Informing Risk of Infertility and Adverse Pregnancy Outcome: Are Nonhuman Primates Really Needed? (S11)

Symposium Chair(s)

• Christopher Bowman, PhD, DABT

  Research Fellow
  Pfizer Worldwide Research
  Groton, Connecticut, United States

• Peter van Meer, PhD

  Senior Assessor
  Medicines Evaluation Board
  Utrecht, Utrecht, Netherlands

Symposium Speaker(s)

• Jane Stewart, PhD, MRCVS

  Reproductive Toxicologist
  Apconix Ltd.
  Cheshire, England, United Kingdom

• Angela Stermer, PhD

  Principal Scientist
  Developmental and Reproductive Toxicology, Non-clinical Drug Safety
  Merck
  West Point, Pennsylvania, United States

• Puck Roos

  PhD candidate
  Utrecht University (NL), Medicines Evaluation Board (NL)
  Utrecht, Utrecht, Netherlands

Educational Co-Support Provided by: HESI and American College of Toxicology

Non-human primates (NHP) are an important, but limited resource to support safety assessment of new pharmaceuticals, in particular monoclonal antibodies. Use of sexually mature NHPs are even more limited, but can be used to inform risk of infertility and adverse pregnancy outcomes. Current examples of NHP use and alternatives to NHP use to inform developmental to reproductive toxicity (DART) risk will be presented and discussed. This will include a survey of marketed products over a 12-year span to understand how NHPs have been used to assess risk of infertility and how it was reflected in the label. Regarding future use of NHP in DART, we will also challenge industry and regulators that weight of evidence should be the default scenario to determine if experimental data are needed, considering non-NHP options (including standard species if appropriate) if that will inform the human risk assessment before considering use of NHPs only if they will address data gaps not available by other means. If NHPs are needed for DART because no other available test system will provide necessary data (e.g. pharmacological relevance) for the human risk assessment, we will offer some forward-looking considerations and recommendations for improvement. A short panel discussion will be included with the speakers (and other guests). This workshop is an outcome of a HESI DART working group whose members include health authority representatives from US, Europe, and Japan as well as industry.

Presentations:

• 2:00 PM - 2:10 PM CT

  Introduction
  

  Symposium Speaker: Peter J.K. van Meer, PhD – Medicines Evaluation Board
• 2:10 PM - 2:40 PM CT

  Developmental Toxicity Risk Assessment of Pharmaceuticals: Current Use of NHP’s and Alternatives
  

  Symposium Speaker: Jane Stewart, PhD, MRCVS – Apconix Ltd.
• 2:40 PM - 3:15 PM CT

  Current State of NHP Use Supporting Fertility Risk Assessment
  

  Symposium Speaker: Angela R. Stermer, PhD – Merck
• 3:15 PM - 3:45 PM CT

  Break
• 3:45 PM - 4:15 PM CT

  Fertility Assessment in NHP: Evaluation of Marketed Products and Opportunities to Reduce Monkey Use
  

  Symposium Speaker: Puck Roos – Utrecht University (NL), Medicines Evaluation Board (NL)
• 4:15 PM - 4:45 PM CT

  Looking Forward: Are NHP Really Needed for DART Assessments?
  

  Symposium Speaker: Christopher Bowman, PhD, DABT – Pfizer Worldwide Research
• 4:45 PM - 5:00 PM CT

  Panel Discussion