In Vivo is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Drug/Diagnostic Co-Development: When to Begin the Tandem Ride

Executive Summary

Targeted drug development raises a new conflict of interest possibility when a company hoping to market a drug is also trying to win approval for the diagnostic that proves the drug's efficacy. That problem of "self-validation" is one aspect of the even broader drug/diagnostic question: when and how a company should go about validating a biomarker it wants to incorporate onto a drug label.

You may also be interested in...



GSK's Early Link-Up with Abbott for an Immunotherapy Companion Diagnostic

GSK's first immunotherapy is still 4-5 years away, but it is already commissioning a companion diagnostic for it. By striking a deal with Abbott for a commercial screening test this early, the pharma may be laying the groundwork to address any regulatory concerns around using the test to enrich its clinical trials populations, which could allow for lower numbers of patients to be enrolled in order to prove efficacy.

The Pace of Development of Molecular Imaging Agents

The adoption of new in vivo molecular imaging agents may eventually follow the current path of in vitro diagnostics, which for some products is shifting from a cost-effectiveness standard for reimbursement toward an evidence-based. But the companies most likely to support the clinical trials that would establish such benefits are only slowly integrating the development of molecular agents into their core businesses. IVD - an area of acquisition interest for these companies -may be the force that transforms them into more biologically minded and innovation-driven entities, and in so doing it may bolster the development of molecular imaging agents.

The Pace of Development of Molecular Imaging Agents

The adoption of new in vivo molecular imaging agents may eventually follow the current path of in vitro diagnostics, which for some products is shifting from a cost-effectiveness standard for reimbursement toward an evidence-based. But the companies most likely to support the clinical trials that would establish such benefits are only slowly integrating the development of molecular agents into their core businesses. IVD - an area of acquisition interest for these companies -may be the force that transforms them into more biologically minded and innovation-driven entities, and in so doing it may bolster the development of molecular imaging agents.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

ID1131437

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel