Clinical development, biometrics and drug registration

Debioclinic, a Contract Research Organization (CRO) specialising in oncology, internal medicine and central nervous system, provides regulatory, biometric and clinical support either for Debiopharm's development activities or for other pharmaceutical companies. These activities are in line with ICH (International Committee on Harmonization) requirements and cGCP (current Good Clinical Practice) guidelines.

Milestones

The Company has conducted over 80 current Good Clinical Practice studies in 20 countries, with more than 6000 patients.

Management

Silvano Brienza Chief Executive Officer - Scientific Director, Debioclinic S. A.

Dr. Brienza received his Italian Medical Degree in 1983 from the University “La Sapienza” of Rome and obtained a French certificate in Oncology in 1992. He has more than 15 years experience in clinical research, initiated first in the hospital as an oncologist and continued in the industry as responsible, at various degrees, for the development of anticancer drugs. He extended his clinical experience at the Paul Brousse Hospital in Villejuif, France as assistant oncologist. He joined Debioclinic S.A. in 1992. He is in charge of the Oxaliplatin program and obtained, with his clinical research team, the first approval of this drug in 1996.