Every second counts: what real cell and gene therapy launches teach us

Wednesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

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Every second counts: what real cell and gene therapy launches teach us

For cell and gene therapies (CGTs), the path from a successful clinical readout to reliable commercial supply remains one of the most technically and operationally demanding transitions in the pharmaceutical industry. The final 24 months before launch is a critical window that is still often underestimated by the teams navigating it. During this period, processes must become robust and scalable, tech transfer and validation must be completed, manufacturing capacity secured, and supply chains prepared to support commercial demand.

This webinar will cover the practical aspects of preparing for CGT commercial approval and manufacturing, based on real lessons from launched programs. The session will be delivered by Lonza’s Global Head of Launch Excellence and Digitalization for Specialized Modalities.

If commercialization is part of your roadmap, whether you are early in development or already planning late-stage manufacturing, this webinar will help you prepare for the realities of commercial manufacturing and supply.

Learning points:

Understanding the transition from clinical to commercial manufacturing, including process robustness, validation, and GMP expectations.
Practical insights into tech transfer and scale-up challenges and how to avoid common late-stage delays and comparability risks.
Key operational priorities in the final 24 months before launch, including raw materials, vector supply, capacity, and supply chain planning.
How to prepare processes for commercial scale and cost of goods, including automation and process industrialisation.

Alexander Huber, PhD

Senior Director, Commercial and Strategic Programs at Lonza

Alexander Huber is a seasoned executive with a proven track record of 12 years in the advanced therapies sector, having worked for Novartis and Lonza.At Novartis, he was part of the cell and gene therapy unit, working on early and late phase projects with increasing levels of responsibilities. As part of the team launching Kymriah, he led the ramp up of the manufacturing site in Kobe, Japan. The site received commercial approval in November 2020 as the first CART manufacturing site in Asia.Today, he leads the global "launch excellence" team in the specialized modalities platform of Lonza. His team is responsible for commercialization of novel advanced therapies from various global customers produced at Lonza. Besides his role at Lonza, he is working as academic editor for the international journal “Swiss Medial Weekly”.

Mr. Huber studied molecular biology at the ETH Zürich, Switzerland. In his PhD thesis he was working on the development of a gene therapy against epilepsy. He lives in Rheinfelden, Switzerland, is married, and has three children.

In 45 Days

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