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PBHLTH222A

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PBHLTH 222A - Biomedical Innovation Policy

School of Public Health Graduate PBHLT - School of Public Health

Subject

PBHLTH

Course Number

222A

Department

School of Public Health

Course Level

Graduate

Course Title

Biomedical Innovation Policy

Course Description

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. Focus will be on the US but will examine industrial policy and innovation nationalism within a global context. Students are required to read peer-reviewed articles, keep up with journalistic reports and participate in classroom discussions. Lectures will be pre-recorded and posted on bCourses and it is expected that students will have watched these lectures and done the readings prior to class.

Minimum Units

3

Maximum Units

3

Grading Basis

Default Letter Grade; S/U Option

Instructors

Robinson

Prerequisites

Graduate standing. Undergraduates will be considered on case-by-case basis.

Repeat Rules

Course is not repeatable for credit.

Course Objectives

• 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, innovation prizes, and advanced market commitments, among others. • 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. o Intellectual property policy with respect to generics and biosimilars • Discuss the basic structure of regulatory market authorization: o FDA review of safety and efficacy for pharmaceuticals o Accelerated review and the evolution of evidentiary demands o Market authorization for medical devices, diagnostic tests, digital therapeutics • Explain the basic principles of health technology assessment and their applicability to insurance coverage and pricing.

Formats

Lecture

Term

Fall and Spring

Weeks

15 weeks

Weeks

15

Lecture Hours

2

Lecture Hours Min

2

Lecture Hours Max

2

Lecture Mode of Instruction

In Person

Outside Work Hours

7

Outside Work Hours Min

7

Outside Work Hours Max

7