ABSTRACT
Jason H. Sakamoto, PhD,a Biana Godin, PhD,a Ye Hu, PhD,a,f Elvin Blanco, PhD,a Anne L. van de Ven, PhD,a Adaikkalam Vellaichamy, PhD,b Matthew B. Murphy, PhD,c Saverio La Francesca, MD,d Terry Schuenemeyer, RN, MS,d Bruce Given, MD,e Anne Meyn,a and Mauro Ferrari, PhDa,faThe Houston Methodist Research Institute, Houston, Texas, USAbAnna University, Chennai, IndiacCelling Biosciences, Austin, Texas, USAdHarvard Apparatus Regenerative Technology, Holliston, Massachusetts, USAeArrowhead Research Corporation, Pasadena, California, USAfWeill Cornell Medical College, New York, New York, USA Keywords: nanotechnology, nanomedicine, nanovectors, chemotherapeutics, personalized medicine, diagnostics, biomarkers, nanofluidics, regenerative medicine, patient advocate, clinical translation, regulatory challenges, nanoparticle, drug development, precision medicine, biobarriers, controlled drug release, clinical translation
motivate fiscally conscious consumers to flock to warehouse-style retailers to purchase mass-produced generic products; rather than paying a premium at privately owned and operated boutique shops that sell unique goods marketed toward specific subgroups of customers. Unfortunately, this trend superficially appears to have been adopted with vigor by large pharmaceutical companies, “Big Pharma” as they are commonly referred to, as they develop and market blockbuster drugs to treat the masses. As a result, an individual patient’s clinical needs have been blurred in efforts to accommodate entire populations of patients. But before we lump Big Pharma into the likes of retail giants that mass-produce products to lower costs and boost margins, one must understand the harsh realities of drug development. On average, it is estimated that a single new drug compound costs over $1 billion and 10-15 years to develop [1]. And shockingly, only one out of five new drug compounds actually generates revenue equal or greater to its inherent developmental costs [1]! It is obvious that to disrupt this drug development trend, a “perfect storm” of novel emerging technologies, non-conventional regulatory approaches, Big Pharma support, and health insurance reform must converge to initiate the shift toward developing personalized therapies (Fig. 59.1).Personalized medicine is the collection and analysis of clinically relevant patient data (e.g., genomics, proteomics, metabolomics, etc.) to determine the most effective, tailor-made treatment strategy possible. The transition to individualized therapy is a palatable idea to embrace since its application is deeply rooted in the logical evolution of clinical medicine; however, its ubiquitous implementation will require an unprecedented synchronized integration of effort from the pharmaceutical industry, the Food and Drug Administration (FDA), and medical insurance companiespushed by scientific advancements and pulled by clinical demand from physicians and patients. Nanotechnology has been hailed by many as the enabler of individualized therapy since nano-based medicine, or nanomedicine, allows us to interact with disease at the scale of biology. We are now able to bring the battle to the level where a war is being waged. Nanotechnology provides scientists and clinicians with access to disease pathways, mechanisms to exploit minuscule pathologic changes in anatomy, strategies to augment imaging modalities, and tools to collect near-over whelming amounts of patient information to reveal new approaches
to identifying vulnerabilities of complex ailments such as cancer, heart disease, and other clinical challenges.
