■ Nîmes University Hospital Making innovation accessible to all

Nîmes University Hospital

Making innovation accessible to all

Innovation is an integral part of the DNA of the Nîmes University Hospital. It supports it in two ways: its own production and support for industrial or academic projects.

“In 2020, we launched around one hundred research projects, including twenty on Covid-19, and participated in 150 new projects for industrialists and other institutions,” explains Anissa Megzari, Director of Research, University Hospital and International Partnerships. With some twenty patents and software, the institution has formed partnerships with the CCI du Gard and the SATT AxLR to support its teams and disseminate their inventions. Two events are planned for the autumn: the third edition of the Innov’Action trophy, which rewards a project carried out by a CHU professional, and an eponymous awareness day, to inform and decomplex. The Nîmes University Hospital supports industrial innovation through its Medical Device Evaluation Institute (IDIL), the organisation with Eurobiomed and AD’OCC of an annual national day dedicated to MD (the next one is scheduled for 21 October 2021), its biological resource centre and its co-development partnerships (surgical robotics, serious games, etc.). The credo of this regular buyer of the latest technical innovations? “Cross-disciplinarity and partnerships to promote innovation in health and the economic influence of the region.”

Galenics and robotisation

Spearheading innovation at the CHU, the Medicines Production Unit offers customised galenic preparations and works on 3D printing of medicines - with a national leadership position for publications on this topic. “This unit will soon be equipped with new premises that comply with pharmaceutical industry regulations for 3D printing and the manufacture of innovative medicines,” says Dr Ian Soulairol, hospital pharmacist in charge. This first extension will open its doors in February 2022 and a second extension to accommodate start-ups in this field is under study. An international expert in the application of industrial techniques on a very small scale for personalised medicine, the university hospital also has a platform for manufacturing placebos for randomised double-blind clinical studies and is exploring promising avenues: phages, transplantation of faecal microbiota and therapeutic cannabis.

Another area of innovation is robotisation. “Automated machines are being acquired to secure and rationalise the delivery of medicines,” explains Dr Clarisse Roux-Marson. Their advantage? The automation of the preparation of doses to be administered and the preparation of unit doses. The aim is to prevent medication errors; in the long term, the unit doses will be provided with a data-matrix code for optimal tracking from preparation to administration. A first for a university hospital. Another first is the CEPRIM (Centre for the Evaluation and Prevention of Iatrogenic Drug Risks). The multi-disciplinary team provides longterm ambulatory monitoring of complex patients who are most at risk of an adverse event. “The aim of this centre is to improve therapeutic adherence and to guarantee the proper use of drug treatment.”

Radiology: a multifaceted innovation

Anchored in the field and concerned with the medical service rendered, radiology research is closely associated with industry in four areas. “The physics of ionising radiation (diagnostic radiology) is the first area,” explains Prof. Jean-Paul Beregi, head of the Radiology and Medical Imaging Department. 3D scanners, which use low or very low doses, improve patient safety and offer a competitive alternative to conventional radiography. Second axis: interventional radiology for oncology (precise ablation of the areas to be treated) and vascular applications, the development of new embolisation particles to calm osteoarticular inflammations, tumour destruction by cryoablation (a specific industrial partnership of the CHU), the exploration of new indications for the prostate, liver and thyroid. The third area is imaging. “AI software allows us to detect anomalies in MRI images that are predictive of Alzheimer’s disease and antiphospholipid syndrome or APS.”

The fourth and final area is public health and health monitoring. The result of a partnership with the Toulouse start-up Medexprim, the creation of a warehouse of imaging and ancillary data is aimed at cancer prevention and the production of AI software to predict the response to a treatment. “Radiology promotes innovation, 6P medicine and public-private alliances around data.” Today it can replace surgery. There is an ethical imperative: the human guarantee with regard to technologies and data. The carer remains responsible for the machines… and master of their interpretation.

© CHU de Nîmes

CHU de Nîmes Place du Pr Robert-Debré F-30029 Nîmes cedex 9 Tél. : +33 (0)4 66 68 30 52 E-mail : anissa.megzari@chu-nimes.fr http://www.chu-nimes.fr/

Soutenir les innovations thérapeutiques et la réorganisation du système de santé

Quelles sont les missions du Leem ?

Le Leem est l’organisation professionnelle représentative des entreprises du médicament opérant en France. Il rassemble 260 entreprises adhérentes qui emploient 100 000 salariés, soit près de 3 % de l’emploi industriel en France. Les missions du Leem sont multiples. La première consiste à défendre les intérêts de ses adhérents et, plus largement, de promouvoir des écosystèmes favorables au développement de l’innovation, à la relocalisation et l’implantation d’activités industrielles pour soutenir l’emploi et mettre à la disposition des patients tous les traitements, qu’il s’agisse de médicaments matures ou innovants. Le Leem a également pour mission de négocier avec l’État la politique conventionnelle de fixation et de régulation des prix des médicaments en France. Enfin, en tant qu’organisation professionnelle, le Leem est mandaté pour négocier la politique sociale du secteur.

Quels sont selon vous les grands processus à l’œuvre dans l’industrie pharmaceutique ?

Nous assistons à une révolution thérapeutique sans précédent portée par trois tendances lourdes : le passage de la chimie aux sciences du vivant avec les biotechnologies qui ouvrent la porte à une médecine personnalisée plus efficace, la combinaison de différentes technologies (génomique, IA, data, jumeau numérique…) en complément des médicaments, et l’évolution du produit (médicament) vers le service (optimisation de son administration via les plates-formes d’observance et l’éducation thérapeutique). Les cadres classiques explosent. Le suivi in vivo des patients bénéficiant de produits de niche complètera les essais cliniques. On se dirige progressivement vers des mécanismes d’évaluation conditionnels qui prennent en compte la présomption de performance (guérison). Le système de santé va devoir s’adapter pour capter les économies générées par les traitements innovants (thérapies géniques de l’hémophilie, traitement de l’hépatite C…), très efficients mais souvent onéreux, afin de mieux les financer.

Comment le Leem contribue-t-il à l’innovation en santé ?

Le Leem fournit aux politiques des éléments d’éclairage sur les évolutions en cours (impact financier et opportunités de transformation du système de soins) ainsi que des éléments d’appréciation sur le positionnement compétitif de la France en matière d’essais cliniques. La France doit maintenir son leadership en oncologie et dans les maladies orphelines tout en rattrapant son retard pour les maladies métaboliques. Cela implique notamment de raccourcir les délais d’autorisation des comités de protection des personnes, qui sont chargés de délivrer un avis avant toute mise en œuvre d’un projet de recherche ou d’un essai thérapeutique. De manière plus globale, le Leem milite pour une politique du médicament lisible, prévisible et stable, propice à l’attractivité et capable de renforcer la capacité des filiales françaises à défendre la recherche sur le territoire national. Il faudra enfin réduire le délai d’accès au marché (temps d’attente entre la délivrance de l’AMM et la fixation du prix) : il est de 566 jours en France contre 127 jours en Allemagne ! Les annonces faites le 29 juin dernier par le Président de la République dans le cadre du Conseil stratégique des industries de santé nous semblent de nature à combler ce retard. La mise en œuvre de ces mesures est primordiale : il en va de notre compétitivité.

Un entretien avec M. Philippe LAMOUREUX,

Directeur général du Leem (Les Entreprises du Médicament)

Quel regard portez-vous sur les conflits d’intérêts ?

Rappelons d’abord la différence entre les liens d’intérêts, incontournables pour le développement de nouveaux médicaments avec les professionnels de santé qui ont accès aux patients, et les conflits d’intérêt qui sont des liens d’intérêt tus dans le cadre de la participation à la prise de décision administrative ou politique. Rappelons qu’entre la loi anti cadeaux de 1993 et la loi de modernisation du système de santé de 2016, la France dispose aujourd’hui de la réglementation la plus exigeante au monde. Le Leem s’est par ailleurs doté d’un comité de déontovigilance indépendant, le Codeem, et ses adhérents se conforment à un solide dispositif de déontologie professionnelle. Attention toutefois à la confusion entre liens et conflits d’intérêts qui a conduit à un affaiblissement de l’expertise dans la sphère publique et qui conduit à un décrochage de la France. Le rapport commandé au Pr Truchet par le Gouvernement précédent formule des recommandations de sagesse et l’application de deux règles d’or : promouvoir une transparence totale des liens d’intérêts et éviter ou interdire toute décision non collégiale dans le système de santé.

Quelle stratégie de R&D avez-vous définie en matière de maladies rares, de maladies infectieuses et de cancer ?

Nous nous investissons beaucoup, avec nos entreprises adhérentes, dans les thérapies géniques et cellulaires, porteuses d’innovation dans les domaines du cancer et des maladies rares, avec des traitements de plus en plus personnalisés issus de la recherche translationnelle. Des innovations majeures sont attendues pour le traitement de l’hémophilie, de la drépanocytose, du myélome multiple,… Les polythérapies associant plusieurs molécules suscitent beaucoup d’espoir en oncologie. Les zoonoses génèrent des travaux de recherche accrus, tout comme la lutte contre l’antibiorésistance qui implique le partage du risque entre la puissance publique et l’industrie. In fine, ces perspectives thérapeutiques inédites devront aller de pair avec la réorganisation du système de santé vers plus d’efficience.

Supporting therapeutic innovations and the reorganisation of the health system

Frédéric Collet, President of Leem at the presentation of the CSR Trophies / Frédéric Collet, Président du Leem lors de la remise des Trophées RSE

What are Leem’s missions?

Leem is the representative professional organisation of the pharmaceutical companies operating in France. It brings together 260 member companies employing 100,000 people, i.e. almost 3% of industrial employment in France. Leem’s missions are many and varied. The first is to defend the interests of its members and, more broadly, to promote ecosystems favourable to the development of innovation, relocation and the establishment of industrial activities in order to support employment and make all treatments, whether mature or innovative medicines, available to patients. The Leem also has the task of negotiating, with the State, the conventional policy of setting and regulating the prices of medicines in France. Finally, as a professional organisation, Leem is mandated to negotiate the social policy of the sector.

In your opinion, what are the major processes at work in the pharmaceutical industry?

We are witnessing an unprecedented therapeutic revolution driven by three major trends: the shift from chemistry to life sciences with biotechnologies opening the door to more effective personalised medicine, the combination of different technologies (genomics, AI, data, digital twinning, etc.) to complement drugs, and the evolution of the product (drug) towards service (optimisation of its administration via compliance platforms and therapeutic education). Classic frameworks are exploding. In vivo monitoring of patients benefiting from niche products will complement clinical trials. We are gradually moving towards conditional evaluation mechanisms that take into account the presumption of performance (healing). The health system will have to adapt to capture the savings generated by innovative treatments (gene therapies for haemophilia, treatment of hepatitis C, etc.), which are very efficient but often expensive, in order to better finance them.

How does Leem contribute to health innovation?

Leem provides politicians with information on current developments (financial impact and opportunities for transforming the healthcare system) as well as information on France’s competitive position in terms of clinical trials. France must maintain its leadership in oncology and orphan diseases while catching up on metabolic diseases. This means, in particular, shortening the authorisation deadlines of the personal protection committees, which are responsible for issuing an opinion before any research project or therapeutic trial is implemented. More generally, Leem advocates a clear, predictable and stable drug policy that is conducive to attractiveness and capable of strengthening the ability of French subsidiaries to defend research in France. Finally, it will be necessary to reduce the time of access to the market (waiting time between the granting of the marketing authorisation and the setting of the price): it is 566 days in France compared to 127 days in Germany! The announcements made on 29 June by the President of the Republic within the framework of the Strategic Council for the Health Industries seem to us to make up for this delay. The implementation of these measures is essential: our competitiveness is at stake.

How do you view conflicts of interest?

First of all, let’s recall the difference between links of interest, which are essential for the development of new medicines with health professionals who have access to patients, and conflicts of interest, which are undeclared links of interest in the context of participation in administrative or political decision-making. It should be remembered that between the anti-gift law of 1993 and the law to modernise the healthcare system of 2016, France now has the most stringent regulations in the world. Leem has also set up an independent ethics and monitoring committee, the Codeem, and its members comply with a solid professional ethics system. However, beware of the confusion between links and conflicts of interest, which has led to a weakening of expertise in the public sphere and which is leading to a dropout from France. The report commissioned from Pr Truchet by the previous government makes wise recommendations and advises the application of two golden rules: promoting total transparency of links of interest and avoiding or prohibiting any non-collegial decisions in the health system.

What R&D strategy have you defined for rare diseases, infectious diseases and cancer?

Together with our member companies, we are investing heavily in gene and cell therapies, which are driving innovation in the fields of cancer and rare diseases, with increasingly personalised treatments stemming from translational research. Major innovations are expected in the treatment of haemophilia, sickle cell disease, multiple myeloma, etc. Polytherapies combining several molecules are giving rise to great hope in oncology. Zoonoses are generating increased research work, as is the fight against antibiotic resistance, which involves sharing the risk between public authorities and industry. Ultimately, these new therapeutic prospects will have to go hand in hand with the reorganisation of the health system towards greater efficiency.

An interview with Mr Philippe LAMOUREUX,

Managing Director of Leem (Les Entreprises du Médicament)

© Leem

Philippe Lamoureux at the “Health 2030” press conference / Philippe Lamoureux lors de la conférence de presse « Santé 2030 »