This intensive five-day course is taught face-to-face with online support and written assignments. Students will be assessed on practical applications of this course, creating a successful business plan, performing regulatory and market analysis and exploring ways of financing.
Each of the five days has a dedicated theme and will start with an introductory lecture, followed by lectures, case studies and discussions led by subject specialists from the University of Oxford and guest lecturers from other universities, companies and organisations.
Module content:
Day 1: Pre-clinical to clinical testing
- Introduction to the translation pathway, examples and challenges
- Pre-clinical testing ethics
- Pre-clinical testing models
- Clinical Trials Phase I and II
- Clinical Trials Phase III and Market Approval
Day 2: Ethics, safety and regulation
- Nanomedicine ethical issues
- Manufacturing and quality assurance of nanomedicine products, the absolute requirement for GMP
- Current regulatory approach to nanomedicines
- MHRA, EMEA, FDA process and example rulings
- Regulatory classification, device / drug / implant / injectable
Day 3: Product protection and commercial potential
- Intellectual property, including patent strategy and patent search
- Introduction to markets
- Industry specifications, competition and analysis of the healthcare, nanomedicine and bionanotechnology markets
- Assessing the market and commercial potential for maximum impact; risk and return
Day 4: Financing
- Net present value, raising capital, funding projection and financing rounds
- Securing private investment
- Securing investment from public sources
- Introduction to elevator pitches and panel presentations
- Nanomedicine networks and institutions
Day 5: Case studies and exercises
- Metrics of success and failure, exit strategies
- Learning from notable nanomedicine successes and failures
- Case study – Oxford SME with a medical nanotechnology
- Small group exercise