2021 ASCPT Journal Awards Presented
Join us in congratulating this year’s recipients of the ASCPT Journal Awards!
The recipients of the Clinical Pharmacology & Therapeutics Award
are Mwango Kashoki, MD, MPH, Zahra Hanaizi, PharmD, Stella Yordanova, MA, Richard Veselý, MD, Christelle Bouygues, PharmD, Jordi Llinares, MD, and Sandra L. Kweder, MD, for their original research article, “A comparison of EMA and FDA decisions for new drug marketing applications 2014-2016: Concordance, discordance and why
.” The paper covers the joint efforts of a group of international regulatory scientists who studied the concordance of new drug approvals between the US Food and Drug Administration and the European Medicines Agency for a period of 3 years, resulting in the most comprehensive study of its kind to date. Asking the question, “Are regulators communicating across borders?” the authors concluded that yes, cross-border dialogue between international regulatory agencies is a well-established, almost daily occurrence.
CPT: Pharmacometrics & Systems Pharmacology
presented its award to senior author Wilhelm Huisinga and his co-authors Corinna Maier, MS, Niklas Hartung, PhD, Jana de Wiljes, PhD, and Charlotte Kloft, PhD, for their original research article, “Bayesian data assimilation to support informed decision-making in individualized chemotherapy
.” The authors presented a new methodology for supporting dose-selection in a therapeutic drug/biomarker monitoring setting, and their fully-Bayesian data assimilation approach overcame the limitations of current state-of-the-art approached based on point estimates (MAP), allowing for a comprehensive uncertainty quantification. Applied to cytotoxic chemotherapy, this allowed them to quantify the risk of life-threatening neutropenia and the probability that the therapy would prove ineffective.
Choosing to recognize the paper that best represents the timely, impactful, influential, and careful research that exemplifies translational science, Clinical and Translational Science
presented its 2021 Award to Ksenia Blinova, PhD, Derek Schocken, PhD, Dakshesh Patel, PhD, Chathuri Daluwatte, PhD, Jose Vicente, PhD, Joseph C. Wu, MD, PhD, and David G. Strauss, MD, PhD, for their original research article, “Clinical Trial in a dish: Personalized stem cell-derived cardiomyocyte assay compared with clinical trial results for two QT-prolonging drugs
.” This bench-to-bedside paper demonstrates that the immaturity and inherent variability of induced pluripotent stem cell-derived cardiomyocytes (iPSC-CMs) can significantly obscure subject-specific drug response prediction in the clinic—a very important finding.
Congratulations to all our award recipients for their outstanding contributions to the ASCPT Family of Journals!