On 25 April 2016, the Innovative Medicines Initiative (IMI) launched an online consultation on advanced therapy medicinal products (ATMP) with the goal of identifying the potential of IMI as a platform for enhancing ATMP research and development. The consultation was open to all citizens and organisations, and the deadline for submitting contributions was 26 July 2016. Contributors were encouraged to consider in particular the following questions:
- Have the key challenges that can be addressed through collaborative, public-private initiatives been properly identified?
- Which of the proposed potential initiatives should be prioritised?
- Are any areas missing?
- What are the key European or national initiatives that IMI shall synergise with?
Feedback received
In total, IMI received 34 responses to the consultation. The feedback is summarised in this document . In addition, all contributions are published below.
The subject was discussed further at the IMI Stakeholder Forum on 28-29 September 2016 in Brussels, Belgium.
Comments sent by organisations
- Academic AMTP Working Party The Netherlands and Belgium (Flanders) - Netherlands / Belgium
- Agence de la Biomédecine - France
- Alliance for Regenerative Medicine (ARM) - international organisation
- Andalusian Agency for Health Technology Assessment (AETSA) - Spain
- Association of the British Pharmaceutical Industry (ABPI) - United Kingdom
- British Society of Gene & Cell Therapy (BSGCT) - United Kingdom
- Cell and Gene Therapy Catapult (CGT) - United Kingdom
- Centro de Investigación Biomédica en Red - Bioingeniería, Biomateriales y Nanomedicina (CIBER-BBN) - Spain
- European Association of Hospital Pharmacists (EAHP) - European organisation
- European Eye Bank Association (EEBA) - European organisation
- European infrastructure for translational medicine (EATRIS) - European organisation
- European Society for Blood & Marrow Transplantation (EBMT) - European organisation
- European Society for Molecular Imaging (ESMI) - European organisation
- EuroTech Universities Alliance - European organisation
- Genetic Alliance UK - United Kingdom
- Guild of Healthcare Pharmacists (GHP) - United Kingdom
- Innovate UK - United Kingdom
- Medical Research Council (MRC) in conjunction with Health Research Authority (HRA) & Medicines and Healthcare products Regulatory Agency (MHRA) - United Kingdom
- Miltenyi Biotec GmbH - Germany
- National expert group on ATMPs in the Netherlands - Netherlands
- National Institute for Health and Care Excellence (NICE) - United Kingdom
- Newcastle Cellular Therapies Facility - United Kingdom
- NHS ATMP Working Party – a subgroup of the National Pharmaceutical NHS QA Committee - United Kingdom
- Paul-Ehrlich-Institut - Germany
- Spanish National Cancer Research Centre (CNIO) - Spain
- VDI/VDE Innovation + Technik GmbH - Germany
Comments sent by individuals in their personal capacity
- Pablo Caballero
Hygea Salud y Nutrición, Business Association of the Health Technological Park (Granada, Spain), eHealth Chapter of Technological Cluster Granada Plaza Tecnológica, Granada eHealth Business Summit, Spain - Yuri D'Alessandra
Monzino Cardiology Centre, Italy - Peter Dubruel
University of Ghent; European Society for Biomaterials, Belgium - Hudecek and Einsele et al. (joint comment)
Full list of co-authors:
Michael Hudecek, Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Germany
Hermann Einsele, Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Germany
Attilio Bondanza, San Raffaele Scientific Institute, Milan, Italy
Chiara Bonini, San Raffaele Scientific Institute, Milan, Italy
Fabio Ciceri, San Raffaele Scientific Institute, Milan, Italy
Franco Locatelli, IRCCS Ospedale Pediatrico Bambino Gesu, Rome, University of Pavia, Italy
Mirjam Heemskerk, Leiden University Medical Center, Netherlands
Heike Walles, Tissue Engineering & Regenerative Medizin, Universitätsklinikum Würzburg, Germany - Helena Kelly
Royal College of Surgeons in Ireland (RCSI), Ireland - Gabriele Thumann
Hôpitaux universitaires de Genève, Service d'ophtalmologie, Switzerland - Patricia Vella Bonanno
(Organisation and country not stated) - Christof von Kalle and Manfred Schmidt (joint comment)
National Center for Tumor Diseases & German Cancer Research Center, Germany