Bridging the Gap: Integrating Quantitative Systems Pharmacology and Pharmacometrics in Drug Development

Clinical Pharmacology & Therapeutics, vol. 119, pp. 830–833

Abstract

Quantitative Systems Pharmacology (QSP) and Pharmacometrics (PMX) have historically existed at the two ends of the model-informed drug development (MIDD) spectrum. The session "Mind the gap - successful bridging of QSP and PMX in drug development" at the 2024 American Conference of Pharmacometrics brought together QSP scientists and pharmacometricians with the aim to develop better understandings of how to bridge this gap. The current perspective is based on the concepts that were presented and the follow-up panel discussion.

Authors 10

1. Georgi I. Kapitanov corresponding
   Affiliation as printed

   Certara USA, Inc. Sheffield UK

2. Justin C. Earp

   United States Food and Drug Administration · Center for Drug Evaluation and Research

   Affiliation as printed

   Office of Clinical Pharmacology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration Silver Spring Maryland USA

3. Kapil G. Gadkar

   Genentech

   Affiliation as printed

   Preclinical PK/PD, Genentech, Inc., Genentech South San Francisco California USA

4. Jin Y. Jin

   Genentech

   Affiliation as printed

   Clinical Pharmacology, Genentech, Inc. South San Francisco California USA

5. Amita Joshi

   Genentech

   Affiliation as printed

   Clinical Pharmacology, Genentech, Inc. South San Francisco California USA

6. Anna Georgieva Kondic

   Bristol-Myers Squibb (United States)

   Affiliation as printed

   Pharmacometrics, Translational Medicine and Clinical Pharmacology, Bristol Myers Squibb Princeton New Jersey USA

7. Cynthia J. Musante

   Pfizer (United States)

   Affiliation as printed

   Pfizer Research and Development, Pfizer, Inc. Cambridge Massachusetts USA

8. Blerta Shtylla

   Pfizer (United States)

   Affiliation as printed

   Pfizer Research and Development, Pfizer, Inc. San Diego California USA

9. Mirjam Nadine Trame

   Certara (United States)

   Affiliation as printed

   Certara USA, Inc. Radnor Pennsylvania USA

10. Piet H. van der Graaf Aachen Leiden Academic Centre for Drug Research Leiden The Netherlands

    Leiden University · Cincinnati Children's Hospital Medical Center

    Affiliation as printed

    Certara USA, Inc. Sheffield UK

    Cincinnati Children’s Hospital Medical Center Cincinnati Ohio USA

    Leiden Academic Centre for Drug Research Leiden The Netherlands