Press Releases


CMIC Announces

01

JUNE 2017

CMIC, Inc. Celebrates its New Bioanalysis Laboratory Expansion --- TK, PK and PD Bioanalysis under “One Roof” in a Regulated GLP Environment.

Hoffman Estates, IL ----- CMIC, Inc. (the Company), an emerging U.S. Bioanalysis (BA) Contract Research Organization (CRO) with an overreaching coverage in Japan and Asia Pacific region under CMIC HOLDINGS Co., Ltd., announced today that the Company has opened up a new advanced GLP laboratory for Pharmacodynamics (PD) and sample storage along with a dedicated genomics biomarker and related oligonucleotide (Oligo) analysis room.

The new 2017 lab space is 5,000 ft2 (464.5 m2), in addition to the original 22,000 ft2 (2,050 m2) GLP lab, which was designed and built by the Company in 2010, in Hoffman Estates, IL, and is conveniently located within 30 minutes from Chicago O’Hare International Airport for prompt sample shipment and easy client access.

The added new facilities significantly increase lab space for storage of preclinical/clinical samples and newly establish a dedicated genomics testing lab. The genomics lab, equipped with qPCR and next generation sequencer instruments, further enhances the Company’s capabilities to evaluate possible mutations in patients’ DNA for both resistance to developing compounds or possible efficacy.

At the ribbon cutting ceremony on June 1st for the new lab opening, Ms. Keiko Oishi, Representative Managing Director for CMIC HOLDINGS Co., Ltd. and CEO, CRO Business for the entire CMIC group said, “CMIC group has been driving the bioanalysis and other non-clinical CRO analysis since 2015. This multi-million dollar investment to the Chicago BA lab is a cornerstone not only for our CRO’s strategic growth, but also for the entire CMIC group’s U.S. presence.”

The ribbon cutting ceremony for the new lab opening was also attended by Mr. William McLeod, Mayor of Hoffman Estates, key customers and other approx. 100 honorable guests and CMIC employees.

CMIC, Inc. (formerly JCL Bioassay USA), located in Hoffman Estates, IL, is a leading CRO and a provider specialized in Bioanalytical services in support of TK/PK studies for pre-clinical and clinical developments. 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. For more information, visit: http://www.cmic-inc.com/

Since its establishment in 1992, CMIC has been a leading CROin Tokyo, Japan and overseas subsidiaries have located in China, Singapore, Korea, Philippines, Malaysia, and others for geographical coverage within Asia, the most rapidly growing market in the world. CMIC has global/Asian clinical trial hands-on experience and expertise providing clients with the value-added services to support Phase I-IV clinical trials in various therapeutic areas. In addition to monitoring, DM/STAT and project management services, CMIC offers strategic and regulatory affairs consultation that requires strong networking skills with the regulatory authorities, as well as extensive knowledge of regulatory requirements. Our scope of services encompasses such business functions as Contract Manufacturing Organization (CMO), Contract Sales Organization (CSO) and Site Management Organization (SMO). For details, please visit http://www.cmic-holdings.co.jp/e/

For further information: Ms. Jenny Lin Chief Operating Officer and Test Facility Manager (847) 645-0407 Ext. 107 jenny-lin@cmicgroup.com


07

APRIL 2016

CMIC, Inc. Achieves CIOReview Ranking for 20 Most Promising Biotech Technology Solution Providers 2016

FREMONT, CA—March 9, 2016

CMIC, Inc., a trusted provider of Bioanalytical services, joins an elite number of companies that have earned a spot on 20 Most Promising Biotech Technology Solution Providers list of 2016 by CIOReview.

In a deliberation session with the honorary industrial experts, a list of 20 Most Promising Biotech Technology Solution Providers 2016 has been concluded with. The positioning is based on evaluation of CMIC’s specialties in offering bioanalysis for non-clinical and clinical projects, both GLP and non-GLP, to meet critical drug development milestones. CMIC helps sponsors overcome the challenges in bioanalysis with scientific expertise, rapid turn-around-time and high quality services.

“CIOReview's 20 Most Promising Biotech Technology Solution Providers list is a validation from the CIO community in the recognized brand as a Trusted Partner. By being voted by CIOs, CMIC has proven its expertise in Biotech Technology placing it amongst the top percentile of enterprise ICT vendors in the US”, said Jeevan George, Managing Editor of CIOReview.

“We are pleased to be selected as one of the 20 Most Promising Biotech Solution Provider in 2016. With our solid 30+ year history supporting Pharma and Biotech in drug research and development, we fully understand how vital it is to execute our bioanalysis with quality and speed. We always seek the best way to bring value to our sponsors, such as investing ahead of curve and constantly improving our lab processes, so we can be ready to exceed our sponsor’s needs. It is great to receive recognition such as this. It motivates us to continuously working at our best”. Said Jenny Lin, Chief Operating Officer, CMIC, Inc.

About CIOReview

Published from Fremont, California, CIOReview is a print magazine that explores and understands the plethora of ways adopted by firms to execute the smooth functioning of their businesses. A distinguished panel comprising of CEOs, CIOs, VCs, analysts including CIOReview editorial board finalized the “20 Most Promising Biotech Technology Solution Providers 2016” in the U.S. and shortlisted the best vendors and consultants. For more information, visit: http://www.cioreview.com/

About CMIC, Inc.

CMIC, Inc. (formerly JCL Bioassay USA), located in Hoffman Estates, IL, is a leading CRO and a provider specialized in Bioanalytical services in support of TK/PK studies for pre-clinical and clinical developments. 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. For more information, visit: http://www.cmic-inc.com/

About CMIC HOLDINGS Co., Ltd. Since its establishment in 1992, CMIC has been a leading CRO (Contract Research Organization) in Tokyo, Japan and has expanded its geographical coverage within Asia, including China, Taiwan, Singapore, Korea and Malaysia, the most rapidly growing market in the world. CMIC has global/Asian clinical trial hands-on experience and expertise and can provide clients with the value-added services to support Phase I-IV clinical trials in various therapeutic areas. In addition to monitoring, DM/STAT and project management services, CMIC offers strategic and regulatory affairs consultation that requires strong networking skills with the regulatory authorities, as well as extensive knowledge of regulatory requirements. Our scope of services encompasses such business functions as Contract Manufacturing Organization (CMO), Contract Sales Organization (CSO) and Site Management Organization (SMO). For details, please visit http://www.cmic-holdings.co.jp/e/



26

MAY 2015

JCL Bioassay USA, Inc. Changes Its Name to ‘CMIC, Inc.’ to Integrate into the CMIC HOLDING Co. Ltd. Group and Reflects Overall Organization’s Vision

Mike Suga, Corporate Officer and spokesperson for CMIC HOLDINGS Co. Ltd.., announced today at the Hoffman Estates lab that ‘JCL Bioassay USA, Inc.’ officially changed its name to ‘CMIC, Inc.’ as of May 25, 2015

Following JCL Bioassay USA’s acquisition by CMIC HOLDINGS Co. Ltd. on March 1, 2015, JCL begun the journey of being part of the CMIC HOLDINGS group. As part of the integration, we have changed our name to ‘CMIC, Inc.’. Our new name better connects us with the CMIC organization and matches the vision to bring our clients more value through expanded laboratory services in the future

“We are excited to continue our integration into CMIC HOLDINGS organization. Our new name reflects the commitment to continued investment and growth in our operations”. Said Jenny Lin, Vice President of Operations and CSO

“As CMIC, Inc., we will accelerate our growth of services in North America and most importantly better aligns with our overall vision to bring value with each client interaction,” Said Mike Suga, Corporate Officer, President Office

About CMIC, Inc. CMIC, Inc. (formerly JCL Bioassay USA), located in Hoffman Estates, IL, is a leading CRO and a provider specialized in Bioanalytical services in support of TK/PK studies for pre-clinical and clinical developments. 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, Inc. helps sponsors to overcome challenges in bioanalysis with expertise, rapid turn-around-time and high quality services. For more detailed information, visit CMIC, Inc. at www.jclbiousa.com.

About CMIC HOLDINGS Co., Ltd. Since its establishment in 1992, CMIC has been a leading CRO (Contract Research Organization) in Tokyo, Japan and has expanded its geographical coverage within Asia, including China, Taiwan, Singapore, Korea and Malaysia, the most rapidly growing market in the world. CMIC has global/Asian clinical trial hands-on experience and expertise and can provide clients with the value-added services to support Phase I-IV clinical trials in various therapeutic areas. In addition to monitoring, DM/STAT and project management services, CMIC offers strategic and regulatory affairs consultation that requires strong networking skills with the regulatory authorities, as well as extensive knowledge of regulatory requirements. Our scope of services encompasses such business functions as Contract Manufacturing Organization (CMO), Contract Sales Organization (CSO) and Site Management Organization (SMO). For details, please visit http://www.cmic-holdings.co.jp/e/



11

Mar 2015

Leading Japanese CRO Continued Investment in Large Molecule Services

JCL Bioassay USA, Inc. today announced its continued investment into its ligand binding assays (LBA) services with the addition cutting edge instrumentation. We are expanding our Electrochemiluminescence (ECL) platform with the addition of the MSD SECTOR S600. This is the latest MSD instrument available and will increase sample throughput capacity, dynamic range and sensitivity for large molecule analysis several fold over current ELISA plate readers. It also gives us another tool to support our clients fit for purpose needs. Our LBA services span from development, validation, to analysis supporting both non-clinical and clinical bioanalysis of biologics.

“With the rapid growth of our business, it is our unwavering determination to serve the growing demand of LBA services. The introduction of MSD provides us with the latest technology. Coupled with JCL’s in-house expertise, we continue to position our labs to meet our client’s needs with quality data”. Said Jenny Lin, Vice President of Operations and CSO, JCL Bioassay USA, Inc.

About JCL Bioassay USA, Inc. JCL Bioassay USA, located in Hoffman Estates, IL, is a leading Japanese CRO and a global provider specialized in Bioassay services in support of TK/PK studies for pre-clinical and clinical developments. 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, JCL Bioassay USA helps sponsors to overcome challenges in Bioanalysis with expertise, rapid turn-around-time and high quality services. For more detailed information, visit JCL Bioassay USA Inc. at www.jclbiousa.com.



28

Feb 2014

Leading Japanese CRO Expands its Large Molecule Services

JCL Bioassay USA, Inc. today announced the expansion of services covering ligand binding assays (LBA) under the leadership of Kyle Abuarjah. The LBA services span from development, validation, to analysis supporting both non-clinical and clinical bioanalysis of biologics. These services will be supported using Enzyme Linked Immunosorbent Assay (ELISA) and Electrochemiluminescence (ECL) platforms.

We have harmonized and leveraged our quality and delivery expertise of our small molecule service to LBA. This began with an extensive search for a scientist to expand our technical leadership to build on our harmonization efforts. Kyle Abuarjah brings over 13 years of LBA experience to JCL. Kyle received his Bachelors of Science in Clinical Laboratory Sciences from the University of Texas Medical Branch at Galveston and received his Masters of Business Administration from Athabasca University. Kyle is certified by the American Society of Clinical Pathology (ASCP) and is a member of the American Association of Pharmaceutical Scientists.

“Introducing our large molecule service coupled with 30 plus years solid experience in Bioanalysis will further extend our partnership with our clients and meet the growing market needs of developing new Biologics”. Said Jenny Lin, Vice President of Operations and CSO, JCL Bioassay USA, Inc.


17

April 2013

Leading Japanese CRO Standardizes on Thermo Scientific Watson LIMS

JCL Bioassay Uses Thermo Scientific Watson LIMS to Optimize Communication, Data Management and Quality Control during U.S. Expansion

JCL Bioassay USA, Inc. today announced the successful implementation of Thermo Scientific Watson LIMS, the industry’s leading bioanalytical LIMS (laboratory information management system). JCL Bioassay Corporation, one of the largest contract research organizations (CRO) in Japan specializing in Bioassay to support preclinical and clinical development, recently expanded its bioanalytical services to the U.S. and standardized on Watson LIMS in US laboratories to enhance sample management, data reporting and improve lab operation efficiency.

Thermo Scientific Watson LIMS are purpose-built to drive the business to the highest level of efficiency. Thermo Scientific Watson LIMS is a leading bioanalytical laboratory information management system that is relied upon by 19 of the top 20 pharmaceutical companies and CROs worldwide. It brings critical time and cost savings to pharmaceutical companies and CROs involved in drug metabolism, pharmacokinetic (PK) and toxicokinetic (TK) studies for drug discovery and development by reducing validation time and improving overall efficiency.

“By implementing Watson LIMS, it dramatically changes the landscape of lab operations. Not only does it provide an easy access for sample management, basically we are one click away from any given sample storage information, it also greatly enhances method validation, sample analysis and data management efficiency in our labs. With Watson LIMS, we know we can generate analytical data quicker and transfer the data to our sponsors securely. Watson LIMS system ensures regulatory compliance and adds greater value to the high quality services we provide to our sponsors”. Said Jenny Lin, Vice President of Operations and CSO, JCL Bioassay USA, Inc.


19

Mar 2013

JCL Bioassay USA and Xceleron Announce Partnership in Early Clinical Investigations

JCL Bioassay USA, a Leading Japanese CRO specialized in Bioassay services utilizing ultra sensitive and proprietary methodologies, has announced a partnership with Xceleron, a leader in the design and execution of novel clinical investigations using ultra-sensitive Accelerator Mass Spectrometer (AMS) analytical technology. The partnership will offer drug developers access to the broadest range of sensitive and robust analytical platforms in early clinical development across Asia, Europe and North America.

Phase 0 and enriched Phase 1 studies have been used successfully in recent years to investigate a range of developmental endpoints including drug presence at the tissue or cells of interest, absolute bioavailability and human metabolism. Investigations of this type conducted early in development allow critical decisions to be made confidently and very cost-effectively when compared to later stages of clinical development.

The partnership between JCL Bioassay USA and Xceleron will provide access to clinical design expertise and the most appropriate Bioassay platform for the purpose of early clinical investigation. JCL Bioassay USA and Xceleron have between them developed over 100 analytical methods for Phase 0 and enriched Phase 1 investigations. This has been made possible because both companies have recently constructed, equipped and staffed laboratories specifically for the purpose of ultra-low level analyses under GLP and GCP conditions.

“With 27 years experience in providing services for Bioassay work coupled with the most state -of-the-art analytical instruments, our researchers are well positioned in conducting ultrasensitive bioanalysis. This has led to the continuous growth of our company as a leader in the bioanalytical field and enables our customers to make rapid and precise decisions on their drug development programs. The partnership with Xceleron further expands the geographic and technological scope of the services we can provide to our customers and promotes the use of cost-effective analytical platforms to detect low level analytes in early drug development ” said Jenny Lin, Vice President of Operations and CSO of JCL Bioassay USA, Inc.

“This partnership emphasizes the critical role of contemporary analytical platforms in driving down the cost per launch. Whether in Phase 0 or enriched Phase I, we can confidently provide critical PK and PD information cheaply before Phase II” said Dr. Michael Butler, CEO of Xceleron.