Ye (Stella) Zhou

• Served as a primary liaison with external KOLs and internal cross-functional teams R&D, Quality, Marketing, and Clinical Affairs to ensure the successful completion of the clinical trials • Authored research proposal and business plan for financing and funding and successfully completed series-A financing • Authored clinical trial protocols (in both Chinese and English) for IVD study (liquid biopsy) • Negotiated and finalized the contract with clinical trial site • Initiated and closed out the clinical study for companion IVD test in renal cancer patients • Analyzed the results of the clinical trial and drafted clinical study reports

• Led the effort of developing and presenting the business plan and completing the pre-A financing. • Led R&D team develop innovative NGS-based liquid biopsy assays and pioneered in designing multi-centered clinical trials to validate these assays. • Led the company receive the NGS CAP Accreditation and the NGS NCCL (National Center of Clinical Laboratory) EQA Certificate. • Authored and finalized clinical investigation protocols for the liquid biopsy clinical trials. • Negotiated the contract and budget with CROs. • Managed and worked with CROs to conduct clinical trials across 16 national hospitals and managed two multi-centered clinical trials for liquid biopsy tests for different types of cancers. • Collaborated with cross-functional teams including operations, quality, regulatory affairs, marketing and sales, to strategically plan for product market launching. • Served as a medical science liaison and established the collaboration with academic institutes and national cancer centers. • Actively communicated with national and regional government, such as CFDA and China National Health Commission (now NMPA), to stay posted on the changes and updates of the regulations.

•Tested gene-targeted oncology drug candidates in xenograft mouse models and analyzed changes in tissue-specific gene expression profiles caused by drug treatment •Designed and developed PK/PD studies for prostate cancer drug candidates •Designed and conducted clinical trials with Johnson&Johnson on circulating tumor cell study •Designed a rodent model that mimics aging process in human and using it to determine whether low androgen level as aging can promote the incidence of prostate cancer •Designed and used a rodent model to test that low androgen level can select prostate stem cell outgrowth and used RNA-seq to discover if low androgen could induce genomic rearrangement in prostate stem cells

Project Conducted: Conducted research on current international regulation on biosimilar and drafted a report on current regulatory oversight on Biosimilar Provided strategies for performing non-clinical study on a non-opioid biologic 510(k) draft and submission for a steerable biopsy needle Developed a clinical monitoring plan for Marijuana phase II study in mentally impaired veterans Developed pharmacovigilance strategy and pharmacovigilance plan for a newly marketed drug with a series of unexpected adverse events reporting Drafted an efficacy and safety report on FDA advisory meeting for an orphan drug mannitol Designed and developed a clinical study protocol for phase IV study