Building a Personalized Medicine Infrastructure at a Major Cancer Center

Abstract

Our understanding of cancer biology is rapidly increasing, as is the availability and affordability of high throughput technologies for comprehensive molecular characterization of tumors and the individual's own genetic makeup. Thus, the time is right to implement personalized molecular medicine for all patients with cancer. Personalized approaches span the full cancer care spectrum from risk stratification to prevention, screening, therapy, and survivorship programs. Several molecular therapeutics have entered clinical trials creating a huge opportunity to couple genomic markers with this emerging drug tool kit. The number of patients managed in major cancer centers creates a challenge to the implementation of genomic technologies required to successfully deliver on the promise of personalized cancer care. This requires a major investment in infrastructure to facilitate rapid deployment of multiplex, cost-effective, and tissue-sparing assays relevant across multiple tumor lineages in the Clinical Laboratory Improvement Amendments (CLIA) environment. Efforts must be made to ensure that assays are accessible to patients most likely to be enrolled onto molecular-marker–driven trials and that the tests are billable and payable, which will make them accessible to a wide range of patients. As the number of patients and aberrations increase, it will become critical to provide decision support for genomic medicine. Institutional commitment is needed to optimize accessibility and quality of research biopsies and to facilitate novel personalized cancer therapy trials. This article will focus on the challenges and opportunities that accompany the building of infrastructure for personalized cancer therapy.

Problems, challenges and promises: perspectives on precision medicine

“…Oncology is the medical field most rapidly adopting genomic-era medicine, with most major cancer centres developing personalised medicine initiatives [6,12,[60][61][62][63][64][65]. As such, oncology also appears poised to be the pioneer of precision medicine approaches as it seeks to interpret ever growing datasets for individual patients.…”

Institutional implementation of clinical tumor profiling on an unselected cancer population

“…The clinical benefits of identification and targeted inhibition of driver genomic alterations have been demonstrated in multiple cancer types (1)(2)(3)(4)(5)(6)(7). These successes have led to the notion that systematic assessment of "actionable" cancer genomic changes may enable precision oncology (8,9).…”

Translational Pharmacokinetic-Pharmacodynamic Modeling for an Orally Available Novel Inhibitor of Anaplastic Lymphoma Kinase and c-Ros Oncogene 1

“…Most lung cancers (∼90%) are non-small cell lung cancers (NSCLCs), which consist of a number of subtypes driven by various activated oncogenes (Ettinger et al, 2010;Larsen et al, 2011). Recent advances in molecular profiling technologies have significantly enhanced the development of personalized, molecularly targeted therapies based on individual genetic or protein profiles (Meric-Bernstam et al, 2013;Arnedos et al, 2014). Consequently, molecularly targeted agents for NSCLC patients have become one of the successful personalized cancer therapies (Moreira and Thornton, 2012;Cardarella and Johnson, 2013;Li et al, 2013).…”