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Roche Sees Biomarker-Guided Discovery As Key To Unlocking Tumor Microenvironment

 
• By Bridget Silverman

For Roche, PD-L1 is just the first target to emerge from its big investment in understanding the immunosuppressive tumor microenvironment. The company’s research operations use biomarkers to guide discovery and increasingly important early development and combination strategies – potentially a more fruitful use of biomarker strategies than parallel development of companion diagnostics and therapeutics.

Roche, with its feet firmly planted in both pharma and diagnostics, is heavily invested in the search for biomarkers. In addition to looking at their use as a basis for companion diagnostics and patient selection in the treatment setting, the company is highlighting the role of biomarkers as tools for understanding cancer biology and the complexities of the tumor microenvironment to guide research and early development.

Markers like PD-1/PD-L1 unleash huge waves of enthusiasm about their potential for getting drugs to patients, but the complexities of cancer biology inevitably complicate any triumphant narrative, as the recent...

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More from Clinical Trials

UK And US Regulators In Sync On RWD External Control Arms

 
• By Vibha Sharma

The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

More from R&D

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.

Global Pandemic Deal Adopted As 124 Countries Say Yes; US Sits Out

 
• By Neena Brizmohun

Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.

ClinicalTrials.gov Or ISRCTN: Getting Transparency Right For UK Trials

 
• By Vibha Sharma

ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.