Ensure first-time right GMP production of gene therapies: Proven strategies for pre-clinical manufacturing and early process development

Avi Nandi is the Chief Technical Officer at The Center for Breakthrough Medicines. He has 15+ years of industry experience in Gene Therapy, Viral Vectors, and Vaccines with a MS in Biology and MBA and has contributed to the regulatory approval of ZOLGENSMA in US and 10+ Rest of World markets.

Avi supported a pipeline of gene therapy products in development from preclinical to Phase III development and led development and implementation of 4 gene therapy manufacturing processes across 4 GMP and 3 laboratory sites.

He also has 10+ years experience in vaccine and viral vector development including, AAV, adenovirus, herpesvirus, alphavirus, lentivirus, and RNA. His past experiences include: AveXis / Novartis Gene Therapies – Head of Technical Development, Seqirus / CSL – Head of Virology and Cell Culture, Process and Product Development Lead, Novartis Vaccines and Diagnostics – Technical Development Scientist, R&D Microbial and Molecular Scientist Harvard Medical School – Viral Pathogenesis Scientist.

Tatiana Nanda has over 11 years of experience in biotherapeutics across mAbs and cell and gene therapies and is currently the Head of Cell and Gene Drug Product Development at the Center for Breakthrough Medicines.

In this role Tatiana is responsible for design and implementation of a diverse and client-focused Drug Product service portfolio and the establishment of internal formulation and manufacturing platforms. Prior to joining CBM, she was in Janssen, where she led the DP scientific strategy and execution of Oncology and Ocular compounds across multiple modalities including autologous CAR-T’s and AAV gene therapies. 

She was also involved in the startup of J&J’s commercial LVV manufacturing facility in Raritan, NJ. Prior to this, Tatiana worked at GSK in Biopharmaceutical Product Sciences. Tatiana has a BS in Microbiology from the University of Tennessee, a MS in Economics from the Moscow State University, and a PhD in Biophysics & Lifesciences from UT/ORNL.