Overcome barriers in biomarker development

There are multiple biomarker barriers for entering the clinical practise. Here we list the most important barriers and how Fournier-Majoie Foundation approaches them.

Biomarker barriers for entering clinical practise Fournier-Majoie Foundation's approach
Type of barrier Description Solution How
Few incentives to move discoveries further The inventor does not want to take time away from research: the academic tenure process and the reward & merit systems put emphasis on scientific publications (patents) only Coaching & training
+ Financial support
Collaboration with TTO's
Show cases
Funding Undertaking a development project requires a lot of money and €'s are difficult to attract (valley of death)
Public funding (both governmental and NGO) usually stops with publication of discovery
Funding
+ Network
Project funding by Fournier-Majoie Foundation
Look for partners for co-funding
Lack of clinical insight The marker may fail to justify changing the clinical decisions about the disease's treatment Improved market/disease understanding Involve clinicians early on in the project steering committee
Qualitative research (focus groups) involving physicians
KOL management Getting diagnostic tests reimbursed will require key opinion leaders to lobby on your behalf Training & coaching Integrate health economics early in study protocol
Help with relation management
Deficient study/sample populations Small sample sizes, poor choice of control groups, poor medical annotation data… Training & coaching
+ Opening our network of service providers
Improve access to quality bio banks (retrospective studies) or CRO's (prospective studies)
Inappropriate statistical methods used A poor choice of method might have been made, the method itself may be a bad one, or a method may be misapplied Training & coaching
+ Opening our network of service providers
Involve biostatisticians and bio-informaticians in an early phase
Lack of assay robustness The assay may be non-robust, not locked down or reduced to a single standard procedure, or not portable from one laboratory to another Opening our network of service providers Partnering with professional assay developers (service companies)
Limited insight in IP & freedom to operate Location of granted patents, or patent applications (which upon grant) determine whether your product would infringe Improved market understanding
+ Opening our network of service providers
Have a reputable IP Analytics firm to conduct regular Infringement Searches
Regulatory requirements The development of diagnostics or medical software is highly regulated. Meeting regulatory objectives requires know-how & implementation of the In Vitro Diagnostic Directive in the EU and FDA regulations in the US Training & coaching
+ Opening our network of service providers
Keep informed about existing and new regulation(s)
Involve regulatory experts at the right moments during the project
Complex quality assurance & quality control requirements Regulatory requirements include quality system requirements (e.g. ISO certification) Training & coaching
+ Opening our network of service providers
By gap analysis (audit), training sessions… give the assistance to set up a quality system
Limited understanding of the market environment/competition

Any organized effort to gather information about markets, current medical practice or customers. Market research is a key factor to get advantage over competitors

Improved market understanding
+ Opening our network of service providers
Perform market research studies and competitor monitoring
Identification of proper partners Collaboration with third parties (biobanks, service companies…) during the development phase is needed. Also commercialization requires partnering with diagnostic companies Business development Offer assistance with business development, as well as legal assistance for contract negotiations
Qualitative research (focus groups) involving bio pharma companies (companion Dx)