The Business of Science (Ph.D. course)

Taught by Nicolas Ponzio, Ph.D. from New Jersey Medical School

Introduction to the course

There are a myriad of research and non-research departments in the biopharma industry. All of these work together to help launch a treatment (new drug) and continue its safety monitoring. The objective of this course is to provide students a deep insight into the drug development and commercialization process. Lecture topics are designed for those who may be interested in a career in a Pharma company. The course will also be your opportunity to interact with professionals from the pharmaceutical industry who give lectures and provide guidance throughout the course.

Structure of the class

Classes are held on Wednesdays from 6-9 PM. A majority of the sessions will involve 1-2 hours of lectures and 1-1.5 hours of individual or group activities. Students will be e-mailed reading materials related to the lecture 1 week before each lecture and will be expected to read them and submit 2 questions by Tuesday before the class. These questions will be discussed in class by the invited lecturer.

Core concepts covered during the course

  • Biopharmacology industry overview, Target identification and validation and Methods in lead optimization
  • Preclinical studies, Good Lab Practice (GLP) and Investigational New Drug (IND) application
  • Personalized medicine
  • Regulatory affairs and the FDA
  • Clinical trials Phase 1-3, Good Clinical Practice (GCP) and New Drug Application (NDA)
  • Non-disclosure agreement (NDA), Portfolio management and Intellectual property (IP)
  • Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP)
  • The evolving healthcare system and market access
  • Funding the biopharmaceutical industry