Juanita Williams-Gould

• Lead and advise product teams on US regulatory strategies to accelerate product development while fulfilling evolving US regulations and FDA regulatory initiatives. • Lead preparation of meeting materials and teams for pivotal FDA meetings. • Perform life-cycle maintenance activities to ensure regulatory compliance of investigational and approved products. • Collaborate with cross-functional global teams for effective and consistent communications and submissions to FDA and other health authorities. • Lead and participate in internal process improvement initiatives. • Acted as an Amgen regulatory representative for external collaborative industry organizations.

♦ Assist with preparations for pre-approval inspections. ♦ Assist with the preparation and simultaneous NDA and MAA submissions for FINETPLA for the treatment of Dravet Syndrome. ♦ Manage regulatory timelines and coordinate accurate and timely collection of documentation from divisions (i.e., nonclinical, CMC, clinical, safety, labeling, etc.) for regulatory submissions. ♦ Prepare, review, and QA regulatory submissions. ♦ Proactively advise regulatory team on progress, issues, or changes that impact regulatory submissions timelines.

♦ Contribute to strategic planning for product development programs. Anticipate challenges and potential opportunities and recommend regulatory pathways for future development. ♦ Assist clients with preparation and submission of regulatory documentation to health authorities (original NDAs, NDA supplements, INDs, meeting requests, etc.). ♦ Coordinate cross-functional teams (i.e., CMC, nonclinical, clinical, safety, labeling, etc.) to ensure accurate and timely collection and submission of information to health authorities. ♦ Collaborate with clients to identify issues that may impact timelines and development programs. ♦ Maintain a thorough understanding of the status of regulations and issues that may impact product development for clients.

♦ Performed all regulatory functions to submit amendments/supplements for protocol amendments, labeling changes, PBRERs, DSURs, etc., to INDs and the BLA for a licensed product. ♦ Collaborated with EU and ROW affiliates to enable compliant and timely regulatory submissions to Health Authorities (HAs) in those countries. ♦ Managed regulatory timelines and coordinated with cross-funtional teams (i.e., clinical, safety, labeling, regulatory submissions, etc.) to ensure on time submission of responses to FDA queries. ♦ Proactively advised project teams and transparently communicated progress, issues, or changes that could impact timelines and development programs.

♦ Managed regulatory timelines and coordinated with all departments to ensure compliance with federal regulations and continued progression of all ongoing and new vaccine development programs. ♦ Prepared and submitted amendments for 7 active INDs, including new protocols, protocol revisions, annual reports, CMC amendments, etc. ♦ Contributed to strategic planning for product development programs. Anticipated challenges and potential opportunities and recommended regulatory pathways for future development. ♦ Proactively and transparently communicated progress, issues, or changes that impacted timelines and development programs. ♦ Sustained current overview of federal regulations and regulatory guidances to advise divisions of regulatory requirements for product development. ♦ Oversaw company initiative to transition to eCTD submissions by the mandated FDA deadline. ♦ Assessed regulatory programs of subject companies undergoing due diligence for partnering opportunities.

♦ Managed and coordinated the review of the majority of the CAR T gene therapy INDs submitted to FDA; over 28% of other gene and/or cell therapies submissions (300+ INDs/IDEs/MFs); 41 marketing submissions (BLSs, 510(k)s, PMSs); and over 100 meeting requests. ♦ Managed over 50% of Breakthrough Therapy Designation INDs approved by OTAT and numerous Orphan designated products.. ♦ Routinely advised sponsors and staff about regulations, procedures, requirements, and timelines for regulatory submissions. ♦ Oversaw multiple product submissions with co-developed companion diagnostics. ♦ Fostered review team consensus and ensured FDA recommendations were communicated to sponsors in a timely manner. ♦ Coordinated, organized, and chaired formal and informal meetings between FDA and sponsors. ♦ Routinely expedited and coordinated the review of Expanded Access requests. ♦ Developed and implemented staff training on the management of medical product submissions.