SMC QUALITY

SMC Laboratories is highly regarded worldwide as a consulting CRO that designs studies in line with the demands of pharmaceutical companies and research institutions.

SMC Quality

SMC quality consists of the following 5 items.

  1. Disease models with established positive controls

  2. Accumulation of evalution data using reference compounds

  3. Established process for creating reliable disease models

  4. Large amounts of historical data

  5. High clinical correlation

We provide customers with data from SMC quality pre-clinical pharmacology studies that can translate to results in clinical trials

Our animal facilities received the approval of Animal Welfare Assurance for foreign institutions from the Office of Laboratory Animal Welfare (OLAW) of the National Institutes of Health (NIH) on November 30, 2015.
This is an assurance by the OLAW that SMC’s facility meets the standards of United States Public Health Service (PHS) policy and PHS-funded animal activities. PHS funding components include the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA).

CRO Consultant

Supporting over 600 clients worldwide

We support more than 600 pharmaceutical companies and bio-ventures in over 29 countries with our cutting-edge research and pharmacology studies.

  • Number of clients

  • Region

  • Breakdown by region

Established positive controls for STAM™ and IPF models, experience in evaluating a wide variety of test substances

  • We have experience in evaluating various classes of test substance in our pharmacology studies, such as small molecules, antibodies, nucleic acids, and cells.
  • Our STAM™ model utilizes Telmisartan as an established positive control and guaranteed evaluation system.
  • In addition, we have experience in evaluating compounds such as OCA and CVC, that are undergoing clinical trials and can be incorporated as a reference control.
  • Our clients have published data generated in our STAM™ model in 42 publications and 76 academic conferences so far.
  • Moreover, 15 companies have used data generated in pharmacology studies provided by SMC to complete CTA applications, and are currently conducting clinical trials.
  • For the IPF model, we offer two established positive controls - dexamethasone for preventative studies, and nintedanib for therapeutics studies.

Experts in liver disease research

  • Through discussions with our clients who are the top runners of NASH therapeutic drug development, we have accumulated the latest industry information and expertise in our field.
  • Our company handles 10 types of liver disease models, including NASH and liver fibrosis models, with a volume of historical data for each model.
  • We participate in international conferences such as NASH summit, AASLD, DDW and are striving to collect the most advanced knowledge in the field of liver research.

CRO specialised in NASH-HCC

  • Using our expertise in the field, we are able to offer various study designs tailored to the clients needs.
  • Our expert histopathologists are also able to perform third-party evaluation of samples from NASH and fibrosis models made by clients.

Abiility to suggest and perform a variety of evaluations and analyses for fibrosis

  • Based on our extensive experience in fibrosis related staining and immunostaining, we are able to assess fibrosis and establish novel test systems based on your needs.

Patents

  • International publication No.: WO2011/013247 Title of the invention: "Steatohepatitis-Liver Cancer Model Animal”
  • Publication No. (JP) : 2009-178143 Title of the invention: "Steatohepatitis-Liver Cancer Model Animal (EN)”

Case study

  • Galectin Therapeutics,Inc.(NASDAQ:GALT),had conducted a series of studies targeting the Fibrosis-stage of STAM™ mice before they received the approval from the FDA to proceed with first human clinical trial for treatment of fatty liver disease with advanced fibrosis.

    Galectin Therapeutics

  • Allergan plc (NYSE: AGN) had conducted a study targeting the NASH-stage of STAM mice before the received the approval from the FDA to proceed with first human clinical trial for treatment of liver fibrosis in adult subjects with NASH.

    Allergan