Section outline

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  • Wednesday, April 1, 2015; 10:30 AM - 12:00 PM

    Discussion Seminar: Introduction
    History and phases of drug development, role of regulatory agencies; ethics of drug development; program design; intellectual property.

    Faculty:  Richard Chin

    Location:     Mission Hall 1106

    • Session Slides:

    • DrugDev Lecture1-1 File

    • Required Reading/Viewing:

    • Guidance documents URL
    • FDA guidance documents URL

    • Resources:

    • Zepeda EPI260 Case Study File
    • Dronaderone Case Study File
    • Epi260 - Case Study knishimura File

    • Assignment: Read a guidance document from FDA or EMA on an indication of your choice and write up your thoughts on the indication, the endpoints, magnitude of clinical benefit that the agency expects, and what you see as strengths and weaknesses of the document.

       

    • Assignment Due Date:  Due April 8: Students should email their assignments to Marlene Grenon at marlene.grenon @ucsf.edu and bring a copy to this lecture.

       

  • No Attendance Required: Wednesday, April 8, 2015; 10:30 AM - 12:00 PM

    No Attendance Required: 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:  Richard Chin

    Location: 

    • Session Slides:

    • Lecture 2-1 File

    • Required Reading/Viewing:

    • Drugs at the FDA URL

    • Assignment: Homework Assignment due April 15: 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 Marlene Grenon and bring a copy to this lecture.

    • CaseStudyAssign 2012 File

    • Assignment Due Date:  Case Study Assignment due April 15th: Email to marlene.grenon@ucsf.edu

  • Wednesday, April 15, 2015; 10:30 AM - 12:00 PM

    Discussion Seminar: What you need to file and IND/IMPD

    The preclinical studies, information and the process that are required to get approval to carry out clinical studies in humans.

    Faculty:  Richard Chin

    Location:     Mission Hall 1106

    • Session Slides:

    • Epidemiology 260 Spring 2012 File

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

    • Required Reading/Viewing:

    • Principles and Practice of Clinical Trial Medicine (2008), Chapter 2, pages 31-37.

    • FDA website info on the IND Application URL

  • No attendance required: Wednesday, April 22, 2015; 10:30 AM - 12:00 PM

    No attendance required: Phase I Trials: dosing and design
    Basic principles of Phase I designs; definition and assessments of Phase I endpoints; conventional and novel dose escalation models; design of pharmacokinetic and pharmacodynamic correlative studies.

    Faculty:  Richard Chin

    Location: 

  • Wednesday, April 29, 2015; 10:30 AM - 12:00 PM

    Discussion Seminar: Late phase clinical trials
    Good Clinical Practice; protocol design and writing; case report forms; investigator brochure; regulatory filings; budget; staff training; data management; safety reporting; site closeout; data analysis; report writing; record retention; regulatory requirements for approval; NDA/BLA and pre-NDA meeting.

    Faculty: Menghis Bairu and David Feigal

    Location:     Mission Hall 1106

    • Session Slides:

    • MB4 25UCSF Lecture 6(FINAL) File

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

    • Assignment:

      Go to http://www.ich.org/products/guidelines.html and download two of the documents, one of which should be E6, and another of your choice. You should read them, and discuss how the guidelines might 1) protect patient safety and 2) protect data integrity. Homework assignment due: May 6th, 2015.

    • Assignment Due Date: Case Study Assignment, Part I: Due May 6th: Email assignment to Dr. Chin and cc: Marlene Grenon by Monday, 05/6/15.

      May 1: Bring a copy of your current draft case study.

      Be prepared to present your case study in a small group.

  • Wednesday, May 6, 2015; 10:30 AM - 12:00 PM

    No Attendance Required: Vaccines
    What are vaccines and how does their development and use in practice differ from therapeutics. Vaccine safety and public perception; chance association vs. cause and effect. Importance of other governmental (e.g. CDC) and multinational (e.g. WHO) organizations. Evolution of antigen discovery and 'smart' adjuvants. Illustrative case studies including vaccines against (a) meningococcus ACWY, (b) meningococcal B, (d) influenza and pandemic influenza, (e) group B strep. Commercial considerations.

    Faculty:  Richard Chin

    Location:  

    • Session Slides:

    • Scharschmidt Vaccines - Part 1 - 2012 File
    • Scharschmidt Vaccines - Part 2 - 2012 File
    • Scharschmidt Vaccines - Part 3 File
    • Scharschmidt Vaccines - Part 4 File

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

    • Required Reading:

    • Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases URL
    • Margarit, I. Preventing bacterial infections with pilus-based vaccines: the group B streptococcus paradigm . J Infect Dis. 2009 Jan 1;199(1):108-15. File
      Not available unless: Your ID number contains 02
    • Reverse vaccinology: developing vaccines in the era of genomics. Sette A, Rappuoli R. Immunity. 2010 Oct 29;33(4):530-41. Review. PMID: 21029963 File
      Not available unless: Your ID number contains 02

  • Wednesday, May 13, 2015; 10:30 AM - 12:00 PM

    Discussion Sessions: Cell, tissue and gene therapies - No Class this week

    Faculty: 

    Location:

    • Session Slides:

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

    • Required Reading:

    • Carpenter MK, Frey-Vasconcells J, Rao MS. Developing safe therapies from human pluripotent stem cells File
      Not available unless: Your ID number contains 02

    • Optional Reading:

    • Dunbar CE, Larochelle A File
      Not available unless: Your ID number contains 02

  • Wednesday, May 20, 2015; 10:30 AM - 12:00 PM

    No Attendance Required: Devices and drug/devices combinations
    Medical device development is as varied as the thousands of different types of devices, ranging from diagnostics, to implants, to the equipment used to deliver care. Medical device regulation is risk based and relies as much on design principles and performance standards as on clinical trials. The device life cycle is more likely to be iterative, with long duration of use, and safety and efficacy is often closely linked to training and skilled users.

    Faculty:  Richard Chin

    Location:  

    • Session Slides:

    • UCSF Device Regulation 2012 File

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

    • Required Reading:

    • Maisel, W File
      Not available unless: Your ID number contains 02

  • Wednesday, May 27, 2015; 10:30 AM - 12:00 PM

    Discussion Seminar: Use of biomarkers in clinical development
    The use of diagnostic biomarkers and surrogate biomarkers in drug development will be covered. Review of case studies of how these different types of biomarkers have been utilized in drug development.

    Faculty: June Lee

    Location:     Mission Hall 1106

  • Wednesday, June 3, 2015; 10:30 AM - 12:00 PM

    Discussion Seminar: Case Study: Safety Issues, Adverse Event Reporting, Signal Detection
    Brief overview of reporting requirements for FDA, EMEA; Types of reporting classifications; MEDRA; Case studies of safety issues, adverse event reporting; signal detection.

    Faculty: Pamela Munster

    Location:      Mission Hall 1106

    • Session Slides:

    • Phase I designs TICR 5-6-15 File

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

    • Required Reading:

    • Detailed guidance on the collection, verification. URL
    • Detailed guidance on the European database URL

    • Assignment:  Case Study Assignment: Due June 3, 2015. Email to Marlene.grenon@ucsf.edu and to Dr. Chin