Context Advanced therapy medicinal products (ATMPs) is a class of innovative therapeutics which includes gene, cells and tissue engineered products. ATMPs offer unprecedented promise for the long-term management and even cure of diseases, especially in areas of high unmet medical need, such as cancers and haematological, ocular, neurodegenerative and genetic diseases. However, the translation from research into patient benefit faces many challenges and requires the involvement of many stakeholders (including academic start-ups, biotech industry, regulatory agencies). For ATMPs to fulfil their potential, specific skills and knowledge in four key areas need to be available in the workforce, which are currently lacking: manufacturing, clinical trials, regulatory approval and reimbursement. Objectives The main objective of the project is to support early career researchers in developing currently missing scientific knowledge, transversal skills and competences to meet the key challenge areas existing in the ATMP development cycle. By establishing an innovative and focused learning programme, ADVANCE aims at establishing a strategic partnership between key players from education, research and industry that contribute to innovation of ATMPs to jointly develop curricula for early career biomedical professionals. Participants The “next generation of ATMP developers” – i.e. early career biomedical academics (PhDs, Postdocs), including doctors in training, clinician scientists and SME-based professionals, who are considered to be an important component of the labour market and the critical intermediaries of the ATMP development pipeline - are the core target group for the three-stage blended learning programme foreseen by ADVANCE. Activities and outputs The three-stage blended learning programme consists of three complementary and interconnected modules all addressing key challenge areas in ATMP development : (1) online course (for teaching “basic” scientific knowledge); (2) webinars (for in-depth scientific knowledge and skills, combined with career coaching; and (3) face-to-face workshops (for training transversal skills and competences). Both the webinars and the online course will be free of charge and available to a broad audience. The three curricula (IO1-3) will be complemented by digital credentials (IO4) and a sustainability plan (IO5). Methodology The project methodology for developing the courses is based on the ADDIE principle – an instructional design model – consisting of 5 interrelated steps that will be implemented in the project accordingly: 1) Analysis; 2) Design; 3) Development; 4) Implementation; and 5) Evaluation. 1. During the Analysis phase, learning objectives for the courses will be defined based on a previously established competency profile (within the Erasmus+ funded C-COMEND project) for scientists involved in medicine research and development, including ATMPs, to ensure matching with labour market needs. 2. During the Design phase, the consortium will design the curricula of the courses based on the established learning objectives. The curricula will apply multi-competency training and Bloom’s taxonomy will be used to classify educational learning objectives into levels of complexity. 3. During the Development phase, the content of the training activities will be designed, including interactive learning methods which promote the transfer of course content into observable competencies and cater for different learning styles. 4. The Implementation phase will consist of the delivery of the online course, the webinars and career coaching sessions as well as the workshop programme. 5. In the Evaluation phase, the feedback obtained from participants as well as faculty, organisers and project partners will be used to optimise the second delivery of the online course and workshop cycle. Envisaged results and impact: • Outputs available to a broad audience (aim online course 500, webinars 700 and workshop 60 participants). • Enhanced quality and relevance of competencies and knowledge to the labour market in the biomedical sciences. • Improved course participants' career opportunities and employability in the field. • Fostered interaction between research, education and innovation. • Supported mobility between countries and between public & private sectors. Longer term benefits: • Increased European competitiveness of ATMP development. • Increased number of scientific ideas turned into innovative products bringing growth and jobs to the European economy. • Strengthened public-private strategic partnership and collaborations in the field of ATMPs. • Improvements in public health due to better trained professionals who will drive effective and accelerated ATMP development and offer safer and affordable treatments for patients with high unmet medical needs.
The main objective of the project was to support early career researchers in developing previously missing scientific knowledge, transversal skills and competences to meet the key challenge areas existing in the Advanced Therapy Medicinal Products’ (ATMPs) development cycle. By establishing an innovative and focused learning programme, ADVANCE aimed at establishing a strategic partnership between key players from education, research and industry that contribute to innovation of ATMPs to jointly develop curricula for early career biomedical professionals.
Advanced therapy medicinal products (ATMPs) is a class of innovative therapeutics which includes gene, cell- and tissue engineered products. ATMPs offer unprecedented promise and high potential for the long-term management and even cure of many so far incurable diseases such as various cancers and haematological, ocular, neurodegenerative and genetic diseases. However, the journey of translation of the scientific findings into patient benefit faces many challenges and requires the involvement of many stakeholders (including academic start-ups, biotech industry, regulatory agencies) coming together to tackle them in multidisciplinary settings. For ATMPs to fulfil their potential, specific skills and knowledge in four key areas need to be available in the workforce, which are currently lacking: manufacturing, scientific advances and clinical trials, regulatory approval, market access and reimbursement. The needs addressed in the project were to train the early career researchers in these areas, adding the perspective of career development and transversal skills to boost mobility in and between the sectors.