Biotechnology & Regulatory & Safety Evaluation Specialty Section-Considerations Regarding Nonhuman Primate Use in Pharmaceutical Development
Considerations Regarding Nonhuman Primate Use in Pharmaceutical Development
Thursday, September 22, 2022
1:00 PM to 2:30 PM (US EDT, UTC -4)
Hosted by: Biotechnology Specialty Section (BTSS) and Regulatory and Safety Evaluation Specialty Section (RSESS)
Dr. Wange’s presentation will focus on approaches to limit the use of nonhuman primates (NHPs) in drug development and will be given in two parts. The first half of the talk will provide an overview of the guidance on “Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic,” which was issued as final guidance earlier this year under FDA’s COVID-19 public health emergency authority. The second half of the presentation will focus on alternatives to the NHP for assessing the risks of biotherapeutic proteins to embryofetal and postnatal development. An overview of existing guidance that supports use of alternative in vivo approaches and weight-of-evidence (WOE) analyses for assessing developmental toxicity risk will be provided. He will also provide an assessment of the degree to which non-NHP sources of information have been leveraged for assessing embryofetal and postnatal development through an analysis of the sources of nonclinical data that have been used to inform section 8.1 of the US product labels for biologics approved by CDER over the last several years.
• Ronald Wange, PhD, Associate Director for Pharmacology and Toxicology, OND, CDER
Registration required for this free webinar.