title: Translational Medicine Guide transforms drug development processes: the recent Merck experience.
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.
authors.affiliation: Merck, Darmstadt, Germany.
authors.forename: Hugues
authors.initials: H
authors.lastname: Dolgos
authors.affiliation: Massachusetts Institute of Technology Sloan School of Management, Cambridge, MA, USA; Co-Bio Consulting, LLC, Acton, MA, USA. Electronic address: trusheim@mit.edu.
authors.forename: Mark
authors.initials: M
authors.lastname: Trusheim
authors.affiliation: Merck, Darmstadt, Germany.
authors.forename: Dietmar
authors.initials: D
authors.lastname: Gross
authors.affiliation: Merck, Darmstadt, Germany.
authors.forename: Joern-Peter
authors.initials: JP
authors.lastname: Halle
authors.affiliation: Now at Baxalta, Cambridge, MA, USA.
authors.forename: Janet
authors.initials: J
authors.lastname: Ogden
authors.affiliation: Merck, Darmstadt, Germany.
authors.forename: Bruno
authors.initials: B
authors.lastname: Osterwalder
authors.affiliation: EMD Serono is the Biopharma Division of Merck KGaA, Darmstadt, Germany.
authors.forename: Ewen
authors.initials: E
authors.lastname: Sedman
authors.affiliation: EMD Serono is the Biopharma Division of Merck KGaA, Darmstadt, Germany.
authors.forename: Luciano
authors.initials: L
authors.lastname: Rossetti
mesh_terms: D055808:Drug Discovery; D004345:Drug Industry; D006801:Humans; D016730:Program Development; D057170:Translational Research, Biomedical