Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Plenary and Drugs Track
Presenter
Jessica Bernhardt, MS
ESG Program Manager
Division of Application Services (DAS)
Enterprise Application Branch (EAB)
Office of Digital Transformation (ODT)
Office of Information Management and Technology (OIMT)
US Food and Drug Administration (FDA)
Jessica Bernhardt currently is the Program Manager for the Electronic Submissions Gateway (ESG) and AdminApps programs at the Food and Drug Administration (FDA). She took on the role of ESG Program Manager at the start of 2023 and oversaw the successful completion of the ESG AWS Migration. Jessica joined the FDA in 2020 as the AdminApps Program Manager, which she has successfully managed for the past three years.
Jessica started her career in Government nine years ago when she joined the Social Security Administration (SSA) as an IT Specialist. After a year working as an IT Specialist for a year, was assigned to lead and manage an IT Modernization project, promoting the use of the Agile development lifecycle. In 2016 she was promoted to Team Lead within the Enterprise Architecture (EA) and Software Governance group (SG). As a Team Lead in EA & SG she helped to define, promote, and manage the EA & SG program as well as various development projects at SSA. In 2020 she moved into a purely Project Management role, managing a large agile IT Modernization effort for several of SSA’s core business systems. During her tenure at SSA, she helped to promote the EA Program, integrating it into both the Waterfall and Agile development lifecycles, mentored employees in EA and Project Management and managed several development projects. Additionally, while working at SSA she obtained her Master of Science in Information Systems Management with a concentration in Project Management. Prior to joining SSA, Jessica worked for five years in private industry IT at the International Union of Painters and Allied Trades (IUPAT) as a Business Analyst/Project Manager. While at the IUPAT, she helped with the IT Modernization of their Membership, Education and Dues system providing Analytical, Testing, Training and Project Management support. Prior to leaving she and her team successfully rolled out the application to multiple District Councils and Local Unions throughout the country.
Jessica currently lives in Gambrills, Maryland with her husband and their four children. When she is not busy working and continuing to advance her knowledge in IT you can usually find her at the dirt bike track watching either her husband or their twin boys ride.
Bin Duan
ESG NextGen Lead Architect
CTO | Precise Software Solutions Inc.
FDA Contractor
Division of Application Services (DAS)
Enterprise Application Branch (EAB)
Office of Digital Transformation (ODT)
Office of Information Management and Technology (OIMT)
Dr. Duan is a visionary and result focused IT executive with 20 years of progressive responsibility leading IT strategy, architecture, technology innovation, business operation, and delivering strategic product offerings and large-scale IT programs. He is the Chief Technical Officer of Precise Software Solutions. Prior to Precise, Dr. Duan held leadership roles in Oracle, CSRA and Nielsen. Dr. Duan has a PhD degree in Aerospace Engineering and an MBA. He is currently an Adjunct Professor at George Mason University teaching graduate level classes on Big Data and Advanced Data Analytics.
Abstract
This session from the 2024 FDA Regulatory Education for Industry Conference, presented by Jessica Bernhardt with Bin Duan joining for the Q&A, introduces ESG NextGen, the planned modernized replacement for the legacy Electronic Submission Gateway (ESG). ESG NextGen serves as the central transmission point for secure electronic submission of premarket and postmarket regulatory information for review by the FDA and international partners like Health Canada. Key enhancements include a user-friendly unified submission portal (replacing Web Trader), improved usability, increased submission file size capacity (initially up to 1 TB), and improved submission tracking and history visibility within the portal. It incorporates robust security features like multi-factor authentication and zero trust. The platform will offer three submission methods: the Unified Submission Portal, AS2, and API. ESG NextGen is built on a cloud-based architecture for enhanced scalability and availability, supporting diverse devices including iOS. Registration is free with no limit on user accounts per institution, although different user roles (submitter, power user, agent) offer varying levels of access to submission history within a company. The FDA has collaborated extensively with industry, centers, and Health Canada on its development, incorporating feedback from stakeholders. The planned go-live for Release 1 is between FY24 Q4 and FY25 Q1, at which point legacy ESG will be retired and existing user accounts migrated to the new system. Training and user guides will be provided to facilitate a seamless transition. Future enhancements include features like two-way communication and an intelligent chatbot.