Translational Medicine Guide transforms drug development processes: the recent Merck experience

Drug Discovery Today
Hugues DolgosLuciano Rossetti

Abstract

Merck is implementing a question-based Translational Medicine Guide (TxM Guide) beginning as early as lead optimization into its stage-gate drug development process. Initial experiences with the TxM Guide, which is embedded into an integrated development plan tailored to each development program, demonstrated opportunities to improve target understanding, dose setting (i.e., therapeutic index), and patient subpopulation selection with more robust and relevant early human-based evidence, and increased use of biomarkers and simulations. The TxM Guide is also helping improve organizational learning, costs, and governance. It has also shown the need for stronger external resources for validating biomarkers, demonstrating clinical utility, tracking natural disease history, and biobanking.

References

Feb 14, 2014·Science Translational Medicine·Syril D Pettit
Nov 28, 2014·Science Translational Medicine·Georg N DudaHans-Dieter Volk

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Citations

Aug 26, 2016·Xenobiotica; the Fate of Foreign Compounds in Biological Systems·Tetsuo YamagataCarl Petersson
Oct 4, 2016·Clinical and Translational Science·J PlaksinG Gold-von Simson
Jun 20, 2019·Xenobiotica; the Fate of Foreign Compounds in Biological Systems·Carl PeterssonHugues Dolgos
Sep 7, 2019·International Journal of Cancer. Journal International Du Cancer·Dinja T KrugerSabine C Linn
Jun 13, 2020·Critical Reviews in Toxicology·Deepika DeepikaVikas Kumar
Sep 1, 2019·Alzheimer's Research & Therapy·Jeffrey CummingsPhilip Scheltens
Feb 24, 2019·Viruses·Daniel Hasche, Frank Rösl
Dec 29, 2019·Nature Biotechnology·Saco J de VisserMarcel J H Kenter
Dec 5, 2019·The Journal of the Acoustical Society of America·Rick P C Cousins
Apr 21, 2017·Clinical Science·Paul B WrenAndrew Lockhart
Oct 10, 2018·Frontiers in Bioengineering and Biotechnology·Tracy T L YuYves Bayon
May 18, 2018·Frontiers in Microbiology·Daniel HascheFrank Rösl
Nov 18, 2020·Nature Reviews. Drug Discovery·Christoph H EmmerichMichael J Parnham
Feb 3, 2021·Annales pharmaceutiques françaises·P Moingeon
Mar 6, 2021·Journal of Biomolecular Structure & Dynamics·Sadanandam NamsaniJayant Kumar Singh

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