RESEARCH TRIANGLE PARK, N.C.--(companion diagnostics development.)--Developing companion diagnostics (CDx) is a time sensitive project and the majority of drug companies prefer to keep at least some CDx development in-house. According to new research by Cutting Edge Information, 61% of surveyed pharmaceutical companies have internal teams responsible for
“In-house development is not always practical, however, which is why more than one-third of the companies we surveyed do not have internal companion diagnostics development teams.”
Cutting Edge Information’s recent study, “Companion Diagnostics and Biomarker Development: Partnership Strategies and Benchmarks,” found that in-house biomarker and diagnostic development significantly outweighs outsourced development. In-house development is an easier solution for many companies because they retain more control over the process. Contracting can often be a difficult, time-consuming and expensive process. Internal development teams are easily able to coordinate development processes with other internal stakeholders. The company can also be certain that their product is the diagnostic development team’s primary focus, rather than multiple same-class compounds.
“As pharmaceutical companies prepare for the wave of expiring blockbuster patents, they’re looking at companion diagnostics to help identify patients for targeted therapies,” said David Richardson, research manager at Cutting Edge Information. “In-house development is not always practical, however, which is why more than one-third of the companies we surveyed do not have internal companion diagnostics development teams.”
One of the profiled companies in the study opted to outsource CDx development to avoid losing between three and six months just to set up the required facilities to do so in-house. Diagnostic development companies are much more familiar with the process, timelines and costs involved in developing tests for targeted therapies.
“Companion Diagnostics and Biomarker Development: Partnership Strategies and Benchmarks” (http://www.cuttingedgeinfo.com/research/clinical-development/companion-diagnostics-biomarkers/) explores the best practices for collaborating and partnering with diagnostics companies to develop companion diagnostics. The study is designed to help pharmaceutical companies:
- Learn how competitor companies approach and manage companion diagnostics development.
- Explore diagnostic development metrics for key therapeutic areas including oncology, cardiovascular, virology, CNS and inflammation.
- Develop consistent criteria for partner selection and implement consistent partner selection processes.
- Follow timelines to create an optimal development window for linked drugs and diagnostics.
- Set expectations internally and with partners.
For more information about companion diagnostics or clinical development benchmarks, contact Elio Evangelista at 919-403-6583.