CMIC, Inc. is a leading CRO (Contract Research Organization) and a provider specialized in bioanalytical services in support of TK/PK/PD Biomarker studies for pre-clinical and clinical developments. Located in Hoffman Estates, IL, the company provides cutting-edge capabilities and sophisticated expertise in bioanalytical method development, method validation/qualification and study sample analysis for small and large molecules. As a strategic drug development partner, CMIC helps sponsors to overcome challenges in bioanalysis with expertise, rapid turn-around-time, and high-quality services.
CMIC has over 30 years of experience in bioanalytical small molecule analysis and a reputation for excellence and a strong commitment to help improve lives around the world. With a dedication to the drug development market and continued success, CMIC has become a leading CRO in Japan and North America. Today, CMIC continues to grow and expand its facility and capabilities to meet the needs of our clients and the changing drug development environment.
The “CMIC” name originally stood for “Current Medical Information Center”, and the company remains committed to the advancement of medicines and healthcare revolution.
In order to achieve such a goal, the company has set up CMIC CREED, consisting of:
- Wellbeing (Fully live every moment)
- Challenge (Liberate opportunity by changing our vantage point)
- Change (Transform without seeking refuge in conventional wisdom)
- Communication (Proactively reach out to people and society)
Pioneering Duo of CMIC, Inc.
CMIC, Inc. is Founded by two influential leaders, Mr. Kunio Momiyama and Dr. Kaz Nakamura. Both founders are so entrepreneurial to create a totally unprecedented business model and were willing to invest based upon their own confidence. Prior to CMIC, Inc. Kunio founded the very first Japanese BioAnalytical lab, Nihon Igaku Rinsho in 1984 and Kaz founded the very first Japanese CRO, CMIC in 1992.
Challenging Journey of CMIC, Inc.
The company had two major turning points. The company started lab operation at its purpose-built GLP facility as JCL Bioassay, USA in 2010. The company’s Japanese HQ, JCL Bioassay and its origin, Nihon Igaku Rinsho were the No. 1 BioAnalytical lab in Japan since its foundation in 1984, but “JCL” name was not known to the U.S. pharmaceutical industry at all. The JCL management during the initial several years needed to be so patient with a long-term vision in order to gain trust and name recognition from U.S. clients.
Another turning point was 2015 when the company joined CMIC Group through CMIC’s acquisition of the entire JCL. Around that time, the BioAnalytical industry was rapidly expanding (and is still doing so) biologics and oligonucleotides solutions, and the CMIC management needed not only to leverage JCL’s excellent heritage in small molecules but also to add state-of-the-art lab infrastructures, advanced analytical instruments, experienced high-quality scientists and professional supporting staff as well as new clients with CMIC’s global coverage. Such lab expansion and service menu addition for a much broader client base took two years to officially announce its completion in 2017.
Precession and Value Added Benefits
This prominent company is specialized in pre-clinical and clinical developments. CMIC today, delivers highest-quality data with a very quick turn-around-time (TAT). Being a renowned drug development partner, CMIC also aids its sponsors in surmounting issues related to Biomarkers and Bioanalysis.
Some of the extraordinary offerings from CMIC;
Biomarker
CMIC supports exploratory research to fully validated assays covering pre-clinical and clinical studies. When reliable kits are not available, the company develops robust in-house assays using vendor supplied antibodies to create assays. These assays are either singleplex or multiplex in design. The company has measured over 50+ protein biomarkers in different matrices including serum, plasma, urine, and tissue lysates. CMIC having a team of scientists with more than 15 years of experience in molecular biology and cell biology in key therapeutic areas, team CMIC believes that they hold a decisive edge in helping clients select the best biomarkers for their programs.
Large Molecules
CMIC is one of the leading large molecule bioanalysis labs. In the competitive field of drug development where timely go/no-go decisions must be made to bring effective class-leading drugs to market, CMIC has:
- A proven track record of enabling their pharmaceutical clients to succeed in a timely manner.
- A team of technical experts whose breadth of expertise range from molecular and cellular biology to analytical chemistry; covering key therapeutic areas including oncology, immune-oncology, immunology, and neuroscience.
- Excelled at successfully developing and validating the most demanding and challenging assays within the specified deadlines, where others have given up.
At CMIC, company’s tool-box for large molecule contains the latest bioanalytical tools providing versatility for your programs to take advantage of; Cell-Based Assays, Genomics, Proteomics, Preclinical and Clinical Bioanalysis, Small and Large Molecules, Custom Exploratory Biomarkers, and Laboratories in US and Japan.
Oligonucleotides
Since 2012, team CMIC has supported hundreds of studies for oligonucleotide-based drugs, including qualification, full method validation and GLP sample analysis studies for oligonucleotide-based drugs, in tissue and plasma for preclinical and clinical studies.
What Sets CMIC Apart?
- Partnered with recognized global leaders in RNA-targeted discoveries
- Nearly 100 individual compounds successfully validated since 2012
- Vast experience with chemically modified oligonucleotides including GalNAc conjugate, cholesterol conjugate, thymidylic acid and phosphate
Supported Small Molecule Studies
- Validated single methods with up to 6 analytes
- Compounds containing radioactive isotopes
- Compounds that are highly absorbent (non-specific binding) or have poor stability
- Complex matrices: ocular tissue, brain tissue, human tumor tissue, skin patch
- Provide prefilled transfer containers to support sample stability at the sites
Small molecule bioanalysis is a well-established science, but not all small molecule studies are straight forward – CMIC is a partner that can handle any situation.
Benefits for CMIC Customers
As a strategic partner, CMIC helps its clients streamline their drug development efforts to achieve two goals:
- Maximize the probability of success
- Minimize drug development time and costs
CMIC’s World Class Facility
CMIC mirrors its Japanese laboratories to provide a seamless method and knowledge transfer. Company’s GLP-compliant state-of-the-art facility has the capacity to accommodate quick turnaround and high volume projects from around the country. Conveniently located in Hoffman Estates only 20 minutes from Chicago’s O’Hare International Airport, firm’s location in the Midwest allows team CMIC to conveniently serve pharmaceutical and biotechnology companies across the country.
CMIC built this facility in 2008 with the purpose to maximize efficiencies and provide their scientists with a world-class quality environment, CMIC is equipped with the following features:
- Biosafety Level 2 lab
- UV-free lab
- Controlled substance license (schedule III-V)
- On-site Emergency back-up power supply
- Video security and restricted entry
- On site / off site archives
- Building management systems
- Temperature and humidity monitoring systems
- State-of-the-art sample monitoring system (24/7)
Quality Instrumentation and Technologies
CMIC’s sophisticated analytical instrumentation and advanced technologies produce ultrasensitive analyses. Together with post-collection data analysis and comprehensive quality, CMIC clients will receive the highest quality efficiency and safety data for their compound.
Highly-Skilled Researchers
CMIC researchers are committed to the advancement of medicine. With every project, they provide unsurpassed excellence and innovative solutions driven by CMIC’s core values of trust, teamwork, dedication, respect, and integrity. The company’s highly educated and experienced scientists will work directly with your R&D scientists to ensure that clients get the most from their investment. Their project team is comprised of two technical experts for each assay performed to provide continuous verification of the assay conducted.
CMIC’s Quality Commitment
The Quality Assurance Unit (QAU) at CMIC, Inc. was established to provide data quality and study integrity in accordance with FDA Good Laboratory Practice (GLP) and 21 CFR Part 11 regulations.
CMIC QAU staff members are Registered Quality Assurance Professionals in Good Laboratory Practice (RQAP-GLP) and have more than 25 years of combined experience inspecting and auditing studies designed to comply with the US FDA as well as international regulations such as OECD GLP. Each QAU staff member receives ongoing training and education in Quality Assurance.
Future Prospects
CMIC is rapidly growing in the U.S., and adding new services not only in BioAnalysis (TK/PK/PD biomarker) but also in clinical operation as well as CMC for the U.S. clients. CMIC has been in Japan / Asia Pacific for many years, and will also be in the U.S. a one-stop R&D solution provider (CMIC calls it “Pharmaceutical Value Creator”) in the near future.
“Our vision is to be recognized as a leader in bioanalytical services that clients can trust to deliver high-quality data, rapid turnaround, and unparalleled customer service while making every project a success,” asserts Mike Suga is a President and CEO of CMIC.
