Urs E. Gasser Email and Phone Number

Concepts – Strategy – RealisationClinical Research and Project Management Medical Writing and Medical Affairs Quality Risk Management, Training and Coaching

- Cofounder of Biomit Inc., Member of the Management Committee and Executive Board- Build and lead an international trial management team- Coordination of project related activities with European affiliates- Cost estimates, contracts, resource management, budget controlling- Responsible for clinical study portfolio subcontracted by biotech, pharmaceutical, and medical device companies (Planning, conduct, analysis and reporting of clinical studies; phase II to IV) - Managing the development of a new internet-based EDC version for online data entry, query management, source document verification, data management and reporting- Development of Electronic Data Capture (EDC) applications

- Management of a Clinical Research department and member of the company management board- Conduct of international clinical studies (phase II to IV) at Swiss investigational sites in Oncology, Virology, Infection and Metabolism- Trial design, protocol writing and conduct of national clinical studies (Neurology, Psychiatry, Cardiology, Oncology, HIV Adipositas and Hepatitis C) and writing of clinical reports and publications- Line extensions for products in Oncology and Neurology (phase II/III study program)- Transfer of medical knowledge, consulting of product teams and development of medical marketing strategies- Member of risk management task forces and responsible for post marketing surveillance programs- Member of the working party „Clinical Research in Switzerland“ at the Swiss Society of Chemical Industry in Switzerland (SGCI)

- Concept and development of an innovative formulation (3-layer matrix tablet with dual-release kinetics of two active substances) - Scale up production - Clinical development (phase I to III)- Filing for marketing approval - Marketing strategy and successful launch of Madopar DR in 1997- Overall responsibility for project management and budget

- Launch plan for an anti-depressive (scientific and medical part) - Medical and issue management of psychotropics (Benzodiazepines)- Product responsibility, life cycle management and line extensions of the Parkinson Disease product portfolio - Medical and sales training of sales force - Collaboration with patient organisations- Editor of the journal „Neuro-Form“ for Swiss Neurologists

- Development and validation of two in vitro models (primary cell cultures) to study trophic factors and toxic effects on neuronal cells involved in Parkinson’s and Alzheimer’s disease