Webinars

Marc Ellison, Director of Regulatory Solutions

Marc Ellison is the Director of Regulatory Solutions at Instem, a software and services vendor. His background is in programming preclinical data collection systems, having been with the organization since 1997. He currently oversees all of Instem’s software and services for supporting the SEND standard. In 2012 he first joined the CDISC SEND team to work on developing the SEND standard by providing expert technical knowledge about Provantis data collection. As a long term CDISC volunteer, he is a member of the CDISC extended SEND leadership team and is the subteam lead overseeing the development of the SENDIG-DART for reproductive toxicology. Marc has been a regular presenter at many industry conferences, providing his expert knowledge of the SEND standard. He also authors the Sensible SEND blog, the industry’s only regular blog focusing exclusively on the world of SEND.

Todd Bourcier, Director in the Division of Pharmacology and Toxicology

Dr. Todd Bourcier is the Director in the Division of Pharmacology and Toxicology in the Office of Cardiology, Hematology, Endocrinology, and Nephrology (OCHEN) in the Office of New Drugs of the US FDA. Dr. Bourcier is a participant in the ICH S1 Expert Working Group that developed the S1B addendum introducing a weight-of-evidence approach to developing a more data-based carcinogenic assessment strategy for small molecules. He has contributed to key events in this effort, notably the conduct of a prospective evaluation study that supported inclusion of the WoE approach in the S1B addendum. Dr. Bourcier contributes to implementation of the S1B addendum within FDA and has been involved in review of multiple WoE submissions since adoption of the addendum in 2022.