20 April 2020

Orphelia Pharma recrute un/une Chargé Assurance Qualité
20 April 2020

Basée à Paris et à Lyon, ORPHELIA Pharma SAS est une société biopharmaceutique dédiée au développement et à la commercialisation de médicaments pédiatriques en oncologie et en neurologie. Sa mission est d’améliorer significativement les médicaments administrés aux enfants en développant des produits efficaces, sûrs et faciles à utiliser. ORPHELIA Pharma conduit des projets de recherche innovants à travers des collaborations académiques et industrielles. ORPHELIA Pharma possède plusieurs projets dans le domaine de la neurologie et de l’oncologie. Son projet le plus avancé, Kigabeq®, est actuellement en phase de lancement commercial. Nous sommes à la recherche d’un Chargé Assurance Qualité (h/f) basé dans notre établissement de Paris. Vous êtes titulaire d’un diplôme d’ingénieur ou pharmacien justifiant d’une formation en Assurance Qualité. Vous avez une expérience d’au moins 1 an dans un poste similaire sur un site exploitant. Sous la responsabilité du Directeur des Affaires Pharmaceutiques, vous participerez à l’ensemble des activités Qualité d’un établissement pharmaceutique exploitant, et notamment : Développement et suivi du système qualité exploitant : Participer activement et avec force de proposition à la structuration du Système de Management de la Qualité, Gérer le système documentaire de l’entreprise, Former les collaborateurs aux procédures de l’entreprise, Vérifier la cohérence de l’application des procédures qualité et de la réglementation en matière de qualité, Proposer et suivre la mise en œuvre d’actions qualité, préventives ou correctives, Contrôler les indicateurs du tableau de bord qualité et alerter systématiquement des anomalies, Evaluer la criticité et suivre les déviations, les CAPA et les Change Controls, Evaluer les conséquences des modifications de l’environnement sur le système qualité, Gérer les réclamations pharmaceutiques, Participer à la Revue Qualité Produits (RQP), Veiller à la conformité de la distribution des produits en relation avec les distributeurs et les dépositaires, Répondre aux questions internes et externes concernant la qualité, Participer aux relations avec les autorités de santé, Préparer les revues de direction, les revues qualité et la démarche d’amélioration. Audits : Aider à la planification des audits et suivi des plans d’actions associés, Maintenir le planning des audits, Réaliser les audits internes. Qualifications / Compétences requises Les qualifications requises sont celles liées aux missions à exercer au sein d’ORPHELIA Pharma, entreprise à taille humaine mais à dimension internationale, pour laquelle vous aurez la possibilité de construire un système qualité adapté aux besoins de l’entreprise : Maitriser les normes de qualité applicables à l’Exploitant, Compétences pour la mise en œuvre d’un système qualité exploitant et en […]
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11 March 2020

ORPHELIA announces the appointment of Laurent Martin as Chief Pharmaceutical Affairs Officer
11 March 2020

Paris and Lyon, March 11th, 2020 – ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of paediatric drugs in the fields of oncology and neurology, announces the appointment of Laurent Martin as Chief Pharmaceutical Affairs Officer, effective January 6th, 2020. Pharmacist and scientist by background, Laurent has got more than 25 years of experience in drug development, especially in rare and serious pathologies. Laurent contributed to the development, the European approval and the marketing of several orphan drugs at Orphan Europe (now Recordati Rare Diseases). More recently, he was Chief Development Officer and Qualified Person at DBV Technologies, where he led global developments (USA, Europe) of innovative biological drugs mainly for children. « Laurent’s large experience in the development of drugs for rare and paediatric diseases is a significant asset for ORPHELIA Pharma » comments Hugues Bienaymé, Founder and General Manager. « Laurent will be instrumental in strengthening ORPHELIA Pharma’s pharmaceutical structure. We plan to file an application to operate as a pharmaceutical licensed company (the French “Exploitant” status) in order to market our products in France. » « I was convinced by ORPHELIA Pharma’s model, which I am very happy to join at this period of strong development of the company » says Laurent Martin. « The essential paediatric products developed by ORPHELIA Pharma perfectly match with my regulatory expertise and my wish to work on the marketing of medicines with high medical benefit.»
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28 January 2020

Orphelia Pharma fund raising
28 January 2020

ORPHELIA Pharma raises 4 m€ to fund its commercial operations and clinical developments French family offices join as new shareholders and Board members Paris and Lyon, January 28th , 2020 – ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of paediatric drugs in the fields of oncology and neurology, announces it has raised 4 million € in December 2019. The proceeds will be used to grow the company’s team, develop its commercial and clinical infrastructure and advance its projects. Initiative OCTALFA led this financing round and was joined by three French family offices managed by serial entrepreneurs, namely Ravenala holding (Alain Tornier), PAF Kapital (Christophe Pasik, Jean-François Auffret and Pierre Ferran) and Cemag (André Ulmann). « We thank all our shareholders for their confidence in our venture and our programs », said Hugues Bienaymé, founder and CEO of ORPHELIA Pharma. « In 2020, we plan to record our first revenues with the launch of Kigabeq® and Ivozall® and initiate two clinical trials. We will also apply for a pharmaceutical establishment license in France and we anticipate to hire 7 new people. » In addition, the company announced that André Ulmann and Christophe Pasik have joined ORPHELIA Pharma’s Board of Directors. « We are particularly pleased to have Alain, André and Christophe with us. Their track record as successful entrepreneurs will be of invaluable help in guiding ORPHELIA Pharma to building a portfolio of paediatric medicines for rare and severe diseases » added Gilles Alberici, Chairman of ORPHELIA Pharma. « We look forward to working with them to accelerate the structuring of the company and to develop and launch new effective medicines for children. » About ORPHELIA Pharma ORPHELIA Pharma is a biopharmaceutical company based in Paris and Lyon that develops and markets drugs for the treatment of rare and serious paediatric diseases. Our mission is to provide patients with essential hospital products in the fields of epilepsy and oncology with formulations adapted to the paediatric population. Our first product, Kigabeq®, obtained its Marketing Authorization in September 2018 and is being launched in Europe. Our second product, Ivozall®, was granted a European marketing authorization in November 2019 for the treatment of Acute lymphoblastic Leukaemia. ORPHELIA Pharma also conducts research projects through academic and industrial collaborations.
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7 January 2020

Launch of Kigabeq® in France
7 January 2020

ORPHELIA Pharma announces the commercial launch of Kigabeq® in France Paris and Lyon, January 7th, 2020 – ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of paediatric drugs in the fields of oncology and neurology, announces today the preparation of Kigabeq® launch in France after having reached an agreement with the Comité Economique des Produits de Santé (CEPS). Kigabeq® is the first pediatric formulation of vigabatrin, an essential antiepileptic drug. Available as 100 mg and 500 mg scored soluble tablets for oral and (naso)gastric administration, Kigabeq® is indicated in the first-line treatment of infantile spasms, an extremely severe early childhood encephalopathic epilepsy. Kigabeq® has been developed exclusively for children aged  between 1 month and 6 years and was granted a Paediatric Use Marketing Authorization (PUMA). « The price fixing in France highlights the clinical significance of Kigabeq® from the Haute Autorité de Santé (HAS) and CEPS perspectives, is the ultimate step prior to effective market launch in France », comments Hugues Bienaymé, general Manager of ORPHELIA Pharma. « We are working hard with our manufacturer and our wholesaler to make Kigabeq® available to neuropediatricians from April 2020 ». « Vigabatrin is an essential component of the treatment of infantile spasms or West syndrome », adds Pr. Stéphane Auvin, neuropediatrician at Robert Debré hospital. « For this population of very young children, the accuracy of delivered dose and the ease of use allowed by Kigabeq® will facilitate therapeutic management ». « The upcoming launch of Kigabeq® is the culmination of several years of research and efforts carried out in collaboration with ORPHELIA Pharma » concludes Dr. Catherine Chiron, neuropediatrician at Necker-Enfants-Malades Hospital and Research Director at Inserm. « We are particularly pleased that this collaboration now provides an optimized solution to our young patients ». About infantile spasms West Syndrome, or infantile spasms, is an early childhood epileptic encephalopathy which combines axial spasms in cluster, a marked psychomotor retardation and an hypsarrhythmic electroencephalogram. It is a rare disease with an estimated incidence of around 5 per 10,000 living births. It affects infants whose development was normal or children with impaired cognitive development prior to spasms. Children with infantile spasms must be treated as soon as possible to stop spasms and improve prognosis. About ORPHELIA Pharma ORPHELIA Pharma is a biopharmaceutical company based in Paris and Lyon that develops and markets drugs for the treatment of rare and serious paediatric diseases. Our mission is to provide patients with […]
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