Marc DeCristofaro
Director, Medicinal Safety Daiichi Sankyo
Marc is a director in the Medicinal Safety department at Daiichi Sankyo. He has been at Daiichi Sankyo for 6 years where his responsibilities include non-clinical safety support for various projects and regulatory submissions. He also represents Daiichi Sankyo on various industry consortium, including HESI and IQ.
He has an MS and PhD in Toxicology from the University of Michigan and has worked in the industry for over 20 years at various biotech and pharmaceutical companies, including Allergan and Novartis. Marc is also a Diplomate of the American Board of Toxicology (DABT).
Seminars
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.
