Professor Eli Keshavarz-Moore
One-hour written examination (70%)
This course is designed to provide a structured approach to understanding the ways in which a discovery in bioprocessing and the life sciences is taken through to a real outcome. The students will learn about ways of evaluating potential commercial opportunities, selecting an optimal route for their commercial exploitation and constructing business plans in order to raise appropriate funding.
Following completion of the course, students will have an understanding of:
- how to undertake the technical and commercial assessment of research projects.
- what it takes to patent research
- the requirements for clinical trials
- how to asses the manufacturing facilities requirements or outsourcing alternatives
- know how to structure a business plan
- how to create financial spreadsheets
The bioprocessing and life sciences industries have a number of unique features that distinguishes them from other fast growing sectors. The contents of the course are designed to achieve the aims outlined above by focusing on the factors and constraints that define successful operations in these industries.
The content includes:
- Systematic approach to commercialisation of a concept in bioprocessing/ lifesciences. Assessment of an idea, go, no-go options, planning flow chart. Overview of biopharmaceutical, biotechnology, and diagnostics industries. Structure, characteristics, size and trends. Intellectual property rights and management of product and process patents.
- Definitions, importance to the sector, timelines, impact on product planning, estimated costs. Regulatory requirements. Framework for different sectors of the industry (e.g. Pre-clinical to post licensing), GLP, GMP, GCP compliance, biocontainment needs.
- Market research and marketing strategy. Speed to market considerations, current practices in the sector and future trends. Operations management. Planning of clinical trials and manufacturing, options in production, costing operations, labour requirements and planning. Financial planning.
- Preparation of NPV, discounted cash flow and profit and loss accounts and interpretation of them in this sector of industry. Sensitivity analysis
- Constructing a business plan. Internal company business plan versus external: similarities and differences. Successful management structure and profile, product definition, technology platform and portfolio of IPRs, stages of funding (e.g. seed fund), Gantt chart and milestone preparation, rounds of refinancing, presentation of financial data. Exit route. Insurance. Executive summary.
- Financing solutions