Message from the CEO

Message from the CEO

Thank you for visiting the LinkedBio website.

I am Sung-Woon Hong, CEO of LinkedBio Inc.

LinkedBio was founded in 2021 with a clear philosophy: to stand alongside sponsors as a trusted, sponsor-sided execution partner throughout the challenging journey of drug and biologic development — someone you can always rely on as “your side.”

Challenges Facing the Pharma & Biotech Industry in Drug and Clinical Development

Today’s pharmaceutical and biotech industry faces greater challenges than ever, driven by rapidly escalating costs and the increasing complexity of development strategies, including clinical trial design. Those who have worked on the front lines of drug and clinical development understand these difficulties firsthand.

Perhaps the most daunting reality is that in drug and clinical development, success or failure is often determined only after the majority of time and resources have been invested. We have witnessed far too many cases where programs fail at that critical juncture due to inadequate regulatory procedures, suboptimal development strategies, or process shortcomings. These setbacks extend beyond individual companies — they impact the broader pharmaceutical and biotech industry.

In practice, many pharmaceutical and biotech companies, constrained by limited resources, struggle to deploy the right specialists at the right time for each development phase. Instead, they attempt to stretch existing staff beyond their areas of expertise — a common but ultimately counterproductive approach.

Strategic oversights that occur when the right experts are not engaged at the right stage may seem minor at the time, but frequently become major obstacles down the line. Conversely, we also see companies that hire specialists prematurely — before their expertise is needed — only to carry the burden of fixed personnel costs without productive utilization.

Having experienced these challenges firsthand in the field, LinkedBio was built on the unwavering core value of going beyond advisory work to function as an extension of our sponsors’ own organizations — thinking together, executing together. We continue to actively partner with sponsors based on this philosophy.

Delivering High-Quality R&D Capabilities Built on Deep Expertise

Deploying the right specialists at every stage of development

We possess strategic planning and operational capabilities spanning the full drug development lifecycle — from non-clinical studies through Phase I, II, and III clinical trials to IND approval.

Proven Track Record: Our team of pharmaceutical and medical experts with 20+ years of experience has successfully delivered 9 IND approvals and managed 21 development programs to date.

Multidisciplinary Expert Team: Top talent from non-clinical efficacy/toxicology, regulatory affairs, clinical operations, and other disciplines collaborate to produce high-quality study outcomes with agility and precision.

Embedded Hands-On Project Management: We assume defined roles and responsibilities as if we were the sponsor’s own internal team, maximizing the probability of project success through hands-on support.

Rigorous Ethics and Collaborative Excellence

We believe that drug and biologic development is a noble, life-impacting endeavor. Every member of the LinkedBio team upholds strict regulatory compliance and unwavering ethical standards as the foremost principles governing our work.

Grounded in a spirit of service excellence, we build close collaborative relationships and, through our deep expertise, work alongside sponsors to generate trustworthy research and trial results — contributing to the advancement of the bio-healthcare industry.

Until your invaluable research assets bear fruit as successful therapeutics, LinkedBio pledges to be your most steadfast and trusted partner.

Thank you.

LinkedBio Inc.

Sung-Woon Hong, CEO

CEO Sung-Woon Hong

Sung-Woon Hong

CEO

LinkedBio Inc.