Our team guides Medical Device/IVD and Pharma as they navigate technology and partner selection for unique diagnostic testing. We provide commercialization guidance to ensure rapid revenue growth by identifying target markets, go-to-market options, and partner options.
We know and advise which diagnostic partners have a proven track record in developing clinical trial assays and companion diagnostics. We can provide guidance if the development quotes make sense based on our direct experience having worked at these companies.
Key to the commercial success of a new therapeutic with a CDx is regulatory and commercial preparation for testing. BioPharmaDx has in-depth experience ensuring alignment between therapeutics and CDx.
The use of an IVD companion diagnostic device with a therapeutic product is stipulated in the instructions for use in the labeling of both the diagnostic device and the corresponding therapeutic product. Drug approval will depend on the Device approval and vice versa.
Launch readiness involves many months of pre-planning to ensure that on day one of therapeutic approval physicians can order the test and obtain supporting results allowing prescription or use of the new therapeutic. Day-One readiness is critically important to the early success of the new therapeutic
BioPharmaDx has extensive experience working with Pharma to advise, plan, and direct the coordinated preparation of diagnostic testing with therapeutic regulatory approval.
Our team can explore new markets, patient preferences, doctor, institutional preferences, and reimbursement.
Our industry professionals are available to staff your booth and provide professional greeting services to interested clients. Our professionals have extensive experience in the industry and represent your company professionally- anywhere in the world.
We have expertise scouting academic and commercial sites for desired assets. We can reach out on a confidential basis to explore key details/facts of a desired technology.
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