New York City Metropolitan Area
A highly motivated team lead and scientist with excellent strength in quick learning, strategic/analytical thinking, ideation, intellection, problem solving, and people management. • Lead assay development, validation and regulated bioanalysis of immunogenicity (ADA, NAb, and T-cell response), biomarker, and viral shedding assays in gene therapy drug development. • Oversight of external CRO partners • Strategic planning of resources and ensuring high quality deliverables within timelines in support of key stakeholders • Experienced in representing bioanalysis in cross-functional teams. • Excellent written and oral communication skills. In-depth knowledge in • Drug development, both gene therapy and small molecule • FDA/EMA Guidance, including Bioanalytical Method Validation, Immunogenicity, Viral shedding • Prism, Abase and Biovia Electronic Notebook (ELN)
1. Leading assay development, validation and regulated bioanalysis platforms: • Ligand binding assays, including ADA assay (MSD). • Cell-based immunogenicity assays, including NAb assay and ELISpot assay. • qPCR assays, including viral shedding assay. • Developing bioanalytical strategies for gene therapy programs. 2. Managing CROs • Leading evaluation & /reassessment of CRO’s capabilities in supporting regulated bioanalysis and lab audits. • Managing assay development, qualification, validation, and bioanalysis for clinical studies conducted at CROs in the US, Canada, UK, and France. 3. Representing bioanalysis in cross-functional teams • Contributing to internal cross-functional meetings with Research, Pharmacology, Toxicology, CMC, clinical operation and clinical development. • Contributing to external team meetings with central lab and clinical trial managing organization, including sample collection/processing instructions in the lab manual, and DTA drafting, reviewing, and implementation. • Facilitating sample tracking among clinical sites, central lab, and bioanalytical CRO labs for global clinical studies. 4. People management and in-house biomarker bioanalytical assay development/validation • Leading a scientific team to develop in-house large-molecule biomarker assay and viral shedding gene therapy assays. • Equipment evaluation, purchase, set up, training and maintenance. • Evaluating new technologies. • Contract managing and negotiating.
1. Provided direct oversight and interacts with the CROs for quantitative analysis of biological samples, gene synthesis, construct cloning, plasmid production and QC, AAV production for clinical and/or preclinical studies. 2. Collaborated with clinical/preclinical drug development program teams. 3. Directly led CRISPR transcriptome engineering and mRNA modulation projects for rare diseases, presented results and timelines at meetings and exercised independent judgment. 4. Trained and supervised junior scientists.
1. Initiated a CRISPR-based project for gene regulation and analyzed samples for large molecule expression using qPCR and MSD. 2. Performed large molecule bioanalysis of samples from cells, plasma, muscle tissues treated with PTC small molecule compounds using ELISA, MSD and Luminex. 3. Designed and developed cell-based assays for HTS to identify small molecules to modulate mRNA expression in mammalian cells. 4. Investigated the mechanisms of how small molecules regulate protein expression using a rare genetic disease model using qPCR, MSD, flow cytometry and Ussing Chamber electrophysiological assay. 5. Collaborated and worked with cross-functional groups, external groups and CROs. 6. Trained and supervised a junior scientist.
Research Advisor: Dr. David M. Bedwell, Department of Microbiology, University of Alabama at Birmingham. Dissertation Committee Members: Drs. David M. Bedwell, Zsuzsanna Bebok, Robert Allen Kesterson, Kevin L. Kirk and Steven M. Rowe. 1. Characterized a new synthetic aminoglycoside compound that suppresses CFTR-G542X nonsense mutation more efficiently than an earlier drug in vitro and in vivo: • Designed a series of dual-luciferase reporters containing different CFTR nonsense mutation contexts to test readthrough activity in mammalian cells. • Evaluated and compared the readthrough ability of aminoglycoside derivative drugs in multiple assays, including cell-based dual-luciferase readthrough assay, tissue-based immunofluorescence staining and electrophysiology assay. 2. Identified amino acids inserted at CFTR premature stop codons in human cells during drug-induced nonsense suppression and characterization of their functional consequences: • Developed and optimized a tag-fusion system in mammalian cells for easy detection, purification and quantitation of full-length-protein production induced by readthrough drug. • Helped identify three amino acids inserted at a stop codon during readthrough using tadem mass spectrometry (MS-MS). • Demonstrated the effect of amino acids inserted during nonsense mutation on CFTR protein maturation and function • Demonstrated that a CFTR potentiator (VX-770) and corrector (VX-809) can enhance the function of CFTR mutants obtained by nonsense mutation. 3. Designed reporters for high throughput screening readthrough compounds and Nonsense-mediated mRNA decay (NMD) inhibitors.
Research Advisor: Dr. Jianye Zang, School of Life Sciences, University of Science and Technology of China. Expression, purification and crystallization of the tandem tudor domain of Sgf29 from Saccharomyces cerevisiae. • Helped build a reporter suitable for yeast-original Sgf29 domain expression in E.coli. • Optimized the yield of protein production, expressed, purified and screened crystals for the tandem tudor domain of Sgf29 in E.coli. • Helped resolve the structure of the tandem tudor domain of Sgf29.