PHM 858 - The Drug Development Process

Description

Project management standards and best practices in drug development process, including clinical trials. Topics include: understanding global regulations and requirements; risk management in commercial biomedical research; decision-making and problem-solving for drug development projects; portfolio management for prioritizing biotech and life sciences; and managing projects throughout the drug development lifecycle.

Topics

• Understanding global regulations and requirements
• Risk management in commercial biomedical research
• Decision-making and problem-solving for drug development projects
• Portfolio management for prioritizing biotech and life sciences
• Managing projects throughout the drug development lifecycl

Recommended Background

Some experience working on laboratory or clinical research projects is useful.

Recommended Textbooks

Drug and Biological Development from Molecule to Product, 1st Edition Evens, R. [Springer]

Available free online from MSU library

Purchase on Amazon

Instructor(s)

Dr. David Juckett's career has been diverse, ranging from cancer and aging research to solar physics, biospheric effects of radiation, and epidemiological evidence for epigenetic effects in disease. Interwoven with these research interests has been proprietary work in the discovery and development of bio-therapeutics.