Hello, I am Ameeta Parekh with the FDA’s Center for Drug Evaluation and Research, also known as CDER. In this module, I will discuss the role that consortia can play in biomarker development and qualification.
The development of qualified biomarkers as drug development tools can be a complex process. This entails biomarker discovery and development, as well as the stages of biomarker qualification process as delineated by the 21st Century Cures Act, with the receipt of a Letter of Intent, Qualification Plan, and full qualification package. At each stage, FDA reviews and makes a decision on the supporting materials that have been provided, with the ultimate goal of making publicly available the information supporting a biomarker for its proposed context of use.
Regulatory qualification of biomarkers for a specific use in drug development and regulatory decision making involves several steps of evidence generation and analytical and clinical validation. As a result, developing a biomarker with the goal of regulatory qualification for a specific context of use across drug development programs often requires significant resources and expertise.
Therefore, collaborative efforts can be useful for these endeavors, as they can facilitate the sharing of resources such as biological samples, data, scientific knowledge, and expertise. In addition, the collaborators can leverage the costs of developing biomarkers for qualification.
Consortia can provide a framework for such collaborations.
A consortium is a collaborative group, managed by a convening or coordinating organization, involving multiple stakeholder organizations, including at least one non¬profit or 501(c)(3) organization (such as academia, government, or foundation) and at least one for-profit organization (for example, pharmaceutical, biotechnology, or medical device company).
- A consortium setting can provide a neutral environment to foster scientific collaborations among stakeholders for partnering, sharing, and leveraging the resources for biomarker development and qualification.
- A consortium can help facilitate efforts such as plan workshops and scientific discussions to gather input from the scientific community on the approaches and scientific evidence for biomarker qualification and to streamline advances in regulatory science in general.
- A consortium setting can provide an opportunity for regulatory scientific staff to engage and to discuss current thinking on biomarkers and other regulatory science efforts.
- As an example, the consortium model has enabled the development and successful qualification of several biomarkers.
- The consortium model has been increasingly utilized for the development of biomarkers.
- A majority of consortia have a formal governance structure with a clear mission statement, targeted deliverables, timeframes, milestone-driven work streams that define decision-making roles, opportunities for providing input into the strategic direction, transparency, and accountability to sustain an environment of trust, and mechanism for broad access to consortium output.
A large number of established consortia aim to improve drug development. Examples of their outputs include biomarkers, clinical trial methods, data standards, animal models, standard terminologies, and access to tools, technology platforms, data sets, and biospecimens.
In addition, several consortia focus their research to advance specific therapeutic areas, while many advance basic sciences.
CDER is involved in several consortia to promote the development of research tools, platforms, clinical databases, and predictive models to advance knowledge of diseases and safety profiles of drugs.
Project results generated by these consortia efforts are made broadly available to the public to benefit public health.
CDER has established a process for CDER staff to engage with consortia. For more information, see our Manual of Policies and Procedures available on our website.
Biomarker developers looking for partners with similar interests and objectives may consider Consortia-pedia as a starting place. Consortia-pedia is a searchable catalogue developed by a nonprofit entity that contains profiles and research focus of hundreds of research consortia, and the catalog is updated periodically.
Visit the Consortia-pedia website to learn more about this resource.
This module discussed the role that consortia can play in developing biomarkers for regulatory qualification. To learn more about CDER’s engagement with consortia efforts, visit our website.