Chuyển sang chế độ ngoại tuyến với ứng dụng Player FM !
C&G Regulatory Guidance with Lineage Therapeutics' Brian Culley
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.
Register for Bioprocess Online’s Bio Expo Live, being held July 30th through August 1st . This inaugural expo is a fantastic opportunity for biopharma companies and contract manufacturers to evaluate the latest and greatest from the comfort of your desktop or mobile device. Conveniently, we’ve broken down the lineup into Upstream Solutions July 30th, Downstream Solutions July 31st, and Quality, Analytical, and Data Solutions August 1st. It’s absolutely free to register for this series of short, digestible, and interactive sessions -- just hit the links above to register for Bio Expo Live today!
Chương
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)
208 tập
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.
Register for Bioprocess Online’s Bio Expo Live, being held July 30th through August 1st . This inaugural expo is a fantastic opportunity for biopharma companies and contract manufacturers to evaluate the latest and greatest from the comfort of your desktop or mobile device. Conveniently, we’ve broken down the lineup into Upstream Solutions July 30th, Downstream Solutions July 31st, and Quality, Analytical, and Data Solutions August 1st. It’s absolutely free to register for this series of short, digestible, and interactive sessions -- just hit the links above to register for Bio Expo Live today!
Chương
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)
208 tập
Tất cả các tập
×Chào mừng bạn đến với Player FM!
Player FM đang quét trang web để tìm các podcast chất lượng cao cho bạn thưởng thức ngay bây giờ. Đây là ứng dụng podcast tốt nhất và hoạt động trên Android, iPhone và web. Đăng ký để đồng bộ các theo dõi trên tất cả thiết bị.