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.
Citation: Hugues Dolgos, Mark Trusheim, Dietmar Gross, Joern-Peter Halle, Janet Ogden, Bruno Osterwalder, Ewen Sedman5, Luciano Rossetti Translational Medicine Guide Transforms Drug Development Processes: The Recent Merck Experience doi:10.1016/j.drudis.2016.01.003
Available online: 14 January 2016
Copyright: © 2016 The Authors.Published by Elsevier Ltd.This is an open access article under the CC BY license
(http://creativecommons.org/licenses/by/4.0/).
Acknowledgments
We thank Wilhelmina Bagchus, Beatrice Brunkhorst, Laetitia Devy-Dimanche, Johannes Gleitz, Hans Juergen Grote, Stefan Hecht, Mirek Jurzak, Thekla Kurz, Noreen Nugent, Britta Paschen, Sally Pennell, Sigrid Roesener, Catherine Scholz, Kerstin Seemann, Philippe Serrano, Henry Wang, Jonathan Willmer, DeeAnn Yabusaki, Michael Zuehlsdorf, Tammy Dellovade, Klaus Duecker, Markus Fluck, Marc Gleichmann, Beatrice Greco, Caroline Kant, Scott Lauder, Ralph Lindemann, Giorgio Massimini, Alain Munafo, Florence Porte, Oliver von Richter, Frank Zenke. Special thanks to Berndt Kirschbaum, and Anna-Lisa Jenkins for their executive sponsorship during their tenure. In addition, we thank Stefan Jaekel, Simon Geissler, and Ken Hance (case study 1); Brigitte Brockhaus, Pascal Girard and B. Meibohm (case study 2); and Hui Tian (case study 3) and to Feinstein Kean Healthcare for assistance with the figures.
