[E-Daily Reporter NA EUN-KYUNG ] #AIMS BioScience (AIMS), a new drug development strategy consulting firm affiliated with ILDONG PHARM Group, announced on the 18th that it has been selected as the implementing agency for the “Planning Project for an Operational Model of a Technology Support Team Linked to a Distributed Infrastructure to Promote the Development of New Antimicrobial Agents” and has begun research.

This project is being carried out as part of the “Project to Strengthen Research Capabilities for Overcoming Infectious Diseases,” led by the Korea Disease Control and Prevention Agency (KDCA). It is funded by a donation from the family of the late Chairman Lee Kun-Hee, planned by the Drug Resistance Research Division of the KDCA’s National Institute of Infectious Diseases, and commissioned by the Inter-Ministerial Foundation for Infectious Disease Research and Development (GFID). The research period is six months.

The core of the project is to identify bottlenecks that arise during the development of new antimicrobial agents and to establish an operational model for a technical support team that connects experts and testing, analysis, and manufacturing infrastructure—which are currently dispersed across the country—in accordance with the specific needs of each development stage.

New antimicrobial agents are developed through various stages, beginning with the evaluation of antimicrobial activity and mechanisms of action, followed by infected animal models, preclinical testing, pharmacokinetics and pharmacodynamics (PK/PD), toxicity testing, analytical method development, and manufacturing processes. Since universities, research institutes, hospitals, and biotech startups often lack the full range of capabilities required in-house, they may face difficulties in identifying experts and testing facilities suitable for each development stage, synthesizing the respective results, and establishing follow-up development strategies.

In particular, antibiotic resistance is a factor contributing to the rise in infectious diseases that are difficult to treat with existing antibiotics, increasing the need for new antimicrobial agents. Rather than directly providing research or testing funds for individual candidate compounds, this project focuses on establishing a system that identifies the development stage and bottlenecks for each candidate compound and connects them with the necessary experts and testing infrastructure.

Through this project, AIMS plans to systematize technical support functions for each development stage, including candidate optimization, efficacy and mechanism-of-action evaluation, preclinical testing, PK/PD and toxicity evaluation, and drug manufacturing and quality control (CMC). It will also establish support criteria based on the type of antimicrobial agent, such as small-molecule antimicrobials, antimicrobial peptides, bacteriophages, live bacterial therapeutics (LBP), and endolysins.

To this end, it will categorize relevant experts and testing, analysis, and manufacturing infrastructure by function and conduct surveys and in-depth interviews with domestic developers. Based on this, AIMS plans to design a standard operating procedure (SOP) that follows the sequence “request submission → data review → bottleneck diagnosis → expert and infrastructure matching → execution management → completion evaluation,” and to establish a cost model and verification system tailored to the scope of support.

AIMS will leverage its consulting experience in new drug development strategies, preclinical and clinical pharmacology, CMC and regulatory science, and decision-making strategies for this project. The network established with domestic universities, hospitals, research institutions, biotech companies, as well as contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs), will also be utilized in designing the operational model.

Ultimately, the project will integrate the following elements into a single operational model: a technical support function specification, a support matrix by antimicrobial substance type, an expert database, a physical infrastructure map, the results of a demand survey, criteria for matching experts and infrastructure, standard operating procedures and forms, a cost model, and funding scenarios.

The operational model being developed will also be utilized to establish an actual support system for antimicrobial substance development in the future. Based on the project results, a plan is underway to validate and refine the support system through a pilot operation in 2027–2028, followed by a full-scale operation from 2029 to 2031.

Han Seung-hoon, CEO of AIMS, stated, “While Korea possesses excellent research capabilities in antimicrobial agents as well as testing, analysis, and manufacturing infrastructure, there is a lack of a system that effectively coordinates these resources to address development bottlenecks specific to each candidate compound.” He added, “By leveraging AIMS’s experience in new drug development consulting and its network of experts across various fields, we will establish an operational model that provides practical solutions detailing the procedures through which developers can access support in real-world settings.”