WORK PACKAGES

JOIN4ATMP’s activities will be divided into 7 work packages that will guarantee the achievement of the concrete project objectives. Every work package will be coordinated by a leading institution that will ensure the achievement of measurable sub-objectives. By completing these objectives, the partners mobilise strive to categorise obstacles to ATMP progress, map potential solutions based on real-world use cases and design actionable recommendations having an impact beyond the project’s lifetime. An efficient project management will ensure smooth workflow and effective coordination between partners, while communication activities will ensure optimal visibility, wide outreach to stakeholders and a solid base for results management.

Explore in detail by moving your mouse and clicking over the diagram

WP1 How to increase the predictability of preclinical safety and efficacy data

The ultimate goal of WP1 is to establish potential solutions for preclinical testing that ease ATMP development in the future without compromising patient safety.

The constitution of an annotated database gathering preclinical results of current ATMP used clinically will evaluate safety and efficacy correlations between preclinical studies and their predictability for or reproducibility in patients. In addition, the generation of interviews from relevant external experts involved in ATMP development will lead to the creation of a map of ATMP development obstacles and how to solve them.

The findings and extracted quintessence of the retrospective data collection and expert interviews will be compiled into a recommendation for a minimal set of parameters and models that should be required for different ATMP types before entering first in-human clinical testing.

The main objectives of WP1 are:

Collect ATMP preclinical study results in an annotated database
Map hurdles experienced during preclinical ATMP development and how these hurdles were overcome
Assess innovative in vitro alternatives to animal testing for their predictive potential for human toxicities to new ATMPs
Consolidate learning into recommendations for preclinical testing strategies with the highest predictive value for safety and efficacy.

WP2 Road to standardised Good Manufacturing Practice ATMP production across the EU

WP2 sets tasks to enable evolution towards standardised Good Manufacturing Practice (GMP)-compliant ATMP manufacture throughout EU member states in strict dialogue with national competent authorities. Real-world developer experiences will offer realistic solutions towards standardised as well as decentralised ATMP manufacture. Based on these experiences, recommendations for the existing regulatory environment will be established.

The main objectives of WP2 are:

Map ATMP manufacture regulatory criteria in different EU member states
Map ATMP manufacture organisational and infrastructural requirements
Chart guidelines for monographs for pharmaceutical-grade raw materials
Design criteria for a dynamic regulatory framework relying on new technological platforms
Design a blueprint for an EU-wide GMP unit coordination platform.

WP3 Streamlining clinical ATMP development: From early phases to marketing authorization

The current situation for clinical ATMP development from its early phases up to market access in the EU will be mapped in WP3. The analysis of exploitable alternative options and the proposition of tailored approaches will facilitate early clinical development towards market authorization from both regulatory and financial points of view.

The main objectives of WP3 are:

Map the regulatory and policy needs to improve clinical translation of complex innovative ATMPs
Address gaps and uncertainties in regulatory and policy aspects pertaining to clinical ATMP development and market approval
Boost clinical ATMP development by academia and SMEs through new incentives and financing schemes.

WP4 New frameworks for value assessment, pricing and reimbursement schemes

WP4 will use real-world data to map hurdles in the commercial uptake of ATMPs, including pricing and reimbursement challenges. We will propose how ATMP developers could improve their interactions with health technology assessment (HTA) bodies throughout ATMP development, improve usability of real-world data for HTA evaluation, and propose alternative pricing and reimbursement schemes.

The main objectives of WP4 are:

Map current interactions with HTA and regulatory bodies during ATMP development and promote early, stronger and unified approaches
Explore existing practices and propose potential solutions to improve the usability of real-world data and evidence
Examine different models of performance-based agreements relying on use cases for ATMPs with different characteristics and propose innovative pricing and reimbursement schemes
Help academic and SME developers understand the economic value of ATMPs.

WP5 Increasing ATMP regulatory awareness in producers and ATMP acceptance in patients and healthcare professionals

WP5 aims to increase awareness and knowledge of ATMP regulatory issues and procedures in their developers and manufacturers and ATMP acceptance by patients, the public and healthcare professionals. To tackle these two aims and target the appropriate stakeholder groups, a platform offering improved information will be developed.

The main objectives of WP5 are:

Improve awareness and knowledge of the regulatory processes among academic and SME ATMP developers and manufacturers
Introduce improved information exchange to raise ATMP acceptance EU-wide and support equitable ATMP access
Involve end-users in the ATMP development process to raise ATMP awareness, acceptance and legitimacy in the lay public.

WP6 Project management and scientific coordination

WP6 will provide a clear organisational framework, guidance and all support mechanisms to enable a smooth project workflow in JOIN4ATMP and ensure that objectives and milestones are met on time.

The main objectives of WP6 are:

Quick set-up of management & communication structures and processes
Central monitoring of project activities, deliverables and deadlines to ensure timely qualitative achievement of project results through scientific coordination and impact-oriented project management
Ensure efficiency, high quality and maximum usability of project outcomes
Proper risk-analysis and conflict management.

WP7 Innovation Management: Communication, Dissemination, Exploitation

WP7 will ensure consistent and optimal communication, dissemination and sustainability activities. Optimal visibility of the JOIN4ATMP project and results will be guaranteed as well as broad outreach to all relevant stakeholder groups. Sustainability activities will safeguard that high-quality results are captured, assessed and used after the 3 project years. Finally, a proper IP management strategy will lay the foundation for beneficiary interactions and JOIN4ATMP sustainability that takes background knowledge of beneficiaries as well as newly created results into account.

The main objectives of WP7 are:

Communication: Ensuring clear partner interaction & creating visibility and broader outreach
Disseminating results to targeted stakeholder groups
JOIN4ATMP sustainability: Ensuring use of results and pathways to impact.