CMIC, Inc
Maximizing Drug Development Success

Over the years, the pharmaceutical industry has borne the brunt of rising costs and the increased number of regulations pertaining to the development and testing of new drugs. Even when costs and timelines were meticulously strategized in the clinical development plan, final budgets were retrospectively usually much higher, whereas deadlines were often not met. This paved the way for the creation of contract research organizations (CRO)—whose roots can be traced back to 1940s—for staying on track with compliance, budget, and timelines. Even as this sector became increasingly specific, the world’s second-largest pharmaceuticals market, Japan, remained largely untouched by R&D activities taking place across the world. As a project team leader in drug development, Dr. Kazuo Nakamura recognized the trend and pioneered the CRO business in Japan. In 1985, he laid the foundation of Japan’s first CRO, the CMIC Group, with the intention of contributing to global health maintenance and enhancement measures.

With its unique “Pharmaceutical Value Creator (PVC)” business model, CMIC Group assists pharmaceuticals and biotechnology companies, bio-ventures, medical device manufacturers, and medical institutions in amending their R&D program. Governed by a mission to create value and contribute to greater advances in the pharmaceutical industry, the Chicago-based CMIC, Inc., a subsidiary of CMIC Group, is committed to bringing in innovation to respond to the diverse needs of the pharmaceutical industry. “We handle the needs of Bioanalytical testing, from receiving incoming samples, storing them safely to processing and testing them, and reporting the results in real-time and in GLP-compliant manner,” informs Jenny Lin, COO of CMIC, Inc. “As a part of our pentagonal service model, we specialize in Bioanalytical testing in support of TK, PK, PD and Biomarks in the course of drug research and development.”

CMIC group as a whole offers contract research services in analytical development, Bioanalytical development, clinical development, cGMP process development and manufacturing. When a pharmaceutical product is globally approved, the company also serves as a contract sales organization (CSO) for aiding in marketing and sales efforts.

As a part of our pentagonal service model, we support Bioanalytical testing of all stages of drug research and development programs. We are proud of our craftsmanship in the lab, our promptness in communication, our data quality and unparalleled customer service

CMIC group’s innovative pharma model offers its R&D programs to its clients in the healthcare business and works extensively with medical device companies to promote patient individual healthcare treatment. Despite the diversity of services offered, the CRO business remains as the base of the pentagonal service of CMIC Group, accelerating drug development efforts across the world.

As one of four global contract research laboratories in the CMIC Holdings group, CMIC, Inc. focuses on providing Bioanalytical services that clients can trust to deliver high-quality data, rapid turnaround, and unparalleled customer service. It provides Bioanalytical testing for small molecules, Biologics, Oligonucleotides and Biomarkers. It supports drug research and development on oncology, immuno-oncology, immunology, and neuroscience. CMIC, Inc. also offers services on exome and whole genome sequencing, cell-free DNA biomarkers evaluation, and genetic biomarkers evaluation like CYP mutations using Next-Generation Sequencing (NGS) in its genomics lab. Aside from supporting regulated Bioanalytical testing, the CMIC, Inc. labs are also equipped to aid non-regulated, non-GLP studies such as drug candidate screening selection processes before carrying out a fully regulated pre-clinical GLP or animal-TK study. The extensive instrument in the laboratories can be deployed to tackle challenging and high sensitivity studies with Sciex Triple Quad 6500, 5500 LC-MS/MS systems, as well as ELISA/MSD, Gyros, qPCR platforms across Japan and US. Often, sponsors approaching CMIC, Inc. do not have an existing Bioanalytical testing process in place, in which case, the company can promptly develop assays from scratch. CMIC, Inc. can also carry out a method transfer globally and adheres to its sponsor’s procedures during study execution. Once the procedures have been qualified, validated and/or cross-validated across labs to ensure that the assay’ intended purpose is served, the samples are analyzed, and results reported promptly.

Over the years, CMIC Inc. has consistently impressed its sponsors with it excellent data quality and quick data turn around. “One of our sponsors, a U.S.-based leading biotechnology company, first partnered with us eight years ago, and over time, we have coordinated with them for over 160 studies,” extols Jenny. The fact that this client that came on board eight years ago is still an active client speaks volumes about CMIC, Inc.’s determination to build long-lasting relationships and deliver efficiency and long-term value to its clients.

The 25-year-old CMIC group, headquartered in Tokyo, has three manufacturing plants, six labs and 33 work sites to carry out pre-clinical and clinical research activities in Japan. These labs include animal testing Bioresearch Center and GMP labs for Chemistry, Manufacturing and Controls (CMC) development. In terms of Bioanalytical testing, CMIC group strategically positions its lab across Japan, China and US to ensure the effective assay transfer and continuity of research across countries.

CMIC Group has grown to become one of the leading players in Asia, with offices across Hong Kong, Vietnam, Taiwan, Korea, and Singapore. Besides CMIC, Inc. in Chicago, the company also has a subsidiary and good manufacturing practice (GMP) site in New Jersey. CMIC, Inc. is a fully GLP-compliant lab designed from scratch with state-of-the-art instrumentation.

According to Jenny, CMIC’s focus on quality and craftsmanship is a typical Japanese characteristic that draws sponsors back to the CRO time and again. “From the very beginning, our processes and systems have been built to ensure the double-checking procedures for critical steps are in place. The fit-for-purpose design of our labs also offers a seamless flow of lab work so that our qualified employees can execute their work flawlessly,” states Jenny. To meet the needs of the clients and the changing drug development environment, the company emphasizes regular communication with sponsors about their challenges and requirements. To maximize the probability of success and minimize drug development time and cost, CMIC, Inc. also ensures proper data storage with adequate backup, so that the integrity of research is preserved even in case of a mishap. In addition, the company enjoys a niche position in the market due to its familiarity with varying regulatory requirements to support R&D programs across the globe. Over time, the firm will continue providing sponsors high-quality Bioanalytical services. In parallel, CMIC, Inc. will remain committed to streamlining drug development efforts and working in newer areas as and when the need arises.