University of Iowa

St. Cloud State University

Principal Investigator/ Regulatory Affairs, Oncology/ Cell & Gene Therapies at FDA

Research, Regulation and Management of Cell & Gene Therapies, Oncology Products and Therapeutic Vaccines at FDA

Chief, Tumor Vaccine and Biotechnology Branch

Senior Investigator/ Regulatory Affairs, Oncology/Cellular and Gene Therapies

• Head of a translational research lab developing novel cell and gene therapy products. Current projects include development of immunomodulatory AAV vectors for gene therapy and engineering novel CAR-T cells for cancer therapy. Lab is also studying non-pathogenic human RNA viruses as a potential vector for gene therapy, developing novel processes to manufacture cell and gene therapy products and assays to identify CQAs predictive of safety and efficacy.  
• Gene editing technologies are also studied to assess its effect on safety and efficacy of gene edited therapeutic products.
• Perform regulatory review of applications for oncology and gene and cell therapy products including viral/ non-viral vectors, oncolytic viruses, CAR-T cells, other various cellular immunotherapies, therapeutic cancer vaccines and products manufactured using gene editing/ modifying technology such as CRISPR/Cas9, TALEN etc.
• Train fellows on regulatory review of gene and cell therapy applications.
• Provide regulatory advice to manufacturers of gene, cell therapy and combination products in formal and informal settings.
• Provide expertise to develop new policies in the emerging area of cell and gene therapies and in preparation of regulatory documents such as guidance documents etc. 
• Participate in various working groups within FDA and between academic and industry partners. 
• Provide outreach to various stakeholders.

Principal Investigator/ Regulatory Affairs

Work with interdisciplinary team of Virologist, Biochemist, Immunologist, and Computational biologist to predict, test and evaluate vaccine effects on human immune system.
Development of Protein and RNA based immune modulators.
Development of cellular assays to screen multifunctional antivirals.

Research, Division of Infectious Diseases

Responsible for preparing purified viral antigens for various immunodiagnostic products. 
Inactivation of viruses by physical and chemical methods, and validation by using variety of viral assays (HAI, TCID50, plaque assays) 
Worked with various pathogens in BSL-2 and BSL-3 facility (HIV, Influenza, HSV-1, HSV-2, CMV, EBV, HHV-6, HHV-8, Dengue)
Preparation and validation of new SOPs.
Responsible for regulatory affairs including quality control of finalized products.

Nirjal Bhattarai