Academic Program Proposal

Date Proposal Activated	Institution and Proposal	Degree Awarded	Academic Program Name	Objection Deadline
	Johns Hopkins University Proposal	Post-Baccalaureate Certificate (P.B.C.)	Biopharmaceutical Business and Policy	7/29/2026
Biopharmaceutical Business and Policy Program Description
The program’s learning outcomes reflect the rigor and breadth expected of graduate- level coursework and are appropriate for a flexible, modular delivery format. Upon completion of the certificate, students will be able to: <br> <br>1. Understand the structure and economics of the pharmaceutical industry, including R&amp;D, manufacturing, commercialization, and global supply chains. <br> <br>2. Evaluate regulatory and policy frameworks in major markets (U.S., EU, emerging markets) and how these shape innovation, pricing, and market access. <br> <br>3. Analyze drug development and commercialization pathways from discovery through launch, including the use of data- and AI-enabled approaches in clinical development, regulatory approval, and lifecycle management. <br> <br>4. Apply business strategy tools (e.g., competitive analysis, portfolio management, mergers and acquisitions) to pharmaceutical contexts. <br> <br>5. Assess global market access and reimbursement dynamics, including health technology assessment (HTA), payer perspectives, and value-based pricing. <br> <br>6. Develop strategic recommendations for real-world pharmaceutical cases, integrating scientific, regulatory, and commercial considerations. <br> <br>7. Engage with ethical and societal debates around access to medicines, affordability, innovation incentives, and global health. <br> <br>8. Evaluate the strategic, regulatory, and ethical implications of data- and AI-enabled technologies for pharmaceutical innovation and access.