The topic From Bench to Bedside: Navigating Biosafety in Gene and Cellular Therapy is presented by Dr. Alka Arora, Quality Program Manager at UHN.
The advancement of cell and gene therapy towards standard clinical practice necessitates rigorous biosafety measures at every phase of development, spanning from initial basic laboratory research to clinical trial and commercial production. Adherence to meticulous biosafety protocols in conjunction with GxP requirements mitigates potential risks for the personnel involved in research and manufacturing and ensures the safety, purity, and efficacy of the product. The discussion will underscore the importance of implementing and adhering to comprehensive biosafety standards to enable the safe and successful translation of cell and gene therapies from the laboratory to the patient’s bedside.
Dr. Alka Arora Bio:
With over two decades of experience in CL2 and CL3 research and clinical diagnostic labs, including a Ph.D. in DNA vaccine development for HIV and a Post-Doctoral fellowship working with lentiviral vectors for HIV and SCID gene therapy, Dr. Arora offers extensive expertise in Laboratory operations, safety, and quality. As a former Project Manager at Sunnybrook Research Institute, she established a CL2 Influenza virus research lab and initiated a biosafety program for Sunnybrook Research Institute. Subsequently, at the Hospital for Sick Children, she oversaw biosafety for 150+ labs, established CL2 + facility (CL2 with CL3 operational practices) for work with lentiviral vectors alongside a comprehensive training program, and provided guidance to the pharmacy team on the safe handling of gene therapy products for clinical trials. Currently, as Quality Program Manager at UHN, Dr. Arora oversees quality for Apheresis and Cell Processing at Princess Margaret Cancer Centre, where CAR T-cell therapy is used as the standard of care treatment.
The webinar will be held on April 2, 2024 at 12:00 CST.
Registration is limited so we encourage you to RSVP soon! Please reply to this email (cabsacsb@gmail.com) to confirm your attendance and a Zoom link and meeting invitation will be provided to you.
Please submit any questions in advance and there will be an opportunity to ask questions after the session.
