Jenny Lin | Chief Operating Officer & Board Member | CMIC Inc.

Jenny Lin: A Leader Building Quality Organizational Systems

Jenny Lin, the Chief Operating Officer and Board Member of CMIC Inc., holds 27 years of executive/lab management experience in bio-analytical and analytical laboratory operations in support of drug discovery, pre-clinical and clinical drug development. Moreover, she is proficient in GLP, GMP, GCP, OECD, ICH and 21 CFR part 11 regulations and in business strategic planning and execution. Her expertise includes building organizational quality system, staff training, bioanalytical/analytical method development/validation, bioanalytical sample analysis, analytical development for CMC submission, chromatography purification, stability studies, reference standard certification, QC support for GMP manufacture. She has been also a selected member for Global Bioanalysis Consortium (GBC) making recommendations for global Bioanalysis harmonization. She serves as editorial board member for peer reviewed journal and chair for international conferences.

Moreover, she is an author and co-author for approximately 40 publications, white papers and presentations and is the inventor of 7 issued US patents. Jenny earned her BS in Analytical Chemistry at Peking University and her MS in Medicinal Chemistry at University of Connecticut. She is a member of the American Society of Mass Spectrometry (ASMS), American Association of Pharmaceutical Scientists (AAPS), American Chemical Society (ACS), National Association of Professional Woman (NAPW) and Global CRO Council (GCC).

A Pioneer in the CRO Business

CMIC, Inc., is a subsidiary of CMIC Group and a leading CRO (Contract Research Organization) specialized in bioanalytical services, whose cutting-edge capabilities and sophisticated expertise in various aspects helped it achieve a greater stature in the business. Its bioanalytical services are in support of TK/PK/PD Biomarker studies for pre-clinical and clinical developments. It firmly focuses and holds expertise in bioanalytical method development, method validation/qualification and study sample analysis for small, large molecules and Oligonucleotide. CMIC Group was founded in 1992 as Japan’s first CRO. The “CMIC” name stood for “Current Medical Information Center”, and the company remains committed to the advancement of medicines and healthcare revolution. CMIC Inc., as one of the CMIC Group’s subsidiaries in US, helps sponsors overcome challenges in bioanalysis with expertise, rapid data turn-around-time, and high-quality customer services.

CMIC Group’s core values intercepted through, W & 3C;

  • 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

The Story behind CMIC

CMIC Inc., a CMIC Group’s non-clinical service subsidiary in Chicago, Illinois is a global CRO with over 30 years’ experience. The laboratory offers bioanalysis for non-clinical and clinical projects, both GLP and non-GLP within a state-of-the-art facility that has the capacity to accommodate quick turnaround for high-volume projects. CMIC’s skilled researchers provide deep expertise in small and large molecule bioanalysis, biomarker services and oligonucleotide bioanalysis expertise. Purpose built in 2010, CMIC Inc.’s contract bioanalytical and biomarker laboratory is located nearby Chicago O’Hare International Airport and is one of four global contract laboratories in the CMIC Holdings group.

Current large molecule capabilities include analysis of oligo, peptide, or antibody therapeutics using standard ELISA or MSD-ECL ligand-binding platforms. A variety of formats are available including but not limited to direct, indirect, sandwich, competitive, and multiplex which can be performed with off-the-shelf assays or developed in-house. For oligonucleotide detection by hybridization assay, CMIC Inc. brings a wealth of experience with capture and detection probe-based assays for quantitation of antisense or siRNA based therapies.

CMIC Inc.’s flow cytometer has the ability to detect up to 13 colors, and is equipped with a 96-well plate loader to handle high-throughput applications. The software is 21 CFR Part 11 compliant, and displays easily viewed data. Immuno-phenotyping on whole blood, PBMC, or bone marrow can be performed with a general panel to determine the percentage of T- and B-cells, Natural Killer, and monocyte/macrophage lineage within the leukocyte population. Alternatively, specialized panels such as regulatory T-cells (Treg cells) can be characterized. Treg cells play a role in regulating or suppressing other cells in the immune system, and can be defined by the cellular markers CD25, FoxP3, and CTLA4, and the intracellular cytokines IL4 and TGFβ. Another specialized type of T-cell (one that is important for battling foreign invaders) is the CD4+ memory T-cell, which can be identified by staining CD45RA and CCR7 to determine the percentage of naïve, central memory, and effector memory T-cells within the overall T-cell population. Other flow cytometry applications include confirmation of gene expression in order to establish potency of gene therapy, or the efficacy of a treatment regimen.

Real-time qPCR has emerged as a powerful tool for bioanalysis, and offers the ability to explore mRNA gene expression. RNA can be isolated from whole blood, PBMC, bone marrow, solid tissue, or matrices such as urine, saliva, or cerebrospinal fluid and then added to a reverse-transcriptase quantitative PCR to accurately quantify mRNA levels. Alternatively, DNA can be isolated and added to a qPCR to identify single nucleotide polymorphisms, for detection of known mutations, or to determine individual copy number variation. One of the more powerful applications of qPCR is the ability to multiplex, which is the detection of many targets within the same reaction. This can be leveraged for biomarker screening to determine which genes are differentially regulated in response to therapeutic treatment. CMIC Inc.’s qPCR instruments are compatible with a variety of flourophores and are fully supported by the vendor, providing for seamless design of specialized panels, thereby saving precious time and cost. Yet another application for qPCR is detection of viral nucleic acids in order to determine the remaining levels of a vaccine or gene therapy vector in order to establish washout and allow further optimization of a dosing regimen.

CMIC Inc. plans to add droplet digital PCR and cell-based assays to augment current GLP capabilities for bioanalytical support of gene therapy programs. While industry and regulatory contemporaries are building out a knowledge base for new and updated assays, CMIC Inc. will be well positioned to support large molecule biologics ranging from monoclonal antibodies, biosimilars, anti-cancer compounds, peptide-based therapies, gene therapy, and vaccines.

Future of CMIC Group

CMIC Group’s CREED as a corporate philosophy, consists of Wellbeing, Challenge, Change and Communication (W&3Cs). The company has been applying this philosophy to continuously evolve itself in line with market changes, and will do so in the future. Moreover, by further expanding from the current “Pharmaceutical Value Creator” (PVC) business model, the company has an aspiration to become a “Personal Healthcare Value Creator” (PHVC) to address the up-coming personalized medicine movement and individual patient quality of life.