Drug Development Gets Even More Personal, Precise and Tailored

March 27th, 2012
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As we’ve discussed, Eric Topol’s “How to Change Medicine” provides valuable insights on how tailoring treatments in the clinic could boost health care effectiveness and lower costs. But we at Popper and Company would like to see industry take an additional step by using the techniques Dr. Topol recommends for patient care to develop drugs more efficiently.
The technology Topol recommends to stratify patients could also streamline drug development. In fact, the FDA is suggesting that faster approvals of antibiotics could result from smaller clinical trials that test antibiotics targeted against drug-resistant bacteria.
We now know enough about molecular biology that we can apply genomics/proteomics/metabolomics to drug development (DNA screening, identifying and validating surrogate markers, or characterizing tumors by genetic makeup). However, tailored treatments can run into challenges, including  heterogeneity in tumor cells as recently described in the New England Journal of Medicine, that resist even targeted biological treatments.

But as our pace of understanding accelerates, even knowing that tumor cell heterogeneity exists can allow us to use animal models to find correlations between gene expression and proteomics that show the progression of cancer.
There is currently a tsunami of genetic information that is being applied to diagnostics and disease management. Genetic testing is available for 2,000 conditions, and that number is expected to rise rapidly. Better preclinical characterization of drugs, more targeted applications of new and existing compounds, and a focus on actionable genes like EGFR, BRAF and many others could make tailored, cost-effective treatments a reality.
Do you think the life sciences industry has enough biological knowledge at our disposal to create a new world of tailored treatments? Or does the tumor heterogeneity study show that what we don’t know can stymie our efforts? What other methods can tailor treatment development? Share your ideas and thoughts with us here.

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About the Author:

I have more than 20 years of R&D and business development experience in the life sciences and pharmaceutical industry. I’ve led research teams involved in all aspects of drug discovery and have designed, negotiated and managed many R&D collaborations. I also have extensive experience in technology evaluation, technology development, and strategic planning. Send me an email.