CMIC, Inc.: Conquering Zeniths of the Pharmaceutical Industry

Technology has been aiding the evolution of our lives with the same pace it has been reforming a plethora of conventional disciplines. But the true notion of reformative technology comes from within people and organizations engaged in unveiling the comprehensive potential of any discipline. It is through research, numerous organizations develop transformative technologies, services or solutions. It is through research, consortiums working in the field of Medicine, find cures to fatal diseases and aid in enhancing human lives.

In our endeavor to bring into spotlight such transformative organizations through our issue titled, “The NextGen Companies to watch in 2019”, we’ve come across an organization that is setting Contract Research benchmarks across the globe. Allow us to introduce, CMIC, Inc., a leading CRO, specialized in bioanalytical services in support of TK/PK/PD Biomarker studies for pre-clinical and clinical developments. The company exhibits its contemporary capabilities and sophisticated expertise in bioanalytical method development, method validation/qualification and study sample analysis for small and large molecule as well as oligonucleotide pharmaceuticals. As a strategic drug advancement partner, CMIC helps sponsors surpass adversities in bioanalysis with expertise, rapid turn-around-time (TAT), and unparalleled services.

CMIC has over 25 years of experience and reputation for excellence and a strong commitment to helping improve lives around the world. The organization has become a prominent CRO in Japan and North America, with a commitment to the drug development market and persistent success. Currently, CMIC continues to grow and expand its facility and capabilities to be au fait of the needs of its clients and the evolving drug development environment.

CMIC was founded by Dr. Kaz Nakamura, an influential leader who created the very first Japanese Contract Research Organization, CMIC, in 1992 and possesses exceptional entrepreneurial spirit and aim to create a totally unprecedented business model. Today CMIC employs more than 6,500 employees worldwide with nearly $700M in sales revenue. CMIC Holdings Group is the largest CRO in Japan with major affiliates in the U.S. and Asian countries like China, Korea, Singapore and several others.

A Voyage towards Glory

Being an integrated member of CMIC Holdings Group, CMIC, Inc. commenced its lab operations at its purpose-built GLP facility 10 years ago in Chicago. Although having a great foot print as a top CRO in Japan, the CMIC brand name was not known to the US pharmaceutical industry at the time. The company administration, during the early years, needed to be persistent with a longstanding vision to gain faith and acknowledgement from U.S. clients.

Later in 2015, bioanalytical industry was growing swiftly with biologics and oligonucleotides solutions, and CMIC management needed to not only utilize the existing outstanding heritage in small molecules bioanalysis but also enhance their state-of-the-art laboratory infrastructure, innovative analytical instruments, and add additional skilled talents and professional supporting staff to meet the rapid growing demands for drug development innovation. With the continuous rapid growth of the business, CMIC also invested millions of dollars in general lab expansion which was successfully completed in 2017.

Delivering Excellence

CMIC exhibits expertise in pre-clinical and clinical developments. Today, CMIC delivers highest-quality data with a very quick turn-around-time (TAT). Being a prominent drug advancement partner, CMIC also aids its sponsors in overcoming issues related to biomarker bioanalysis.

Following are a few offerings from CMIC:

– Biomarker

CMIC provisions exploratory research to fully validated assays covering pre-clinical and clinical studies. When reliable kits are not accessible, the company produces robust in-house assays using vendor provided antibodies. 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. 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 it holds a decisive edge in aiding clients select the finest 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 empowering their pharmaceutical clients to succeed in an opportune method.
  • A team of technical specialists 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 developing and validating the most demanding and arduous assays within the specified deadlines, where others would have given up.

CMIC possesses a versatile tool-box that greatly aids client programs that are based on ‘large molecule’ therapeutic. Clients are offered a large menu of bioanalytical tools that include cell-based assays and assays that are genomics and proteomics based. CMIC prides in having more than one tool to address a client’s needs. With this versatility, CMIC provides Preclinical and Clinical bioanalysis in the ‘small’ and ‘large’ molecule space that includes PK, TK, and PD biomarker analysis across US and Japan.

– Oligonucleotides

Since 2012, team CMIC has been the leading CRO for Oligonucleotide Bioanalysis and provided support for several hundreds of studies leading to oligonucleotide-based therapeutic drug development. Team CMIC routinely develops robust assays, conducts method qualification, method validation, and GLP/GCP sample analysis studies in various human and animal-based biological matrices. “We are partnered with recognized global leaders in RNA-targeted discoveries and have successfully validated nearly 100 leading compounds which steers us ahead of our competitors in the market place”, says Jenny Lin, Chief Operating Officer of CMIC, Inc.

Transforming the World

For an organization to be socially responsible in supporting and aiding the protection, enhancement and sustenance of life, there is nothing less than earning the trust of its clients as well as the common public. This aspect of an organization not only helps it earn goodwill, but also marks it presence in the world. CMIC actively volunteers in this responsibility. It undertakes efforts for rare diseases, pursuant to its commitment, ‘whether in youth, when potential has yet to blossom, or in later years, when the fruits of one’s life are maturing, every individual has an equally earnest desire to live every moment to its fullest’ enshrined as one of the concepts of CMIC’s CREED which includes:

  • Wellbeing (Fully live every moment)
  • Challenge (Liberate opportunity by changing the vantage point)
  • Change (Transform without seeking refuge in conventional wisdom)
  • Communication (Proactively reach out to people and society)

For the Rare Disease Day campaign, in addition to sponsoring events, CMIC Japan internally publicized February as the month of RDD campaign. It involved activities such as raising awareness through putting in-house posters, seminar event for listening to direct voices from rare disease patient and educating employees through a dedicated site on the intranet and in-house SNS for enhancing the knowledge of rare diseases. During this campaign, all CMIC members were encouraged to wear the RDD official pin badge and hand out the CMIC group’s original RDD pocket-sized tissue packages to clients, business partners, family members and friends for RDD activity promotion.

CMIC developed the world’s first diagnostic reagent to measure urinary L-type fatty acid binding protein (L-FABP), “RENISCHEM®”. The product was introduced at the American Society of Nephrology Kidney Week 2018 conference in San Diego. L-FABP assay can diagnose renal diseases resulting from tubular dysfunction with high precision. The completion of development of L-FABP as a new early diagnosis item is expected to improve treatment in patients by its accurate diagnostic result of disease state leading to gradual reduction in the number of patients who are referred to dialysis treatment.

Earning Faith

As a strategic partner, CMIC helps its clients modernize their drug development and advancement efforts to achieve two goals: Maximize the probability of success and Minimize drug development time and costs. To support global studies, CMIC ensures laboratories provide a seamless method and knowledge transfer to its laboratories across the globe. The company’s GLP-compliant state-of-the-art facilities have the capacity to accommodate quick turnaround and high volume projects across the globe. With CMIC, Inc. conveniently located in Hoffman Estates only 20 minutes from Chicago’s O’Hare International Airport, the firm’s location allows team CMIC to conveniently serve pharmaceutical and biotechnology companies within US.

The Future Holds Progress

“Our vision is to be recognized as a leader in bioanalytical services, over which, clients can trust to deliver high-quality data, a rapid turnaround, and an unparalleled customer service while making every project a success,” says Jenny. 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 for the U.S. clients.  As a leading Contract Research Organization, CMIC plans to spread its roots more in the U.S. as a one-stop R&D solution provider in the near future.