PTI - international

I. Examine Current CMC Requirements for Biopharmaceuticals

• Outline CMC regulatory framework
• Identify relevant FDA and ICH issued CMC guidances
• Determine the key differences in CMC requirements for biopharmaceutical and pharmaceutical products
• Identify CMC challenges unique to biopharmaceuticals

Exercise: Determine Participants' Backgrounds and Identify Common Course Goals

II. Determine Strategies for the CMC section of an IND and IND Amendments

• Determine appropriate CMC data required for each clinical trial phase
• Identify level of CMC data necessary for drug substance
• Identify level of CMC data necessary for drug product
  • Define current FDA expectations regarding specific biopharmaceutical issues: 
    • stability studies 
    • product characterization     
    • method validation vs. qualification   
    • animal source raw materials
    • specification setting
    • master/working cell banks
    • viral clearance
    • process scale-up issues

Exercise: Critique the CMC section of an IND

III. Plan for FDA/Sponsor Meetings

• Identify key CMC meetings
• Define purpose and focus of each meeting:
  • Pre-Investigational New Drug Application (Pre-IND)
  • End-of-Phase Two (EOPII)
  • Pre-Biologic Licensing Application (Pre-BLA)
• Identify specific CMC issues relevant to each FDA/sponsor meeting
• Outline procedures for submission of written meeting requests and information packages
• Enhance communication with FDA by conducting "CMC-specific" meetings

IV. Streamline CMC Section of the BLA

• Identify level of CMC data necessary for drug substance
• Identify level of CMC data necessary for dug poduct
• Discuss development history reports
• Define current FDA expectations