Exit Survey: Question Title * 1. Identification Name Function Organisation Question Title * 2. I research and develop an ATMP, more precisely A gene therapy An autologous cell therapy An allogeneic cell therapy A tissue engineered therapy Other (give some explication) Question Title * 3. Currently, my research is in the following phase Preclinical Clinical Phase 1 Clinical Phase 2 Other (give some explication) Question Title * 4. For the process of bringing my therapy to the patient, I need more in dept training on How to manufacture my product (industrialisation) How to ensure that my products is in line with the regulations (regulatory) How to set-up and perform clinical trials (clinical operations) How to provide my product to patients worldwide (supply chain & logistics) How to set pricing and address reimbursement (health economics and market access) How do I prevent that others are just copying my ATMP or vice versa (IP) How to create a company for my product to mature to a therapy for patients (business) How to finance the different stages of the process of bringing my product to the patient (finance) Other (give some explication) Question Title * 5. On the topic of industrialization, I want to learn How my research process is translated into a GMP-process Where I can manufacture my product in a GMP-compliant environment How to make my process more efficient and robust How to lower the costs of manufacturing my product How to make sure my process and product are in control and quality compliant How to align manufacturing to support clinical trials How to validate procedures for the processing of human tissues and cells? Other (give some explication) Question Title * 6. On the topic of regulatory, I want to learn What are the European regulations and how are they adopted/interpreted in the different regions Which regulations do we have to take into consideration when we want to reach patients outside Europe How to collaborate with regulators How to perform a gap analysis of my product against quality and safety requirements needed for the submission to the regulatory agencies How to prepare and submit a dossier for submission to regulatory agencies. Other (give some explication) Question Title * 7. On the topic of clinical operations, I want to learn Which (non)clinical trials are mandatory to proof safety and efficacy of an ATMP What is Good Clinical Practice (GCP) and why is it needed Who are the different stakeholders in a clinical trial and what are their roles How to apply new approaches to clinical trial design, such as adaptive concepts How to determine the optimal sample size for a clinical trial How to reach patient recruitment goals How to inform doctors and patients about their participation in my clinical trial Other (give some explication) Question Title * 8. On the topic of supply chain and logistics, I want to learn About the impact of centralized and decentralized manufacturing on the supply chain What is Good Distribution Practice and how do I audit my logistics partner What are the roles and responsibilities of the partners within the supply chain and the logistic process How will my product be received in the clinic and how do I make sure that the physician does the right handling steps What carriers or temperature loggers to use What steps to take to maximally reduce risks during transportation Other (give some expliction) Question Title * 9. On the topic of health economics and market access, I want to learn How to position my therapy and define its (added) value How to create the value story and manage supportive data What is reimbursement and how to set up a reimbursement plan How to set a pricing for my therapy in relation to uptake How to relate pricing to standard care for the disease that your therapy is addressing How to work with Key Opinion Leaders How to create a launch plan How to work with patient focus groups? Other (give some explication) Question Title * 10. On the topic of IP, I want to learn If my ATMP is not copying protected methodologies (freedom to operate) How I set up an IP strategy for my therapy About the cost of the different filings Other (give some explication) Question Title * 11. On the topic of business, I want to learn How to define the further investments and engage future investors How to build a business plan/financial plan Other (give some explication Question Title * 12. On the topic of finance, I want to learn How I can finance my research project (grants) About tips and tricks in grant writing Where and how I can get investments to support the creation of a start-up company About the process of having investors on board What are the costs of different steps in the process of bringing a therapy to the patient eg clinical trials, market authorization, interaction meetings with regulatory agencies, etc Other (give some explication) Question Title * 13. Anything else you would like to mention? Done
