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  • Regulatory NewsRegulatory News

    MedTech Europe Urges Tailored Approach to Validating Biomarker Assays

    MedTech Europe issued a discussion paper to propose a fit-for-purpose approach for the validation of biomarker assays used in early clinical trials, offering three new guiding principles. The 8-page discussion paper takes issue with a trend among some competent authorities seeking to mandate CE marking on predictive biomarker assays prior to being used in clinical trials. It asserts that industry agrees with “overarching safety goals” that assays should be appropriately...
  • Regulatory NewsRegulatory News

    EMA Offers Support for More Research on DIVI Biomarkers

    European Medicines Agency (EMA) Executive Director Guido Rasi this week sent a letter of support to the Safer and Faster Evidence-Based Translation (SAFE-T) Consortium and the Predictive Safety Testing Consortium (PSTC) to encourage further study of ways to monitor for drug-induced vascular injury (DIVI) in early clinical drug development. "Drug-induced vascular injury in nonclinical animal toxicology studies can cause considerable delays in the drug development pr...
  • Regulatory NewsRegulatory News

    Biomarker Qualification: FDA Explains Process and Opportunities for Engagement

    In a set of newly released presentations, officials from the US Food and Drug Administration (FDA) explain changes to the agency's biomarker qualification program and detail early opportunities for biomarker developers to engage with FDA. "A qualified biomarker can be used in multiple drug development programs without the need for [the Center for Drug Evaluation and Research] CDER to reconfirm the suitability of the biomarker's qualified context of use," said Marianne No...
  • Regulatory NewsRegulatory News

    EMA Lays out Plans for Companion Diagnostic Guideline

    The European Medicines Agency (EMA) on Friday released a concept paper for public consultation outlining issues it plans to address in an upcoming guideline on the challenges in developing companion diagnostics for personalized medicines. Specifically, EMA says its guideline will address the development of companion diagnostics for precision medicines in the clinical development and post-approval phases, and will include a glossary defining terms used in the guideline as...
  • Regulatory NewsRegulatory News

    FDA Offers Biomarker Qualification Case Studies

    As part of an educational series on qualifying biomarkers for use in drug development, the US Food and Drug Administration (FDA) has released two fictitious examples of how biomarkers can improve the drug development process and how FDA works with researchers, pharmaceutical companies and patient advocates to qualify biomarkers. One follows a researcher who discovers a promising biomarker of drug-induced kidney injury in rats and explores how he partnered with rese...
  • Regulatory NewsRegulatory News

    Qualification of Drug Development Tools: FDA Updates Process

    Thanks to the 21st Century Cures Act , there will be an updated, multi-stage process for qualifying Drug Development Tools (DDTs), which include biomarkers, animal models and clinical outcome assessments. The US Food and Drug Administration (FDA) on Thursday said its goal is to transition from the legacy process to the new one, outlined in section 507 of the law, through a phased approach and the agency is currently developing a transition plan for existing projec...
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    A First for FDA: Cancer Treatment Approved for Any Solid Tumor with a Specific Biomarker

    The US Food and Drug Administration (FDA) on Tuesday granted accelerated approval to Merck’s Keytruda (pembrolizumab) for patients whose cancers have a specific biomarker. FDA noted in a statement : "This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated." Keytruda, an anti-PD-1 therapy that has been approved to treat a variety of cancers dating back to 2014 ...
  • Regulatory NewsRegulatory News

    FDA Unveils Regulatory Science Progress Report

    The report, covering fiscal years 2015 and 2016, notes significant US Food and Drug Administration (FDA) progress in refining non-clinical and clinical tools to better evaluate medical products, advancing manufacturing and quality, and enhancing internal IT tools to support the scientific review of regulatory applications. Non-Clinical In terms of the non-clinical predictive models, the report notes that FDA researchers developed a wide variety of computational tools th...
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    Biomarkers Used as Outcomes: FDA Wants to Hear More on Examples

    The US Food and Drug Administration (FDA) is seeking comment from interested stakeholders to determine the utility of a list of examples of biomarkers used as outcomes in development of FDA-approved new molecular entities and new biological therapeutics. The comments, which should be submitted by 18 November , may assist FDA in developing databases on biomarkers for drug development in the future, the agency said. Background Biomarkers are frequently use...
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    Total Kidney Volume Qualified as a Biomarker by FDA for ADPKD Trials

    The US Food and Drug Administration (FDA) on Thursday released new guidance providing a qualified context for use for the biomarker total kidney volume (TKV) in studies for the treatment of the common, life-threatening genetic disease known as autosomal dominant polycystic kidney disease (ADPKD). According to the PKD Foundation , ADPKD is the fourth leading cause of kidney failure, and more than 50% of people with ADPKD will develop kidney failure by age 50. And accord...
  • Regulatory NewsRegulatory News

    FDA Offers New Guidance on Qualified Biomarker for COPD Trials

    The US Food and Drug Administration (FDA) on Wednesday issued guidance providing a qualified context of use (COU) for the biomarker plasma fibrinogen in interventional clinical trials of patients with chronic obstructive pulmonary disease (COPD) at high risk for exacerbations and/or all-cause mortality. This guidance describes the experimental conditions and constraints for which this biomarker is qualified through the CDER Biomarker Qualification Program, and ca...
  • Regulatory NewsRegulatory News

    FDA: What's Slowing Progress in Some Disease Areas?

    In a post to FDA Voice – the US Food and Drug Administration's blog – recently appointed Deputy Commissioner for Medical Products and Tobacco Robert Califf says progress toward curing some diseases, such as Alzheimer's, is being slowed by a lack of understanding of disease biology. Why are There Effective Treatments for Some Diseases and not Others? Califf raises this question, and points to some diseases like HIV/AIDS, where advances in scientific understanding hav...