Plenge Lab
Date posted: May 26, 2015 | Author: | No Comments »

Categories: Drug Discovery Human Genetics Precision Medicine

This week I want to focus on the role of biomarkers in drug discovery and development, which is one of the three pillars of a successful translational medicine program (see slide deck here). The focus is on Alzheimer’s disease, based on recent articles published in JAMA. At the end of the blog you will find postings for new biomarker positions in Merck’s Translational Medicine Department.

[Disclaimer: I am a Merck/MSD employee. The opinions I am expressing are my own and do not necessarily represent the position of my employer.]

Before I start, I want to point to a few blogs that provide counterarguments to some of the optimistic opinions expressed in this blog. The first is David Dobb’s negative view on big data (here); the second on Larry Husten’s concerns about conflicts of interest between academics and industry, as it relates to a recent NEJM series (here). I will not comment further, but it is worth pointing readers to these blogs and related blogs for a balanced view on complicated topics.

I have expressed the strong opinion that what ails drug discovery and development is that we pick the wrong targets, don’t develop robust biomarkers, and we don’t test therapeutic hypotheses quickly enough in clinical trials.

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The primary purpose of this blog is to recruit clinical scientists into our new Translational Medicine department at Merck (job postings at the end). However, I hope that the content goes beyond a marketing trick and provides substance as to why translational medicine is crucial in drug discovery and development. Moreover, I have embedded recent examples of translational medicine in action, so read on!

[Disclaimer: I am a Merck/MSD employee. The opinions I am expressing are my own and do not necessarily represent the position of my employer.]

There is a strong need to recruit clinical scientists into an ecosystem to develop innovative therapies that make a genuine difference in patients. This ecosystem requires those willing to toil away at fundamental biological problems; those committed to converting biological observations into testable therapeutic hypotheses in humans; and those who develop therapies and gain approval from regulatory agencies throughout the world.   The first step is largely done in academic settings, and the other two steps largely done in the biopharmaceutical industry…although I am sure there are many who would disagree with this gross generalization!

The term “Translational Medicine” has been broadly used to describe the second step, thereby bridging the Valley of Death between the first and third steps.…

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