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.
Professor Cramer spent more than 25 years in the healthcare, pharmaceutical, and financial services sectors. He was Managing Director at Merrill Lynch in the Global Healthcare Investment Banking Group, and Managing Director at JPMorgan in the Corporate Finance Group providing M&A services and financing to global healthcare enterprises. Earlier, Prof. Cramer was Vice President, Corporate Planning & Development for Merck & Co., Inc. with worldwide responsibilities for...
Executive in Residence
Robert Essner is the retired chairman and CEO of Wyeth, which was one of the world's leading research-based pharmaceutical companies. He led the transformation of Wyeth into a science-based industry leader with strong positions in drugs, biotechnology, vaccines, nonprescription products and animal health. During his more than 30 years in the industry, Mr. Essner served as chairman of both U.S. and global pharmaceutical...