Jody L. Roth has over 26 years of experience in drug development as a regulatory and project management professional. Her expertise includes managing drug development from discovery to post-marketing phases and across multiple therapeutic areas. She has spent the last 12 years in global development with emphasis in the US (FDA), EU (EMA),Canada (Health Canada) and Japan (PMDA), as well as exposure to emerging market regions including, but not limited to Netherlands, Thailand, Korea, China, and Israel. Jody has obtained US approvals for BLAs, supplemental NDAs and BLAs as well as filed multiple INDs to support initiation of new molecules for development.
Jody’s expertise is in FDA interactions, target product profile (Labeling) goals and risk management. Jody is known for her deep expertise in developing global comprehensive regulatory strategy and key messages for a comprehensive story to adequately describe how the molecule fits within the treatment paradigm for that particular therapeutic class of compounds. Jody also has deep expertise in leading teams and developing integrated project management plans. She led a global oncology team to obtain initial approvals.
Jody believes in setting a common vision and clear end goals so that all teamwork and activities ladder up to the overall objectives. A key part of this is identifying the communication plan and ensuring that all team members and stakeholders are integrated into the strategy and ongoing activities. Jody believes that a key attribute of a good project manager is to document all the assumptions, risks and barriers to implementing the agreed upon strategy and then work with the team daily to overcome any hurdles they may be facing