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Talking Tox, and Changing Drug Development

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Oh, the memories of my earliest days here at Genome Technology. As a journalist new to the field of genomics, I was intrigued to hear about the promise of it all: the impact it would have on medical treatment, drug discovery and development — well, you remember. Too much hype led to the bubble burst, and all of us have been understandably skeptical since then of sweeping claims (and sometimes any claims at all) made about the impact of genomics.

But in the past five years, change has indeed happened. And as it turns out, that change occurred pretty much where people originally predicted it would — it may have taken a little longer than initially expected, but here it is. Genomics is indeed having an impact on medicine, pharma pipelines, and much more.

In the early days, people noted that genomics would have its earliest effect on the discovery side of pharmaceutical companies, arguing that these were target-finding technologies that belonged upstream. Over the past few years, though, we’ve seen systems biology tools creeping their way into the drug development side of things. Indeed, when Mark Cockett gave me a tour of Bristol-Myers Squibb last year, he noted that some of the biggest effects his company had seen from genomics were coming in the form of toxicogenomics — a decidedly downstream part of the pipeline.

Senior Editor John MacNeil decided to investigate and see if this was indicative of a trend, and he found he was onto something. Not only is genomics revolutionizing toxicology — in some cases actually moving that entire section of development squarely into the discovery phase to fail compounds as early as possible — but pharmacogenomics is starting to make its mark in development. Meanwhile, that upstart tool, RNAi, has gotten to the clinic faster than anything we’ve seen — and in the form of a therapeutic itself. I think you’ll find this story a great look into how systems biology is truly changing how pharmas operate, and we’ll keep you posted in the future as these changes become more and more noteworthy.

In other news in this issue, we look into the technology enabling population genetic studies. Genotyping is a crucial tool that has emerged from the genome community. You are probably familiar with many of the sequence-based genotyping tools — the old microsatellite standby — but genotyping technologies based on mass spectrometry and microarrays have truly come into their own recently. We take a look at some of the technologies available, what they’re capable of, and how they’re being used.

Don’t miss the second in our series of systems biology roundtables. After our last set of participants duked it out to try to settle on a definition of systems biology, we gave this recent group of experts a more immediate challenge: how should systems biology be implemented? In academia or pharma? What skills does it take to become a player? How can you get involved in the field if you’re not already? Our group offered great suggestions in a candid, insightful conversation.

 

Meredith W. Salisbury, Editor

 

Correction

In last month’s issue of Genome Technology, a story in our Spotlight on Pharmacogenomics page erroneously reported that Roche is already using the P53 chip to stratify patients during clinical trials of Nutlin. In fact, the company is using the test to stratify patients in trials of other drugs in its pipeline.

 

The Scan

Follow-Up Data Requests to Biobank Participants Ineffective, Study Finds

An effort to recontact biobank enrollees for additional information reports low participation in a new BMJ Open study.

Study Finds Widespread Transmission of Resistant Bacteria in Vietnam Hospitals

A sequencing study in The Lancet Microbe finds widespread transmission of drug-resistant Escherichia coli, Klebsiella pneumoniae, and Acinetobacter baumannii in two Vietnam ICUs.

Novel Brain Cell Organoids Show Promise for Autism Research

University of Utah researchers report in Nature Communications on their development of brain cell organoids to study SHANK3-related autism.

Study Finds Few FDA Post-Market Regulatory Actions Backed by Research, Public Assessments

A Yale University-led team examines in The BMJ safety signals from the US FDA Adverse Event Reporting System and whether they led to regulatory action.