Licensing of new biopharmaceutical candidates requires careful assessment of their potential, IP as well as scientific and regulatory issues. We identify the potential of a biopharmaceutical or a portfolio, key issues and risks from a drug development, regulatory and scientific point of view. Our results will support the client’s decision-making and negotiation processes.
- Definition of the overall evaluation process and time lines
- Identification of the team and team members’ responsibilities
- Set up the team for smooth interaction (communication approach and tools)
- Rolling review process: review of data room information and timely identification of missing information
- Identification of gaps, their criticality and impact assessment
- Identification of scenarios and milestones for the decision making process