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Survey:
1.
Identification
Name
Function
Organisation
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)
3.
Currently, my research is in the following phase
Preclinical
Clinical Phase 1
Clinical Phase 2
Other (give some explication)
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)
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)
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)
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)
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)
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)
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)
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
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)
13.
Anything else you would like to mention?
