AIMS Bioscience (AIMS), a new drug development strategy consulting company of the Il-Dong Pharmaceutical Group, announced on the 18th that it has been selected as the implementing agency for the project titled “Planning of an Operations Model for a Distributed Infrastructure-Linked Technical Support Group to Promote the Development of New Antimicrobial Substances” and will commence research.

The core of this project is to establish a support system that enables researchers and companies developing new antimicrobial substances to more easily identify the experts and testing institutions needed in the development process. It is being promoted as part of the Korea Disease Control and Prevention Agency’s (KDCA) “Strengthening Research Capabilities to Overcome Infectious Diseases” program, and donations from the bereaved family of the late Chairman Lee Kun-hee will be utilized. The research period is six months.

New antimicrobial substances are developed to inhibit or eliminate microorganisms, such as bacteria, that cause infections. To develop them into actual pharmaceutical products, multiple procedures must be completed, ranging from verifying whether a candidate substance is effective against bacteria, to animal studies, toxicity assessments, tests to determine how the drug behaves in the body, and the development of manufacturing processes.

The challenge is that universities, research institutes, hospitals, and bio-venture companies find it difficult to carry out this entire process on their own. When a specific test is required, they must individually identify which institution to commission, which experts to consult, and they also need specialized capabilities to determine the next development step based on multiple test results.

This project is designed to establish a support system to reduce such difficulties in the development process. It is not a project that directly funds research or testing costs for specific candidate substances. Instead, it will first diagnose the development stage of each candidate substance and identify where progress is stalled, then create a system that connects it with the necessary experts and testing, analytical, and manufacturing institutions.

For example, if the antimicrobial efficacy of a candidate substance has been confirmed but toxicity assessment is required, the relevant testing institution will be connected, and if manufacturing process development is needed, experts in that field or production infrastructure will be linked. To this end, the project plans to define the entire procedure, from how to apply for support, document review, diagnosis of development issues, connections to experts and institutions, management of progress, through to final evaluation.

AIMS Bioscience plans to organize what types of support are required at each development stage, including candidate optimization, efficacy and mechanism-of-action evaluation, non-clinical studies, pharmacokinetics/pharmacodynamics (PK/PD), toxicity assessment, and chemistry, manufacturing and controls (CMC).

Criteria will also be established according to the types of substances under development. Targets include not only small-molecule antimicrobials but also antimicrobial peptides, bacteriophages (viruses that attack bacteria), live biotherapeutic products (LBPs) that use live microorganisms, and endolysins, which are proteins that destroy bacteria.

Domestic experts and testing, analytical, and manufacturing facilities relevant to these fields will also be organized by category. Surveys and in-depth interviews with researchers and development companies will be conducted to identify what kinds of support are actually needed in the development process.

Ultimately, functions of the support system, antimicrobial substance type-specific support criteria, an expert database, available testing and manufacturing infrastructure, criteria for linking experts and institutions, standard operating procedures, and cost models will be integrated into a single support framework.

According to the company, the operations model established through this project will undergo pilot operations in 2027 and 2028, be refined, and then be expanded into full-scale operations from 2029 to 2031.

Han Seung-hun, CEO of AIMS Bioscience, stated, “Although Korea has capabilities in antimicrobial substance research and testing, analytical, and manufacturing infrastructure, there is an insufficient system for integrated linkage tailored to development bottlenecks of individual candidate substances,” adding, “By leveraging our consulting experience in new drug development and our network of experts in various fields, we will establish an operations model that can be practically used in the field.”

Popular News