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Scientists have discovered a gene that may play an important role in the onset of Alzheimer’s disea

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

se. The gene, called SORL1, was uncovered in a huge international study involving 6,000 people from

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

Examples of combination products may in

varying ethnic groups. Dominican families that carry the gene are about three times more likely to

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

evelop Alzheimer’s in old age than those who do not have the gene.

The gene adds to a growing list

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

of dozens of genes that may play an important role in the onset of Alzheimer’s disease. A handful

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

Combination pro

f genes are known to cause early-onset Alzheimer’s, which can strike someone in their 30s or 40s. A

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

other gene, called APO-E4, has been linked to an increased risk of the more common late-onset form

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

of Alzheimer’s that strikes in old age, but just because someone carries this gene does not mean th

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

y will develop dementia.

More research is needed to confirm the role of SORL1 and its importance i

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

Alzheimer’s. Still, the findings could shed new light on possible new treatments for the illness.

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

In the current study, researchers at Columbia University isolated several genes that might be impli

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

Following aspects would a

cated in Alzheimer’s. They then looked for this gene in various ethnic groups, including African-Am

dd to the challenges in developing combination products:

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

ricans, Dominicans, northern Europeans, and Israeli-Arabs. Only the SORL1 gene seemed to be linked

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

o Alzheimer’s.

Those who carry the gene produce excess amounts of a substance called amyloid precu

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

rsor protein. This protein can then be converted into a toxic form of beta amyloid that clogs the b

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

ain and kills brain cells, leading to the symptoms of Alzheimer’s over time.

With further research

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

Professional from academic institutions, pharmaceutical industries, health care indust

scientists may be able to develop new drugs or other treatments that block this beta amyloid pathw

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

ay. Still, much more study is needed before such treatments might be available.

Many factors, besi

.

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

es genes, play a role in the onset of Alzheimer’s. To learn more visit elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

/www.alzinfo.org" title="Alzheimer's Disease">www.alzinfo.org, The Alzheimer’s Information Site

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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