The Medical Direction plays a crucial role in the Abiogen Pharma’s operations. During these years, many clinical activities have been managed internally thanks to the supervision of the Medical Direction team, which addresses the clinical development of Abiogen’s products according to the guidelines, supports the internal Regulatory Office during the audits with the Health Authorities, accomplishes the relationships with the Ethical Committees and controls directly Abiogen Pharma’s clinical trials.
For this purpose, the Medical Direction staff is continuously in touch with the University and the hospital sites in any phase of the clinical development. In the last period, we have to underline the cooperation with Vienna University, MD Anderson Cancer Center (Houston) and Modena University for important clinical activities in psychiatric and oncologic fields.
For historical reasons, the Medical Direction team presents a special know-how in the development of drugs in the osteoarticular area: this is a clear competitive advantage and a strong contribution to Abiogen Marketing & Sales and Business Development in the value creation strategy definition for the proprietary assets of Abiogen’s portfolio in Italy and abroad.
The clinical activities are performed according to GCP-ICH and are supported by an internal biostatistic section, which applies statistic and methodology knowledge to the data analysis and result interpretation of internal clinical trials. Moreover, this biostatic function allows to perform a correct planning of Abiogen Pharma’s clinical trials, suggesting the most appropriate sample size and the consequent statistical analysis plans.
Recently, a Medical Affairs team has been set up to handle scientific post-marketing and real world activities, along with the management of non-interventional studies.