IBC Life Sciences

Description

This course will follow the drug/biologic development pathway and the concomitant CMC requirements by regulatory agencies. As drug development moves from concept to commercialization, the breadth and depth of CMC information required in submissions increases in parallel. It is important for manufacturers to understand the level of CMC compliance expected, so that regulatory submissions contain stage-appropriate information. The course will examine the broad range of DS (Drug Substance) and DP (Drug Product) CMC elements, and in particular, which elements are required, and in what detail, at each stage of development. FDA Guidelines and Points to Consider will be surveyed.

Agenda

• The Evolution of Compliance
• FDA Structure and Function
  • CBER vs CDER
  • CMC Guidelines and Points to Consider
  • face to face meetings with FDA - types and expectations
  • current FDA approaches to CMC review
• The Product Development Timeline from IND to Commercialization
• Comparison of Small Molecule and Biologic CMCs
• The CMC Section of the Original IND
  • CMC Introduction - Statement of Risk
  • drug substance
  • drug product
  • placebo
  • labeling
  • environmental Impact
  • stability - requirements for First in Human trials
• Viral Clearance Validation for Biologics
• Working with Third Parties
  • working with CMOs
  • executing successful Quality Agreements
  • effective use of testing laboratories and compendial methods
• How and When to Report CMC Changes during the IND Phases
  • risk assessment
  • reporting mechanisms
• CMC Content of the End of Phase II Meeting with FDA
• Pre-Approval Facility Inspection
• CMC Section of the Marketing Application(NDA or BLA)
  • in depth analysis of all required CMC sections
  • how FDA evaluates the submission
  • how the FDA review objectives allow rapid integration of new technologies into pharmaceutical/biologic manufacturing, and expedite review
• The Validation Requirements of the Marketing Application
• Post-Approval CMC Commitments and Reporting

Who Should Attend?

• Regulatory Affairs professionals responsible for the Chemistry, Manufacturing, and Controls sections of INDs, BLAs, and PMAs.
• Product Development personnel responsible for assay development and developing small, intermediate, and commercial scale manufacturing, purification, and formulation processes
• Project Management staff
• Validation personnel wishing to understand CMC requirements for validation documentation
• QA personnel who wish to understand the interface of Quality Systems and the submission process

Instructor

Bruce K Burnett, Ph.D., RAC (US, EU), Director, Regulatory Affairs, Duke University
Bruce Burnett received his Ph.D. in Chemistry/Biochemistry from the Massachusetts Institute of Technology. Dr. Burnett brings over 20 years of experience in the pharmaceutical and biotech industry involving R&D, QC/QA, and RA. He is a certified Regulatory Affairs Professional (RAC), and is currently working as the Director of Regulatory Affairs at the Duke Translational Medicine Institute. He came to Duke from AlphaVax, where he served as the Vice President of Quality and Regulatory Affairs. He has also held positions at Biogen, Genetics Institute and Serono. He has worked on successful license applications for four biologics and has been responsible for numerous INDs and meetings with FDA.