From academic powerhouses to high-tech startups, Nashville has become a recognized leader in personalized medicine. Nashville Medical News spoke to some of the industry’s leading experts to get a better glimpse into the treatment possibilities of tomorrow, and what that means for patients today.

SCRI & the New Model of Medicine

“In Nashville, we have one of the largest drug development units in the world,” said Todd Bauer, MD, associate director of Drug Development and principal investigator at Sarah Cannon Research Institute. “We really address every area of oncology through the clinical trials that we have available, especially as it relates to early-phase options.”

According to Bauer, Sarah Cannon enrolls more than 1,000 patients in early-phase clinical trials annually and has conducted more than 170 first-in-man clinical trials to date, including several key trials focused on matching tailored treatments to patients’ tumor profiles. Bauer said personalized medicine is steering treatment away from the “therapy by cancer type” model of yesterday and toward treatment determined by each patient’s genetic mutation or alteration.

“Enrolling patients in clinical trials is important in determining how these mutations affect cancers," he said. To that end, SCRI is offering genetic “basket type” studies in personalized medicine – including the Genentech MyPathway Program and the Novartis Signature Program across the Sarah Cannon Cancer Network – that are expected to last six months to one year.

“Today we are discussing with our patients how technology allows us to look at DNA in their tumor cells, which didn’t exist five years ago,” Bauer said. “The explosion of technology continues to pick up speed and provides us with valuable information to offer more personalized treatment options to our patients.”

Vanderbilt-Ingram Cancer Center

Vanderbilt-Ingram Cancer Center Oncologist Jordan Berlin, MD, directs VICC’s Phase 1 clinical trials program and is co-leader of the GI Cancer program. He said personalized medicine also is changing the way patients are selected for trials.

“We used to take random patients and put them on Phase 1 trials … but now with personalized medicine we can know, at the earliest point, those who theoretically have the best chance of response based on lab data,” Berlin said. “Since we have potential signals, we don’t just go to Phase 2 now but can expand the trial to allow a higher chance of response based on lab data. We do trials that target something specific about a person’s tumor that may give them a better chance of benefitting from treatment.”

Berlin said GI cancers have traditionally lagged in personalized medicine studies, but he believes the ability to identify protein inhibitors in certain cancers will result in more effective treatments. He’s already seen success in treating GI stromal tumors with targeted therapies and urges physicians to consult an oncologist before deeming a patient’s cancer untreatable.  

“We’re getting there one piece at a time,” Berlin said. “We may only find a targeted therapy that works for four to six percent of patients with a single cancer, but as we start adding groups, we start getting larger and larger numbers of patients doing much, much better.”

Personalized Medicine & Cardiac Care

While oncology has long been a focus of personalized medicine, Vanderbilt’s Personalized Medicine department is looking beyond cancer to assess risk of other diseases.

Cardiologist Dan Roden, MD, assistant vice-chancellor for Personalized Medicine, regularly sees patients with genetic heart disease. Now, researchers in Vanderbilt’s Roden Laboratory are investigating mechanisms underlying variability in response to drug therapy, with a particular focus on therapies used to treat cardiac arrhythmias. One set of studies is analyzing common genetic variances between those with and without AFib.

“The biology we’re discovering is incredibly exciting and is in a place in the genome no one would ever think to look,” Roden said. One gene important in AFib, for example, controls early cardiac development. As the heart starts to develop, the gene in question turns off the pacemaker on the left side. That gene could lead to new biomarkers and clearer indications for use of common drugs like warfarin.

“The benefit is that eventually we’ll get to a point where we’ll have enough knowledge of genetic variance,” Roden said. “By understanding disease, we’ll be a in a much better place to develop new therapies.”

In fact, fall 2015 will usher in a new class of drugs for the treatment of high cholesterol – a drug class resulting directly from the Human Genome Project. PCSK9 inhibitors prevent the protein PCSK9 from interfering with the liver LDL removal process, allowing more LDL cholesterol removal from the blood.

“PCSK9 inhibitors are the fruits of a genetic revolution, and we’re just starting to see it,” Roden said. 

DiaTech Oncology

An increasingly visible player in the personalized medicine field is CorrectChemo by DiaTech Oncology. Since launching commercial operations in 2014, the Franklin-based company has run several thousand tests matching patients’ tumor samples with the best possible chemotherapy options, delivering results within 72 hours.

“Research is validating that a ‘one size fits all’ approach to cancer treatment is no longer valid,” said DiaTech Marketing Director and healthcare veteran Amanda Cecconi.

DiaTech’s novel approach is gaining acceptance by the medical community and research continues with The Mayo Clinic and other prestigious institutions. The personalized model also offers potential efficiencies to at-risk organizations wading through the transition to value-based care. 

“Value-based care is driving the industry to find new ways to better manage the cost of cancer,” Cecconi said. “Chemo is usually the No. 1 expense in cancer treatment delivery. Patients don’t want more chemo, they want chemo that works for them.”

InSight Genetics

Another game changer in Nashville’s personalized medicine industry is Insight Genetics, a molecular diagnostics company working to further precision cancer care at times of diagnosis, treatment and therapeutic resistance. A key focus for the company is triple negative breast cancer, which CEO Eric Dahlhauser calls the last frontier in breast cancer.

“Triple negative breast cancer has a very bad prognosis and is a class that’s often defined by what you are not,” Dahlhauser said, noting the many subtypes of cancer possible within a single diagnosis. “There’s a great unmet need here as no targeted therapies exist.”

Formed in 2007, Insight Genetics also focuses on ALK mutations, common in lung and other cancers. “Providers are now driving therapy decisions based on mutations, which is also true for assays in triple negative breast cancer,” he said. “We’re moving away from organ indication and toward an era of understanding the genetic driver behind a cancer and knowing which drugs should work best for each patient.”