The course is appropriate for students in chemistry and life sciences who contemplate possible careers in the pharamceutics and biotech industry and who seek to deepen their understanding of the relevant business context. The course provides perspective on the evolving landscape of pharma and bio-technology from the standpoint of new entrepreneurial companies. It focuses on changes and challenges in the industry, as well as opportunities for startups and new entrants.
The course provides insights through a range of approaches and materials, including readings, cases, lectures, outside speakers, and class discussion. The course meets once a week in a two-hour session.
The written assignments include one of the following:
- An assessment of an existing or novel biotech business
- Case write-ups
- A final paper that pursues one of the course topics (your choice) in depth
- Presentation of a new proposed start-up
The assignments can be written and submitted jointly with another student. All assignments will be presented to the class during the last 2-3 meetings (pending number of participants). There will be no final exam in this course.
TOPICS AND CLASS SESSIONS
- Class 1 – Introduction
- Class 2 – Overview of the Biotech Industry and supporting services
- Class 3 – Development Process of a new chemical or biological drug
- Class 4 – Development Process of a new medical device
- Class 5 – Pre-Clinical Development
- Class 6 – Clinical Development
- Class 7 – Regulatory development
- Class 8 – Building a start-up (business plan, strategy)
- Class 9 – What Do We Want to Be? Business Models & Business Development
- Class10 – Financing the early stage healthcare company
- Class 11 – National Incubator Program
- Class 12 – The Role of Universities and Technology Transfer Offices
- Class 13 – Intellectual Property
- Class 14 - CMC (chemistry, manufacturing, control)
- 15 ,16 – Presentations of students' assignments (In this concluding classes, students will present findings from their final paper).