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Since nanotechnology and nanomedicine can be used to not only treat diseases, but to cure them as well, one must understand the relationship between the goal of nanomedicine and the reality and facts on the ground.  Here, we will examine the opportunities and challenges that will face this technology and whether there is a true desire, from all parties involved, to achieve the ultimate goal from nanomedicine.

Nanomedicine: Basic Capabilities

Challenges

The field of nanomedicine promises significant opportunities for patients, pharmaceutical and biotech industries. Just like any other technology, nanotechnology, particularly nanomedicine, faces several challenges that could potentially delay (or halt) any advancements made in this field.  Some examples of these potential obstacles are:

• Are pharmaceutical and biotech companies really interested in curing diseases?  What will this mean to their business and bottom-line should they succeed in curing and eliminating diseases?

• Are governments interested in curing diseases and prolonging people's lives?

• If diseases are eliminated, will there be a need for physicians, particularly specialists (cardiologists, neurologists, pulmonologists, etc..)?

• Ethically, should this technology be developed and utilized to cure and eliminate diseases, will it be available for everyone or only those who can afford it?

These are only general potential obstacles.  Certainly, there are many more.  There are specific potential obstacles in the way of research and utilizing nanomedicine in humans to a great extent:

• Ensuring that nanobots will perform their jobs without errors.  For example: programmers must ensure that nanobots will travel to the right blocked artery and perform their functions at the correct cells without harming other cells.

• Will the nanobots be attacked and destroyed by our natural self defense mechanisms (i.e. white blood cells)?

• What are the risks of nanobots becoming hazardous or toxic to our bodies?  If some nanobots replaced damaged or dead cells, will the organs accept this foreign body?

How does the body react to medical nanodevices?

The challenges facing nanotechnology

Nanotechnology: Potential Risks

 

 

 

Recent years have witnessed an unprecedented growth in research in the area of nanoscience. There is increasing optimism that nanotechnology applied to medicine will bring significant advances in the diagnosis and treatment of disease. However, many challenges must be overcome if the application of Nanomedicine is to realise the improved understanding of the patho-physiological
basis of disease, bring more sophisticated diagnostic opportunities and yield more effective therapies. Both the optimism and the challenges have prompted governmental science and funding organisations to undertake strategic reviews of the current status of the field1, their primary objectives being to assess potentialopportunities for better healthcare as well as the risk-benefit of these new technologies, and to determine priorities for future funding.

In early 2003, the European Science Foundation launched its Scientific Forward Look on Nanomedicine. I am pleased to see the successful conclusion of this foresight study, which has been the first such exercise focused on medical applications of nanoscience and nanotechnology. The Forward Look involved leading European experts and led to a definition of the current status of the field and debates on strategic policy issues. The recently published Policy Briefing summarised the recommendations made2.  Here the discussions and recommendations are presented in full.

Implementation of these recommendations should ensure continuing European leading-edge research and development in the field of Nanomedicine, resulting in reduced healthcare costs and the rapid realisation of medical benefits for all European citizens. ESF will commit itself to taking the initiative and facilitating the relevant bodies, including ESF Member Organisations and the European Commission, for actions based on these recommendations.

 

 

For the time being, the two biggest obstacles facing nanomedicine are the number of variables in applying theoretical solutions to actual patient problems (unique genetic composition, etc) and the amount of time it takes to create an actual solution (time to market). Both issues will eventually be solved with ever increasing computer power to process better and better models of genomes and patient biology.

 

This Forward Look on Nanomedicine has defined the remit of this emerging and important field.  Nanomedicine is clearly multidisciplinary and builds on the existing expertise in a large number of different scientific fields.  European strengths have been identified, as have the short- and long-term opportunities, and priorities for the development of Nanomedicine-related technologies have been recognised.  When applying nanotechnology to medical uses, it is particularly important to ensure thorough safety evaluation of any new technologies and also to review the likely environmental impact. In each specific case, careful risk-benefit evaluation is required.

Most importantly, an open and continuing dialogue is required to ensure all interested parties, including the general public, are well informed as to the ongoing technology developments in the field of Nanomedicine. As much has been written in the popular press, quality information is required to assist policy makers and scientists to distinguish “science fact” from “science fiction’’.

 

As for any other conventional medicine, the entire life cycle of nanopharmaceuticals includes production, distribution, clinical administration, consumer safety (human body effects and side-effects), and waste disposal. While the clinical applications usually concern only the selected stages of the life cycle, toxicological effects may exist in all the stages. Both clinical applications and toxicology of nanopharmaceuticals must be studied and examined comprehensively. When designing a clinical protocol for a nanopharmaceutical there are new challenges. Clinical trials and epidemiology studies may be significantly different from those for conventional diagnostic and therapeutic agents. Early dialogue and collaboration between scientists, clinicians, toxicologists and regulatory authorities are increasingly recognised as one of the important issues to ensure rapid clinical uses of safe nanopharmaceuticals.

There are very strict regulations and approval processes for any medicine (via regulatory agencies such as FDA, EMEA etc.) or any material proposed for human use. It must undergo rigorous toxicology studies as part of the regulatory approval process. However, the special properties of nano-objects that are only exhibited at the nanoscale suggest that nanopharmaceuticals may also require a new array of toxicological and safety tests. It was agreed that new strategies in toxicology for Nanomedicine must go hand-in-hand with the development of nanopharmaceuticals in order to ensure the safe yet swift introduction of nanomedicines to clinical use.

Drivers & Market Factors

The path-breaking development of nanomedicine technologies is supposed to have an immense effect in providing site-specific therapeutic action with fewer side effects. Nanomedicine, along with techniques that help in early diagnosis of diseases, is bound to provide a big impetus to prophylactic as well as preventive treatment. All these technological advance could mean that treatments are initiated even before the onset of initial symptoms and, in some cases, diseases would be cured or even altogether prevented.

With such a huge potential, nanomedicine can very well be the greatest achievement of all-time providing a better quality of life and physical well-being to every one.  There are several factors that drive research and development in the field of nanomedicine.  For example, pharmaceutical and biotech companies are facing challenges on many fronts. These challenges, which can also be described as market factors, represent the driving force behind the nanomedicine R&D efforts:

• There are increasing pressures to reduce R&D costs.

• Neither big pharma nor the biotech industry is as able to come up with blockbuster drugs as in the past.

• There is a need to put more chemical entities in the R&D drug pipeline and do so faster.

• There is also a need to decrease time to market. Each day delayed in development time can correspond to between $1 million-$3 million in lost revenue and it can take an estimated 7-10 years to develop and market a drug at costs measured in the hundreds of millions of dollars.

• The human genome project is expected to lead to approximately 100,000 targets (points of intervention) that will require evaluation against many compound libraries in the hopes of creating new drug opportunities.

The efforts expended in extending patent protections is a defensive strategy that may protect vital revenue streams but does little to ensure longer-term success.

Nanotechnology can and will resolve some of the pharmaceutical and biotech industries' problems.  It has already enabled new formulations for drugs—for example, the FDA-approved Abraxane from American Pharmaceuticals, which has indications for the treatment of metastable breast cancers and RenaZorb, which provides phosphate control in kidney dialysis patients.  Other drugs that are in the R&D pipeline or in regulatory approval stage are those developed by NanoHorizons for the treatment of skin disorders and infections. In the future, nanotechnology will enhance the drug discovery process, through miniaturization, automation, speed and reliability of assays.

Nano-enabled drug discovery can make important contributions to solving the problems listed above. It can:

• Improve current understanding of chemicals at the cellular/molecular level

• Improve identification and validation of target proteins and drugs

• Increase throughput

• Reduce the time required to identify new drugs

• Reduce the amount of precious reagents required to carry out screening of potential drugs

• Improve visualization of drug interactions  

As previously mentioned, aside from nanomedicine, nanotechnology will provide many solutions to various kinds of problems and needs. Each industry, which will utilize nanotechnology, will have different driving forces based upon the different applications. This is another example of how nanotechnology is, and will be, used in the aerospace industry and the key driving forces behind utilizing it.

 

 

Restraints

With the promise of nanomedicine and nanotechnology, and from the current advancements made in these fields (particularly in the field of nanomedicine), it does not seem that there are major restraints that are facing research.  As indicated in the research page, there are currently several researchers and resources that contribute to R&D in this technology. There will always be a need for funding resources, which may be the biggest, and ultimately the first, restraint facing future R&D efforts.

However, examining the market factors and driving forces behind R&D efforts (as explained above), the pharmaceutical and biotech industries have no other options but to spend on R&D and provide adequate resources to ensure sufficient and lasting research.  There is no question, today, about whether we will have nanomedicine.  It is already here.  For companies, it is now a matter of who is going to get there first and become first to market with a nano-enabled medication.

Perhaps, and as previously mentioned in the challenges section, there will always be the question of: is there a true intention to cure diseases?  I believe this will remain the biggest obstacle and restraining force that faces nanomedicine.  For today's companies, treating a disease contribute to the companies' bottom line.  In fact, for all neurological disorders, there is currently no treatment.  There are medications to reduce the severity of the disease and prevent recurrences, however there is no cure to any neurological disease known to man, today.  Companies generate income and profit from sales of their medications, which includes monthly (in case of a 30 day treatment regimen) refills and the income generated by these refills. There is no doubt that such advancement (i.e. curing diseases) will effect any company's bottom line, since if the disease is cured, there will be no refills.  This is not going to become a problem only for the pharmaceutical industry, but to the sub-specialty physicians, pharmacists and hospitals.  Curing a disease means that there will be - possibly - little need for specialty physicians (i.e. cardiologists, neurologists, oncologists, etc..), as well as little need for pharmacies since each nanobot will become, eventually, a mobile pharmacy patrolling our bodies to detect and cure diseases.  Hospitals may also suffer financial losses if hard to cure diseases are cured.  It is a circle, and if one party is affected, all will.

Essentially, the restraints that face nanomedicine today, and possibly in the future, are ethical and moral in nature, as well as economical (i.e. financial losses as a result of curing diseases and prolonging lives).

Roadmap

 

"The Technology Roadmap for Productive Nanosystems will chart a path beginning with current nanotechnology capabilities to advanced systems. The Roadmap will detail a step-by-step course of development that must take place to move from one stage to another, with milestones for achieving each step. With the support and collaboration of our partners, The Waitt Family Foundation and Battelle, we will be able to identify the gap between the basic nanostructured materials of today, and the potential of productive nanosystems."

Foresight Nanotech Institute

 

Additional information can be found here.

Analysis & Trends

 

The nanotechnology market is forecast to reach $1 Trillion by 2015.

Nanotechnology.com Small Technology IndexTM:

The Nanotechnology.com Small Technology IndexTM is based on 30 international, publicly traded "small tech" stocks and is VERY different from other so-called nanotechnology stock indices in several important ways.