Micron
Spearheading Clinical Development through Imaging Techniques

Scientific advancements and the advent of molecular pathogenesis in healthcare have helped us to understand the complex mechanisms that are involved in a specific disease. Although this change has heralded several novel discoveries in the area of biological sciences, there exist several unmet challenges to solve issues at a basic science level. Take for instance the drug development process wherein finding a drug for a disease is no less than a nightmare. Following the path from discovery of a molecule through the road of development is complex and involves time, money, and multiple disciplines to move it ahead.

Hoping to bring some relief, The Food and Drug Administration Modernization Act (FDAMA) of 1997 had opened doors for imaging modalities to be used as a product development tool in pharmaceutical or medical device clinical trials. However, it was easier said than done. In came several hurdles that posed a challenge in adoption of imaging for clinical trial processes. Makoto Sato was quick to realize the challenges related to imaging in drug development, amid increasing costs and declining rates of success. With a passion for “imaging” that can dramatically improve drug discovery, in 2005, Sato sowed the seeds of the first imaging CRO in Asia— Micron. Micron specializes in clinical research using medical imaging, performs research with real-world data, and develops imaging biomarkers. The company helps finding new pathway to research and development in the medical field possible by fostering new possibilities in imaging technology and supports medical advances with insightful imaging technology.

Following Sato’s legacy of strong leadership, Micron is now led by Michita Sato, president and CEO of Micron, who draws on rich industry expertise to assist the clients in their research and development by utilizing imaging technology. Standing amidst the ocean of standard trial-specific imaging practices like PET, MRI, and CT, Micron comes as a breath of fresh air. Today, in order to help organizations keep up with the advances in medical imaging, Micron has constructed a framework to provide “full support” services.

The company makes it a point that its clients are equipped to reap the benefits of technological advances in medical imaging that are not only instrumental for

the development of pharmaceuticals but also medical devices, regenerative medicine, and AI-based medical device software.

As Japan’s largest imaging CRO, Micron imaging team has cultivated the know-how in collaboration with more than 100 domestic and overseas radiologists/medical and research institutions. This enables the company to recommend the ideal solution package to meet pharma needs. Feasibility, site selection, site initiation, monitoring, and closing–Micron’s CRAs guides clients throughout the lifecycle of clinical development. In essence, these specialists not only have a thorough knowledge of various guidelines necessary for monitoring, such as basic medicine and pharmacology, and GCP ministerial ordinances, but also have advanced communication skills, management skills, data analysis skills, language skills. The perfect concoction of such capabilities allow the CRAs to conduct high-quality clinical trials on schedule and perform cross-site performance checks at all facilities and Action Plan (S-TOP: Situation, Target, Option, Plan) checks to achieve case entry goals. To that end, Micron’s Quality Control Group is well versed in GCP, other clinical trial guidelines, pharmaceutical regulations, and has a wide range of experience that goes the extra mile to provide rigorous quality control of relevant documents and data to ensure the reliability and sufficient service of clinical trials.

At heart, Micron bridges the gap created by the lack of specific and updated knowledge of medical imaging in the current clinical development landscape. With a wealth of know-how and over 15 years of experience, the company is making giant strides in the pharma realm. In fact, the company banks on its strong partnerships with organizations from not only mega pharma but also academia to run multiple joint-research projects.

Micron is laser-focused on ensuring clinical trial success through imaging training in addition to qualifying the imaging facility. Micron, with Imaging CRA ™ and Japan’s largest medical imaging analysis team, has accumulated the know-how to utilize medical imaging at the endpoint of clinical trials and supporting various clinical trials by closely communicating with domestic and foreign KOL or experts. The company is currently promoting the systematization and development of medical image analysis software, including the expanding of capabilities, and recommending optimal clinical trials as a pioneering Imaging CRO. With innovation at its core, Micron looks forward to gaining a foothold as the top integrated medical imaging company in APAC in order to meet the globalization of drug development and make a difference in the world through healthcare research.