Search research articles

ABOUT JoVE

Overview Leadership Blog JoVE Help Center

AUTHORS

Publishing Process Editorial Board Scope & Policies Peer Review FAQ Submit

LIBRARIANS

Testimonials Subscriptions Access Resources Library Advisory Board FAQ

RESEARCH

JoVE Journal Methods Collections JoVE Encyclopedia of Experiments Archive

EDUCATION

JoVE Core JoVE Business JoVE Science Education JoVE Lab Manual Faculty Resource Center Faculty Site

Terms & Conditions of Use

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by

Same author

Sieving for gold: external comparator studies to prioritize drugs for late-stage clinical trial.

Journal of comparative effectiveness research·2026

Same author

Phase 2 trial of imprime and pembrolizumab immunotherapy in metastatic triple negative breast cancer patients who have progressed beyond first line chemotherapy.

Journal of immunology (Baltimore, Md. : 1950)·2025

Same author

When Do Value-Based Contracts Add Value? Insights From Probabilistic Simulations.

Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research·2025

Same author

Clinical development success rates for durable cell and gene therapies.

Nature reviews. Drug discovery·2025

Same author

Managing the challenges of paying for gene therapy: strategies for market action and policy reform in the United States.

Journal of comparative effectiveness research·2024

Same author

Creating win-win-win situations with managed entry agreements? Prioritizing gene and cell therapies within the window of opportunity.

Drug discovery today·2024

Search research articles

Related Experiment Video

Updated: Mar 27, 2026

Author Spotlight: Advancing Biotherapeutic Mass Calculation by Introducing mAbScale, a Python-Based Desktop Application

Author Spotlight: Advancing Biotherapeutic Mass Calculation by Introducing mAbScale, a Python-Based Desktop Application

Published on: June 16, 2023

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

Hugues Dolgos¹, Mark Trusheim², Dietmar Gross¹

¹Merck, Darmstadt, Germany.

Drug Discovery Today

|January 19, 2016

Summary

Merck

More Related Videos

Induction of Invasive Transitional Cell Bladder Carcinoma in Immune Intact Human MUC1 Transgenic Mice: A Model for Immunotherapy Development

Induction of Invasive Transitional Cell Bladder Carcinoma in Immune Intact Human MUC1 Transgenic Mice: A Model for Immunotherapy Development

Published on: October 30, 2013

Studying the Role of Alveolar Macrophages in Breast Cancer Metastasis

Studying the Role of Alveolar Macrophages in Breast Cancer Metastasis

Published on: June 26, 2016

Related Experiment Videos

Last Updated: Mar 27, 2026

Author Spotlight: Advancing Biotherapeutic Mass Calculation by Introducing mAbScale, a Python-Based Desktop Application

Author Spotlight: Advancing Biotherapeutic Mass Calculation by Introducing mAbScale, a Python-Based Desktop Application

Published on: June 16, 2023

Induction of Invasive Transitional Cell Bladder Carcinoma in Immune Intact Human MUC1 Transgenic Mice: A Model for Immunotherapy Development

Induction of Invasive Transitional Cell Bladder Carcinoma in Immune Intact Human MUC1 Transgenic Mice: A Model for Immunotherapy Development

Published on: October 30, 2013

Studying the Role of Alveolar Macrophages in Breast Cancer Metastasis

Studying the Role of Alveolar Macrophages in Breast Cancer Metastasis

Published on: June 26, 2016

Area of Science:

Drug development
Translational medicine
Biomarker research

Background:

Merck is implementing a new question-based Translational Medicine Guide (TxM Guide).
The TxM Guide is integrated into the drug development process starting at lead optimization.
This initiative aims to enhance early-stage drug development strategies.

Purpose of the Study:

To evaluate the initial experiences and impact of the TxM Guide.
To identify opportunities for improving target understanding, dose setting, and patient selection.
To assess the guide's influence on organizational learning, costs, and governance.

Main Methods:

The TxM Guide is embedded within integrated development plans for each program.
Focus on utilizing early human-based evidence, biomarkers, and simulations.
Continuous evaluation of the guide's effectiveness throughout the drug development lifecycle.

Main Results:

Improved target understanding, therapeutic index determination, and patient subpopulation selection.
Increased utilization of biomarkers and simulations in early development.
Enhanced organizational learning, cost-efficiency, and governance within drug development programs.

Conclusions:

The TxM Guide offers significant benefits for optimizing drug development.
There is a need for enhanced external resources for biomarker validation and clinical utility.
Further development is required for natural disease history tracking and biobanking support.