Early insights and a holistic approach are critical to leverage the benefits of a biomarker strategy that includes a 3x greater probability of successful transition from Phase I to regulatory approval.


Comprehensive strategy development establish the right biomarkers for your therapeutic area of interest, use of the data, optimal technology and more.


3


Prepare for commercialization with parallel development of your companion diagnostic (CDx)


Parallel development of a CDx with a novel therapeutic is challenging, but the value of proving your treatment’s efficacy with targeted tests or biomarkers has never been greater.


Should your predictive biomarker advance to a CDx, it is important to proactively plan for your diagnostic and therapy to be commercially ready on ‘day one’.


A CDx can also enable reduced development time and therapy development costs, which can result in more favorable reimbursement and illustrate comparative effectiveness.


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