Exhibitors Search
LinkedBio Co., Ltd.
Booth no.
P70
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Exhibition
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|KOREA LIFE SCIENCE |
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Country
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Address
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|317 Bongeunsa-ro, Gangnam-gu, Seoul, Republic of Korea |
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Tel
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|+82-2-6221-1744 |
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Exhibits
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| We manage non-clinical and clinical development on behalf of sponsor companies, acting as their PM (including development strategy and regulatory/IND stages) |
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Company Type
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| CRO / CMO Company , etc(비임상, 임상 개발 PM 역할 ) |
Exhibitor Information
LinkedBio is a specialized non-clinical and clinical development company. Over the past five years, we have taken on development programs that had run into difficulty ? centered on assets such as cell therapies, advanced regenerative medicine products, oncology drugs, and medical devices ? and carried them through to IND approval and regulatory success.
We take on drug and biotech development projects on behalf of sponsor companies, acting as their PM across the full cycle: from non-clinical studies through Phase 1?3 clinical trials to IND approval and regulatory readiness. Our team is made up of pharmaceutical and medical experts with over 20 years of experience each, working as an extension of the sponsor's own organization.
Since our founding, we have delivered 9 IND approvals across a total of 21 development programs, spanning cell and gene therapies, antibodies, small molecules, and medical devices at various stages of development.
We are looking for development partners who wa
We take on drug and biotech development projects on behalf of sponsor companies, acting as their PM across the full cycle: from non-clinical studies through Phase 1?3 clinical trials to IND approval and regulatory readiness. Our team is made up of pharmaceutical and medical experts with over 20 years of experience each, working as an extension of the sponsor's own organization.
Since our founding, we have delivered 9 IND approvals across a total of 21 development programs, spanning cell and gene therapies, antibodies, small molecules, and medical devices at various stages of development.
We are looking for development partners who wa
Exhibit Description
What LinkedBio provides is sponsor-sided project management. Unlike consultancies that only advise from the outside, or CROs that only run the studies they are handed, we take on real roles and responsibilities inside the sponsor's organization ? directly executing development strategy, study design and operations, and regulatory response.
Our work is organized into three services: full-cycle development partnership, IND strategy and approval readiness, and clinical trial project management. All three come from a single principle: put the right specialist in place at the right moment. Every stage of development calls for different expertise, but few sponsors can keep all of it in house ? and that gap is what turns into delays, cost overruns, and ultimately failed submissions.
Our work is organized into three services: full-cycle development partnership, IND strategy and approval readiness, and clinical trial project management. All three come from a single principle: put the right specialist in place at the right moment. Every stage of development calls for different expertise, but few sponsors can keep all of it in house ? and that gap is what turns into delays, cost overruns, and ultimately failed submissions.
Individual Exhibit/Technology Introduction (Detailed)
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Product Name : Full-Cycle Drug & Biotech DevelopmentWe work alongside sponsors across the entire development cycle, from non-clinical study design through Phase 1?3 trials to marketing authorization preparation. Specialists in non-clinical efficacy and toxicology, ADME, regulatory affairs, and clinical operations are brought in at the right stage, keeping one coherent strategy intact across phases. The point is to remove the drift that happens when a program is split across multiple vendors.
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Product Name : Clinical Trial Sponsor-sided PMWe manage the full clinical trial process as the sponsor-side project manager: CRO selection and oversight, protocol design review, study monitoring, and data quality management, all executed on the sponsor's behalf. This closes the oversight gap that outsourcing alone does not cover ? the part of the trial that remains the sponsor's responsibility no matter who runs it.
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Product Name : IND Strategy & Approval ReadinessWe design the development strategy around IND submission, defining the required non-clinical package and regulatory expectations in advance to raise the probability of approval. We have secured 9 IND approvals since our founding, including novel modalities such as cell and gene therapies where regulatory precedent is thin. Many of these were programs we took over after they had already stalled.
KYUNGYON EXHIBITION CORP.
