E-Articles - Health and Fitness

We often hear on the news of recent outbreaks of a virus somewhere or discussions of the impending Flu season. Viral outbreaks are particularly difficult. Unlike bact

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

eria there is no antibiotic for a virus, because they replicate inside of our cells. Those features which make outbreaks difficult to control also make viruses good c

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

andidates to be used by scientists to treat other diseases.

In the modern age of health care, there is a drug for just about everything. However, if you suffer from

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

a genetic disease, the treatment options may not be as bright. Unlike treating someone's symptoms with a drug, how do you change someone's genetic makeup. One answ

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

er: gene therapy. Still in its infancy, gene therapy is the insertion of genes into an individual's cells to treat a disease. For example, sickle cell anemia is a g

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

enetic disorder in which the hemoglobin in your blood is defective, causing the cell to have a different shape and not carry oxygen as well. But if the DNA in the bo

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ne marrow could be replaced with functional DNA, then the bone marrow would produce fully functional red blood cells and the patient would be cured. This is the pote

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

ntial of gene therapy. But how is this replacement performed? In tissue culture, this process can be accomplished relatively easily, using chemicals which can fuse

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

with the cellular membrane releasing encapsulated DNA into the cell, but changing the DNA of a person is much more difficult. To accomplish this task, scientists use

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

viruses to target specific organs and then deliver a specific gene directly into the target cell, where it can be used by the host to produce the correct protein or

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

be incorporated directly into the genome permanently. So how does this work?

Unlike bacteria, viruses are intracellular parasites. Bacteria are free living organis

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ms capable of living and replicating on their own outside of a human host. While a virus is simply a capsule of genetic material (DNA or RNA) covered in a protein

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

coat. They do not contain the enzymes or machinery to perform any metabolism outside of their host cell. Because of this tight relationship, it is very difficult to

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

produce antibiotics that affect the virus but not the cell. So when a virus comes in contact with its host cell, it is taken up by the cell whereupon the virus take

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

s over control of the cellular machinery and redirects its resources for normal activity to the production of new viruses. With the completion of this cycle, the new

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ly formed viruses are released from the cell back into the body to search out a new host. During this process, if the host cell does not spontaneously die, the virus

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

will kill it.

This process has been modified so that once the virus has been taken up by the cell, the DNA is released or integrated into the genome. The virus nev

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

er starts replicating and the cell does not die. It is the ability to deliver DNA directly into the cell and the ability to control which tissues get the gene that m

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

akes viruses so useful to gene therapy. Current research is involved in being able to better package DNA and control more tightly which cells a virus infects, but t

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

he future potential of gene therapy is tremendous. All using microorganisms that were once a source of disease, but now controlled for use in the treatment of diseas

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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