Toxicological Assessment of Pharmaceutical Impurities (CE8)

CE Course Chair(s)

• Catrin Hasselgren, PhD

  Executive Director
  Genentech
  South San Francisco, California, United States

• Alessandro Brigo, PhD, ERT, DABT

  Senior Principal Scientist - Toxicology Project Leader
  Translational Safety Assessment
  Roche Pharma Research & Early Development
  Basel, Basel-Stadt, Switzerland

CE Course Speaker(s)

• Jessica Graham, PhD, DABT, ATS

  Director, Head of Product Quality and Occupational Toxicology
  Safety Assessment
  Genentech Inc
  South San Francisco, California, United States

• Michelle Kenyon, MA

  Associate Research Fellow
  Drug Safety Research and Development
  Pfizer Research and Development
  Groton, Connecticut, United States

• Joel Bercu, PhD, MPH, DABT

  Exec Director
  Gilead Sciences, Inc.
  Foster City, California, United States

• Jennifer Alleva, PhD

  Director, Regulatory Affairs
  Small Molecule CMC Regulatory Affairs
  Gilead Sciences, Inc.
  Foster City, California, United States

Educational Support Provided by: SciLucent, Inc.

Toxicology assessment is an important part of the manufacturing process of pharmaceuticals to ensure that impurities are managed to acceptable levels. Impurity management is multi-disciplinary requiring interaction of the toxicologist with different parts of the Chemistry, Manufacturing and Control (CMC) organization. Several ICH Quality and Multidisciplinary guidelines are set up to guide pharmaceutical sponsors in ensuring high quality and safe medicines for patients. This session will discuss how toxicological principles are used to ensure that impurities are controlled to safe levels for patients. The ICH Q3A/B guidelines discuss when impurities need to be qualified, which is done by generating biological data (clinical or nonclinical) to understand the safety of the impurity. DNA-reactive (i.e., mutagenic impurities), require specific control, often- times lower than the ICH Q3A/B thresholds because of their innate hazards. Biological drugs involve different syntheses than traditional “small molecules” and require some alternative approaches to toxicological assessment of impurities. Finally, information generated by the toxicologist in incorporated into a CMC regulatory submission to demonstrate the hazards and control strategies of impurities. This course will outline and discuss the basic strategies for toxicological assessment of impurities as well as showcase practical case studies.

Presentations:

• 1:00 PM - 1:20 PM CT

  Introduction and Framework for Impurity Management
  

  CE Course Speaker: Catrin Hasselgren, PhD – Genentech
• 1:20 PM - 2:00 PM CT

  Safety Assessment of Impurities in Biologic Therapeutics
  

  CE Course Speaker: Jessica Graham, PhD, DABT, ATS – Genentech Inc
• 2:00 PM - 2:30 PM CT

  Understanding Impurity Qualification
  

  CE Course Speaker: Michelle Kenyon, MA – Pfizer Research and Development
• 2:30 PM - 3:00 PM CT

  Break
• 3:00 PM - 3:30 PM CT

  ICH M7: Identification and Control of Mutagenic Impurities in Pharmaceuticals
  

  CE Course Speaker: Joel Bercu, PhD, MPH, DABT – Gilead Sciences, Inc.
• 3:30 PM - 4:00 PM CT

  Case Study: How to Assess and Control DNA Reactive (Mutagenic) Impurities in the Pharmaceutical Industry
  

  CE Course Speaker: Alessandro Brigo, PhD, ERT, DABT – Roche Pharma Research & Early Development
• 4:00 PM - 4:30 PM CT

  Leveraging Toxicology Data to Support Impurity Control Strategies in CMC Regulatory Submissions
  

  CE Course Speaker: Jennifer Alleva, PhD – Gilead Sciences, Inc.