Yoshiko Stowell, PhD, RAC, PMP

The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. As the RAPS SF Chapter Chair, I lead volunteers to create chapter activities (in-person/virtual educational and networking events), recruit new members, and engage members and Sponsors.

Manage all aspects of R&D including Regulatory Affairs, Quality Assurance, CMC, and Clinical Operations for a Phase 3 ready program for the treatment of Alzheimer's disease

Prepared to initiate a Phase 3 study for the treatment of Alzheimer's disease Lead gap analysis of the acquired asset and prepared budgets for the Phase 3 ready program Developed and Implemented Quality Systems

Eidos is a subsidiary of BridgeBio. - Co-lead the IND and CTA (Europe, Canada, Asia Pacific, South American) for NCE (AG10) for the treatment of transthyretin amyloidosis (ATTR) cardiomyopathy and polyneuropathy in two Phase 3 studies - Co-lead the development of regulatory strategies for U.S. and EU - Represented Eidos as one of the Joint Development Committee members with a partner for the development of AG10 in Japan (including PMDA consultation) - Lead regulatory review of IND m3 and IMPD - Lead development of DSUR and IB annual updates

- Lead/co-lead for four development programs for clinical/non-clinical/CMC for the treatment of Parkinson’s disease, PHN, and migraine - Worked with the cross-functional groups (Clinical and CMC) to development and implement approval strategies. - Lead all clinical supply activities for the Brand studies including coordination of manufacturing of clinical supplies/registration lots and testing, management of CPO for on time and on budget delivery, and set up of IXRS/eDC. - Managed and participated in the creation and review of regulatory submissions (IND/IMPD/CTA) including CMC amendments, briefing package, SPA, and annual reports. - Played a key role in transferring responsibilities from Impax to Amneal due to company’s merger - Drafted and/or reviewed correspondence with regulatory authorities. - Actively participated in all activities for Phase I, II, and III clinical studies including development of protocol, ICF and IB and review of essential documents - Attended FDA Type C meeting as a CMC lead - Participated in due diligence of new projects as CMC lead - Coordinated EMEA queries and responses at all review cycles leading to Numient MAA approval (Positive Opinion, 9/24/15, Above and Beyond Award, Sep 2015 for establishing clear project scope and drive the team to delivery of project milestones on time) - Coordinated post-approval CMC variation activities for Numient MAA - Identified gaps and worked on other tasks as needed - Authored/reviewed internal SOPs - Proactively worked with QA to be compliant - Analyzed Drug Safety Data and reviewed annual safety reports

- Lead/Co-lead all CMC activities including management of CMOs, CPO, CROs, and raw material suppliers - Coordinated activities for successful submission of NDA for Aricept Patch for the treatment of Alzheimer’s disease (Spot award, 2009 for being a key contributor to the on-time submission) - Authored CMC sections of NDA and IND as a CMC co-lead - Involved in FDA interactions as a CMC co-lead - Managed tech transfer/scale up for transdermal product - Conducted risk assessment (FMEA) and prepared for PAI - Authored or reviewed SOPs, protocols, specification, MBRs, and CAPAs - Supported GLP/non-GLP pre-clinical studies - Worked on transdermal formulation research leading to three US patent applications (US20100178307A1, US20090291127A1 and US20100080842A1) - Attended Executive/Board meetings as a Corporate Translator (Japanese/English) and Technical Lead

- Hands on formulation research and analytical work on transdermal iontophoretic drug/device combination products including next generation of Fentanyl patch for management of postoperative pain, IONSYS (ALZA Area Award, 2005 for detailed but fast execution of a feasibility project) - Developed electrodes and managed scale up leading to US Patent application (US20080154230A1) - Involved in feasibility studies of novel ocular iontophoretic drug delivery system - Conducted in vivo transdermal transport study on different animal models - Co-lead the implementation of Electronic Laboratory Notebook project as one of the first lab in J&J and worked with a vendor to develop customized software to facilitate repetitive analysis to increase the efficiency (Johnson & Johnson Encore Award, 2006 for a significant contribution to the project)