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Useful Advices - Will Your Children Own Their Genes?
The completion of the Human Genome Project was greeted with much enthusiasm and many hopes for a bright future pregnant with new possibilities. Currently incurable
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
diseases would be detected early enough and would be prevented before they developed. Damaged organs would be replaced with brand new cloned organs perfectly compat
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
ble with our bodies as these organs would be specially grown out of our own stem cells. Our children would be healthier and would live longer. The possibilities tha
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
t were in the horizon seemed endless. Some even believed that one day we would even defeat death and would perhaps beat God in his own game.
Over the past forty ye
Over the past forty ye
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
rs, genes have gradually gained a new value as the raw resources or the building blocks of an already happening biotech revolution that has been penetrating virtual
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ly every industry in the world markets. Those who have been involved in the race of deciphering the genetic code of life forms on this planet have also been part of
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
a more vicious race of acquiring patents and intellectual property rights.
Although the ethical challenges posed by the biotech revolution are still being debated,
Although the ethical challenges posed by the biotech revolution are still being debated,
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
patents on biotechnological inventions on living matter, such as genetically modified seeds, micro-organisms, genes, tissues, cell lines and many other components
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
f life are now a reality. This double-edged sword has created a dilemma. On one hand, it is imperative to form a healthy balance between the interests of the invent
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
or and the society via a social contract, such as a patent, which should also encourage scientific progress and a safe platform for the continuation of future inven
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ions. On the other hand, such patents closely related to life and healthcare, under the strict control of a small group of corporate entities, worry many people, wh
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
clearly understand that in the near future one will have to pay royalties or will have no access to certain healthcare services.
In many hospitals today, patients
In many hospitals today, patients
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
, who need to have certain tests done to see if they have a specific gene or a genetic disposition for certain diseases, have to pay a royalty fee to the patent-hol
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ing company for that specific gene being scanned. For many, having to pay a “fee” to have a “gene scan” of “their own genes” is unacceptable. Although the medical t
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
echnology will soon have the capacity to screen thousands of genes and genetic predispositions in the near future, offering a vast selection of new cures and soluti
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
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
ns to various diseases, there is also no doubt that some will use patents to literally extort money from those of us in need of a cure.
If you are diagnosed with a
If you are diagnosed with a
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
rare cancer and need to be treated with a special type of protein that facilitates the growth of a certain anticancer agent, do not be surprised if you find out th
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
t you have to pay a chunky royalty to a company that you have never heard of. You no longer have any rights over your genes or your “own body tissues” as “somebody
.
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
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
else” has already claimed the intellectual rights to “your” body parts “without” your consent or knowledge.
In the future, we all will have to pay our dues to a sy
In the future, we all will have to pay our dues to a sy
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
dicate of biotech elites to have access to our own genetic heritage. Life has finally become a commodity that is tradable, inheritable and also extremely profitable
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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