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Training the next generation of pharmacometric modelers: a multisector perspective

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Abstract

The current demand for pharmacometricians outmatches the supply provided by academic institutions and considerable investments are made to develop the competencies of these scientists on-the-job. Even with the observed increase in academic programs related to pharmacometrics, this need is unlikely to change in the foreseeable future, as the demand and scope of pharmacometrics applications keep expanding. Further, the field of pharmacometrics is changing. The field largely started when Lewis Sheiner and Stuart Beal published their seminal papers on population pharmacokinetics in the late 1970’s and early 1980’s and has continued to grow in impact and use since its inception. Physiological-based pharmacokinetics and systems pharmacology have grown rapidly in scope and impact in the last decade and machine learning is just on the horizon. While all these methodologies are categorized as pharmacometrics, no one person can be an expert in everything. So how do you train future pharmacometricians? Leading experts in academia, industry, contract research organizations, clinical medicine, and regulatory gave their opinions on how to best train future pharmacometricians. Their opinions were collected and synthesized to create some general recommendations.

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Fig. 1
Fig. 2

Change history

Notes

  1. An estimand is a systematic description of how the treatment effect or question of interest will be estimated from a clinical trial.

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Acknowledgements

Steve Duffull would like to thank Daniel Wright for sharing his thoughts and expertise on pharmacometric education. Marc Gastonguay and Matt Riggs would like to thank Sara Miller, PharmD, for her editorial assistance. Justin Wilkins would like to express his appreciation for the thoughts and perspectives provided by Rik Schoemaker, Jan-Stefan van der Walt, Janet Wade and Julia Winkler. Elodie Plan would like to acknowledge Peter Milligan and Marylore Chenel for their insightful review.

Author information

Authors and Affiliations

  1. Astellas, Northbrook, IL, USA

    Peter L. Bonate

  2. Aridhia Bioinformatics, Glasgow, Scotland, UK

    Jeffrey S. Barrett

  3. Merck & Co., Inc, Kenilworth, NJ, USA

    Sihem Ait-Oudhia

  4. Metrum Research Group, University of Minnesota, Minneapolis, MN, USA

    Richard Brundage

  5. Pfizer, Groton, CT, USA

    Brian Corrigan

  6. Certara, Princeton, NJ, USA

    Stephen Duffull & Mark Lovern

  7. School of Pharmacy, University of Otago, Dunedin, New Zealand

    Stephen Duffull

  8. Metrum Research Group, Tariffville, CT, USA

    Marc Gastonguay & Matthew M. Riggs

  9. Department of Pharmacy, Uppsala University, Uppsala, Sweden

    Mats O. Karlsson

  10. Office of New Drug V, Pharmaceuticals and Medical Devices Agency (PMDA), Tokyo, Japan

    Shinichi Kijima

  11. Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland

    Andreas Krause

  12. Certara, Raleigh, NC, USA

    Mark Lovern

  13. Children’s Hospital Los Angeles, University of Southern California Keck School of Medicine, Los Angeles, CA, USA

    Michael Neely

  14. Janssen (Johnson & Johnson), Spring House, PA, USA

    Daniele Ouellet

  15. Pharmetheus, Uppsala, Sweden

    Elodie L. Plan

  16. UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, USA

    Gauri G. Rao

  17. Great Ormond Street Institute of Child Health, University College London, London, UK

    Joseph Standing

  18. Department of Pharmacy, Great Ormond Street Hospital for Children, London, UK

    Joseph Standing

  19. Occams Coöperatie U.A., Amstelveen, The Netherlands

    Justin Wilkins

  20. Food and Drug Administration, Silver Springs, MD, USA

    Hao Zhu

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  1. Peter L. Bonate
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  18. Justin Wilkins
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Contributions

All authors contributed to the development and writing of the manuscript. PLB and AK created the figures. All authors reviewed and approved the manuscript.

Corresponding author

Correspondence to Peter L. Bonate.

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Disclosure

At the time of writing this, Steve Duffull has a shared position with Certara and the University of Otago. Hao Zhu’s section reflects the views of the author and should not be construed to represent FDA’s views or policies. Shinichi Kijima: The views expressed in this article are the personal views of the author. The content of this article does not reflect the views or policies of the Pharmaceuticals & Medical Devices Agency (PMDA) or its staff.

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Bonate, P.L., Barrett, J.S., Ait-Oudhia, S. et al. Training the next generation of pharmacometric modelers: a multisector perspective. J Pharmacokinet Pharmacodyn 51, 5–31 (2024). https://doi.org/10.1007/s10928-023-09878-4

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