Dr. Nicole Filser

Consultancy in pharmaceutical industry and clinical research organization for clinical development and development strategy, regulatory authority advices, clinical operations and Project management

Main responsibilities: • Project management of the product development of an orphan drug • Selection and contracting CROs and other vendors • Writing protocols and relevant study documents • Scientific advice and IND procedures; writing the clinical parts • Overview on overall project from CMC to CTD planning Major achievements so far: Validation of the development plans at FDA and EMA, trial setup and start within planned timelines and budget Therapeutic Areas: Neurology

Main responsibilities: • Built-up lean functional clinical team; line management of 4 people • Established interfaces and collaborations • Set-up development plans and ensured successful validation with international health authorities • Vendor selection and contracting; set up of project management Major achievements: set up functional clinical team, validated development plan for first biosimilar monoclonal antibody Therapeutic Areas: Oncology, Immunology

Main responsibilities: • Led and expanded the clinical operations department with internal and external stakeholders • Successful EMA and FDA inspections • Led clinical development of biosimilars, new and generic drugs • Accountable to investors and the board • Regulatory affairs tasks included CTD writing and presentation to the authorities (1 Biosimilar and + generic product) • Project- and line management (5 people)