Marc DeCristofaro

This practical, discussion-driven workshop brings together regulatory experts clarify evolving expectations for preclinical packages, the use of NAMs, in vitro models, and AI- enabled approaches, and the realities of preparing an IND for multiple global markets.

Through real case studies, both successful and challenged, participants will gain a clear understanding of how to position innovative toxicology data for regulatory acceptance.

• Current FDA Expectations & Global Alignment: Insights from FDA representatives and regulatory experts on IND readiness, emerging trends, and how to ensure early- stage toxicology programs map cleanly to U.S., EU, and APAC requirements.
• Using NAMs, In Vitro Models & AI in Regulatory Filings: Real case studies, successful and unsuccessful, showing how alternative assays and computational approaches were positioned, justified, and reviewed, including instances of regulator pushback.
• Building a Multi-Market Regulatory Strategy from Day One: Designing preclinical packages that meet multiple agencies’ expectations, bridging data gaps, and knowing when to consult your regulatory team.
• Expert Insights from Industry & Consultants: Addressing pitfalls, how to support IND strategy, and how early engagement with regulators can de-risk development.