The Pathology Innovation Collaborative Community (PIcc) is a regulatory science initiative that aims to facilitate innovations in pathology as well as advance safety and effectiveness evaluation, and to harmonize approaches to speed delivery to patients using collaborative, pre-competitive approaches. The collaborative community (PIcc) is open to all stakeholders, public or private, including, but not limited to, academia, industry, health care providers, patients and advocacy groups.
To accomplish advancements and innovation in pathology, the collaborative community believes in spreading tasks across workgroups. The working groups will disseminate project information and updates through educational outreach, scientific presentations, and making all resources broadly and publicly available. These working groups address topics that include but are not limited to:
• Pre-analytical variables,
• A framework for slide scanning,
• (Qualified) reference materials, samples, standards
• Image format, data exchange, and interoperability,
• Best-practices, standards for data collection, documents, whitepapers, or other educational material on regulatory science that could support policy
• Software tools and statistical packages,
• Peer-reviewed studies, protocols, and/or trials,
• Machine-learning and AI-algorithms,
• Identification of practical use cases,
• Submissions to pre-competitive programs (e.g. mock submissions, MDDT program submissions)
• Surveys, forums, seminars, regulatory science education, training programs, bootcamps
• Payor interactions, reimbursement, and financial sustainability
The collaborative community is open to all those working in the field who wish to join. Whenever possible the collaborative community strives to have at least one patient advocacy group among its members. Members are expected to join teleconferences and in-person meetings and to provide input and feedback to inquiries from their colleagues. Members are free to leave the collaborative community at any time. All members will comply with our Code of Conduct.
MDIC serves as the Convener for the PIcc and is responsible for:
• Providing general oversight of the PIcc;
• Administrative and operational support;
• Financial oversight of MDIC-funded aspects of the PIcc;
• Overseeing compliance of PIcc activities with respect to MDIC’s charitable mission.
Note: there is no requirement for members of PIcc to be a member of MDIC.
The collaborative community includes representatives from:
PIcc projects and workgroups strive to:
• account for the patient perspective by including patient advocacy;
• investigate and develop methods and tools for the evaluation of effectiveness; safety, and quality to specify risks and benefits in the precompetitive phase;
• help delineate and strategize the sequence of clinically meaningful deliverables;
• encourage and streamline the development of ground‑truth data sets;
• clarify regulatory pathways by investigating relevant regulatory science questions.
The collaborative community will make materials publicly available and share links to each organization to help all stakeholders. The collaborative community will initially focus on the regulatory environment in the US setting. Development of a repository includes white papers that highlight best practices, relevant policies for different countries and regions (including improving pathology in developing countries), and eventually de-identified data sets from studies, that may be utilized in continued regulatory research.
The collaborative community will strive to achieve three things:
• to unlock the potential of digital pathology using regulatory science approaches to help as many patients as possible;
• to train and educate each other in an interdisciplinary fashion with a focus on pre-competitive regulatory science;
• to create an environment that motivates and encourages all stakeholders to move the field of pathology forward.