Translational Biomarker Development: mind the gap

Of all the disciplines and specialties required to develop new drugs, biomarker development is, in my mind, the specialty that has the most to gain from a modern Translational Medicine organization structure (i.e. a seamless integration of all drug development stakeholders from a project inception to its conclusion).  However, throughout my career, I have experienced situations telling me that biomarker development still appears to be fragmented in many bio / pharma companies. Unlike other specialties, such as pharmacokinetics and toxicology which tend to be formally organized to facilitate connection between Research and Clinical, biomarker development still too often tends to exist in discrete, partially isolated functional groups.


If you have worked in the biomarker field, you might be familiar with the following examples of gaps in connection between biomarker stakeholders:

• A clinical team leader asks for a disease modification biomarker less than six months prior to the start of a clinical study 
• A biology research scientist scrambles to develop and validate a biomarker assay method after his/her favorite biomarker is included in a clinical study protocol 
• Regulatory and Legal produce a Patient Informed Consent form that precludes any post-hoc analysis of clinical samples

Let me suggest a two-prong approach to solve this type of issue:

• Organization structure: many companies would gain in setting up a small translational biomarker group serving as the main interface between all biomarker stakeholders. This "hinge" function should be responsible for identifying, communicating, and resolving requirements and issues associated with biomarkers throughout a program's life cycle. 
• Planning process: based on the FDA guidance "Target Product Profile — A Strategic Development Process Tool", I would argue that biomarker development should follow the same path as a drug program. Thus, I would recommend the creation of a "Target Biomarker Profile" for all drug development programs even if biomarker needs appear to be minimal (determining that nothing needs to be done is not the same as ignoring the issue). This TBP would articulate the intended overall goals for biomarkers associated with a given program, defining the intended decision to be driven by the biomarker, the expected impact level of the biomarker on the program, the timing of deliverable, and last but not least, the intended audience of biomarker data. Similarly to the TPP, the TBP should be an evolving document in which initial assumptions should be revisited and new priorities taken into account. 

Thierry Sornasse for Integrated Biomarker Strategy