B9601-075: Pharmaceutical Development & Commercialization Workshop
M - A Term, 02:15PM to 05:30PM
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This course provides an advanced, critical analysis of pharmaceutical development and commercialization strategies and practices. The course’s emphasis is on advanced competitive strategies to succeed in more challenging pharma environment. It covers selected therapeutic categories and analyzes key stakeholders including competitors and payers, the emerging role of biomarker diagnostics, considerations for clinical study design and regulatory requirements, market access and pricing, global marketing and launch planning, and product life cycle management. During each session product case studies will be analyzed. Therapeutic product areas to be covered include oncology, diabetes and metabolic, psychiatric disorders, cardiovascular, and infectious diseases. Topics to be covered in this course include:
• How R&D and Marketing interface in developing new products including clinical development planning; regulatory and payer strategies; optimum dosing, pricing, formulation planning and life cycle management; and competitive strategies.
• Advanced competition analysis (identifying key market factors, prioritizing key stakeholders, changing role/importance of payers, profiling key competitors, etc.).
• Review of clinical effectiveness and safety; pharmacoeconomic studies; Phase IV/outcomes research; and Risk Evaluation Mitigation Strategies (REMS).
• Impact of regulation and market structure on global sales and marketing strategies.
• Pre-launch/launch planning, market research, thought leader development, branding.
• Market access, global pricing and reimbursement.
• Business development strategies to acquire/license new drugs and technologies.
Important Note: this course is designed for students with at least a basic understanding of the pharmaceutical industry. Students new to the industry are unlikely to benefit from the course given the advanced class discussion. This course is complementary to Profs. Cramer and Essner’s Strategy and Competition in Pharmaceuticals and Biotechnology offered in the spring semester. The course will be useful for students interested in careers in pharmaceuticals, biotechnology, diagnostics, healthcare services, healthcare consulting & banking, life sciences venture capital, private equity, and investment management.
Evaluation is 20% class participation, 30% mid-term writing assignment (3-5 pages), and 50% final paper (4-6 pages) on topics covered in the class sessions.