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Impact to the bioanalytical community of the FDA issuance of the draft guidance on biomarker qualification: evidentiary framework

The FDA released a Draft Guidance in December (2018) on the evidentiary framework and standards required to achieve qualified biomarkers.  It is intended to cover a regulatory gap related to the use of biomarkers outside of specific drug programs.  As such, this Draft Guidance supports the Qualification of Drug Development Tools …

Opportunities for Biomarkers in Immuno-Oncology

Exploring new opportunities for biomarkers in immuno-oncology

Pharmaceutical companies are increasingly relying on biomarkers to deliver precision medicine in immuno-oncology. Biomarkers can accelerate drug development and reduce the overall cost; they also allow sponsors to identify failed treatments sooner so that resources are not wasted on expensive, late-stage trials with unsafe or inactive compounds. Finally, these tests …

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Immuno-Oncology Studies: Optimizing Design, Recruitment and Execution

The rise of immunotherapy has been meteoric — there are now well more than 1,000 immuno-oncology (IO) trials ongoing according to clinicaltrials.gov. Finding and enrolling the appropriate patients for these potentially revolutionary treatments has presented a profound challenge, one that was recently covered in the aptly titled New York Times …

Can We Expand Companion Diagnostics Beyond Oncology?

The majority of today’s approved companion (and complementary) diagnostics (CDx) support personalized medicine efforts in oncology, a testament to researchers’ growing knowledge regarding the genetic pathways impacted in various cancers. That understanding increases our ability to convert such knowledge of biology into treatments that specifically target disease based on a …

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Applying Preclinical Biomarkers to Identify Renal Injuries

Identification of new medicines for kidney disease remains an ongoing challenge in drug development. This challenge includes establishing new biochemical measurements (biomarkers) which can sensitively and accurately reflect the status of renal health and any associated changes in renal function. Sponsors are exploring many options to improve the application of …

What Are the Emerging Noninvasive Biomarkers in NASH?

Novel biomarkers represent a promising means to improve diagnosis of nonalcoholic steatohepatitis (NASH). Currently, a definitive diagnosis requires a liver biopsy, a surgical procedure with many limitations. There are a variety of biomarkers that can assess liver status, but they do not always distinguish between patients with NASH and those …

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The Shift Toward More-Personalized Medicine in China

Chinese biopharmaceuticals are expanding development beyond generics to focus on producing more personalized medicine, novel therapies, biomarkers and companion diagnostics. Steven Anderson, PhD, chief scientific officer at Covance, recently discussed his thoughts on biomarkers and precision medicine in China’s drug development and translational medicine landscape. An emerging focus on biomarkers …

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Accelerating Rare Disease and Orphan Drug Development: Opportunities for Biomarkers, Diagnostics & Patient Engagement

Rare diseases affect more than 350 million people worldwide but patients often face limited options for approved therapies. As a result, many patients have joined advocacy groups first and foremost to connect with others struggling with their rare disease, but also to promote research, unite multiple stakeholders and stimulate new possibilities …