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In Search of Spring


By John Russell

March 12, 2007 | Tired of winter? Here are some signs of spring for systems biology (SB) acceptance and a preview of Cambridge Healthtech’s June conference, Applying Systems Biology, to whet your appetite for summer.                             

1. FDA Survey. Pharmacometrics (PM) consultation — mostly PK/PD modeling and simulation — is influencing FDA’s new drug approval and labeling decisions according to a survey of 31 new drug applications (NDAs) across 12 therapeutic areas submitted during 2005 and 2006. The survey ranked PM influence as pivotal (decisive in the process); supportive (worthwhile and confirmatory); no contribution; or not applicable.

Results: PM analysis was pivotal for roughly 30 percent of 20 approval decisions in which PM was employed, and even more important in labeling decisions where reviewers reported it was pivotal in 40 percent or more of decisions. Overall PM analysis was ranked as important in more than 85% of the 31 NDAs — a clear vote of confidence. Polled reviewers were from the Office of Clinical Pharmacology and Office of New Drugs.

A newly published paper on the results — “Impact of Pharmacometric Reviews on New Drug Approval and Labeling Decisions” — appears in the February issue of Clinical Pharmacology & Therapeutics. Overall survey results and six case studies are presented in more detail. This is the second such FDA survey;  the first covered 42 NDAs, and their combined results bolster the idea that PK/PD modeling can speed and enhance decisions around dosing, trial design, and safety issues.

Here’s an excerpt: “The current report provides evidence that exploratory tools are valuable in helping decision makers make more informed drug development and regulatory decisions. Specifically, the survey depicts cases (e.g., case studies 1 and 6 of the previous and current FDA surveys) where ignoring these analyses did or might have led to longer drug development cycles, delayed availability of effective drugs to patients, increased costs, and/or post-marketing dosing modifications (zolendronic acid and case study 5) to balance benefit-risk.”

Interestingly, the report also says, “While this report focuses on the NDA phase of drug development, we believe the greatest utility of modeling and simulation will be during phases where the sponsor has a greater ability to design more informative trials and make better decisions. These same tools can be applied pre-IND to design the clinical development plan and trials.” Take a moment to read this paper.

2. CSBi Turns 4. MIT’s annual Computational and Systems Biology Initiative symposium has undergone changes since its start in 2003 when it was a multi-day conference, and to some extent a forum for post-doc work. The CSBi event has been honed into a concentrated single-day with a more practical feel. More than 400 signed up for this year’s event and the talks were quite good. Susan Lindquist of Whitehead Institute for Biomedical Research gave a terrific talk on her work using yeast as a platform for studying neurodegenerative disease. Chinese researcher Liping Zhao, unable to get a visa, presented from Shangai via real-time web video. He discussed how Western medicine and Eastern medicine might be better “integrated” suggesting that metabonomics and metagenomics may eventually help explain “traditional” Chinese medicine in scientific terms.

3. Applying Systems Biology. Bio•IT World’s parent company, CHI, will hold its ninth annual SB conference — Applying Systems Biology — in San Francisco, June 21-22 as part of Beyond Genome. This year’s focus is on practical use of SB. The keynote speaker is David Galas from the Institute for Systems Biology and Battelle Memorial Institute. He is followed by Bruce Gomes, head of mathematical modeling for the system biology group at Pfizer. David Shaw will give the opening plenary presentation along with the panel discussion moderated by Bio•IT World’s editor-in-chief Kevin Davies. This is just a taste of what’s a rich program. Of course, don’t miss the annual Bio-IT World Conference & Expo being held April 30-May 2, at the World Trade Center in Boston.

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