Managing Pharmaceutical Research and Development (MGT681)

Instructor:
Michael Kurman

This course provides an overview of the drug and biologics development process from discovery through regulatory approval. Special attention is given to the roles, functions and importance of the various disciplines involved in the R&D process, their interactions with each other, and the strategic management of these functions. Attention will also be given to key technologies used throughout the R&D process. The economics of pharmaceutical R&D as well as trends in licensing, outsourcing and partnerships will be covered. The student will gain an understanding of R&D strategy and the relationship between R&D and sales, marketing and manufacturing. Prerequisite MGT 671- Technology and Innovation Management

Topics covered include:

•  The pharmaceutical value chain
•  The drug development process
•  The economics of drug development
•  Organization and governance of R&D
•  R&D Strategy
•  Portfolio management
•  The roles of sales, marketing and manufacturing in the R&D process
•  Drug discovery and technology-enabled approaches to drug design
•  Toxicological evaluation of new molecules
•  Challenges of dosage formulation and dosage form design
•  Clinical trials: challenges, strategies and measures of success
•  Pharmacovigilance and risk management
•  Outsourcing, partnerships and strategic alliances
•  Measuring and managing R&D performance
•  Portfolio Management