While adeno-associated vector (AAV)-based therapies have seen clinical and commercial success (3 FDA approvals to date), challenges with manufacturing at scale, delivery specificity, packaging capacity, and repeat dosing remain. As advanced therapies broaden to larger patient populations and wider indications, developers will need to consider upgrades and alternatives such as adenovirus, oncolytic virus (e.g., HSV, retrovirus), and lentivirus.
Center for Breakthrough Medicines’ Chief Technical Officer Avi Nandi and SVP of Vector Manufacturing Emily Moran will discuss the above challenges and how advances in technology, accelerated by a CDMO partner, will prepare innovators for the next generation of advanced therapies.
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Emily Moran is Vice President of Vector Manufacturing at Center for Breakthrough Medicines. She is an experienced leader in cell and gene therapy and biologics manufacturing with a focus on commercial readiness, industrialization, and manufacturing stabilization. She most recently served as Head of Viral Vector Manufacturing at Lonza in Houston, Texas. While at Lonza, she facilitated the scale out and scale up of multiple clinical and commercial gene therapy programs as well as the expansion of the viral vector facility. Prior to Lonza, Emily worked in multiple areas of operations at Sanofi Pasteur. She is experienced in gene therapy and large-scale biologics manufacturing, aseptic processing and filling, supply chain and demand planning, and quality auditing, all with a focus on operational excellence. Emily enjoys leading and developing large, high-performing teams and building patient and asset centricity. She has a B.S. in Biology from Ursinus College and an MBA in Project Management from New York Institute of Technology.
Avi Nandi is the Head of Process Development at Center for Breakthrough Medicines. He has 15+ years of industry experience in Gene Therapy, Viral Vectors, and Vaccines with a M.S. in Biology and MBA (Oct ’21) and has contributed to the regulatory approval of ZOLGENSMA in the U.S. and 10+ Rest of World markets. Avi supported a pipeline of 15+ 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. Past experiences include: AveXis / Novartis Gene Therapies – Global 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.
Arsalan Arif is a news media entrepreneur who set out in 2015 to build his vision of an independent biotech news company at Endpoints News.