[Brief Introduction of Seminar]

Micro-needle drugs refer to drugs that deliver active ingredients through the skin using microscopic needles to achieve local or systemic effects. With the increasing demand for micro-needle drug development, the Ministry of Food and Drug Safety published the “Micro-needle Drug Quality Guidelines (Guidebook for Applicants)” in 2021. This guide outlines the quality submission requirements and considerations when developing pharmaceuticals using the micro-needle drug delivery method. In this lecture, we will introduce the current status of micro-needle pharmaceuticals under development and explain the quality considerations and common corrective measures for micro-needle product development based on the guide.

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[Brief Introduction of Speaker]

Choi Jeong-Yoon, Health Research Officer, joined the Ministry of Food and Drug Safety in 2003 and has been engaged in quality-related approval reviews, research and development, and testing of biopharmaceuticals (recombinant drugs) and synthetic drugs. Her key achievements include contributing to the introduction of the Common Technical Document (CTD) system for biopharmaceuticals in Korea, the signing of the Korea-Switzerland GMP Mutual Trust Agreement, and the national approval of COVID-19 mRNA vaccines. Currently, she is responsible for quality review of advanced pharmaceuticals such as synthetic peptide drugs, synthetic oligonucleotides, and microneedle drugs.​​

[Brief Introduction of Seminar]

Micro-needle formulations are considered a necessary dosage form for entering the US OTC drug market due to their unique drug delivery method and expected effects. However, due to the special nature of the dosage form, it is difficult to clearly meet the evaluation criteria of the FDA OTC approval system, and strategic preliminary review is essential. This presentation aims to propose strategic directions for obtaining FDA OTC drug approval for microneedle formulations. It will explain key elements such as OTC monograph application, quality standards, manufacturing facility requirements, and documentation criteria based on OTC GMP inspection content for microneedle production facilities, and share practical strategies and considerations for implementation.

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[Brief Introduction of Speaker]

After earning his doctorate from Korea University's Graduate School of Life Sciences, Jin-Wook Lee conducted research on biopharmaceuticals and microneedle formulations. He then expanded his field to quality control, performing quality control tasks such as establishing new GMP systems, and currently serves as the quality control manager at Small Lab. Recently, he successfully prepared for and responded to an FDA OTC GMP inspection of a microneedle patch production facility by appropriately combining research and quality control practices.​​

[Brief Introduction of Seminar]

Tuberculosis is one of the most deadly infectious diseases in human history. In South Korea, there are 30,000 new cases every year, ranking first among OECD countries. BCG is a safe tuberculosis prevention vaccine that has been in use since its strain was first established in 1921. In South Korea, there are two types of vaccination methods: intradermal (free) and stamp (paid). The intradermal type has excellent efficacy but is distributed in 10-dose vials, posing risks of contamination and difficulties in precise dosage delivery during vaccination. The stamp type has the advantage of leaving minimal vaccination scars but is criticized for its low immune induction capacity and uncertainty in dosage. This lecture aims to present the development and efficacy evaluation of a single-dose BCG microneedle patch that combines the advantages of the intradermal and stamp types into a microneedle formulation, enabling excellent immune induction, no vaccination scars, and precise intradermal dose delivery. To this end, this lecture will focus on the manufacturing process and challenges of the micro-needle-type live BCG vaccine patch, introducing research results on the micro-needle coating platform for intradermal quantitative vaccine delivery, efficacy evaluation of the vaccine patch in guinea pigs, and storage stability.

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[Brief Introduction of Speaker]

Kim Se-min, Executive Vice President, earned his Ph.D. in Engineering from Dong-A University's Department of Mechanical Engineering and has successfully completed numerous process development projects in general manufacturing, fine chemicals, and medical devices. He currently oversees new product development at SNVIA, leading the development of cutting-edge medical products such as microneedle patch-type drugs and photopolymerization medical devices. As a project management (PM) expert, he focuses on establishing efficient development processes to enhance the success rate of new product development projects in the medical field by integrating various international standards such as ISO 13485, ISO 9001, and ISO 22716, along with regulatory science (RA) perspectives.​​

[Brief Introduction of Seminar]

This lecture will introduce the concepts and latest research trends in tumor microenvironments and cancer immunotherapy, which pose challenges in tumor treatment. Additionally, we aim to present the limitations of current drug delivery platforms for anticancer immunotherapy, thereby providing an opportunity to discuss future research directions by enhancing the strengths of microneedles as an anticancer immunotherapy platform and incorporating advanced techniques. This will include the concept of the tumor microenvironment, the principles of anticancer immunotherapy, the limitations of existing anticancer immunotherapy methods, the potential application of microneedles in anticancer immunotherapy, the latest research trends in cancer immunotherapy using microneedles, and research and development strategies for the future commercialization of cancer immunotherapy microneedles.

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[Brief Introduction of Speaker]

Dr. Jae-Hyun Kim earned his master's and doctoral degrees from Hanyang University's Department of Biotechnology with a thesis titled “Development of Next-Generation Nanostructure Technology for Cancer Immunotherapy.” Since 2024, he has been working as a senior researcher at Cursus Bio, developing technologies such as gene delivery therapies using siRNA and mRNA, and peptide antigen delivery vaccine nano platforms. He has published numerous papers in top-tier international journals in the fields of biomaterials and drug delivery, including Advanced Materials, and has garnered significant global attention. Leveraging this extensive research experience, he is currently continuing his research on the commercialization of cancer immunotherapy based on micro-needle platforms at Cursus Bio.​​

[Brief Introduction of Seminar]

Drug development is a highly technology-intensive field that requires a long period of time and considerable effort, so thorough preparation and strategy formulation must be established from the initial stages. In particular, micro-needle formulations present challenges due to their unique characteristics and the lack of clear guidelines, causing many companies to encounter difficulties in development. To minimize such trial and error, it is necessary to clearly establish clinical and regulatory strategies from the initial stages and proceed with development accordingly. In this lecture, we will examine the regulatory strategies and procedures required for micro-needle formulation development through relevant regulations and case studies, aiming to collectively explore the most effective approach to strategic planning. Additionally, we will review the essential regulations, considerations at each stage, and strategic planning directions that employees involved in micro-needle formulation development must understand.

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[Brief Introduction of Speaker]

Park Yang-soo graduated from Chungbuk National University College of Pharmacy and received his master's and doctoral degrees from the same university. He worked in development and licensing at Cheil Pharmaceutical and Hanmi Pharmaceutical. Since then, he has been helping many venture companies and small and medium-sized pharmaceutical companies with their drug development through various licensing consultations at Meditip. Based on his experience working at the clinical trial institution DT&CRO, he provides comprehensive consulting services covering all aspects of licensing and clinical trials. Additionally, during his tenure at Hanmi Pharmaceutical as the RA Team Leader, he gained experience in the development of various improved new drugs, including the first improved new drug in Korea, Amozalatan, as well as salt-modified drugs, isomer drugs, and combination drugs. He has also directly obtained IND approval for technologically leading products such as Orascovery, an oral anticancer drug platform technology, and Lapscovery, a sustained-release recombinant protein platform. Currently, he continues to provide comprehensive consulting services for new drug development and regulatory affairs support to biotech startups and pharmaceutical companies. Additionally, through various external lectures, he actively contributes to the development of the domestic pharmaceutical industry and the enhancement of the pharmaceutical sector's capabilities.​​

[Brief Introduction of Seminar]

Recently, the development of micro-needle-based drugs and other products has been rapidly expanding in various fields, such as peptides, vaccines, and biological agents, based on their advantages in drug delivery precision, user convenience, and reduced skin pain. Therefore, there is a need for the design, evaluation, and regulatory response strategies of non-clinical trials suitable for these products. This lecture aims to enhance regulatory compliance capabilities by explaining key considerations in the development process of microneedle-based products, including the design of nonclinical trials and strategies for securing core data required for IND submission. To achieve this, the lecture will outline the characteristics of microneedle products and introduce nonclinical trial strategies based on an analysis of domestic and international guidelines.

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[Brief Introduction of Speaker]

Jeon Tae-won earned his doctorate from Keimyung University's Department of Public Health and subsequently served as a research professor at Yeungnam University's College of Pharmacy. At Biotoxtech, he served as the GLP Operations Manager, contributing to the establishment and management of non-clinical safety evaluation systems. He also worked at the GLP Center at Hoseo University and is currently the Operations Manager and GLP Testing Division Director (Senior Manager) at HLB BioCode, leading the company's core safety evaluation capabilities. Based on this expertise, he actively participates in advisory and committee activities in major domestic healthcare and GLP safety evaluation fields, including the Korea Food and Drug Safety Evaluation Institute, Seoul Asan Hospital, the Korean Society of Toxicology, and the Health Infrastructure Division of the Health Care Technology Policy Review Committee.​​

[Brief Introduction of Seminar]

The microneedle platform is a minimally invasive drug delivery system that can deliver drugs, vaccines, and biological agents transdermally, and its high patient compliance and clinical efficacy have led to a wide range of potential applications. However, differences in product classification systems, quality requirements, pre-review items, and approval procedures among jurisdictions create substantial regulatory barriers to product development, global commercialization, and export strategy planning. This lecture will compare and analyze the regulatory frameworks for microneedles in major countries such as the United States (FDA), Europe (EMA/MDR), Japan (PMDA), and China (NMPA), and discuss the impact of these differences on multinational clinical trial design, approval strategies, and manufacturing compliance. In particular, we will examine issues such as duplicate data submissions, approval delays, and the application of dual standards in manufacturing processes caused by regulatory inconsistencies, and propose directions for establishing joint guidelines.​

[Brief Introduction of Speaker]

Heonje Cho, Head of Research and Development Promotion (Managing Director), graduated from Dongguk University Graduate School of Business Administration (MBA) and completed a PhD in Regulatory Science (Innovation Policy Studies) at Dongguk University Graduate School of Food and Medical Product Regulatory Policy. He has been involved in the formulation of laws, systems, and policies related to the promotion and support of the pharmaceutical and biotechnology industry, as well as national R&D planning, across major government agencies such as the Ministry of Science and ICT, the Ministry of Industry, Trade, and Energy, and the Ministry of Health and Welfare, as well as local governments. He has also been involved in the establishment and operation of the Pharmaceutical Industry Technology Transfer Center under the Association, the first private technology transfer organization in Korea, He has also been actively involved in fostering the pharmaceutical and biotechnology industry and strengthening its international competitiveness through his activities as a secretary for the Pharmaceutical and Biotechnology Business Development Research Society and the Microneedle Fusion Research Society. Additionally, he serves as a non-executive director of the Korea Pharmaceutical Safety Management Institute, a board member and chairman of the Industry-Academia Cooperation Committee of the Korean Society of Regulatory Science, an investment attraction committee member of Goyang Special Self-Governing City, and an adjunct professor at the Department of Pharmaceutical and Biohealth Industry, Graduate School of Dongguk University.​​

[Brief Introduction of Seminar]

Bio R&D demands data-driven innovation amid the ongoing trends of digital transformation and AI adoption, while global competition over technology and industrial dominance intensifies. Critical issues such as the accumulation of dark data, insufficient data integration and standardization, and the lack of AI-based platforms have led to connectivity gaps and decreased innovation productivity, highlighting the need for strategic transformation. This presentation aims to provide an understanding of strategies for building data-driven platform ecosystems through digital transformation in bio research and development and to propose directions for AI-centered R&D innovation. Ultimately, it focuses on redefining life sciences as a “technology” and enhancing policy and strategic capabilities to design a digitized R&D cycle. To this end, the talk will diagnose structural challenges in bio data, introduce AI-based integrated platform strategies and digital applications within the new drug development value chain, and explore data-driven regulatory innovation and platform construction approaches.

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[Brief Introduction of Speaker]

Dr. Heung-Yeol Kim has long been engaged in policy planning and strategy development in the biotechnology field at the National Biotechnology Policy Research Center, a bio-policy think tank. He has led the planning and coordination of key bio R&D policy initiatives, including the formulation of the 4th Basic Plan for Biotechnology Promotion, the Digital Bio Technology Development Roadmap, Advanced Bio Ecosystem Revitalization Strategy, Synthetic Biology Advancement Measures, and AI-Based New Drug Development Platform Strategy. Recently, he has focused on creating an innovation ecosystem based on laws and regulations, such as research on the implementation of the revised Biotechnology Promotion Act, analysis of global bio technology trends, and the enactment of the Synthetic Biology Promotion Act. Dr. Kim has spearheaded numerous policy studies on mid- to long-term R&D investment strategies, public-private joint response strategies, and technology-industry linked platform design in the bio sector, while also contributing to international cooperation networks, including the OECD BNCT activities.​