[Brief Introduction of Seminar]

Real-world data (RWD) are increasingly being used throughout the drug development lifecycle, from characterizing disease burden and unmet medical needs to optimizing target populations and clinical trial design, constructing external control arms, supporting regulatory decision-making, evaluating post-marketing safety and effectiveness, and informing indication expansion. From this lifecycle perspective, this lecture will examine how important identified risks, important potential risks, and missing information specified in a risk management plan (RMP) can be translated into focused research questions and implemented through non-interventional study protocols suitable for regulatory use. It will also present a case study in which symptom-based adverse events that are difficult to capture using structured data alone are identified through clinical narratives, artificial intelligence, and natural language processing, followed by validation through expert chart review. The lecture will discuss the practical requirements for advancing RMP-based RWD studies beyond routine post-authorization obligations toward a reproducible and regulatory-ready evidence lifecycle that connects evidence generated throughout drug development with post-marketing safety management and further development.

[Brief Introduction of Speaker]

Master’s degree in Public Health from Yonsei Univ., currently pursuing Ph.D.​

Pharmaceutical, medical expert with 20+ years of experience in clinical, academic, and medical departments at Pfizer Korea, Eli Lily Korea, and Daewoong Pharma.​

Specialist member of the ARICTT(Advanced Regulatory Innovation for Clinical Trials Transformation) ​

Expert in post-marketing safety evaluation research based on RWD ​

Extensive practical experience and consulting in regional and international regulations and clinical trials In full-scope ​

[Brief Introduction of Seminar]

Molecular docking in early-stage drug discovery is, computationally, a problem of finding the optimal combination among an enormous number of possibilities. Combinatorial optimization of this kind is one of the areas where quantum computing is most anticipated to contribute. This talk introduces an approach that recasts the docking problem in graph form so that it can be addressed on a quantum computer.

When the possible pairings between atoms of the ligand and those of the protein binding site are represented as nodes of a graph, and mutually incompatible pairings as edges, docking becomes the problem of finding the optimal set of non-conflicting pairings — a Maximum Weight Independent Set (MWIS) problem. Neutral-atom quantum computers are particularly well suited to this formulation: because neighboring atoms cannot be simultaneously excited, the "no-conflict" constraint is enforced directly by the hardware itself.

The talk also shares practical experience from applying this method to protein–ligand systems, and discusses what is achievable with today's quantum computers as well as the challenges that remain.

[Brief Introduction of Speaker]

Dr. Keun-Su Choi is a Principal Researcher at Quantum Intelligence Corporation (QIC) and serves on the Board of Directors of the Korea Quantum Industry Association, where he leads the identification of industrial use cases for quantum computing, spanning pharmaceutical and biotechnology applications as well as chemistry and materials. In drug discovery, he is investigating the reformulation of molecular docking as a graph optimization problem solved on neutral-atom quantum computers, with application to protein–ligand systems. Dr. Choi received his B.S. and Ph.D. in Physics from Seoul National University, specializing in condensed matter theory. He subsequently held research positions at KIST and UNIST, where over more than a decade he applied quantum-mechanical simulation to elucidate atomic-scale phenomena across energy, environmental, and catalysis applications. He has published more than 40 papers in peer-reviewed international journals.​

Radiosensitizers are gaining prominence as a key catalyst to overcome the limitations of radiation therapy. This presentation clarifies the concept and mechanism of radiosensitizers, while highlighting recent major clinical achievements and current development milestones.

Building upon the evolving development trends of radiopharmaceuticals, we will also explore the paradigm shifts and future landscape awaiting the global cancer therapy market.

[Brief Introduction of Speaker]

Hoyun Nam is an expert with over 10 years of experience in market intelligence (MI) within the healthcare sector, currently serving as the Head of Market Intelligence and Business Development (BD) at VSPharmTech. Leveraging in-depth market understanding, she is spearheading optimal strategic partnerships for the company's core oncology pipelines.

[Brief Introduction of Seminar]

Targeted protein degradation technology (also known as PROTAC) has been getting huge attention as a new emerging therapeutic modality after successful in vivo efficacy in animal model in 2015. Beyond inhibition of protein activities, TPD fundamentally degrades disease-causing proteins. Depending on the target biology, degradation of target protein could maximize therapeutic efficacy. Since TPD has better selectivity compared to small molecule inhibitors, it shows reduced or minimized off-target effect. Cell cycle protein has been challenged as cancer target for decades, only few targets were druggable, still many targets are remained undruggable mainly due to dose limiting toxicities. TPD can be an effective approach against hard to druggable target.

[Brief Introduction of Speaker]

Siwoo Choi received both his B.S. and Ph.D. degrees from Sungkyunkwan University. He conducted research on siRNA delivery platform at Bioneer, followed by research on antibody- and antibody-drug conjugate (ADC) therapeutics at Celltrion. In 2018, he founded Uppthera, a company focused on targeted protein degradation (TPD) technology.​

[Brief Introduction of Seminar]

(Keynote Session) Current Status and Outlook of Korean New Drug Technology Out-Licensing

[Brief Introduction of Speaker]

 ​ 

[Brief Introduction of Seminar]

This session provides an overview of China's pharmaceutical and biotechnology market, key industry trends, and emerging partnership opportunities. Participants will gain insights into licensing, strategic collaborations, and cross-border business development, supported by real-world global partnering and commercialization success cases.​

[Brief Introduction of Speaker]

Mr. Zheng is the Managing Partner of YAFO Capital. He has been focusing on cross-border investment in healthcare sector since the beginning of his career life. Mr. Zheng has been involved in 30+ global life science BD transactions and advisory assignments and has led the team to close numerous deals. Before joining YAFO Capital, He was an equity research analyst covering the pharmaceutical and medical device sectors at Roth Capital Partners, a full-service investment banking firm headquartered in California. Mr. Zheng received a MS in Finance from Vanderbilt University in the US and a BS in Finance from the University of International Business and Economics in Beijing.​

[Brief Introduction of Seminar]

Overview and Progress Update: KIT-KIBO Innovative Startup Growth Support Program​ 

[Brief Introduction of Speaker]

Team Leader, Daejeon Innovative Startup Team, KIBO (Jan. 2026–Present)​

[Brief Introduction of Seminar]

Digital innovation, regulatory changes, and capital inflows shaping the global clinical trials market, along with recent key trends​

[Brief Introduction of Speaker]

Current: TRIALIGN Consulting, Founder & Representative Consultant

Previous: Professor at the Graduate School of Medicine & at the Graduate School of Public Health Industry, Cha University; previously served as head of of New Drug Development Division, Sr. director at GC Cell, Head of Clinical Trial Business Unit, Executive Director at DREAMCIS, Country Manager of PAREXEL International Korea, and Global Quality Management Director of PAREXEL International.

Graduated with a Master's degree from Seoul National University; Doctor of Public Health from Cha University of Science.​

[Brief Introduction of Seminar]

This session provides an overview of Malaysia's regulatory requirements for Korean pharmaceutical ingredients and finished products. Participants will gain insights into key regulatory requirements, product registration processes, and important considerations for compliance with NPRA requirements.​

[Brief Introduction of Speaker]

Zarina Rosli is the Head of the Industrial Development and Communication Section at the National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health Malaysia. She is responsible for stakeholder engagement, regulatory communication, and facilitating interactions between NPRA and the pharmaceutical industry. With extensive experience in pharmaceutical regulation, she actively supports industry development by providing guidance on Malaysia's regulatory requirements​