This issue of Consultant Connection discusses how a strong understanding of companion diagnostics (CDx) can help you guide your client’s drug development strategy with a proven pathway to commercialization.
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While pharmaceutical and biotechnology companies recognize the value of a robust CDx strategy, they often have limited knowledge of the diagnostic industry per se and how to develop and commercialize CDx. As a consultant, you can fill a valuable role by helping your clients develop a comprehensive strategy that considers the needs of the various stakeholders who promote co-development of the drug and its accompanying (companion) diagnostic.
Determining the best path for CDx development and commercialization requires a consideration of the entire development continuum, from preclinical studies involving novel biomarker development strategies to analytical and clinical validation, regulatory approval, commercialization and, ultimately, a successful market access strategy.
At a high level, the two proven pathways to commercialization of a CDx are:
An In Vitro Diagnostic Partnering (IVD) Model This is the model best suited to globally disseminated, near-to-patient, fast turnaround testing. It is supported by 3-way collaboration between the IVD manufacturer, the drug developer and the contract research organization (CRO) who executes the clinical trials supporting the regulatory filing of both the drug and the CDx. The IVD manufacturer acts as the IVD sponsor and is responsible for filing the regulatory dossier with the appropriate regulatory agencies. Following approval the diagnostic company can then deploy the assay globally across its installed instrumentation base.
A Single Laboratory Developed Test (LDT) Approach This model is best suited to orphan indications where testing volume is low, and to assays based on technologies that are difficult to operationalize. It can also be an early phase development solution to allow the pharma company to defer the investment in IVD development until later in the clinical program. In this model the clinical testing laboratory undertakes development and regulatory approval of the assay. The assay undergoes specific studies to demonstrate its analytical and clinical performance. This approach is often referred to as a single-site premarket approval (PMA) where the laboratory not only serves the role of the IVD manufacturer but is also responsible for all interactions with the regulatory agencies.
While both approaches hold distinct advantages, the two routes are not mutually exclusive. A deep understanding of each option can help you develop a strategy that aligns with the development of your client’s therapeutic.
Considerations for CDx Success
The field of CDx is advancing quickly as the focus expands beyond oncology to other therapeutic areas. Many factors, such as technology advances in complex genomics (Next Gen sequencing and multiplex genomic assays) as well as continually evolving regulatory requirements are further changing how drug development programs incorporate CDx strategies.
Through our experience in supporting more than two-thirds of all FDA-approved CDx assays, we’ve consistently seen the following trends emerging:
Earlier engagement. A CDx strategy is now often considered much earlier in the development process to align exploratory biomarker thinking with later stage CDx strategy.
Commercialization efforts. When the CDx is closely tied to the adoption of the drug, manufacturers are thinking more and more about market access to drive the uptake of the CDx and go beyond regulatory approval and they are basing their choice of development partners on their ultimate commercialization goal—“Starting with the End in Mind”.
Improved communication. The co-partnership model is most successful when diagnostic and pharma companies carefully communicate to align expectations, deliverables and timelines.
Incorporating a CDx strategy can result in significant reward, but it requires additional coordination and considerations. A holistic approach that encompasses the perspectives of regulatory agencies, payers, manufacturers and CROs is required to achieve commercial viability of the drug and CDx product co-development.
Learn more about how you can integrate technical capabilities, navigate regulations and leverage our global network to advance your clients’ personalized medicine programs.
Due to the growing interest in “personalized medicine”, your clients may be asking you about developing a biomarker strategy to support the use of their compound as a tailored therapeutic. Companion diagnostics are at the heart of these strategies, enabling physicians to identify which patients will best respond to a given therapy in order to select the right drug, for the right patient, at the right time and in the right dose.
Lecia Johnson and her team are standing by to provide consultants with seamless access to Covance global solutions—nonclinical through clinical. Contact us today—we look forward to helping you succeed.