Global Companion Diagnostic Guideline Mapping and Strategy
Pharma & Biotech
49
11
20+
Biomarker and Diagnostics Strategy
Go-to-Market Strategy
Objective
A large pharma new to precision oncology wanted to understand the processes and requirements to ensure that their novel CDx was included into diagnostic guidelines globally
Our Approach
Secondary Research
- Reviewed the current diagnostic and cancer-specific guidelines for each country / region of interest (e.g., U.S., UK, Germany, France, Italy, Spain, Scandinavia, Canada, Brazil, China, and Japan) to establish the current testing guidelines and review the data requirements and guideline submission / review timeline and processes.
Primary Research
- Conducted 49 interviews with pathologists and guideline agency stakeholders to identify the most influential guidelines for IHC CDx testing and understand the process and requirements for implementing a novel companion diagnostic in the lab.
- Assessed adjacent sources of information that influence new biomarker adoption and testing among pathologists.
Outcome
DeciBio created a tactical checklist and timeline of key actions and data the client needed to generate to support guideline inclusion in each market. We established a profile for each high-impact guideline, summarizing the submission process, key individuals, and data requirements to warrant inclusion in the guideline. DeciBio presented the findings to each of the market teams within the organization.
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