Jason Cober is the Director - Regulatory Review, AI, and Digital Transformation at ProPharma Group. He previously led FDA/OPDP's eCTD implementation and has 17 years' experience with the Agency's eCTD specification and guidance development process.

Jo Secnik joined Lilly in 1990 where her career has included assignments in Biopharmaceutical Development, Quality Assurance and Regulatory Affairs. Her experience in Regulatory includes 10 years in global CMC and for the last 14 years supporting the US business on advertising and promotion for marketed products.

Joanne Hathaway joined Otsuka Development & Commercialization (OPDC) as Senior Analyst, Document Management in 2016. In this role, she was responsible for managing promotional materials for all marketed products that required submission to the Office of Prescription Drug Promotion (OPDP) on Form FDA 2253. Joanne took on the challenge of preparing for electronic submission of promotional materials to OPDP through the electronic gateway (eCTD), and was promoted to Manager, Promotion Compliance. Joanne received an Associate of Applied Science degree in Business from Union County College, Cranford, NJ, and a Bachelor of Science degree in Business Management from Kean University, Union, NJ.