Anthony Lodge | CMC – Regulatory Lead
Kite Pharma, a Gilead Company

Anthony Lodge, CMC – Regulatory Lead, Kite Pharma, a Gilead Company

Having studied for a degree in Biochemistry and a PhD in Cell Biology, Anthony spent his early career in drug discovery research in academia and the pharmaceutical industry. Anthony entered the ATMPs field in 2009 through a role at UCL Institute of Ophthalmology’s clinical cell therapy unit. He then worked as a regulatory consultant focusing on CMC for ATMPs at ERA Consulting in London, where he was involved in the successful Marketing Authorisation Application for Chiesi’s tissue-engineered product, Holoclar. Anthony moved to Italy to join Chiesi in June 2016, working on post-authorisation CMC submissions for Holoclar, the MAA for an orphan enzyme replacement therapy, and three clinical-stage ATMP programmes. Anthony joined Kite in July 2018 where he is currently EU CMC-Regulatory Lead for the authorised CAR-T product, Yescarta, and other CAR-T therapies in development.

Appearances:



Conference Day 1 - Tuesday 31st March 2020 @ 09:20

Realizing the promise of ATMPs for patients around the world

  • Working with regulators to navigate scale up challenges in manufacturing
  • Strategies in supply chain and patient delivery
  • Tackling post manufacturing commercialization challenges such as pricing and finding highly skilled experts
  • Durability

Conference Day 2 - Wednesday 1st April 2020 @ 12:00

Yescarta’s journey and beyond

  • Kite is providing CAR-T therapy to lymphoma patients in US, EU and other markets through the commercial product, Yescarta
  • Yescarta reached the market through the FDA’s and EMA’s expedited development programmes (Breakthrough Therapy and PRIME)
  • Kite is expanding global access to Yescarta and developing next generation products for lymphoma and solid tumours

Conference Day 2 - Wednesday 1st April 2020 @ 12:20

Panel discussion: Regulatory submissions: gathering the evidence

last published: 04/Jun/20 08:25 GMT

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