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Roger Leclerc

Roger Leclerc, Senior Director
Regulatory Affairs
& Export Development

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Genome Technology

Genome is all of the genetic information or all of the hereditary material possessed by an organism. Human genome is the entire DNA that a person possesses.

Cutting-edge genome technologies and discoveries are providing genetic information to help reduce suffering of Alzheimer's and diabetes to many forms of cancer. Other findings are the ability to predict whether a patient will respond well to drug treatment for disease or suffer a side effect.

The genome technology has evolved to medical devices on the electronic side. The development has occurred to the measurement and information analysis technology. Some examples are bioinformatics (computational biology), genome chip technology, DNA sequencer, protein structure spectrometer, x-ray analysis equipment for DNA helix structure, semiconductor device technology, information (software, hardware, and networks), and microarray technology.

The genome technology is moving at rapid speed and is certain to impact information technology and semiconductor technology, as well as nano technology in genome technology, creating new technologies and industries.

Stem Cell Technology

Although new and in the experimental stages the results of stem cell research is promising and will certainly impact the health care environment in the future.

Currently, some medical devices companies developing stem cell technologies are so optimistic that once clinically proven it will enable the therapy of heart failure, treatment of blood disorders, cardiovascular disease, cancer; skin cells for dermatological conditions; neuronal cells for spinal cord injury; and liver cells for hepatitis and cirrhosis

The body’s specialized cells cannot reproduce by natural processes if seriously damaged or diseased. Stem cell technology can be used to generate healthy and functioning specialized cells, which can then replace diseased or dysfunctional cells.

Replacing diseased cells with healthy cells, called cell therapy, is similar to the process of organ transplantation. Some conditions or injuries can be treated through the transplantation of entire healthy organs.

Currently available are, The Guidelines for the Clinical Translation of Stem Cells which highlights the scientific, clinical, regulatory, ethical, and social issues that should be addressed so that basic stem cell research is responsibly translated into appropriate clinical applications for treating patients.

The Guidelines address three areas of stem cell research:

  1. cell processing and manufacture
  2. preclinical studies
  3. clinical research

Nanotechnology

Nanotechnology is already having an impact on the diagnosis, treatment, and prevention of disease. It provides early disease detection, diagnosis, and precise effective therapy.

Nanotechnology is functional engineering on an extremely small scale that is used to develop smart materials and implants for the medical industry.

Nanotechnology exploits the structure of materials at a much-reduced dimensional scale approaching individual molecules and their molecular structures. The nanometre-length scale opens the way for the development of new materials for use in highly advanced medical technology.

Some products are already available, such as surgical blades, suture needles, and contrast-enhancing agents for magnetic resonance imaging, bone replacement materials, wound dressings, anti-microbial textiles, and chips for in vitro molecular diagnostics, micro-cantilevers, and micro-needles.
A strategy for a nanotoxicological risk assessment will be needed for all medical technology applications. The application of guidelines for compliance of the safety evaluation of nanotechnology-based products applied in medical technology will be required to cover risks associated with nanotechnology.

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