ORPHELIA recrute un Pharmacien Responsable

Recrutement d’un Pharmacien Responsable et Directeur Assurance Qualité (Qualified Person & Quality Assurance Director) :

Pharmacien possédant l’expérience définie par le Code de la Santé Publique pour être Pharmacien Responsable, vous avez une parfaite maîtrise des activités d’exploitation pharmaceutique et vous avez participé à la mise en place d’un établissement pharmaceutique exploitant. Vous justifiez d’une expérience solide à un poste similaire où vous avez pu développer votre maîtrise des normes, référentiels qualité, réglementations et certifications applicables. Vous disposez d’une bonne expérience de la pharmacovigilance. Une connaissance des petites molécules, toutes voies d’administration, est vivement souhaitée.

Vous êtes reconnu pour votre leadership, vous avez le sens de l’organisation, de la communication, de la prise de décision et un goût prononcé pour la qualité et le respect des délais.

Une excellente maîtrise de l’anglais scientifique et technique est indispensable.

Les missions qui vous seront confiées seront les suivantes :

  • Assurer la responsabilité pharmaceutique de l’entreprise (en tant que Pharmacien Responsable tel que défini par le Code de la Santé Publique), incluant notamment la pharmacovigilance en relation avec les sous-traitants et les distributeurs de l’entreprise, l’information médicale, le suivi et les éventuels rappels de lot, les réclamations, le contrôle de la publicité, la distribution,
  • Participer à l’élaboration des programmes de recherche et développement de l’entreprise,
  • Mettre en œuvre la politique Assurance Qualité de l’entreprise, comme définie dans son Manuel Qualité et sensibiliser les services concernés à l’approche Qualité,
  • Valider les procédures, spécifications et documents du système d’Assurance Qualité,
  • Participer aux actions liées aux Affaires Règlementaires de l’entreprise,
  • Participer aux activités d’accès au marché pour les produits de l’entreprise,
  • Participer aux interactions avec les Autorités Réglementaires concernées par le développement ou l’exploitation des produits de l’entreprise en France, en Europe et à l’étranger,
  • Valider et suivre les contrats qualité avec les différents partenaires (distributeurs, sous-traitants, etc.),
  • Valider les plans d’audits internes et externes (distributeurs, sous-traitants, etc.), coordonner les audits et en assurer le suivi,
  • Coordonner les inspections diligentées par les Autorités Réglementaires, les réponses aux questions et assurer le suivi des inspections,
  • Effectuer la veille règlementaire et qualité.

Poste basé à Paris.

H/F

Rémunération en fonction de l’expérience, Bonus, BSPCE.

Vous pouvez adresser votre candidature à : contact@orphelia-pharma.eu

ORPHELIA at the 2019 ASCO meeting in Chicago

The Annual Congress of the American Society of Clinical Oncology will take place May 31 – June 4, 2019 at McCormick Place, Chicago, IL.

ASCO is the only global multidisciplinary society entirely devoted to clinical oncology.

Please meet us there (contact: jeremy.bastid@orphelia-pharma.eu).

ORPHELIA at the 2018 SIOP meeting in Kyoto (Japan)

The 50th Annual Congress of the International Society of Paediatric Oncology will take place November 16-19, 2018 in Kyoto, Japan.

SIOP is the only global multidisciplinary society entirely devoted to paediatric and adolescent cancer.
The society has over 1500 members worldwide including doctors, nurses, other health-care professionals, scientists and researchers. Our members are dedicated to increasing knowledge about all aspects of childhood cancer.

https://siop.kenes.com/2018#.W9iK1_ZFxoI

Please meet us there (contact: jeremy.bastid@orphelia-pharma.eu and hugues.bienayme@orphelia-pharma.eu).

ORPHELIA at Bioeurope in Copenhagen, Denmark

ORPHELIA Pharma will be present in Copenhagen on November 2018, 5th to 7th, for the annual BIO-Europe Congress. This event is the Europe’s largest partnering conference serving the global biotechnology industry. Do not hesitate to contact us in order to meet at this occasion (contact : gilles.alberici@orphelia-pharma.eu).

More info at: https://ebdgroup.knect365.com/bioeurope/

 

ORPHELIA Pharma has been awarded a €1m loan from Bpifrance

Paris and Lyon, October 22, 2018 – ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of pediatric drugs in the fields of oncology and neurology, announces today that it has obtained the support of Bpifrance through a ERDF (European Regional Development Fund) innovation loan of one million Euros co-financed by the European Union and the Auvergne Rhône-Alpes region. This grant aims to support the development and industrialization of the first pediatric formulation of an essential drug as a salvage therapy of a rare pediatric cancer. “We are delighted to receive the support from Bpifrance which allows us to accelerate the development of our product in this pediatric indication whose unmet medical need is huge“, comments Jérémy Bastid, Chief Development Officer of ORPHELIA Pharma. “This product has a formulation specially adapted for young children and has been developed in close collaboration with clinicians since 2017. This grant will contribute to the development cost of the product until it becomes available to patients in 2 to 3 years“, adds Hugues Bienaymé, General Manager.

About ORPHELIA Pharma

Based in Paris and Lyon, ORPHELIA Pharma SAS is a French biopharmaceutical company dedicated to the development and marketing of oncology and neurology pediatric drugs. Its mission is to significantly improve essential medicines administered to children through the development of efficient, reliable and safe drugs with child-friendly formulations. ORPHELIA Pharma also leads innovative R&D projects through academic and industrial partnerships. Key investors include initiative OCTALFA (lead investor) and Pierre Fabre Medicament.

Granting of the marketing authorization for Kigabeq®

Paris and Lyon, October 1st, 2018 – ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of pediatric drugs in the fields of oncology and neurology, announces today that the European Commission has granted Kigabeq® a European marketing authorization.

Kigabeq® is the first pediatric formulation of vigabatrin, an essential antiepileptic drug and will be available as scored soluble tablets of 100 mg and 500 mg strengths. Kigabeq® is expected to be used as first-line treatment for infantile spasms, an extremely severe early childhood encephalopathic epilepsy. Kigabeq® has been developed exclusively for children and will be granted a PUMA (Paediatric Use Marketing Authorization).

« This approval is a key milestone for ORPHELIA Pharma as Kigabeq® represents the first in a series of pediatric-focused products we plan to launch. We believe it addresses important pediatric needs and will meaningfully improve the lives of children » comments Hugues Bienaymé, Founder and General Manager. « We can now focus on launching Kigabeq® in France and building relationships with distribution partners to commercialize Kigabeq® throughout Europe ».

« This Marketing Authorization comes at the right time for ORPHELIA Pharma and the company will now structure itself upon this first medicine in which we have great expectations » says Gilles Alberici, President. « Our vision is to develop and bring new pediatric drugs with age-adapted formulations to the market for the treatment of life-threatening orphan indications. Today’s milestone is a first step on this exciting journey ».

About infantile spasms

Infantile spasms, or West Syndrome, is an early childhood epileptic encephalopathy which combines axial spasms in cluster, a marked psychomotor delay and an hypsarythmic electroencephalogram. It is a rare disease with an estimated incidence of around 5 per 10,000 living births. It affects infants who were previously normal or children with impaired cognitive development. Children with infantile spasms must be treated rapidly for spasms cessation and to improve prognosis.

About ORPHELIA Pharma

Based in Paris and Lyon, ORPHELIA Pharma SAS is a French biopharmaceutical company dedicated to the development and marketing of oncology and neurology pediatric drugs. Its mission is to significantly improve essential medicines administered to children through the development of efficient, reliable and safe drugs with child-friendly formulations. ORPHELIA Pharma also leads innovative R&D projects through academic and industrial partnerships. Key investors include initiative OCTALFA (lead investor) and Pierre Fabre Medicament.

ORPHELIA Pharma will be present at CPhI in Madrid

Hugues Bienaymé, General Manager and Chief Scientific Officer of ORPHELIA Pharma and Mathieu Schmitt, Pharmaceutical Development Director, will be present to the 2018 CPhI to be held in Madrid, Spain, October 9-11, 2018.
Please meet us there (contact: mathieu.schmitt@orphelia-pharma.eu).

CHMP has adopted a positive opinion for Kigabeq®

Paris and Lyon, August 28th, 2018 – ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of pediatric drugs in the fields of oncology and neurology, announces today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the issuance of a marketing authorization for the medicinal product Kigabeq® by the European Commission. As Kigabeq® has been exclusively developed for use in children, it should receive a Paediatric Use Marketing Authorization (PUMA).

Kigabeq® is the first pediatric formulation of vigabatrin, an essential antiepileptic drug and will be available as scored soluble tablets of 100 mg and 500 mg strengths. Kigabeq® is expected to be used as first-line treatment for infantile spasms, an extremely severe early childhood encephalopathic epilepsy.

« We are particularly honoured with this decision which comes after several years of continuous efforts of ORPHELIA Pharma together with our academic partners », comments Hugues Bienaymé, Founder and General Manager of ORPHELIA Pharma. « This positive opinion is a key milestone in the process to make Kigabeq®, our first medicinal product, available to the pediatric community ».

« The CHMP has acknowledged the interest of Kigabeq® in improving health of epileptic children. We are eagerly awaiting the final marketing authorisation from the European Commission by October », highlights Gilles Alberici, Chairman of ORPHELIA Pharma. « Kigabeq® is expected to be the fourth human medicine to be granted a PUMA in Europe ».

About infantile spasms

Infantile spasms, or West Syndrome, is an early childhood epileptic encephalopathy which combines axial spasms in cluster, a marked psychomotor delay and an hypsarythmic electroencephalogram. It is a rare disease with an estimated incidence of around 0.05 per 10,000. It affects infants who were previously normal or children with impaired cognitive development. Children with infantile spasms must be treated rapidly for spasms cessation and to improve prognosis.

About ORPHELIA Pharma

Based in Paris and Lyon, ORPHELIA Pharma SAS is a French biopharmaceutical company dedicated to the development and marketing of oncology and neurology pediatric drugs. Its mission is to significantly improve essential medicines administered to children through the development of efficient, reliable and safe drugs with child-friendly formulations. ORPHELIA Pharma also leads innovative R&D projects through academic and industrial partnerships. Key investors include initiative OCTALFA (lead investor) and Pierre Fabre Medicament.

Pierre Attali joins ORPHELIA Pharma Board Of Directors

Paris and Lyon, June 25th 2018 – ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of paediatric drugs in the fields of oncology and neurology, announces today that Pierre Attali has joined its Board of Directors.

Pierre Attali, MD, will bring to ORPHELIA Pharma his expertise in clinical development, especially in oncology, acquired during a 30-year career in pharmaceutical and biotech companies. Dr. Attali was successively Head of Clinical Research Department, Licensing Director and General Manager at Synthelabo, Chief Operating Officer and Chief Medical Officer at Bioalliance / Onxeo, Chairman and Chief Executive Officer at Urogene. More recently, he joined Sensorion as Chief Medical Officer and Head R&D. He also founded and managed several biotech companies, such including OSMO, Molecular Engines Laboratories (MEL), and more recently Selexel.

Pierre Attali contributed to the development, registration and marketing of more than 10 novel  drugs and formulations, both in Europe and in the United States. He authored numerous peer-reviewed scientific publications and patents.

« We are particularly honoured to welcome Pierre at ORPHELIA Pharma » comments Gilles Alberici, Chairman of ORPHELIA Pharma. « His deep knowledge of drug development, especially in the oncology therapeutic area, will be invaluable to us ».

 « I am very pleased to join the Board of ORPHELIA Pharma » says Pierre Attali; « I personally know and appreciate the management team since many years. The culture of the company, aiming at improving patient’s care and focusing on paediatric medicines is paramount to my own personal values».

About ORPHELIA Pharma

Based in Paris and Lyon, ORPHELIA Pharma SAS is a French biopharmaceutical company dedicated to the development and marketing of oncology and neurology pediatric drugs. Its mission is to significantly improve essential medicines administered to children through the development of efficient, reliable and safe drugs with child-friendly formulations. ORPHELIA Pharma also leads innovative R&D projects through academic and industrial partnerships. Key investors include initiative OCTALFA (lead investor) and Pierre Fabre Medicament.

ORPHELIA announces the filing of the Marketing Authorization for Kigabeq®

Paris and Lyon, February 27th 2018 – ORPHELIA Pharma, a French biopharmaceutical company dedicated to the development and marketing of pediatric drugs in the fields of oncology and neurology announces today that it has submitted a European Centralized Marketing Authorization Application (MAA) for Kigabeq® in 2017.

Kigabeq® is the first pediatric formulation of vigabatrin, an essential antiepileptic drug, and will be available as scored soluble tablets of 100 mg and 500mg strengths. Kigabeq® is expected to be used as first-line treatment for infantile spasms (West syndrome), an extremely severe early childhood encephalopathy. Kigabeq has been exclusively developed for use in children and is eligible to a Pediatric Use Marketing Authorization (PUMA).

« We take great pride in having developed this unique formulation, which is also our first product», comments Hugues Bienaymé, Founder and General Manager of ORPHELIA Pharma. « It seemed to us that it was of paramount interest to propose a new formulation adapted to the pediatric population, which represents the vast majority of patients treated with vigabatrin in Europe».

« We supported the development of Kigabeq® from the beginning.» says Pr. Rima Nabbout, Head of the Pediatric Neurology Department at Necker – Enfants Malades Hospital. « The benefits of this new formulation rely in a better dose to body weight adjustment and a greater ease of use ».

An acceptability, tolerance and pharmacokinetic study was carried out in 24 French hospitals between 2014 and 2016, with 38 children suffering from infantile spasms or pharmaco-resistant focal epilepsy. The results of this study, presented at the congress of the French Pediatric Neurology Society (SFNP), which took place in Bordeaux between 31st January and 2nd February 2018, demonstrated a good adherence to treatment and an accurate dose to body weight adjustment.

About West Syndrome

West Syndrome, or infantile spasms, is an early childhood epileptic encephalopathy which combines axial spasms in cluster, a marked psychomotor delay and an hypsarythmic electroencephalogram. It is a rare disease with an estimated incidence of around 0.05 per 10,000. It affects infants who were previously normal or children with impaired cognitive development.

About ORPHELIA Pharma

Based in Paris and Lyon, ORPHELIA Pharma SAS is a French biopharmaceutical company dedicated to the development and marketing of oncology and neurology pediatric drugs. Its mission is to significantly improve essential medicines administered to children through the development of efficient, reliable and safe drugs with child-friendly formulations. ORPHELIA Pharma also leads innovative R&D projects through academic and industrial partnerships. Key investors include initiative OCTALFA (lead investor) and Pierre Fabre Medicament.

ORPHELIA PHARMA strengthens its capital base

Paris, January 30, 2018 ORPHELIA Pharma, a French biopharmaceutical dedicated to the development and marketing of pediatric drugs in the field of oncology and neurology today announces that it has strengthened its capital base in December 2017. The completion of this round of financing, subscribed exclusively by initiative OCTALFA, will allow the company to accelerate its projects with the ambitious objective to obtain three European marketing authorizations by the end of 2020.


Our program for the three years to come is particularly rich with the opening of our pharmaceutical facility, the launch of three products, the recruitment of key employees and the strengthening of our academic and industrial research collaborations“, comments Hugues Bienaymé, founder and General Manager of ORPHELIA Pharma. “Our activity is centered on the development of child-friendly formulations of essential drugs for the management of rare forms of epilepsy and for the treatment of the most aggressive forms of pediatric cancers for which the medical needs remain very high. Then, we will progressively add early-stage R&D projects, including the development of new molecules for these rare indications“.

ORPHELIA Pharma also announces that it has relocated its headquarters within the Quartier Latin in Paris and it has opened a branch in Lyon. ORPHELIA Pharma has also strengthened its team with the recruitment of Mathieu Schmitt, PharmD as CMC Director in charge of pharmaceutical development and Jeremy Bastid, PharmD, PhD who will be the Chief Development Officer of the company.


We are very proud to be part of the transformation of ORPHELIA Pharma, whose activity perfectly fits our values and expertise”, comments Gilles Alberici, President of initiative OCTALFA and ORPHELIA Pharma. We have been involved in ORPHELIA Pharma since 2015 and are delighted to see that the company has already achieved significant milestones in thirty months.

About ORPHELIA Pharma SAS

Based in Paris and Lyon, ORPHELIA Pharma SAS is a French biopharmaceutical company dedicated to the development and marketing of oncology and neurology pediatric drugs. Its mission is to significantly improve essential medicines administered to children through the development of efficient, reliable and safe drugs with child-friendly formulations. ORPHELIA Pharma also leads innovative R&D projects through academic and industrial partnerships. Key investors include initiative OCTALFA (lead investor) and Pierre Fabre Medicament. For more information, please visit www.orphelia-pharma.eu

ORPHELIA at the 2017 SIOP meeting in Washington DC

ORPHELIA Pharma will be present at the 49th Annual Congress of the International Society of Paediatric Oncology in Washington DC. http://www.siop2017.kenes.com/

Please meet us there (contact: jeremy.bastid@orphelia-pharma.eu)

ORPHELIA Pharma at AES 2017 in Washington DC

ORPHELIA Pharma will be present in Washington DC on December 1st to 4th, for the next Annual Epilepsy Society meeting.

From best practices to breakthrough thinking, the AES Annual Meeting offers the most extensive education on everything epilepsy. https://www.aesnet.org/

ORPHELIA Pharma et BIO-Europe 2017

ORPHELIA Pharma will be present in Berlin on November, 6th to 8th, for the annual BIO-Europe Congress. This event is the Europe’s largest partnering conference serving the global biotechnology industry. Do not hesitate to contact us in order to meet at this occasion.

More info at: http://www.ebdgroup.com/bes/index.php

ORPHELIA Pharma will be present at CPhI in Frankfurt

ORPHELIA Pharma will be present in Frankfurt on October 24th to 25th, 2017, in the number one Pharma event that brings together most international pharmaceuticals companies. Do not hesitate to contact us to meet at this occasion.

More info at: http://www.cphi.com/europe/

ORPHELIA Pharma at CPhI, Barcelona – Spain

ORPHELIA Pharma will be present in Barcelona on October 4th to 6th, 2016, in the number one Pharma event that brings together most international pharmaceuticals companies. Do not hesitate to contact us to meet at this occasion.

More info at: http://www.cphi.com/europe/