Advice Pool - Health and Fitness

Recent research findings may offer some new hope to 20.8 million individuals in Dallas, Houston, e elsewhere in Texas and throughout the rest of the United States who have diabetes. While an eestimated 14.6 million have been d

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

iagnosed, 6.2 million people (or nearly one-third) are unfortunately unaware that they have the disease.

Researchers recently identified seven new genes connected to the most common form of diabetes. The findings, presented i

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

Examples of combination products may in

three reports by university scientists and one by a private company, offer novel insights into the biology of a disease that affects 170 million people worldwide.

The reports bring thnumber of well-attested genes involved in

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

adult-onset, or Type 2 diabetes up to 10, from the three known previously. The new genes do not immediately suggest any new therapy, but may point to a new biological basis for the disease, from which effctive treatments could

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

emerge in time.

DeCode Genetics, an Icelandic company responsible for one of the reports, has dominated the genetic-research field for the past five years. The other papers come from three academic consortia, led by Dr. David

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

Combination pro

Altshuler of the Broad Institute, Michael Boehnke of the University of Michigan and Mark McCarthy of the University of Oxford in England.

Several researchers said that the new diabetes studies, and a soon-to-be-released repor

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

on seven major diseases prepared by the Welcome Trust in London, were a turning point in the pursuit of the genes that underlie common diseases like diabetes, cardiovascular disease, cancer and schizophrenia. The variant gene

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

are common, but each makes only a small contribution to disease, rendering them hard to identify.

There is considerable overlap in the diabetes genes identified in the recent four reports, giving the authors confidence that

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

t last their whole genome association method is producing reliable results.

Until recently, "there was no sense of progress" in tracking down the genes of diabetes or other common diseases, Dr. Altshuler said. The logjam star

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

ed to break a year ago with DeCode's report of its TCF7L2 gene, and the consistent findings reported by the academic centers "has to be acknowledged as substantial progress," Dr. Altshuler said.

Dr. Boehnke agreed, saying, "I

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

's very exciting to have results in which we truly believe." Up until now, he said, diabetes research has been what his professor warned would be "a geneticist's nightmare."

The importance of the new genes is that they point

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

Following aspects would a

to previously unknown pathways involved in diabetes. Dr. Altshuler agreed with Dr. Stefansson's view that DeCode's TCF7L2 gene has the greatest effect on diabetes, but said the other genes provide new insights regardless of th

dd to the challenges in developing combination products:

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

size of their effects. "The fact that none of the genes found were on anyone's radar screen shows how much there is to learn," Dr. Altshuler said.

"I tip my hat to DeCode," he said. "But the technology is now widely availabl

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

," and, in his view, the only barrier to other teams contributing to gene discovery would be if they dropped the high standards of statistical rigor developed by the three academic consortia.

Several of the new variant genes

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

ake the pancreatic beta cells produce less insulin, Dr. Altshuler said. That suggests that diabetes may start as a disease of too little insulin production, even though patients turn up in the doctor's office making too much i

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

sulin, to which their tissues have become resistant.

The variant genes found so far account for only two to 20 percent of the overall risk of diabetes, implying there are many more to be found. The present genes are not suffi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ient to distinguish reliably between people at low- or high-risk for diabetes, Dr. Boehnke said.

By mapping the human genome, scientists are discovering which individuals are more prone to certain diseases and conditions. But

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

genetics are just half the story – how you treat your body when you're young will also certainly affect your health when you get older. Eventually, it will also affect your wallet. If you're a young individual who tries to mai

.

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

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

Companies that provide selfless information through particip

ebsite, www.precedent.com. We offer a unique and innovative suite of individual health insurance solutions, including highly competitive HSA-qualified plans and an unparalleled "real time" application and acceptance experience

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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