C&G Regulatory Guidance with Lineage Therapeutics' Brian Culley

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When we last caught up with Brian Culley, CEO at Lineage Cell Therapeutics, it was January, 2021. A pandemic was raging. His company was moving mountains to keep its OpRegen dry AMD clinical trial together, and did so despite lockdowns that kept a largely aged patient population from setting foot anywhere near a healthcare clinic. Lineage emerged stronger, signing a collaboration and license agreement with Roche and Genentech later that year. In May of this year, it doubled down on the commitment with a new services agreement with Genentech to support the OpRegen program. All this, while simultaneously progressing its OPC1 spinal cord injury program into Phase 2 and laying the clinical groundwork for programs in hearing loss, vision loss, and neurologic indications. On his long-overdue return to the Business of Biotech, Culley opens up on how the company addressed struggling programs, wrestled manufacturing control issues and delivery inefficiencies in its spinal cord program to the ground, and maintained control of its regulatory progress along the way.

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