Section outline

  • Discussion Seminar: How to Assess an Early Stage Drug Candidate and Drug Development Lessons
    Characteristics of a good drug; target and validation: assessment; biology and animal models; chemical characteristics; pharmacokinetics; regulatory path; case studies. Case studies on drug development including: CAST; FIAU; TGN-1412; gene therapy.

    Faculty:  Menghis Bairu, MD

    Location:     China Basin 6702

    • Session Slides:

    • Lecture 2-1 File

    • Session Audio/Video Recording (Access restricted to registered students):

    • Required Reading/Viewing:

    • Drugs at the FDA URL

    • Assignment: Homework Assignment due April 23: Pick a drug that has an FDA review posted, and read the clinical review, the approval letter, and the package insert. Based on this, and knowledge of the indication, please write a target product profile. Students should email their assignments to Janel Long-Boyle and bring a copy to this lecture.

    • CaseStudyAssign 2012 File