#Japan #Drug Development #Minato, Tokyo #AI Data Corp #AI PharmaCDS

AI Data Corporation Launches AI PharmaCDS on IDX

AI Data Corporation, based in Minato, Tokyo, has announced the official launch of its innovative AI platform, AI PharmaCDS on IDX. This initiative targets one of the 17 key areas outlined by the Japanese government, focusing on drug discovery and advanced medical care. The aim is to streamline and enhance the research, development, and application processes in these vital fields through AI technology.

The AI PharmaCDS on IDX is designed to integrate vast amounts of fragmented data from clinical trials, regulatory affairs, literature, and case information. By utilizing Retrieval-Augmented Generation (RAG) technology, this generative AI solution aims to improve both the efficiency and accuracy of drug research and advanced medical applications. It transforms past experiences and recorded data into actionable intelligence and successful strategies, allowing pharmaceutical companies to speed up drug development and achieve higher precision in approvals.

A Unified AI Platform for Drug Discovery

The AI PharmaCDS on IDX serves as a comprehensive knowledge integration platform, combining crucial medical and pharmaceutical insights, such as research papers, regulatory data, clinical information, and much more. This fusion aids in research development, strategy planning, intellectual property management, and support for practical implementation in drug discovery and advanced medical treatments.

The launch of this service aims to facilitate seamless collaboration among pharmaceutical companies, biotech ventures, research institutions, medical facilities, and policy-making bodies, all working together to accelerate breakthroughs in new drug creation, regenerative medicine, and cutting-edge treatments.

Background: The Importance and Challenges in Drug Discovery

Japan has positioned drug discovery and advanced medical care as one of the key strategic areas in its growth strategy, emphasizing the necessity for strengthened collaboration across academia, industry, and government, integrated with advanced technologies like AI. While Japan stands as a hub for pharmaceutical research, rapid global advancements in joint clinical trials and approvals have emerged. However, the inefficiencies in searching existing literature and prior cases present challenges, often resulting in gaps or redundancies.

The complexities of clinical trial protocols, the sheer volume of academic papers and data, and regulatory compliance (PMDA/EMA/FDA) have complicated knowledge management efforts. As knowledge and compliance documentation become more unwieldy, the risks associated with delayed development and failed approvals increase, particularly if digital transformation (DX) and AI adoption lag.

Against this backdrop, AI Data Corporation aims to establish a knowledge integration foundation to support innovation and faster development in drug discovery and advanced medical fields through its AI PharmaCDS on IDX.

Features and Value Offering of AI PharmaCDS on IDX

1. Knowledge Integration Database: Integrates and manages a diverse array of information, including clinical trial protocols, regulatory documents, case studies, and research papers.
- Utilizes RAG technology for reliable information extraction.

2. Generative AI Decision Support: Assists with inquiries regarding past protocols and FDA rejection reasons, providing relevant documents and generating insightful responses.
- Aids in protocol creation and standardizes terminology while drafting submission documents.

3. Compliance Support: Compiling manuals for PMDA/FDA/EMA compliance and integrating past records into a database to enhance approval success rates.
- Connects with Standard Operating Procedures (SOP) and Good Clinical Practice (GCP) checklists.

4. Healthcare-Specific AI Technology: Employs context-aware AI capable of interpreting specialized terminology and documentation unique to the medical field.
- Addresses specific medical regulatory contexts beyond generic AI capabilities.

5. High-Security National Platform: Operates on a secure, private infrastructure that ensures the preservation and control of Japan's data sovereignty.
- Provides a stringent security environment for safely sharing and searching clinical trial and case information related to international collaborations.

Anticipated Use Cases for AI PharmaCDS on IDX

• - Pharmaceutical Companies/Biotech Ventures: Assists in protocol creation, regulatory document preparation, and strategic development planning through prior case analysis.
• - Research Institutions/Universities: Aids in drafting clinical research plans, preparing documents for Institutional Review Board (IRB) review, and optimizing literature research.
• - Medical Facilities/Advanced Medical Institutions: Supports case searches, evaluation for clinical trial participation, and coordination of clinical research activities.
• - Policy Bodies and Regulatory Authorities: Provides reference information for approval reviews, analyzes regulatory trends, and assists in guideline formulation.

Future Prospects

AI Data Corporation plans to improve RAG analytical foundations by enhancing the collection of clinical data, case information, and regulatory details. They also foresee functional expansions into advanced medical fields like regenerative medicine, rare diseases, biopharmaceuticals, and cell/gene therapy. Strengthening collaborations with research institutions, pharmaceutical companies, and medical facilities both domestically and internationally is a key focus for implementing use cases and commercial expansion.

As noted by the company's president, Takanori Sasaki, “Pharmaceuticals and healthcare function as vital social infrastructure protecting the lives and health of individuals. Through AI PharmaCDS on IDX, we integrate knowledge for drug discovery and advanced medical care, driving forward medical innovation in Japan.”

About AI Data Corporation

Founded in April 2015, AI Data Corporation specializes in both data and intellectual property infrastructure, safeguarding and leveraging data assets for over 20 years. The company has earned the trust of over 10,000 organizations and 1 million individuals. Their comprehensive Data Ecosystem encompasses data sharing, backup, recovery, migration, and deletion services. Significantly, the company has clinched the BCN Award for 16 consecutive years for top sales volume across a wide category.

AI Data Corporation also offers cloud data management, recovery services, and forensic investigations that have garnered high accolades in legal sectors. Furthermore, through their group company’s patent search and filing support systems and the establishment of an IP marketplace for patent transactions, they facilitate intellectual property management and revenue generation. This holistic approach integrates generative AI technology, enabling a fusion between data and IP, while also focusing on nurturing young engineers in collaboration with the Ministry of Defense, thereby enhancing societal infrastructure through data management and IP protection.