Skip to main content
Premium Trial:

Request an Annual Quote

Diagnostics and Drugs Should Be Co-Developed Early During Pre-Clinical Phases, Scientists Say

NEW YORK, March 23 (GenomeWeb News) - Researchers in academia and industry who wish to play a role in the emerging "theranositcs" market should consider partnering with drug or diagnostic companies early in the pre-clinical stages of product developemnt, scientists emphasized during a session at the Biomarker Pipeline conference in Boston last week.

 

The goal of theranostics research, which aims at jointly developing and marketing companion diagnostic and therapeutic products, is to help physicians select the right patients for treatment and track treatment progression, the scientists said.

 

"We all want disease biomarkers," said Brian Edmunds, a manager of new technologies at Eli Lilly, who gave a talk during the conference. "We want to know who's predisposed, how far along a patient is with a disease, who are the correct patients to select for therapy, who are the responders to drug therapy."

 

The US Food and Drug Administration is expected to release a draft guidance on companion diagnostic/therapeutic products later this year. It is unclear whether the guidance will include information on protein biomarkers, or if it will address only DNA-based biomarkers.

 

  In the FDA's latest pharmacogenomics guidance report, the agency said that it might apply its system of identifying and classifying genomic biomarkers towards decisions in the future regarding other types of biomarkers, including protein biomarkers.

 

A timeline is an important factor to consider in the development of a biomarker, Edmunds pointed out. Once a biomarker candidate has been identified, scientists should consider the feasibility of the biomarker, how to implement and how to sell it. Researchers should consider throughout the biomarker-development process why the biomarker is important, Edmunds added.

 

"You have to look at the timeliness so that you can get a co-launch [of the biomarker and the drug]," Edmunds said. "And you have to make sure [the biomarker] always supports the clinical product's goals."

 

The Scan

Researchers Compare WGS, Exome Sequencing-Based Mendelian Disease Diagnosis

Investigators find a diagnostic edge for whole-genome sequencing, while highlighting the cost advantages and improving diagnostic rate of exome sequencing in EJHG.

Researchers Retrace Key Mutations in Reassorted H1N1 Swine Flu Virus With Avian-Like Features

Mutations in the acidic polymerase-coding gene boost the pathogenicity and transmissibility of Eurasian avian-like H1N1 swine influenza viruses, a PNAS paper finds.

Genome Sequences Reveal Evolutionary History of South America's Canids

An analysis in PNAS of South American canid species' genomes offers a look at their evolutionary history, as well as their relationships and adaptations.

Lung Cancer Response to Checkpoint Inhibitors Reflected in Circulating Tumor DNA

In non-small cell lung cancer patients, researchers find in JCO Precision Oncology that survival benefits after immune checkpoint blockade coincide with a dip in ctDNA levels.