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FDA Outlines Goals of Dx-Rx Companion Products; Guidance Expected By End 04


The US Food and Drug Administration will release by the end of the year a draft guidance on the joint development of diagnostic-therapeutic companion products, Larry Lesko, director of the FDA’s Office of Clinical Pharmacology and Biopharmaceuticals, said during a recent meeting.

“We have a guidance now,” said Lesko, referring to the pharmacogenomics data submissions guidelines expected to be made public by the end of the summer. “But we can always do better.”

He spoke to drug and diagnostics makers at a one-day workshop last week in Arlington, Va., that was organized to address the regulatory issues that would likely guide FDA policy on the development of drug-diagnostic companion products.

The draft guidance will be developed by the FDA’s Office of In Vitro Diagnostics, overseen by Steven Gutman, and the Center for Drug Evaluation and Research, whose acting director is Steven Galson.

“There are a tremendous amount of questions,” Lesko said during his opening remarks at the meeting, which was co-organized by the Drug Information Association. “We need to brainstorm.”

As Pharmacogenomics Reporter had previously reported, the FDA hopes to build a framework under which pharmaceutical companies and diagnostics makers can develop targeted therapeutics simultaneously with products that will help physicians stage and monitor diseases, tighten prognoses, and choose drugs and doses.

“As we saw with the pharmacogenomics data submission guidance of last November, FDA is continuing to invest time and effort in preparing itself for the advent of personalized medicines,” said Chris Webster, chairman of the genomics division at the Pharmaceutical Researchers and Manufacturers of America, and director of regulatory strategy at Millennium Pharmaceuticals. “The pieces are falling into place for them.”

Webster, who helped organize the meeting, said that “when the FDA begins to see pharmacogenomics being used in drug development, and pharmacogenomics studies showing up in new drug application submissions, and sponsors coming in and wanting to have a drug and a diagnostic together, that [the FDA] will basically know the science and what it implies, and that they’ll have their own internal structures and procedures in place.”

“Drugs and diagnostics have been considered two separate entities,” Lesko said at the conference. “What we want to do is to close the gap. We need ideas on … the smooth development” of drugs and diagnostics simultaneously.

Pharmacogenomics Reporter will publish a full report on the one-day meeting in the Aug. 12 issue.



Recent Pharmacogenomics Reporter Articles on Diagnostic-Therapeutic Companion Products:

  • Is Your Shop Into ‘Theranostics?’ So is The FDA. Here is How They Can Help
  • Gutman Explains Goal of Theranostics Draft Being Co-Written by OIVD, CDER
  • Woodcock, Gutman Plan Theranostics Guidance; Seek to Marry Dx, Tx Data


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