Drug-Diagnostic Co-Development For Pharma Partners

Itamar Medical is a world leader in proven companion diagnostic solutions for the pharmaceutical industry

A companion diagnostic is a device or technology that is used to predict whether a
targeted drug therapy will work effectively during preclinical development, and is
often used after the drug has received approval to assess its actual effectiveness
in a given population. Utilizing their world renowned EndoPAT device for monitoring endothelial function, Itamar Medical develops companion diagnostic products to support drug discovery anddevelopment from inception straight through to regulatory approval and launch.

Itamar Medical Work Package

Itamar Medical - Pharma

Itamar Medical Pharma

Itamar Medical offers a specialized program for each drug and diagnostic project and includes elements of the following:

  • Consultancy and advice on developing a companion diagnostic utilizing
    EndoPAT technology to support testing of targeted therapies
  • Study design and development
  • Lease of EndoPAT technology for the length of the study
  • On-site staff training
  • Core lab for EndoPAT analysis
  • Investigational use of EndoPAT devices for multi-site clinical trials
  • Full technical support
  • Regulatory support
  • Management provided by a dedicated Project Team Leader (M.D.)

Why Partner With Itamar Medical?

  • Proven Leadership

    Itamar Medical is the world leader in endothelial function companion diagnostics.

  • Regulatory Experience

    Pharmacovigilance regulatory requirements for optimal protection of patients in clinical trials have added an extra layer to drug development. Itamar Medical has proven experience working with drug companies and regulatory bodies -including the U.S. Food and Drug Administration (FDA) to develop companion diagnostics and gain regulatory approval. Itamar Medical works with the Drug Company and regulatory authorities to ensure the test is approved as a companion diagnostic to support the sales of the new drug.

  • Technology

    Itamar Medical’s EndoPAT technology can be used in multiple platform settings.

  • Independence

    Itamar Medical is an independent company that works with many pharmaceutical companies on their companion diagnostic projects. Itamar Medical ensures strict confidentiality with all of its partners.

  • Cost Savings and Shortened Development Time

    By using EndoPAT testing as a surrogate marker for drug “success,” this eliminates useless latter-stage testing on patients who will not benefit and use only those who will. This also allows pharma to bring the data on “failed” patients back into the preclinical development cycle to find a treatment that will work.

Personalized Medicine

Itamar Medical is a world leader in proven companion diagnostic solutions for the pharmaceutical industry

Itamar Medical - Pharma

Itamar Medical Pharma

The old paradigm of one blockbuster drug that works for everyone has already become ancient history. As pharma evolves and recognizes the uniqueness of each individual disease, there is a growing certainty based on new methods of molecular analysis that particular drugs work better in subsets of patients who could not be previously identified or segregated. In previous clinical trials, there have been subsets of patients that either thrived on the drug and others who reaped nothing but side effects from the drug being studied. By personalizing medicine, however, and making use of information about a person’s genes, proteins, and environment, we are now better able to prevent, diagnose, and treat disease.
It’s now estimated that to bring a drug to market in the United States costs more than $1.2 billion. While novel therapies may be effective in clinical trials with a select group of patients, patients often respond differently to new drugs and the drugs don’t always work outside of the limited clinical testing sphere. The costs and consequences of treatment failure are significant. Drug ineffectiveness can range from an average of 75% for cancer drugs, to over 40 and 50% for new diabetes and arthritis medications, respectively. However, by using new companion diagnostics such as EndoPAT with the new generation of agents currently in development, Pharma can preselect those patients most likely to benefit from and exclude those likely to be harmed by a new drug. Companion diagnostics can reduce the cost of drug development by facilitating clinical testing, and allow health insurance companies to offer safer and better drugs with predictable outcomes, ultimately helping lower the cost of patient care.

For further information about Itamar Medical’s companion diagnostic development programs Contact Us