BioInsights - Cell & gene therapy R&D & regulatory evolution in the United Arab Emirates

Cell & gene therapy R&D & regulatory evolution in the United Arab Emirates

Cell & Gene Therapy Insights 2022; 8(6), 655–660

DOI: 10.18609/cgti.2022.098

Published: 23 June 2022
Asawari Bapat

Asawari (Asa) is a Medical Doctor (MBBS, Bachelor of Medicine and Bachelor of Surgery, MGIMS, Sevagram, India) with her specialization in Clinical Pathology,Transfusions, Transplants, Cellular therapies and Gene Therapies, Biotherapies, Lab Medicine and Immunology (DPB, Post Graduation in Pathology and Bacteriology from College of Physicians and Surgeons, India). She specialises in operating, and managing facilities, and projects globally ( PGDHHM, Hospital and Healthcare Management). Asa has 20+ years of ‘Leadership’ experience, in executing projects and operating facilities such as, complex Diagnostic labs, hospitals, and facilities for Cord Blood Banks, Apheresis (Blood Products, Plasma Products), Transfusion medicine, Transplants, Biotherapies (Cellular, tissue and gene therapies) and Regenerative Medicine. She has been piloting and spearheading specialized Labs, Cord Blood Banks, Cell and Gene Therapy Facilities and Biotech Companies towards quality, compliance and financial success.nAsa is performing a critical part of creating, innovating, designing and establishing novel technologies in the field of regenerative medicine as a subject matter expert. Her expertise involves, encompassing new devices, validating new treatment protocols and new products through their life cycle of designing, complying to the regulatory requirements, creating prototypes, technology transfers, testing, verification, validation and scaling for bringing quality in therapeutic solutions to the patients. Asa has been instrumental in document submissions and in representing clients at CBER, CDER, FDA as a consultant and subject matter expert for TRIP submissions, INTERACT and Type A,B and C meetings for Expedited pathways such as Fast Track Approvals, RMAT’s.