Sarah Wallick, PharmD, MS

First regulatory hire for 23andMe Therapeutics and continue to lead as Head of Regulatory Affairs for the Therapeutics Development organization. Led two immuno-oncology programs from preclinical to current clinical stages (Phase 1 and Phase 2). Areas of regulatory oversight include Clinical Regulatory Strategy, CMC Regulatory Strategy, Regulatory Operations, Geographic Regulatory Specialists, and Medical Writing. Submission experience as regulatory lead includes: 2 initial INDs (all Modules) and 1 initial CTA (including IMPD), 11 protocol amendments, 7 CMC (Module 3) & IMPD Amendments, 2 DSURs, and 3 IB updates.

• Served as clinical regulatory lead for FreeStyle Libre product platform. • Led the IDE submission to support pivotal trial for FreeStyle Libre 3. • Authored and led technical PMA supplements, annual reports, and global manufacturing site submissions. • CAPA Approver for regulatory function with CAPA training and certification. • Reviewed and approved manufacturing validation plans and protocols. • Participated in internal and external (FDA and BSI) audits as regulatory SME. • Performed regulatory intelligence research and conducted gap analyses for emerging regulations.

• Negotiated with Health Authorities (FDA, MHRA, ANSM) for periodic reporting summaries. • Met with Health Authorities for individual case reporting queries. • Made final decision on post-market adverse event case reportability. • Authored, reviewed, and approved safety narratives for submission. • Prepared vigilance data reporting summaries. • Led and authored position papers related to reportable criteria.

• Consulting for 503B manufacturing facilities to prepare for FDA inspections and address FDA enforcement actions, such as Warning Letters.

• Served as regulatory lead in the transition from compounding pharmacy to 503B facility under additional FDA jurisdiction as a GMP facility. • Led 3 FDA inspections and responses to resulting FDA 483s (inspection observations).

• Managed drug compounding operations, pharmacy operations, and 5 pharmacy employees. • Implemented company-wide travel clinic including a pharmacist prescriptive authority agreement for travel-related medications and vaccines.