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Regulatory framework for digital slides and AI-based methods

Work Package 6

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The WP6 objective is to develop a sustainable, trustworthy digital AI pathology platform for research and innovation. The sustainability team will develop a step-by-step plan to ensure that the Bigpicture architecture, strategy and operations are rooted in Bigpicture’s core guiding principles.

 

Management Team

  • Katrien Grünberg
    WP6 Lead
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  • Ruth Sullivan
    WP6 Lead EFPIA
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  • Marielle Gallegos-Ruiz
    WP6 Co-Lead EFPIA
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  • Pierre Moulin
    WP6 Co-Lead EFPIA
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Main Objectives

WP6 brings together a multidisciplinary team of Bigpicture partners (academic, SMEs, pharma, regulatory, consultants, etc.), supported by advisors and ad-hoc consultants, who will coordinate the development and validation of the community-based sustainability plans. The sub-objectives are:

1. Develop the AI Pathology community by mobilising all relevant stakeholders;

2. Conduct Market and Stakeholder research to learn about drivers and incentives for using the platform;

3. Identify, develop and validate various community-based business models for the platform;

4. Deliver various scenarios including governance, technical and operational plans for sustainability (mainly in close collaboration with WP2); infrastructure (e.g. decisions on minimal requirements for storage after Bigpicture) and WP3 (e.g. continuation of Honest Broker Model);

5. Define the organisational and governance model of a dedicated organisation that will ensure sustainability after the project period;

6. Implementation and outreach programme for sustainability; and

7. In parallel to Bigpicture: incorporate the new organisation for sustainability (here we use NewCo) (not funded by the IMI).

8. Support all WP’s in scouting for potential intellectual property that may lead to a new spin-off and support the spinoff creation process.

Main Tasks

Phase I – Preparation phase

Task 6.1 – Mobilising and Engaging the Key Community stakeholders. Bigpicture will mobilise the key communities (e.g. clinical, toxicology and veterinary pathologists, AI researchers, SMEs, industry, patient organisations and others) using a well-defined communication plan that fits to needs of these different stakeholder groups and learn about their specific needs and drivers to raise their interest, commitment and trust.

Task 6.2 – Market and Stakeholder research. The aim of this task is to learn about the needs and drivers of each stakeholder group (e.g. nonclinical and clinical pathologists, AI researchers, patients, SMEs, industry, etc.) and the market as a whole which will enable us to design business models that could work for these different groups (fit-for-purpose).

Task 6.3 - Organisation and Governance models. The aim of this task is to design a feasible organisational and governance model that fits the need of all stakeholders.

Task 6.4 - Cost analysis and pricing models for sustainability of Bigpicture. The aim of this task is to calculate the costs and projected revenues of NewCo, the new organisation for sustainability, and develop pricing models.

Task 6.5 - 3-year Business Plan. The aim of this task is to generate a 3-year business plan which will provide multiple scenarios to be used for strategic decision-making. Based on these scenarios, a dedicated organization that will drive future sustainability will be developed and implemented.

Task 6.6 - Roadshow for NewCo. NewCo will organise a roadshow to meet with key funders/ decision makers/payers with the main goal to secure (start-up funding). NewCo will start with the key group of stakeholders (e.g. the participating partners and stakeholders) and later with other relevant national and European initiatives.

Phase II – Implementation phase

Task 6.7 – Promote and support exploitation. WP6 will support each Work Package in its responsibility to scout for potential intellectual property (including data, access, knowledge, methods, etc.) that can either be transferred/licensed to an existing company or may lead to a new spin-off. The WP6 exploitation team will provide expert legal, regulatory and commercial knowledge and network to support the spin-off creation process, including developing a business case in which the commercial and technical feasibility is assessed.

 

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Funding

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 945358. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation program and EFPIA. www.imi.europa.eu

  • Innovative Medicines Initiative
  • European Federation of Pharmaceutical Industries and Associations
  • European Union