Only For Children Pharmaceuticals
35 bis rue Henri Barbuse
75005 Paris

France

 www.o4cp.com

Teamleader

Dr, eMBA Vincent Grek Medical Doctor, EMBA; Drug development  Phone: +33 1 75 00 02 87  Fax: +33 1 43 26 18 81  Contact

Project Staff

Dr, eMBA Estelle Habert-Ortoli Associated Director, pharmacological development  Phone: +33 1 57 27 86 87  Fax: +33 1 57 27 86 80  Contact

Dr, Pharm D. Alice Nolla Head of Pharmacovigilance, Regulatory Affairs & Quality Assurance  Phone: +33 1 57 27 89 90  Fax: +33 1 57 27 57 10  Contact

Institute Presentation

Only for children pharmaceuticals® (O4CP) is a French pharmaceutical company (SAS) founded in 2007 developing adapted medicines for children. The company addresses an important unmet medical need that experts and regulatory authorities have clearly identified: the need for adapted medicines for children.

Description of the laboratories involved within the organisation. Background and facilities:
O4CP is leading a cluster named "Forms4kids" dedicated to the development of paediatric medicines (see www.medicen.org). This cluster has all the facilities for drug development. Because of the heterogeneous needs of the paediatric population, O4CP has identified several manufacturers capable of specifically addressing this target population's needs.

Previous experience relevant to our tasks:
Coordinator of LOULLA&PHILLA FP7 project, O4CP responded to the call Health 4.2.1 (September 2007) and obtained 15 out of 15. Dr Vincent Grek, the contact person for O4CP, is a Medical Doctor and is currently founder and president of O4CP. He has 20 years of experience in Research, Medicine and in the Pharmaceutical Industry. Vincent Grek's areas of expertise include trials in special population (orphan, pædiatric, very severe population), development of biotech products (vaccine, enzyme, gene therapy), trial rescue, GCP (Good Clinical Practices), interaction with regulatory authorities (FDA, EMEA). He has a Doctor of Medicine degree with honors from the University of Liege (Belgium, 1989) and an executive MBA from ESSEC. He specialised in Internal Medicine with a focus on hemato-oncology, infectious diseases and intensive care (Belgium, 1994).