As a scientist with a background in mechanical engineering and biomaterials, I am always interested in studying the latest developments and trends for new materials and am fascinated by the forefront of biotechnology. In this article I focus on the relatively young field of “Nanomedicine”.  My goal is to provide a general overview on the state-of-the-art in this important and growing field and to give a brief introduction of the broad technology areas.  In future articles I will feature representative prominent biotechnology companies and research institutes. As pointed out below, a large number of patents have already issued in this area. I also plan to discuss the progress in each subcategory, focusing on product commercialization, research and development, relevant patents, and law or regulatory policies in nanomedicine.

Nanomedicine is a newly created field going back to only 2000, and has rapidly accelerated and attracted the attention from both public and private research institutes and entrepreneurs. Nanomedicine is an application of nanotechnology to medical uses, targeted at preserving and improving human health. Nanotechnology is defined as “the ability to design and control the structure of an object at all length scales from the atom up to the macro scale”, while nanomedicine specifically covers treatments from the molecular level of the human body, to macroscale level science discoveries and technology developments. The aim of nanomedicine may be broadly described as the comprehensive monitoring, control, repair, and improvement of all human biological systems by engineered devices and nanostructures, with the ultimate goal of achieving a medical benefit.

The current progress in nanomedicine can be divided into the following five categories: (1) Diagnostics; (2) Drugs and Therapy; (3) Implants and Regeneration; (4) Systems Biology; and (5) Medical Instrumentation and Devices.

Nanomedicine Funding Support
The United States of America is the first country to initiate government funding support in nanotechnology and has expended USD 22 billion on it since 2000.  This includes approximately USD 1.5 billion for 2016. In 2005, the NIH published its Roadmap (now called “Common Fund”) of the Nanomedicine Initiative and created a program to support eight Nanomedicine Development Centers nationwide pursuing research in nanomedicine. In addition to the US, the European Commission also joined in this camp by investing 650 million Euros on translational nanomedicine, supporting 180 research projects and involving ~400 industrial partners. Recently, Asian countries, such as, China, Japan, Korea, and Singapore, have devoted significant resources to develop nanomaterials and nanotechnologies which can be applied to clinical applications, and to investigate the toxicology and environment safety issues involved in nanomedicine. Even Africa has established its own Nanosciences African Network (NANOAFNET) to promote research and development in infectious diseases of poverty (IDPs), such as, tuberculosis (TB), malaria, and human immunodeficiency virus (HIV).

The research activities in nanomedicine are also growing. In 1995, the very first nanotherapeutic product received US FDA approval.  This drug is Doxil, a liposomal formulation of the cancer drug doxorubicin that is passively delivered to tumors via the enhanced permeability and retention (EPR) effect based on nanoparticles. By 2004, ~38 products were approved under the category of nanomedicine. The number of approved products had reached 54 by 2013, with another ~150 in various stages of clinical trials. According to a Pubmed search on articles relating to nanomedicine, 12,281 papers were published in the past 10 years, with 3019 papers in 2015 alone. Similarly, the US patent office database shows 898 patents were granted in nanomedicine since 1976, with another 1177 applications pending.

I will be highlighting some of the more interesting patents and applications in future articles, as well as some of the companies and researchers currently spearheading the development of these technologies.  Stay tuned for future installments.

– Jing Zhou, PhD and Anthony D. Sabatelli, PhD, JD

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