interpreting and reporting test results, and involving stakeholders. The article also recommends strategies for further advancing PGx implementation, such as educating healthcare providers and patients, and advocating for test reimbursement. Available PGx resources and implementation programs are also provided.
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Medicine, General & Internal
Clara Wollenhaupt, Thomas Sudhop, Werner Knoess
Summary: The EU's IVDR introduces companion diagnostics (CDx) as a new legal term, aimed at identifying patient subgroups most likely to benefit from a treatment. A systematic search in a clinical trials database identified 3643 trials conducted between 2004 and 2022, analyzing the use of biomarker testing in patient stratification, with PD-L1 and HER2 being the most frequently tested biomarkers. The findings also suggest overlap with non-European authorities implementing the CDx concept, indicating potential CDx candidates under the IVDR.
Article
Pharmacology & Pharmacy
Lauren K. Lemke, Benish Alam, Roy Williams, Petr Starostik, Larisa H. Cavallari, Emily J. Cicali, Kristin Wiisanen
Summary: Pharmacogenetics (PGx) has the potential to improve health outcomes, but the cost of testing is a barrier for equitable access. Reimbursement by insurance providers may lessen the financial burden for patients, but the extent to which PGx claims are covered in clinical practice has not been well-characterized in the literature.
FRONTIERS IN PHARMACOLOGY
(2023)
Article
Genetics & Heredity
Jacob T. Brown, Erin McGonagle, Randall Seifert, Marilyn Speedie, Pamala A. Jacobson
Summary: This workforce education program aims to provide training on pharmacogenomics (PGx) to pharmacists serving rural and underserved areas in Minnesota. The program includes online courses, recorded presentations, in-person workshops, and attendance at a PGx conference. The majority of participants expected an increase in the use of PGx testing in their organizations in the coming years.
FRONTIERS IN GENETICS
(2023)
