XenoTheraputicsDirector Clinical Research
Jan. 2021• Spearheads cutting-edge research and clinical translation of (porcine-based) genetically modified, cell and tissues for transplantation that are safe, naturally differentiated, and immune-corrected to be compatible with the human immune system.
• Executes validation of gene edit confirmation analyses utilizing a range of techniques including qPCR, Flow Cytometry, and Sanger Sequencing.
• Successfully performs genetic animal cloning via Somatic Cell Nuclear Transfer (SCNT), demonstrating sophisticated laboratory competencies and expanding the field's understanding of genetic material manipulation.
• Pioneers the manufacturing, clinical application, and regulatory filings (NADA, INDA, BLA, DMF) of our breakthrough drug product, realSKIN, an FDA RMAT and Orphan Drug designated product, demonstrating innovative thinking and practical execution in a clinical setting.
• Lead immunogenic safety and efficacy response analyses, driving product improvements and ensuring product safety including general immune response of transplant, prevention of transmission of zoonotic diseases, and sterility, potency, and quality assessments for batch lot release, in line with cGMP regulatory requirements.
• Maintains rigorous compliance with 21 CFR Part 11 regulated storage methods for all data to ascertain compliance with regulatory standards and to safeguard scientific integrity.