Aulin, Linda B. S.

Borghardt, Jens M. M.

Dalla Costa, Teresa

Denti, Paolo

Hennig, Stefanie

Ibarra, Manuel

Kloft, Charlotte

Ma, Guangda

Meibohm, Bernd

Michelet, Robin

English

Borghardt, Jens Markus

Institutional Repository of the Freie Universität Berlin

CPT Pharmacometrics Syst Pharmacol. 2023;12:743–747.    | 743www.psp-journal.comReceived: 27 September 2022 | Revised: 23 December 2022 | Accepted: 8 February 2023DOI: 10.1002/psp4.12940  P E R S P E C T I V EBarriers to global pharmacometrics: educational challenges and opportunities across the globe Robin Michelet1,2  |   Linda B. S. Aulin1 |   Jens M. Borghardt3  |    Teresa Dalla Costa4  |   Paolo Denti5  |   Manuel Ibarra6  |   Guangda Ma7 |   Bernd Meibohm8  |   Goonaseelan (Colin) Pillai9,10,11 |   Stephan Schmidt12  |   Stefanie Hennig13,14,15  |   Charlotte Kloft11Department of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, Berlin, Germany2qPharmetra LLC, Nijmegen, The Netherlands3Research DMPK, Drug Discovery Sciences, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany4Pharmaceutical Sciences Graduate Program, Federal University of Rio Grande do Sul, Porto Alegre, Brazil5Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa6Department of Pharmaceutical Sciences, Faculty of Chemistry, Universidad de la República, Montevideo, Uruguay7Department of Pharmacology & Clinical Pharmacology, The University of Auckland, Auckland, New Zealand8Department of Pharmaceutical Sciences, College of Pharmacy, University of Tennessee Health Science Center, Memphis, Tennessee, USA9Division of Clinical Pharmacology, Department of Medicine, University of Cape Town, Cape Town, South Africa10CP+ Associates GmbH, Basel, Switzerland11Phamacometrics Africa NPC, Cape Town, South Africa12Center for Pharmacometrics and Systems Pharmacology, Department of Pharmaceutics, College of Pharmacy, University of Florida, Orlando, Florida, USA13Certara, Inc., Princeton, New Jersey, USA14School of Clinical Sciences, Faculty of Health, Queensland University of Technology, Brisbane, Queensland, Australia15Department of Clinical Pharmacy, Institute of Pharmacy, Freie Universitaet Berlin, Berlin, GermanyCorrespondenceRobin Michelet, Department of Clinical Pharmacy and Biochemistry, Institute of Pharmacy, Freie Universitaet Berlin, Berlin, Germany.Email: robin.michelet@fu- berlin.deDuring the past three decades, pharmacom-etrics has developed considerably and gained recognition globally and across disciplines, causing the demand of well- trained pharma-cometricians to outweigh the availability.1 Thus, high- quality and widespread educa-tion of pharmacometricians is key. A sym-posium and panel discussion titled “Training of the Next Generation of Pharmacometric Talent Around the World” at the third World Conference on Pharmacometrics (WCoP2022, Cape Town) explored this issue and resulted in the perspective presented here.Pharmacometrics is a complex and multidisci-plinary scientific field with strong interplay between academia and industry. As a consequence, pharmacom-etrics education is associated with both opportunities and This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.© 2023 The Authors. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.Stefanie Hennig and Charlotte Kloft shared senior authorship.  744 |   P ERS PEC TIV Echallenges,2,3 prompting unique initiatives and networks across the globe.4– 6 Approximately 15 years after starting a number of educational initiatives,7– 9 their impact needs to be discussed with respect to the initial purpose and how to move forward from them. Therefore, a symposium was held at WCoP2022, a hybrid event with approximately 300 participants worldwide, which aimed to share different perspectives on pharmacometric education and to obtain a global perspective.THE SYMPOSIUM: INTERNATIONAL PERSPECTIVES AND AUDIENCE INPUTThe symposium consisted of six talks where international speakers with diverse backgrounds, all of which are ac-tively training pharmacometric talents, presented their experiences and perspectives on the required skillsets of future pharmacometricians, education and training con-cepts, and related challenges and opportunities, followed by a panel discussion with contributions from the audi-ence. The talks and discussion made clear that different challenges and opportunities for pharmacometrics train-ing exist across the globe, with some being specific for certain localities and others being consistent worldwide, showing high intra- and interregional differences. A de-piction of the main ones is provided in Figure 1 and more details, including the recordings of all talks, representing successful examples, can be found in the Supplementary Material. In the remainder of this perspective, we aim to synthesize the insights of the symposium into three clearly grouped challenges and opportunities which need tailored approaches: the movement of human capital, the multidis-ciplinary nature and the unbalanced spread of pharmaco-metrics across regions.Challenges and opportunities related to the movement of human capital (“brain- drain”)Pharmacometricians trained in low- and middle- income countries often move to the European Union or United States, leading to a brain- drain and difficulties in estab-lishing not only larger teaching and training groups in these countries but also a stronger local pharmacomet-rics community (“geographic brain- drain”). The use of remote working opportunities should in theory allow a dampening of this geographic brain- drain, especially in an in silico field such as pharmacometrics. However, as echoed by the panelists during the symposium and the panel discussion (Supplementary Material), in prac-tice this is not (yet) the case and both pharmaceutical companies and consulting companies hire mostly from EU, USA and Oceania or require working visas at these locations. Furthermore, academic centers, regardless of location, encounter increasing difficulty to attract and retain researchers at the post- doctoral, early to mid- career level and even senior faculty level. Not re- filling open positions as already observed presents a global threat eventually leading to fewer academic centers that offer opportunities for the next generation in the long- term. This in turn makes teaching and training activities and sustainability more challenging, leading to a loss of critical mass to sustain teaching (“academic F I G U R E  1  The local and global challenges for pharmacometrics training and education. Green dots with arrows represent locations of the speakers of the World Conference on Pharmacometrics symposium, and colored circles represent the different challenges and opportunities to tackle them, which are further discussed in the text. The ratio of academic to geographic movement of human capital is depicted semantically using two colors in the same circle. 21638306, 2023, 6, Downloaded from https://ascpt.onlinelibrary.wiley.com/doi/10.1002/psp4.12940 by Freie Universitaet Berlin, Wiley Online Library on [03/07/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License   | 745PERSP ECT IVE brain- drain”; Figure 2). Both brain- drains especially the case in LMIC, where a critical mass of pharmacometri-cians is not always present. A minimum expression of a critical mass is needed to generate human resources and capabilities at a local level, and furthermore to con-nect the local community with the rest of the field glob-ally. As long as this is not achieved, the above- described brain- drain will be the status quo in those countries, preventing the local communities to significantly supply the world with human resources. Therefore, aiming for trained pharmacometricians developing the discipline outside of Europe and US, e.g. by joint efforts such as Pharmacometrics Africa, RedIF and PAGANZ should be seen as part of the way forward. However, a stronger collaboration between academia and industry could be an opportunity for local development of pharmacome-tricians within an academic setting. Initiatives such as internships, industry mentors, on- site visits and projects using shared data (e.g., also from preclinical studies) are potential ways in which students and mid- level re-searchers can strive for a “best- of- two- worlds” approach. Academia and consulting companies are currently fos-tering this approach by “sharing” and offering part- time employees training and supervising opportunities. This might reduce the need to move away from their local or academic position. This stronger collaboration could also lead to increased mentoring support from indus-try in the form of e.g. industry mentors, expert knowl-edge sharing and providing guidance to students and early- career scientists. Indeed, sharing expertise back to academia is one of the essential points how industry partners can contribute towards moving forward from the status quo. Lastly, financial and logistic support for student scholarships, attendance of conferences, or fund academic- industry exchanges, especially from industry, for the training of the next generation of pharmacomet-rics talents might stimulate dedicated programs to stay active or grow capacity and attract talents to academic positions, which might make a (part- time) academic ca-reer more attractive for scientists.Challenges and opportunities related to pharmacometrics as a multidisciplinary fieldDue to the multidisciplinary nature of pharmacometrics, there are two key challenges to exploring the potential of yet not identified next- generation talents: undergraduate students with the right skill set and mind- set need to be attracted background- specifically to the discipline and op-portunities of pharmacometrics that are mostly new for them. Background- specific material could be developed to this end in a global effort. The curriculum of any academic training program should, especially at the beginning, ac-knowledge this diversity in backgrounds. Yet, all involved will quickly learn and see the diversity as an advantage. A critical aspect in developing the multidisciplinary pharma-cometric mindset in young scientists is the understanding of fundamental principles of pharmacokinetics, phar-macodynamics, biopharmaceutics and pathophysiology. Dedicated modules in these basic sciences could be part of international training programs and included as recom-mended or mandatory parts of graduate programs. What can be left for on- the- job training might differ for students from different scientific backgrounds. Furthermore, the required expertise will strongly depend on the area in which a pharmacometrician works. Therefore, to build a one- size- fits- all university educational program is chal-lenging (e.g., clinical, preclinical, or authorities). Instead, education could focus on a curriculum based on a desired set of core competencies. Multidisciplinary and specialized (under- ) graduate courses could be developed in consen-sus with the pharmacometrics community and recognized by a professional international body, which would help to attract interested students from various disciplines early F I G U R E  2  Imbalanced flow of pharmacometricians between academia, and pharmaceutical industry and consultancy, leading to a possible decrease in newly trained pharmacometric talent. 21638306, 2023, 6, Downloaded from https://ascpt.onlinelibrary.wiley.com/doi/10.1002/psp4.12940 by Freie Universitaet Berlin, Wiley Online Library on [03/07/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License746 |   P ERS PEC TIV Eon. Our colleagues have provided more details about the practical implementation of such an approach from a US perspective.The aforementioned multidisciplinary mind- set allows pharmacometricians to be “good model communicators” who can efficiently translate between different disciplines, and identify the most impactful question for pharmaco-metric analyses.10 Therefore, training to communicate results, implications, and assumptions of pharmacomet-ric analyses should be considered equally important as methodological training. Good model communicators are pivotal for a sustainable future of pharmacometrics and to facilitate the move from an expert discipline to a fully embedded discipline within project teams.Challenges and opportunities related to the unbalanced spread of pharmacometricsThe pharmacometrics community is relatively small but globally spread. A combination of local, international, and global collaborations could lead to optimal use of the unique insights across the world and allow students access to a large international network. International organizations such as the International Society of Pharmacometrics and WCoP are facilitating and spearheading global networking and collaboration initiatives. Furthermore, in past years, hybrid and remote working formats have been shown fea-sible for a pharmacometrics career. Especially smaller re-search groups and consulting companies have taken the opportunity to recruit from anywhere on the globe while allowing pharmacometric talents to work in their origi-nal country. This might improve talent retention and also allow better collaboration between remote- working phar-macometricians and local academic groups to foster local development of pharmacometric groups and strengthen the connection in the pharmacometrics community.ROADMAP FOR NEXT STEPSTraining the next generation of pharmacometricians is a challenging task. Until now, it has been tackled through var-ying approaches across the globe, showcasing unique local challenges that might (only) be solved on a global scale. For example, the practical implementation of such an approach from a US perspective is provided in a companion paper to this one (under review). Indeed, joint efforts for continuous and sustainable development of pharmacometrics are cru-cial: overarching umbrella initiatives, for example, led by one of the hosts of the large pharmacometrics meetings, such as PAGE, ACoP, or WCoP, connect local initiatives such as the networks and training programs here (RedIF, PMXAfrica, PharMetrX) and others (Asian Pharmacometrics Network, PAGANZ) and share their strengths while mitigating their challenges and weaknesses. This could lead to a central-ized location where interested students can learn about pharmacometrics and which training opportunities exist within reach, i.e. an expansion of the ISoP website with all pharmacometric training programs and networks could be a good starting point. Stronger collaboration between academia and the pharmaceutical industry in the form of internships, scholarships, and exchanges could foster the sustainable growth of pharmacometric skills in early ca-reer scientists across the globe. Furthermore, financial and mentoring support also of the pharmaceutical industry of pharmacometricians- in- training in the form of scholarships, academic- industry exchanges and sponsored conference at-tendance could, especially in LMIC, increase the retention of these young talents locally. As a next step, an open debate across the pharmacometrics community on how to tackle the identified challenges would be beneficial. We invite the readers and the global pharmacometrics community to reach out with their point of view, ideas, or suggestions in an open debate to achieve this goal.FUNDING INFORMATIONSH was partly supported by the Alexander von Humboldt Foundation, Germany.CONFLICT OF INTEREST STATEMENTThe authors declared no competing interests for this work.DISCLOSUREAs an Associate Editor for CPT: Pharmacometrics and Systems Pharmacology, Stefanie Hennig was not involved in the review or decision process for this article.ORCIDRobin Michelet   https://orcid.org/0000-0002-5485-607X Jens M. Borghardt   https://orcid.org/0000-0001-7000-9308 Teresa Dalla Costa   https://orcid.org/0000-0001-9227-2991 Paolo Denti   https://orcid.org/0000-0001-7494-079X Manuel Ibarra   https://orcid.org/0000-0002-0484-6367 Bernd Meibohm   https://orcid.org/0000-0003-3923-3648 Stephan Schmidt   https://orcid.org/0000-0002-4998-1167 Stefanie Hennig   https://orcid.org/0000-0001-5972-3711 REFERENCES 1. 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White paper: landscape on technical and conceptual requirements and competence framework in drug/disease modeling and simula-tion. CPT Pharmacometrics Syst Pharmacol. 2013;2(5):e40. 9. Zhang T, Cho CR, Bonate PL. Perspectives on training quan-titative systems pharmacologists. CPT: Pharm Syst Pharmacol. 2022;11(6):669- 672. doi:10.1002/psp4.12783 10. Bonate PL. Be a Model Communicator: and Sell your Models to Anyone [Internet]. Peter Bonate; 2014. Available from: https://books.google.com/books/ about/ Be_a_Model_Commu nicat or.html?hl=de&id=ro8nr gEACAAJSUPPORTING INFORMATIONAdditional supporting information can be found online in the Supporting Information section at the end of this article.How to cite this article: Michelet R, Aulin LBS, Borghardt JM, et al. Barriers to global pharmacometrics: educational challenges and opportunities across the globe. CPT Pharmacometrics Syst Pharmacol. 2023;12:743-747. doi:10.1002/psp4.12940 21638306, 2023, 6, Downloaded from https://ascpt.onlinelibrary.wiley.com/doi/10.1002/psp4.12940 by Freie Universitaet Berlin, Wiley Online Library on [03/07/2023]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License

Barriers to global pharmacometrics: educational challenges and opportunities across the globe

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Barriers to global pharmacometrics: educational challenges and opportunities across the globe

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