Jenny Lin, COO
Driving toward Hoffman Estates, IL, from Chicago’s O’Hare International Airport, one would notice a splendid, modern bio-analytical laboratory, CMIC, Inc. spread over a vast 270,000 square foot area. The bio-analytical testing lab facility, owned by CMIC Group, stands as an exemplary model of innovation supporting pharma and healthcare, serving the world through their numerous supports in drug discovery and development. CMIC Group was founded in Japan by Dr. Kazuo Nakamura in 1992 with a mission to contribute to quality drug development and thereby promote and apply science for the welfare of the public. The inception of CMIC also marked the beginning of contract research organizations (CRO) in Japan alongside helping the country develop the legislative framework required to provide clinical research services for the nation’s pharmaceutical industry.
Although CMIC began its journey in Japan, they specifically built their Bioanalytical lab facility in Chicago. The strategic location provides their clients and sponsors convenient access for sample delivery from east or west coast of US, Japan and Europe; not to mention their facility is close to the Airport. The purpose-built, state-of-the-art facility started operating in full swing in 2010 with an aim to provide scientists with a world-class, quality-driven testing environment. What makes the lab unique is its design, multiple layers of data backup, and the workflow they have implemented that helps scientists minimize errors while executing various tests. The GLP (good laboratory practice) compliant facility is fit-for-purpose built for bioanalytical testing and houses a spacious sample storage, sample preparation, genomic laboratory, pharmacodynamic biomarker laboratory, LC-MS-MS testing lab, sample weighing room, reference standard storage and other administrative and utility spaces. The facility also has a bio-safety level 2 lab designed mainly for conducting tests on disease-causing pathogenic samples. Additionally, the facility is also licensed to handle controlled substances.
Backed by excellence in small molecule Bioanalysis for more than 30 years, CMIC, Inc. is a part of CMIC Group’s 12 overseas bases and global employee strength of more than 6,500. Being the largest CRO in Japan with significant affiliates in the U.S. and Asian countries including China, Korea, Singapore, and Taiwan to mention a few, CMIC Group strives to provide the best in terms of offerings and services. The firm continues to provide bespoke solutions for bio-analytical small molecular, exploratory biomarkers for different therapeutic focuses and large molecular bioanalysis including oligonucleotide-based therapeutic drugs. With an experience spanning over 30 years, CMIC provides unmatched communication and customer service, data quality, and rapid turnaround times. “We identify ourselves as a ‘pharmaceutical value creator,’ and we actualize it through our numerous efforts to bring quality and excellence in support of pharmaceutical/ Biotechnology research,” Says Jenny Lin, COO of CMIC, Inc.
Indubitably, the size, complexity, duration, and cost of clinical trials and experiments continue to rise owing to the increasing demands of the healthcare sector.
To optimize research economically, pharma companies rely on CROs with a code of ethics and adopt the growing trend of outsourcing as well as building strategic relationships with them. To that end, CMIC Group follows a strict business code of ethics and continues to improve through extensive training and education, making them front runners serving pharmaceutical research. Not only do they improve clinical research operational efficiency but also minimize clinical trial delays and cost, which are primary concerns for pharmaceutical companies.
Setting a New Benchmark in Pharmaceutics
CMIC Group has adopted a unique ‘pentagon’ business model that has CRO at its base and Contract Manufacturing Organization (CDMO), Contract Sales Organization (CSO), healthcare, and Innovative Pharma Model (IPM) as other pillars. There are numerous pharma and biopharma companies that outsource their drug development and manufacturing initiatives on a contract basis because of the soaring costs and increasingly complex trials and procedures.As a CRO, CMIC Group provides comprehensive support to those organizations and helps them gain access to the finest solutions. The company offers managerial support for the commercialization of drugs for marketing and sales in different parts of the world as a contract sales organization. The firm also extends its services to businesses that enhance individual healthcare besides building an innovative IPM. CMIC’s IPM services utilize the knowledge they have acquired through experience and provide solutions to an extensive clientele that includes local and overseas pharma companies, academia, and fund management firms.
We support the entire lifecycle of drug research and development
Since CMIC Group has multiple labs in different countries, many of their sponsors leverage this opportunity to utilize CMIC expertise to support their global drug submissions, and studies between countries. Technology and assay transfer can also be carried out seamlessly and cost effectively among group member companies across continents.
Supporting the Entire Lifecycle of Drug Research
What drives CMIC ahead is the relentless support they provide during the entire life cycle of drug research. As Jenny says, “We support the entire lifecycle of drug research and development, and ensure quality and excellence during every phase of analysis.” This includes method development, method transfer, method qualification, validation, cross-validation, and sample analysis. Most of the biotech companies working with CMIC have minimal in-house Bioanalytical assay development capability for drug development. CMIC provides seamless support for method development from scratch. While working with large pharma companies having the capability to develop methods, clients usually transfer the assays to CMIC’s lab and perform the method transfer. CMIC accepts projects in any stage of drug research and development, from early stage of drug screening and selection, pre-clinical and clinical trials. The firm specializes its Bioanalysis services in four niche segments, namely small and large molecule, biomarkers, and oligonucleotides.
While working on the small molecules, CMIC ensures accuracy and precision among multiple analytical platforms including ultra-high performance liquid chromatography-mass spectrometry (LC-MS/MS), ultra-high-performance liquid chromatography coupled with fluorescence detector (UPLC-FLD), ultra –high-performance liquid chromatography with ultraviolet detector (UPLC-UV).
CMIC’s expertise allows them to tackle multiple-analyte methods and the analysis of radioactive compounds as well as high absorbance compounds. Because the lab is capable of performing multiple analyses using a single method, the sponsors can significantly reduce the expenses associated with the testing.
The demand for high throughput and accurate quantification and analysis of oligonucleotide therapeutic drugs is on the rise. CMIC is equipped with advanced facilities and hands-on expertise in the quantitative bioanalysis of oligonucleotides. Their scientists resort to hybridization-based assays for absolute quantification of oligonucleotides in the biological matrices besides utilizing platforms such as Shimadzu and Waters HPLC-UV, Shimadzu HPLC-FLD and AB Sciex Triple Quadrupole.
CMIC also supports method transfer, development, qualification, validation, and sample analysis of protein-based therapeutics. Their expertise in oncology, immuno-oncology, immunology, and neuroscience is worth mentioning.
“The company implements a centralized and direct communication model which is led by Principal Investigator during the course of study execution. Through this mechanism any study related issues can be identified, communicated promptly and resolved on a timely basis. CMIC does encourage utilizing the same team to manage and execute assay transfer, method validation and study sample analysis. Jenny says that there will be no loss of know-how compared to processes being distributed/transferred among various teams and not centrally controlled. The communication model adopted by the firm not only adds accuracy but also helps to build direct communication with the clients and transparency throughout the entire lifecycle of the studies. The quality assurance department also works closely with the PI to ensure the studies and tests adhere to all the mandatory regulations in place. The PI works as a core communicator who conveys the details about the project to the sponsors and ensure timely data delivery. Requirements of the sponsor is duly noted and processed by the same PI, thus ensuring timely response and unmatched client satisfaction.
Serving the Future
Started as a company that assisted drug development, CMIC Group has now expanded its services to cover almost all areas of pharmaceutics, including manufacturing, sales, and marketing. They also provide professional supports for medical device manufacturers, academia, and bio-ventures. While reaching new heights with continued business success, CMIC does not forget about their social responsibility. They understand that along with sustained business growth, social stewardship is also a key factor for achieving holistic success. And for that reason the company provides prophylaxis and health-enhancing services to the public, ensuring that it reaches the deserved.
"We identify ourselves as a ‘pharmaceutical value creator,’ and we actualize it through our numerous efforts to bring quality and excellence in the field of pharma research"
Citing the company’s expansion plans, Jenny informs that CMIC aims to widen its scope of health maintenance and enhancement measures by incorporating prevention, diagnosis, and treatment of diseases, including rare diseases that affect a small proportion of the population. “We are focusing on pharmaceuticals to swiftly deliver safe and effective drugs to patients,” concludes Jenny.