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Research ArticleMinireview

Future of Biotransformation Science in the Pharmaceutical Industry

Valerie M. Kramlinger, Deepak Dalvie, Carley J.S. Heck, Amit S. Kalgutkar, James O’Neill, Dian Su, Aaron M. Teitelbaum and Rheem A. Totah
Drug Metabolism and Disposition March 2022, 50 (3) 258-267; DOI: https://doi.org/10.1124/dmd.121.000658
Valerie M. Kramlinger
Translational Medicine, Novartis Institutes for Biomedical Research, Inc., Cambridge, Massachusetts (V.M.K.);
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Deepak Dalvie
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Carley J.S. Heck
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Amit S. Kalgutkar
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James O’Neill
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Dian Su
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Aaron M. Teitelbaum
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Rheem A. Totah
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Abstract

Over the past decades, the number of scientists trained in departments dedicated to traditional medicinal chemistry, biotransformation and/or chemical toxicology have seemingly declined. Yet, there remains a strong demand for such specialized skills in the pharmaceutical industry, particularly within drug metabolism/pharmacokinetics (DMPK) departments. In this position paper, the members of the Biotransformation, Mechanisms, and Pathways Focus Group (BMPFG) steering committee reflect on the diverse roles and responsibilities of scientists trained in the biotransformation field in pharmaceutical companies and contract research organizations. The BMPFG is affiliated with the International Society for the Study of Xenobiotics (ISSX) and was specifically created to promote the exchange of ideas pertaining to topics of current and future interest involving the metabolism of xenobiotics (including drugs). The authors also delve into the relevant education and diverse training skills required to successfully nurture the future cohort of industry biotransformation scientists and guide them toward a rewarding career path. The ability of scientists with a background in biotransformation and organic chemistry to creatively solve complex drug metabolism problems encountered during research and development efforts on both small and large molecular modalities is exemplified in five relevant case studies. Finally, the authors stress the importance and continued commitment to training the next generation of biotransformation scientists who are not only experienced in the metabolism of conventional small molecule therapeutics, but are also equipped to tackle emerging challenges associated with new drug discovery modalities including peptides, protein degraders, and antibodies.

SIGNIFICANCE STATEMENT Biotransformation and mechanistic drug metabolism scientists are critical to advancing chemical entities through discovery and development, yet the number of scientists academically trained for this role is on the decline. This position paper highlights the continuing demand for biotransformation scientists and the necessity of nurturing creative ways to train them and guarantee the future growth of this field.

Footnotes

    • Received August 31, 2021.
    • Accepted November 23, 2021.
  • No external funding was used to support this manuscript.

  • The views expressed in the manuscript are solely those of the authors and do not represent the views of the companies and institutions they are affiliated with.

  • The authors declare that they have no conflicts of interest with the contents of this article.

  • ↵1 Current affiliation: Crinetics Pharmaceuticals, San Diego, California

  • ↵2 Current affiliation: Drug Metabolism and Pharmacokinetics, Mersana Therapeutics Inc., Cambridge, Massachusetts

  • All authors contributed equally.

  • https://dx.doi.org/10.1124/dmd.121.000658.

  • Copyright © 2022 by The American Society for Pharmacology and Experimental Therapeutics
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Drug Metabolism and Disposition: 50 (3)
Drug Metabolism and Disposition
Vol. 50, Issue 3
1 Mar 2022
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Research ArticleMinireview

Industry Opportunities for Biotransformation Scientists

Valerie M. Kramlinger, Deepak Dalvie, Carley J.S. Heck, Amit S. Kalgutkar, James O’Neill, Dian Su, Aaron M. Teitelbaum and Rheem A. Totah
Drug Metabolism and Disposition March 1, 2022, 50 (3) 258-267; DOI: https://doi.org/10.1124/dmd.121.000658

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Research ArticleMinireview

Industry Opportunities for Biotransformation Scientists

Valerie M. Kramlinger, Deepak Dalvie, Carley J.S. Heck, Amit S. Kalgutkar, James O’Neill, Dian Su, Aaron M. Teitelbaum and Rheem A. Totah
Drug Metabolism and Disposition March 1, 2022, 50 (3) 258-267; DOI: https://doi.org/10.1124/dmd.121.000658
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