Pharma CDx Development and Commercialization Ad Board

DeciBio conducted 25 interviews with stakeholders at pharmaceutical companies to better understand their perspectives on Companion Diagnostic (CDx) development and commercialization. Stakeholders gave insights into partnership models and selection criteria, commercial and market access strategies, and emerging technologies. In response to each interview question, DeciBio provides several condensed takeaways and a curated list of quotes indicative of stakeholder feedback.

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New Offering: Report + Aria Package

We’re excited to now offer an integrated Report + Aria package for our Agentic Advisory Boards. Alongside your tailored advisory board report, you’ll also receive access to Aria, our AI-powered tool that lets you chat directly with the board transcripts.

With Aria, you can:

• Ask specific questions and get instant, transcript-based answers
• Quickly explore themes, opinions, and verbatim insights shared during the session
• Save time on manual searching and unlock deeper value from advisory board discussions

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Question List:

• What is your current strategy for CDx development in your drug pipeline?
• What types of collaboration models that you find most appealing for CDx partnerships?
• How do you approach CDx commercialization and market access strategies?
• What are your top criteria when selecting a CDx Partner?
• Do you expect to increasingly leverage single-site lab CDx models or distributed kit CDx models in the future? Why?
• What emerging / novel technologies, if any, do you expect to utilize as a CDx in the near future?
• What role do you see computational pathology playing in your CDx development efforts?
• What is your expected timeline to integrating computational pathology in your CDx development strategy? Why?
• What potential benefits and challenges do you foresee with implementing computational pathology as a CDx?
• Considering the different components involved in the process like the algorithm, slide viewer, and scanner - all of which may come from different vendors - how do you, or how do you plan to, evaluate potential partners?
• What are your expectations around in-house pharma algorithm development versus co-development with a partner, considering the different commercialization considerations for an IVD algorithm versus an IVD kit?
• Can you share how your company is incorporating liquid biopsy technologies into your Companion Diagnostic strategies?
• What is your expected 5-year split between your solid tumor vs. liquid biopsy CDx activity?
• What advantages or limitations you've experienced with liquid biopsy-based CDx compared to tissue-based approaches?
• How do you perceive the potential for a Minimal Residual Disease (MRD)-based Companion Diagnostic?
• How is your company leveraging ctDNA as an early endpoint in clinical trials?
• What steps are you taking to ensure global harmonization of CDx development and approval processes?
• How are you addressing the challenges of developing CDx for complex biomarkers or multi-analyte signatures?
• How do you plan to leverage Real-World Evidence (RWE) or post-market data to support Companion Diagnostic (CDx) adoption or label expansions?
• What do you see as the biggest disruptors in the CDx space over the next 5-10 years?
• Do you have a contrarian perspective about the use of CDx over the next 5 years? How might your views differ from the mainstream?
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