IND-Enabling Nonclinical Studies: Are You Prepared?
Date: March 17, 2023
- William Salminen, PhD, DABT, PMP, Vice President, Nonclinical Safety and Toxicology, Premier Consulting
- Andrew Emanuel, Senior Director, Nonclinical Development, Premier Partners
Completing nonclinical studies to support FDA investigational new drug applications is an essential milestone for progressing a new drug into the clinic. Conducting studies according to relevant regulatory requirements, such as good laboratory practices, and guidelines from the FDA and the International Council for Harmonisation is essential for ensuring acceptance by the FDA and that IND-opening clinical trials can proceed without a clinical hold.
For outsourced animal studies, it is tempting to rely solely upon the nonclinical laboratory for study design, conduct, and reporting. However, these laboratories and their study directors have many competing pressures, and it’s important for sponsors to provide appropriate oversight of their studies to verify that they are receiving adequate attention.
Also, IND-enabling studies require significant input on design, conduct, and reporting from the sponsor. It is important to confirm that a lab has appropriate processes and controls in place to conduct studies that meet the applicable regulatory requirements or, if not, to provide even greater input and oversight than might otherwise be required. Although the scientific results are dependent upon the drug, this webinar will provide practical guidance for designing, contracting, monitoring, and reporting nonclinical/toxicology studies to ensure regulatory acceptance by the FDA.
Watch this webinar to find out how to best prepare for conducting and managing IND-enabling nonclinical studies and meeting FDA guidelines.
Topics will include:
- Critical aspects of nonclinical laboratory qualification
- Obtaining comparable laboratory quotes
- Logistics of study startup through reporting
- Monitoring best practices
- Ensuring GLP compliance and regulatory acceptance by the FDA