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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The US Food and Drug Administration is expected to release a draft guidance on companion diagnostic/therapeutic products later this year.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."


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