Dr. Heinz Lubenau

Heading the development of anti-angiogenic, live, bacterial cancer vaccines. Overall responsibility for all aspects of drug development including project management, manufacturing, preclinical and clinical studies, regulatory affairs. Scientific advice procedures. Preparation of transition into first-in-human trials. Budget planning and control, human resources.

Heading the preclinical and clinical development of first biosimilar filgrastim from preclinical studies through clinical phase I and III to marketing approval and market launch. Executive project manager Ratiograstim. Preclinical and clinical development manager of glycoPEGylated G-CSF from first pharmacodynamic animal studies to clinical phase II. National and European Scientific Advice procedures. Multinational clinical trials in patients with solid tumors and haematological malignancies.

Responsibility for clinical trials of all phases in cardiology, diabetes and hypertension in Germany, Austria, and Switzerland. Coordination of clinical project teams. Feasibility studies for clinical trials. Recruitment of project managers, CRAs, and secretaries.

Building up and coordination of a clinical monitoring team for clinical trials of all indications. Clinical co-monitoring. Recruitment and training of CRAs.

Management of clinical trials in hypertension and cardiology including a series of phase I drug interaction studies. Extension of clinical trial activities to Austria and Switzerland.

Clinical project management of multicentre phase III trials in hypertension and associated diseases in Germany. Organisation and conduct of investigator meetings.

Clinical project management and monitoring of multicentre phase III trials in hypertension in Germany.

Training on the job in all areas relevant for clinical trial management. Working in international project teams in the headquarter and international therapeutic research centre.