While preparing the agenda items for discussion at the upcoming Enpr-EMA annual workshop, to be held at the EMA in London, on Thursday 28 May 2015, it has been agreed by the Enpr-EMA chair and co-chair to ask all Enpr-EMA registered networks to provide a short written paragraph with regards to any news or achievements which each network considers as being important and which has happened since the last Enpr-EMA workshop in June 2014.
These are the Teddy Network’s activities realised between June 2014 and February 2015.
ESTABLISHMENT OF TEDDY GOVERNING BODIES
The TEDDY Network officially established its governing bodies during the first General Assembly that was held in Castellaneta Marina (Italy) on October 3rd, 2014 at the Nextwork Forum (2014 edition): the Scientific Coordinating Committee (SCC) and the Strategic Planning Board (SPB), a committee aimed at ensuring the adherence to TEDDY high quality standards (please refer to attached memorandum).
Participation in the setting up of the european paediatric clinical trial research infrastructure (EPCTRI)
Starting from January 2015, TEDDY is working on the preparation of a proposal for a new paediatric research infrastructure (RI) devoted to implementing paediatric clinical trial to be coordinated by Mark Turner (University of Liverpool).
The proposal has been disseminated among TEDDY members and as of today Italy, Poland, Spain and Albania, as TEDDY members are candidates to participate in the RI.
SURVEY TO MAP THE NETWORK’S EXPERTISE, COMPETENCES AND INFRASTRUCTURES
As more relevant activity, TEDDY has started an internal survey to clearly map the expertise and competences of the clinical centres participating in the TEDDY Network.
The survey will have two main objectives: 1) to collect information on paediatric clinical trials expertise and 2) to identify Partners’ cross-competences that do not directly deal with paediatric clinical trials and study conduct, but involve aspects such as regulatory requirements, ethics and governments.
Results of this mapping process will be made available through TEDDY website to facilitate the contact between Sponsors of paediatric clinical trials and TEDDY research centres.
The survey will also be useful to scan the competences of possible participants in the EPCTRI, also in terms of centres availability and capacity in participating in paediatric CT.
A new improved website is being developed by TEDDY Coordinator.
Once finalised, the website will not only be a window for presenting the Network, its Partners and activities, but it will also become a service tool for facilitating the conduct of paediatric trials.
The website will in fact collect standard operating procedures for conducting clinical research in paediatrics that will be at disposal of TEDDY members, and will provide news and updates on the paediatric research field.
ANALYSIS OF FP7 PROJECTS FOR PAEDIATRIC DRUG DEVELOPMENT AND PARTICIPATION IN EUROPEAN COMMISSION PUBLIC CONSULTATION
The TEDDY Network is maintaining and keeping updated a database collecting information on projects funded under FP7 to develop off-patent paediatric drugs. The dataset contains projects data and achievements, and comparisons with a similar US initiative, the Pediatric Trial Network.
On the basis of the above collected information, in September 2014, TEDDY participated in the European Commission’s consultation for Horizon 2020 Societal Challenge “Health, demographic change and wellbeing” for the programming exercise 2016/2017.
TEDDY key recommendation was the renewal of funding to study off-patent medicines for children in Horizon 2020, also in consideration of the fact that off-patent medicines are not funded by any other programme, at EC or national level (contrary to e.g. cancer or rare diseases, or elderly).