Yuwei Wang Email & Phone Number

Fresno, CA, US

Cambridge, MA, US

• Played a key role in U.S. market launch of orphan gene therapy through accelerated approval and supported its EU submission and post-marketing change controls
• Led submission process for amendments, supplements, annual reports, and post-marketing submissions, direct communicated with FDA in critical negotiations
• Developed regulatory strategy and led cross-functional teams to implement plans with risk assessments and guided SMEs with regulatory insights in document development
• Authored and reviewed eCTD Modules and provided risk assessment to pre/post-marketing changes and manufacture deviations
• Received company’s annual Culture Award in 2022 in recognition of exceptional performance

Clovis, CA, US

• Established a regulatory affairs course for PharmD students covering regulatory requirements for Drugs, Biologics, and Medical Devices
• Chaired Academic Progression and Standards Committee, interpreted policies, identified solutions, and promoted the appropriate use of standards to assess and uphold academic standards
• Mentored student rotations as a preceptor on public health of diabetes prevalence, statistical data analysis, and Pharmacoeconomics and cost of therapeutics
• Conducted research on regulatory landscape for lyophilized liposome-based RNA drug development and licensing. Published findings as first author in peer-reviewed journals

Dublin, Coolock, IE

• Led Kybella lifecycle CMC development and supported its global marketing
• Authored and updated Module 3 sections to support its global marketing
• Led Kybella post-marketing formulation optimization and managed project with cross-functional teams on excipient vendor selection and clinical supply manufacturing
• Reviewed project protocols and study reports, managed document and change controls

Teaneck, NJ, US

• Led Tech Transfer for clinical supply manufacturing and prepared regulatory documents to support product's IND applications
• Led the tech transfer with two European CMOs and successfully scaled up the process for commercial production
• Managed project with cross-functional teams and internal / external stakeholders to ensure production met regulatory standards and on-time delivery
• Authored Module 3 sections, validation reports for IND amendment submissions supporting continuous phase II clinical trial and future NDA submission
• This achievement led to a pharmaceutical company (Bristol-Myers Squibb) acquiring the drug

Teaneck, NJ, US

• Developed an innovative lyo-formulation and filed it to global patent agencies
• Developed freeze-drying process at pilot scale, applied Quality-by-Design (QbD) for optimizing critical formulation and process parameters
• Authored and reviewed formulation process validation reports supporting IND application

Teaneck, NJ, US

• Successfully developed a cell-based assay specifically for evaluating tubulin-binding drug's efficacy
• Published findings as first author in peer-reviewed journals

Salt Lake City, Utah, US

• Developed novel implant devices and siRNA drug combination delivery systems
• Biocompatible bone filler mediated liposome-based siRNA targeting delivering to osteoclasts to inhibit excess bone resorption
• Device-based local delivery of siRNA against mammalian target of rapamycin (mTOR) in a murine subcutaneous implant model to inhibit fibrous encapsulation
• Awarded the university's Graduate Research SEED Grant for my project on a bone filler and siRNA combination delivery system
• Mentored an undergraduate in research skills and supervised her graduate research project, resulting in her co-authorship on one of my publications.
• Published as first author in 6 peer-reviewed journals

北京, Beijing, CN

• Purified and identified functional proteins from natural snake venom using chromatographic techniques and HPLC-MS, followed by testing their pharmaceutical effects in both in vitro assays and in vivo animal models
• Published findings as first author in a peer-reviewed journal

Phd, Pharmaceutics

Master Of Science - Ms, Medicinal And Pharmaceutical Chemistry

Bachelor'S Degree, Pharmaceutical Sciences