About us
PMB
PMB is a human-sized company located near Aix-en-Provence (France), specialized in the design and manufacture of complex mechanical assemblies for the industries of Defense, Medical and Research. Since the late 2000s, we have developed complex systems integrating particle accelerators: an automated PET radiopharmaceutical system, a linear accelerator for non-destructive testing, and a radiotherapy system.
FLASHKNiFE is a FLASH radiotherapy system combining a 10 MeV linac and an interactive robot, mounted on a mobile base. FLASH-RT consists in the delivery of a very high dose in a fraction of a second. It gives great hope to cancer patients all over the world and shall revolutionize radiation therapy in the near future, making it safer, more precise and more efficient.
Role in the FLASHKNiFE Project
The company is engaged as project leader in the consortium, coordinates the project and is highly implicated in all work packages of the project. This includes the development and manufacturing of the device as well as the appropriate validations, the clinical study, CE marking and ISO 13485:2016 certification, preparation of the product launch on the market and dissemination and communication work.
ALCEN
ALCEN is a French diversified group active in five sectors: Health, Defense & Security, Energy, Aeronautics & Space, Large Scientific Instruments.
ALCEN’s ambition is to establish an ongoing policy of innovation applied first and foremost to its own products and services. To achieve this, ALCEN has developed a particularly extensive in-house technological base. It works closely with research and clinical centers, systematically transfers technological developments and feedback from one field to another and develops its technologies in specialized laboratories organized around a select number of top experts. ALCEN has built an original and fully-integrated technological model boasting exceptional productivity.
Role in the FLASHKNiFE Project
ALCEN supports its subsidiary ALCEDIAG in the coordination of the EDIT-B project, and provides for example transversal services such as legal support or websites management.
Institut Gustave Roussy
Leading Cancer Centre in Europe, Gustave Roussy is ranked #6 world’s best oncology hospital according to Newsweek magazine and the first one outside the United States. The institute treats patients with all types of cancer at any age and is expert in the treatment of rare and complex tumours.
The institute places innovation at the heart of a human, scientific and technological revolution in the fight against cancer.
Their physicians and researchers respond to a continuing challenge: deliver patients the fruits of the most recent advances. They devote their energies and their skills to this great challenge: to speed up progress in order to expand the limits of knowledge and offer patients continuing improvements in the specificity of their treatment.
Role in the FLASHKNiFE Project
Institut Gustave Roussy participates in the design of the clinical study, the enrollment of the patients with collection of the detailed demographic baseline characteristics and clinical data. Dr Eric Deutsch is the principal investigator of the clinical study.
Investigator Prof Eric Deutsch
Professor Eric Deutsch is a radiation oncologist and specialist in therapeutic innovations applied to tumor irradiation. He is the head of the Gustave Roussy Radiotherapy Department and leads the Institute’s “Teaching and University Relations” division.
With a doctorate in Radiobiology, Eric Deutsch is a professor of oncology-radiotherapy at the University of Paris-Saclay, where he teaches oncology and radiobiology.
Head of the Inserm 1030 joint research unit “Molecular Radiotherapy and Therapeutic Innovation”, Prof. Deutsch’s research work is devoted to the study of the combination of new anticancer drugs with radiotherapy.
His interest is focused on understanding the biological effects of radiotherapy, the interaction of the tumor with its microenvironment and the mechanisms of cell death. More recently, he has developed a research activity dedicated to radiomics and artificial intelligence in order to personalize treatments by radiotherapy combined with immunotherapy.
Eric Deutsch is strongly involved in early clinical trials and in gastrointestinal cancers.
Universitätsklinikum Erlangen
The world’s state-of-the-art operating theatre, up-to-date equipment, science-based diagnostic and therapeutic procedures: the 42 departments and eight institutes of Universitätsklinikum Erlangen comprehend every field of modern medicine. The university hospital buildings are mainly situated close to the city, alongside the garden of the margrave’s palace and provide more than 1.300 beds.
Teaching, research and medical care are of the highest standard. Research results from Erlangen are setting standards for prevention, diagnostics and therapy. Every patient benefits from the latest available treatment methods.
Extensive quality assurance systems and close multidisciplinary collaboration guarantee optimal care. More than 9.400 employees are working to achieve their common purpose: to promote health and to cure disease.
Role in the FLASHKNiFE Project
Universitätsklinikum Erlangen participates in the design of the clinical study and the enrollment of patients with collection of the detailed demographic baseline characteristics and clinical data.
Centro Hospitalar Universitário Lisboa Norte (CHULN)
The North Lisbon University Hospital Center (CHULN) is one of the main hospitals of the Portuguese National Health Service (SNS), and results from the merge of two important public University Hospitals, Santa Maria Hospital and Pulido Valente Hospital.
CHULN has considerable assets in human resources, applied technologies and in accumulated know-how along with the support it renders to the populations from its area of direct influence, and with the guarantee of a differentiated referencial response in multiple clinical areas, both national and internationally, including in the Portuguese-speaking African Countries (the “PALOP”).
By the end of 2020, the North Lisbon University Hospital Center had a total of 6.538 professionals, with over 1400 medical doctors, distributed across 11 Clinical Departments and 42 Clinical Units.
Role in the FLASHKNiFE Project
CHULN participates in the design of the clinical study, the enrollment of the patients with collection of the detailed demographic baseline characteristics and clinical data.
ProductLife Group
ProductLife Group’s mission is to improve human health by delivering regulatory compliance services for the safe and effective use of medical solutions.
Since almost 30 years, PLG supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 140 countries. It provides consulting and outsourcing services in the areas of regulatory affairs, quality and compliance, market access (pricing & reimbursement), vigilances and medical information, covering both established products and innovative therapeutics & diagnostics.
With a goal of continuously improving the value delivered to people and customers, PLG is committed to long-term partnership, innovation, flexibility, and cost efficiency.
Role in the FLASHKNiFE Project
ProductLife Group wants to bring to EIT Health community the best skilled and efficient support within its domains of expertise: regulatory intelligence, strategic advice and operational execution for the development and registration of new innovative medicinal or combination products like the EDIT-B product.
In the FLASHKNiFE Consortium, PLG is helping in defining all the regulatory framework following the future MDR regulation EU 2017/745, supporting in implementing a Quality management system ISO 13485, drafting Quality Manual, setting up essential procedures and obtaining CE marking at the end of the process.