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MILS International: Breaking Diagnostic Barriers with Advanced Metabolic Screening

MILS International

Breaking Diagnostic Barriers with Advanced Metabolic Screening

Adanced metabolic biomarker detection is the next step in improving inborn errors of metabolism (IEM) diagnosis and patient outcomes. Traditional metabolic screening, including urine organic acid analysis and blood acylcarnitine profiling, often fails to reveal the full complexity of IEMs. With over 8,000 known rare diseases, 80 percent of which are hereditary, the need for comprehensive testing has never been more critical. MILS International, a Japanese government-certified medical testing institution, is redefining metabolic diagnostics with its cutting-edge, untargeted metabolomics platform. Genetic advancements have led to the identification of more than 1,000 IEMs, revealing the intricate nature of metabolic disorders. Yet clinical testing remains underutilized, limiting the detection of key metabolic abnormalities. MILS bridges this gap with a multifaceted approach that enhances diagnostic capabilities. While urine is the primary testing medium, supplementary blood and cerebrospinal fluid analyses strengthen metabolic marker detection. "Our IEM metabolomics examination service provides fast, data-driven diagnostics for clinical IEM patients, with continuous advancements to support more clinicians," says Dr. Chunhua Zhang, MD, PhD, and director. Examining a broader range of metabolic markers enhances disease detection and enables faster, more targeted treatment strategies. A 2023 research report, Comparison of Untargeted Metabolomic Profiling vs. Traditional Metabolic Screening to Identify Inborn Errors of Metabolism by Ning Liu et al., found that untargeted metabolomics achieves a six-fold higher diagnostic yield than conventional screening. Since 1997, MILS has provided metabolomics testing services to doctors in Southeast Asia and Japan, supporting over 45,000 patients. It has contributed to the confirmed diagnoses of 110 diseases while ensuring industry-leading turnaround times for clinical intervention. At the helm of MILS' success, Dr. Zhang has been instrumental in advancing its capabilities and solidifying its reputation as a leader in metabolic diagnostics. A globally recognized expert in metabolomics, her work in IEM diagnostics and biomedical mass spectrometry has driven major breakthroughs in rare disease detection. For over two decades, she has led groundbreaking research in high-risk screening and newborn testing using mass spectrometry. As a professor of rare disease medicine at Peking Union Medical College Hospital and a researcher at Kanazawa Medical University, she has contributed significantly to the global understanding of IEM diagnostics. Her contributions to international academic initiatives, including over 130 publications, continue to refine diagnostic methodologies, reinforcing MILS as a trusted partner for clinicians worldwide.

Digital Magazine

Mils International: Breaking Diagnostic Barriers With Advanced Metabolic Screening

Life Sciences Marketing and Communication

Regulus Pharma Services, Ltd.

Bridging Language Barriers in Life Sciences

Katsuo Hoshi, Representative Director

Bringing medical devices and drugs from R&D labs to patients demands precision at every step. Accuracy in language is crucial to guarantee that scientific data, regulatory submissions and clinical documentation are correctly conveyed. A single misstep can lead to costly delays, regulatory setbacks and safety risks. Regulus Pharma Services is a trusted partner for pharmaceutical companies, biotech innovators and medical device manufacturers seeking precise, reliable translation services for global regulatory processes. From investigational drug brochures, clinical trial protocols and standard technical documents to package inserts, inquiries and biotechnology documents, Regulus Pharma ensures that complex science is translated into clear, compliant communication. In an industry where every word can make or break a breakthrough, Regulus Pharma is the silent force helping innovation reach the world. “Our mission has always been to provide consistent, best-quality translation services to help our clients seamlessly navigate the development and regulatory processes,” says Katsuo Hoshi, representative director. Regulus Pharma began as a general technical translation agency, assisting industries with translating export manuals and consumer product documentation. Later, a pivotal partnership with a bilingual Japanese-American physician shifted the organization’s focus to the medical, pharmaceutical and biotechnology sectors. Over the years, Regulus Pharma has evolved alongside industry demands. Today, it focuses on regulatory science, providing translation services at every stage of drug and medical device development. These include preclinical studies, clinical trials, new drug applications, consultations with regulatory authorities and post-approval activities, and post-marketing surveillance. Minimizing Errors, Maximizing Consistency A key element of Regulus Pharma’s strength is its carefully curated network of expert translators. Each translator brings extensive experience in medical and pharmaceutical translation, and many hold advanced academic degrees, including Ph.Ds in medical science..

Cell and Gene Therapy

M Regenerative Clinic

Leading the Way in Personalized Regenerative Treatments

Dr. Midori Meshitsuka, Director

M Regenerative Clinic has perfected the balance between cutting-edge innovation and individualized care to deliver regenerative treatments with exceptional speed. With an on-site laboratory directly integrated with its treatment areas, M Regenerative Clinic’s setup allows immediate processing of harvested stem cells. This integration minimizes the time between cell extraction and treatment application, which is critical for preserving cell viability and enhancing therapeutic potential. The clinic’s physicians can adjust the specifics of the therapy based on the patient's health condition and needs. This approach provides personalized medical care that is both effective and responsive to each patient’s unique health circumstances. The clinic ensures every treatment offered is at the pinnacle of current scientific knowledge. Partnering with the Institute of Medical Sciences at the University of Tokyo (IMS), it actively engages in cutting-edge research on stem cells, exosomes and induced pluripotent stem (iPS) cells. “Such alliances empower our clinic with a robust, evidence-based approach, allowing us to provide patients with advanced and effective therapeutic options that extend beyond mere symptomatic relief,” says Dr. Midori Meshitsuka, director..

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Therapeutics

Evolving Digital Biomarkers in Clinical Trial Space

Kazuto Yamada, Senior Director, Head of Clinical Development Planning and Supervising Five R&D Functions, Otsuka Pharmaceutical

Drug Discovery and Development

The simple things in life are still the best, even in clinical development

Ken Lee, General Manager and Region Head, Clinical Development, Asia Pacific, Syneos Health

Life Science Testing And Compliance

Driving Strategic Cmc Innovation For Global Therapeutic Impact

Masahiro Niwa, Head of Drug Product & Device Development Japan, Takeda Pharmaceutical

Therapeutics

Workforce Pipeline Securing New Zealand's Medical Future

Jonathan Albrett, Director of Clinical Training, Taranaki District Health Board

Life Science Testing And Compliance

Harnessing Emotional Intelligence In Nursing Leadership

Whitney Johnson, Clinical Supervisor, and Group Reflective Practice Facilitator, Alfred Health

IN MY OPINION

Drug Discovery and Development

Emphasizing the Importance of Assuring Product Quality

Raymond R. Tjandrawinata, Director of Business Development and Scientific Affairs, Dexa Medica

LAST WORD

Life Science Testing And Compliance

Challenges To Clinical System In China

Cheryl Chen, Director of Clinical Operations, BeiGene

IN FOCUS

Japan's Rise as a Leader in Clinical Diagnostics and Trials

Japan’s clinical testing sector is poised for significant advancements in 2025,driven by rapid expansion, innovative diagnostic methodologies, and enhanced regulatory frameworks.

Learn more

The Rising Demand for Multilingual Excellence in Japan's Pharma Industry

Learn more

EDITORIAL

Innovation at Every Step

The clinical testing landscape in Japan is undergoing a quiet revolution, fueled by the region’s growing leadership in cell and gene therapy. As researchers push forward with hundreds of trials—many now in late-phase development—the country’s regulatory bodies are clearing new paths with designations like “Fast Track” for regenerative treatments. Decentralized and virtual models are opening doors to more diverse patient participation, while AI-driven analytics and real-time monitoring are tightening quality control in cell and gene therapy (CGT) manufacturing.

Behind the scenes, another transformation is unfolding—this time in how pharmaceutical information is communicated. Today’s translation workflows blend advanced neural machine translation tools with expert human oversight to ensure medical content isn’t just accurate but culturally and contextually precise. As life sciences companies look to scale innovations beyond borders, these language services are proving essential in bridging scientific ambition with global execution.

Driven by these trends, the life sciences market is projected to grow at a CAGR of approximately 11.75 percent from 2024 to 2032.

In this edition of Life Sciences Review APAC, we provide insights into recent developments in the life science market and how companies offer services aligned with the latest trends.

The magazine features a thought leadership article by Kazuto Yamada, Senior Director and Head of Clinical Development Planning and Supervising Five R&D Functions at Otsuka Pharmaceutical, highlighting how new technologies like digital biomarkers make clinical trials more patient-focused and efficient. It also features an article from Raymond R. Tjandrawinata, Director of Business Development and Scientific Affairs at Dexa Medica, who sheds light on the urgent need for better quality control in pharmaceuticals.

The edition also features stories of life science companies delivering solutions that play a crucial role in driving innovation. One such company is MILS International, which specializes in advanced metabolic diagnostics using precision metabolomics and medical mass spectrometry.

In this edition featuring Top Clinical Testing Services in Japan 2025, Top Cell and Gene Therapy Company in APAC 2025 and Top Pharmaceutical Translation Services in APAC 2025, we hope you find the right partner to meet your organization's needs.

Life Sciences Review APAC
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