Post marketing enhancements and clinical trial advancements

  • by: |
  • 09/10/2012

OPQ, I see you

BioCentury reports that the FDA is considering the creation of a new office to oversee quality throughout the lifecycle of a drug.

According to CDER Director, Dr. Janet Woodcock, the new Office of Pharmaceutical Quality would take on some of the functions currently within the Office of Pharmaceutical Science, as well as some functions from the Office of Manufacturing and Product Quality in the Office of Compliance. Woodcock said it is imperative that CDER "have a drug quality program as robust as those programs we presently have for drug efficacy and drug safety."

Woodcock also proposed to elevate the Office of Generic Drugs to a "super" office as a result of the new user fee program for generics. OGD Director Greg Geba would continue to lead the office and would report to Woodcock.

And speaking of adaptive clinical trials

Exciting story in the New York Times about advances in treatment for squamous cell lung cancer and, “a new type of treatment in which drugs are tailored to match the genetic abnormality in each patient.”

The study is part of the Cancer Genome Atlas, a large project by the National Institutes of Health to examine genetic abnormalities in cancer. The study of squamous cell lung cancer is the second genetic analysis of a common cancer, coming on the heels of a study of colon cancer.

“As a result, the usual way of testing drugs by giving them to everyone with a particular type of cancer no longer makes sense. So researchers are planning a new type of testing program for squamous cell cancer that will match the major genetic abnormality in each patient with a drug designed to attack it, a harbinger of what many say will be the future of cancer research.”

“The old way of doing clinical trials where patients are only tied together by the organ where their cancer originated, those days are passing,” said Dr. Mace Rothenberg, senior vice president of Pfizer oncology.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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