PBHLTH 222AW
Biomedical Innovation Policy
This course examines the policy framework for biomedical technology, including medical devices, drugs, diagnostics, digital therapeutics, and algorithms. Emphasis will be placed on the funding of research and development, the protection of intellectual property, FDA market authorization, insurance coverage, and algorithm design. The focus will be on the US but we will examine industrial policy and innovation nationalism within a global context. Students will be required to read peer-reviewed articles, keep up with journalistic reports, and participate in online discussions.
Topics
- ● Compare the strengths and limits of alternative mechanisms for stimulating R&D investments in the life sciences: research grants, commercialization grants, tax credits, patent-protected pricing, and innovation prizes, among others. Be able to apply these principles to develop a package of policy incentives to encourage investment in novel antibiotics. ● Describe the basic principles and applications of intellectual property policy and the tradeoffs between greater access to current treatments. via low product prices, and greater incentives for investment in new treatments, via high prices. ○ Intellectual property policy with respect to generics and biosimilars ● Discuss the structure of regulatory market authorization, including FDA review of safety and efficacy for pharmaceuticals and market authorization for medical devices, diagnostic tests, digital therapeutics. Apply these principles in video debate over FDA accelerated review. ● Be able to explain the principles of health technology assessment (HTA) and the challenges raised in their application to insurance coverage and pricing for Medicare.
Official catalogue course objectives and student learning outcomes
Sources
- Course catalogue ↗2026-2027