FlowMetric was established in 2010 and today operates primarily as a contract research organization (CRO) from its facilities in Pennsylvania and Italy. What are the circumstances surrounding the company’s establishment and how has it developed?

As early as 2004, I recognized the need for a more formal approach to flow cytometry as a platform to advance biologics while working as a bench scientist for Johnson & Johnson. In 2010, I formally incorporated FlowMetric and raised about $2.5 million to start the company as a CRO dedicated to providing flow cytometry across the drug development process–everything from pre-clinical drug development through translational research, and ultimately in clinical trial work.

In the first year, there were two of us, and after a year we were four. With a strong industry background and network, I was able to select talented individuals across the industry from drug development backgrounds to join my endeavor. Today, FlowMetric is 30 employees strong in Pennsylvania in the U.S., with six employees in FlowMetric Europe located in Lodi, Italy, and we are planning to open laboratories in APAC later in 2017. At the heart of our success has been our dedicated service and expertise in high complexity flow cytometry and translating that expertise into actionable data for our clients.

What are some of the main applications of flow cytometry?

Flow cytometry is the analysis of individual cells through a complex system combining optics, fluidics and electronics. Fluorescently conjugated antibodies bind to markers on the surface of cells, inside cells, and on molecules produced by cells themselves, and can thereby be used to identify many immune phenotypes and human disease states. The fluorescent intensities can then be converted into a mathematical value and can be quantified across each cell. We can monitor a billion different cells in a day, one cell at a time. When diagnosing a disease, a pathologist will only look at hundreds of cells at a time. Flow cytometry is in essence an analytical technique for Big Data analysis. It is possible to identify cells based on associated markers, and very precisely monitor multiple parameters simultaneously.  Flow cytometry is the perfect platform for advancing drug development.  Its specificity, precision, and high throughput nature allow for efficient tracking of drug efficacy and safety.

Although flow cytometry is not limited to biologics, the nature of biologics lends itself very well to interrogation using this technology.  Leukemias and lymphomas are diagnosed using flow cytometry, so there are very relevant clinical aspects to what we do, but the true opportunity at the time FlowMetric was founded was in understanding that this technique, this platform, could be used far more extensively than was being done at that time.

What services can FlowMetric offer its clients from the pre-clinical stages through the clinic?

Part of the pre-clinical service is based around the ability to derive or develop meaningful mechanism-of-action studies for our clients. Everything we do is hypothesis-driven experimental design, with meaningful systematic approaches.

In addition to pre-clinical services, we also offer services throughout the remainder of the drug development phases. The first is translational research, which transcends the space before a drug is submitted as an IND through designing the first safety clinical trials. The decision to move a therapeutic into the clinic needs to be supported by the science and there needs to be a strong indication that the drug will be successful through clinical trial.  Having the knowledge of good assays measuring if the drug will be safe, effective, and how effective it will be relative to what is already on the market, is key to developing a strong drug package for approval. Lastly, we offer services in all the clinical trial phases, using flow cytometry to identify modulatory effects of a therapeutic drug candidate in multiple therapeutic areas.

How does FlowMetric address questions surrounding the efficacy and safety of drugs?

The first prerequisite is the safety of the drug and whether the drug has any reaction that was not anticipated. We look primarily at the immune system for specific modulatory responses, as the cells of the immune system are great sentinels for understanding whole-body wellness. We also can identify cytokine storm, a potentially fatal immune reaction that can take place after the introduction of a therapeutic drug into a patient for the first time.

We hone in on answers that allow our clients to determine mechanism of action in order to aid them in understanding how their drug is effective in their patients. We produce this data based on custom assays that we develop in a GLP environment which adds the highest level of rigor to our assays.

In what ways can flow cytometry be utilized during drug development?

Pharmaceutical and biotech clients request mechanism-of-action studies, functional assays, signaling assays, and proliferation assays.  However, the primary service we provide is immunophenotyping, looking for increased or decreased expression of their marker of interest caused by their therapeutic drug. What differentiates us is our ability to develop, validate and analyze high-complexity flow cytometry (up to 18 colors/20 parameters on one cell, simultaneously). This is not common for CROs–we are at the highest level of ability in the market. Our capacity allows our clients to assess a greater number of biomarkers in one small sample, and evaluate the data across those markers at one time.

In clinical trial work, there is not always a second sample or a second chance to analyze that sample, therefore, at FlowMetric, we pride ourselves at being experts in high complexity flow cytometry assays.

What are FlowMetric’s key objectives going forward?

As well as opening a facility in Asia, we are increasing our U.S. footprint, and now have representatives in scientific hubs across the U.S. on the East and West Coasts.  Point-of-care diagnostics will be the next phase of rapid growth for us, and flow cytometry offers a whole host of opportunities in this area that are as yet virtually untapped.