1. In Vivo
  2. >>Archive

Waiting for New Words on Pharmacogenomics

FDA is near to issuing revisions to its draft guidance on pharmacogenomics. The biggest issues center around how to validate emerging biomarkers. The update should: further define the process for using markers in an NDA; call for a new genomics advisory committee; define the role of the committee that will look at voluntary submissions in the aggregate; and add clarity to the preferred data format for voluntary submission. The agency is expected to sidestep the issue of different standards for treating non-clinical and clinical biomarkers.

The US Food and Drug Administration is near to issuing revisions to its widely discussed draft guidance on pharmacogenomics, four months past the end of the comment period. They are expected sometime before the end of July, when FDA will hold a workshop on tandem pharmaceutical/diagnostic development. The biggest issues not addressed in the draft center around biomarkers: how to take emerging markers and give them enough validation to support their use. (See "Forging a Path for Pharmacogenomics at the FDA," IN VIVO, March 2004 Also see "Forging a Path for Pharmacogenomics at the FDA" - In Vivo, 1 March, 2004..)

The updated guidance should address four industry concerns, says Christopher Webster, director of regulatory strategy and intelligence at Millennium Pharmaceuticals...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on In Vivo for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Archive

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Early Development Deals: Ipsen's Strategy For Biomarker-Driven Success

 
• By Eliza Slawther

Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.   

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access In Vivo, or if you love it how it is, now is the time to have your voice heard.

In Partnership with Cerba Research

Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

More from In Vivo

Crisis Or Opportunity? US MFN Policy Could Test Japan’s Appetite For Reforms

 
• By Lisa Takagi

While the adoption of most favored nation drug pricing in the US stands to affect Japanese biopharma firms now heavily reliant on this market, it might also present an opportunity for pricing and policy reforms at home.

Rising Leaders 2025: Ovid’s Meg Alexander On Neurology’s Next Frontier

 
• By Jo Shorthouse

Ovid Therapeutics' president and COO Meg Alexander is leading the company’s strategic pivot toward innovative neurological treatments, potentially creating a new class of medicines for rare neurological disorders.

The Goldilocks Isotope: Perspective Therapeutics’ ‘Just Right’ Alpha Radiotherapeutic

 
• By David Wild

Thijs Spoor's bet on lead-212 is paying off as Perspective Therapeutics advances three clinical programs with promising early efficacy signals and a comprehensive manufacturing strategy.