Yuchen Tsai

 Review and evaluate nonclinical data of drug applications (including IND, NDA and BLA) for safety assessments.  Communicate conclusions with a multidisciplinary review team (including clinical and clinical pharmacology reviewers).  Make regulatory recommendations to and communicate/meet with industry representatives.

 Make regulatory recommendations in CMC, non-clinical and clinical topics  Provide regulatory guidance to the study teams to aid in the preparation of regulatory submission. Author and submit regulatory documents, such as IND and amendments, in eCTD format.  As Sponsor's Authorized Representative, manage the communication with the FDA and the study teams to facilitate regulatory review and address study issues. Manage the life cycle of IND studies.

 Author and maintain regulatory documents, including INDs, amendments, IND annual reports, and clinical trial protocols  Edit and review informed consent forms according to GCP regulation  Review regulatory documents for clinical research site activation  Participate in investigator meetings, and discuss with drug sponsors to exchange information of clinical study designs and execution

 Review, evaluate, and summarize pre-clinical results, including pharmacological and toxicological studies, for submissions of INDs and amendments  Author and update regulatory documents for clinical trials, including INDs, IND annual reports, Investigator’s Brochures, correspondence letters, clinical trial protocols, and clinical study reports  Meet with drug sponsors to exchange information of clinical study designs and trial results  Comprehensively study scientific literature, familiarize with current study reports, and update sponsors with drug safety information

 Serve as a key person in charge of developing three pre-clinical cancer drugs that show 120-fold potency than competitors  Lead the project to identify more than 100 DNA damage hotspots in collaboration with scientists from various institutions  Constantly present findings at meetings and international conferences  Demonstrate expertise in supervising, mentoring, and training six graduate/college students and two lab managers  Deputy to the principal investigator in securing more than $1.2M in grant funding through completion of projects in a timely manner

 Provide recommendation regarding clinical trial design, business development, and fund raising strategy to a pharmaceutical company through surveying first-hand opinions from professionals and researching databases

 Discovered a new biomarker ISG15 for cancer, fibrosis, and inflammation, which resulted in a patent application  Successfully identified the cell signaling and immune responses induced by cancer drugs

 Ensured accuracy in reviewing the university inventions and drafting patent applications  Initiated and maintained active communications with technology licensing customers

 Accurately processed clinical samples and profiled gene expression in cancer patients  Administered all data in accordance with the Good Clinical Practice (GCP)

 Purified dengue virus from patients to accurately monitor viral mutation and disease progression  Accomplished the development of a highly sensitive quantitative real-time PCR (qPCR) assay to quickly determine the patient viral load  Created a cell-line based model of viral protein expression to study viral-host interaction

Dissertation: "The Regulator Role of ISG15, a Small Ubiquitin-like Modifier, in Tumorigenesis and Cancer Progression"

Dissertation: "Expression of the Envelope Glycoprotein and Establishment of a Cell Fusion Assay of Dengue Virus"