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C&G Regulatory Guidance with Lineage Therapeutics' Brian Culley
Manage episode 425320778 series 2739469
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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.
Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com.
Subscribe to our monthly Business of Biotech newsletter.
Get in touch with guest and topic suggestions: matt.pillar@lifescienceconnect.com
Find Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/
Bab
1. Bioprocess Online's BioExpo Live Updates (00:00:00)
2. Optimizing Organizational Leadership and Transparency (00:13:05)
3. Strategic Leadership and Funding in Biotech (00:21:01)
4. Biotech Regulation and Future Challenges (00:28:34)
5. Regulatory Speed and Agility in Biotech (00:38:08)
6. Efficiency and Cost in Cell Therapy (00:46:06)
7. Cell Therapy Manufacturing and Collaboration (00:50:29)
222 episod
Manage episode 425320778 series 2739469
We love to hear from our listeners. Send us a message.
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.
Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com.
Subscribe to our monthly Business of Biotech newsletter.
Get in touch with guest and topic suggestions: matt.pillar@lifescienceconnect.com
Find Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/
Bab
1. Bioprocess Online's BioExpo Live Updates (00:00:00)
2. Optimizing Organizational Leadership and Transparency (00:13:05)
3. Strategic Leadership and Funding in Biotech (00:21:01)
4. Biotech Regulation and Future Challenges (00:28:34)
5. Regulatory Speed and Agility in Biotech (00:38:08)
6. Efficiency and Cost in Cell Therapy (00:46:06)
7. Cell Therapy Manufacturing and Collaboration (00:50:29)
222 episod
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