ITOR paves way for rapid cancer drug development

This week, Greenville Health System announced the formation of the Institute for Translational Oncology Research. This announcement could not be more timely as it comes in the midst of a burgeoning national dialogue on the direction of oncology.

This visionary cancer initiative, called ITOR, will help pave the way for new breakthroughs in rapid drug development, diagnostic discovery and advanced cancer care. Through this collaboration and innovation, we will be able to make new therapies accessible to patients far more quickly than traditional models have allowed.

ITOR is part of the GHS Cancer Center, a recognized regional multi-disciplinary center. ITOR builds on the success of GHS’ Clinical Research Unit and its biorepository tissue-banking service, which helped make GHS one of the country’s prominent players in the development of promising new oncology drugs. Numerous first-in-human studies have been conducted through the CRU, which began in 2004 as part of GHS’ long-standing relationship with Cancer Centers of the Carolinas. 

Our goal is to facilitate and integrate research so that it can be rapidly channeled into clinical application. We believe we are uniquely positioned to develop a cooperative platform that will become a model in the evolving field of oncology drug development. ITOR partners will include leading pharmaceutical companies, research universities, private industry and the government. We have more than 30 current partners and collaborators, including Amgen, Novartis, AstraZeneca, Eisai Pharmaceuticals and Oncolix, and we envision home-grown synergy with the Cancer Research Center of the University of South Carolina and Lab 21, a United Kingdom diagnostics company which located its U.S. headquarters in Greenville to be close to ITOR.

One third of men and one quarter women in America have had cancer, meaning that nearly every family in the United States has been affected by it. That includes my own -- my mother had breast cancer at age 26, my sister had colon cancer at age 40. Both, thankfully, are survivors.

Great strides have been made since the National Cancer Act in 1971, which began the “War on Cancer” and the mobilization of the nation’s resources to attack cancer. We have gone from the day where our understanding was primarily based on where the cancer was located to today, when we’ve the ability to “interrogate” cancer cells for an unprecedented level of understanding.

Thanks to new technology and research, we can classify the disease by the specific molecular markers that actually drive the cells to become cancerous. Harnessing fields such as data mining and computational analysis will help organize and analyze cancer at the molecular level.

Here alone, approximately half of the 500-plus clinical trials at GHS are related to cancer, ranging from first-in-human Phase I therapies to national multicenter cancer trials.

We are truly at a transition point in cancer care delivery. Individual patients with individual tumors are beginning to be treated with an approach specifically designed for them – not the one-size-fits-all approach commonly used today.

This transition is exciting but will require us to re-examine every aspect of the research and clinical operations of oncology delivery.

Nationwide, we see a continued decline in the number of new therapies reaching the patient. That’s because of the cost and time involved in bringing a new drug to market. Simply from an economic standpoint, the cost of drug development is unsustainable. Using the current model, the average cost of a new drug from discovery to clinic is between $750 million $1.2 billion and requires 8-12 years.

The new personalized therapies may only make the funding dilemma only more complicated.

In addition, the new science behind the new drugs is causing heated ethical debates among some oncologists about the clinical trial system, which keeps some trial participants on placebos or non-effective treatments to test the comparative effectiveness of one drug over the other. Because the science behind the new treatments is so different from what’s come before, some physicians and researchers think the rules for testing need to be changed.

Doing so, however, will require better coordination between the Federal Drug Administration, the governing body that approves therapies, the National Cancer Institute and the pharmaceutical companies that fund the clinical trial process leading to approval.

This is exciting but also adds to the complexity of how we as a nation, still  at war on cancer, are going to systematically incorporate this new level of understanding into validation models that will achieve this vision of truly personalized oncology treatment.

Much is known, much more is unknown. Through the GHS Cancer Center and the Institute for Translational Oncology Research, GHS will be part of the discussion – and the solution.

To join us in the discussion, go to ITOR-ghs.org. The site includes additional commentary from fellow GHS oncologists, as well as links to the American Society of Clinical Oncology and a N.Y. Times series highlighting the national discussion.

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