Diffusion is an innovative biopharmaceutical company developing novel therapies that enhance the body's ability to deliver oxygen to the areas where it is needed most, including hypoxic tumors like GBM. As the Chief Regulatory Officer at Diffusion, I'm responsible for the development and execution of the regulatory strategy for the program portfolio as well as serve an advisor at the Leardership Team and to the Board of Directors.

Specializes in rare diseases; orphan drug development. Drugs and biologics, global.

ICON is a contract research organization that helps companies with their drug development. One aspect of that support offered to industry is in the Regulatory Affairs Arena. We provide regulatory support (strategy and operational) in all areas of regulatory for all types of products and applications.

Regulatory Affairs. I began my experience at Nabi as an associate in Regulatory Operations. After one year I transitioned into the strategy side of Regulatory Affairs as an associate, and I was promoted to a Sr. Associate soon afterwards. While at Nabi, I gained experience with Drugs and Biologics, Marketed and Pre-Marketed Products, US, Canada, and EU experience, Clinical and CMC experience, as well as with FDA interactions, including assisting with preperations for Advisory Committee Meetings and Dispute Resolution Meetings.

Aided in the review of Extramural Grants, including preparing for meetings with the scientific review commitees and IRBs and preparing reports based on the results of the meetings.

Aided in the review of Extramural Grants, including preparing for meetings with the scientific review commitees and IRBs and preparing reports based on the results of the meetings.