The Alliance leads Regulatory Science
THE ALLIANCE AIMS TO WORK ON:
Temporary framework to synergize and tackle larger scale projects
Harmonizing & standardizing a reference set to be used in end to end workflow by:
Creating tools and datasets
Progressing and enabling market access
Creating clarity on regulatory pathways via mock submissions
Harmonizing efforts between various stakeholders to optimize interoperability, integration and implementation
The Alliance is soliciting project blueprints. Please download the project proposal form and submit to DigiPathAlliance@gmail.com.
Marble et al., unpublished
Following is a brief explanation of the differences between the Alliance and the Digital Pathology Association (DPA):
The Digital Pathology Association (DPA) and the Alliance for Digital Pathology: 2 Complementary Organizations Aligned by a Common Goal
(status March 2020)
DPA: The DPA has been in existence for 10 years and is comprised of pathologists, scientists, technologists and industry representatives dedicated to advancing the field of digital pathology.
Alliance for Digital Pathology: The Alliance is focused on advancing regulatory science, particularly focused on ML/AI applications in digital pathology. It started in 2019 as an open collaboration between the FDA, MDIC (Medical Device Innovation Consortium), the DPA and scientific key opinion leaders in the field of digital pathology.
Scope: The DPA scope is broad (education, Path Visions meeting, global membership, regulatory & standards etc) while the Alliance is narrowly focused on specific tasks which are pain points and barriers to the successful validation and standardization of a clinical, interoperable, modularized, integrated digital pathology solution (from tissue acquisition to diagnostic algorithm).
Permanence: The DPA is built for long term sustainability with its member structure and funding to drive key initiatives critical for global DP adoption. The Alliance is intended to be a short-term initiative to remove key roadblocks to acceptance and will disband when its mission is fulfilled. To ultimately benefit the entire field from the experience of the Alliance, key deliverables and processes developed by the Alliance will be made available and when applicable transferred to the DPA for long term sustainability.
Regulatory Initiatives: The DPA is funded and organized to support clarification of regulatory processes towards market authorization of new DP products. The Alliance is a regulatory science initiative to advance regulatory science as a field. Regulatory science challenges current concepts of benefit and risk assessments, pre-market approval strategies, patient’s involvement and various ethical aspects. The Alliance works, whenever possible with regulatory entities (including the FDA) on topics to advance regulatory science associated with DP solutions and resolve specific technical issues associated with its implementation.
Overall Message: The DPA and Alliance are complementary organizations. The DPA is actively supporting and funding Alliance initiatives and encourages all interested individuals and organizations to support the Alliance AND to be active members of the DPA.
To learn more and join the DPA, click here: http://www.digitalpathologyassociation.org