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Renee Williams, who was the child of heavy parents, had been morbidly obese for most of her life. At 13 years of age she was nearly 300 po

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

unds and during her early twenties, by which time she was married with 2 children, her weight had reached 400 pounds.

In 2003 her life cha

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

Examples of combination products may in

nged dramatically when she suffered severe injury to her left leg in a car accident and found herself unable to walk and confined to her be

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

. Her weight now started to rise rapidly and, by the beginning of 2007, she had reached 800 pounds.

Confined to bed, Renee's only window o

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

n the world was the television and her laptop computer and she resolved to do whatever it took to lose weight and marry her new fianc? and

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

Combination pro

nce again to become a mother to the children, who had seen her confined to her bedroom for over a year. As a result, she began the search f

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

or a bariatric surgeon who would be prepared to perform weight loss surgery for her.

Although gastric bypass surgery is routinely performe

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

on morbidly obese patients with a body mass index (BMI) between 40 and 60, the risks of surgery increase considerably as BMI rises and, wi

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

th a BMI of 137, Renee Williams was considered to be at exceptionally high risk from surgery. No fewer than twelve surgeons turned her down

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

therefore before she finally found two surgeons from the Renaissance Hospital in Houston who were prepared to undertake the operation.

On

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

20 February 2007 Renee Williams made history when she became the largest woman ever to undergo weight loss surgery. Her laparoscopic gastri

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

Following aspects would a

c bypass surgery went well in spite of the fact that surgery lasted five hours, rather than the normal one or two hours, and required two o

dd to the challenges in developing combination products:

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

erating tables and the adaptation of standard operating equipment and techniques.

Initially, her recover went well and, in the two weeks a

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

fter surgery, she lost 67 pounds which was an excellent start on her road to losing the 650 pounds which her surgeons were predicting for t

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

e three years following surgery.

On 4 March 2007 however she suddenly began experiencing chest pains and these were quickly followed by a

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

massive heart attack from which she died.

Tragically, Renee Williams did not realize here dream of marrying on Valentine's Day 2008 or of

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

Professional from academic institutions, pharmaceutical industries, health care indust

eing able to fulfill he wish to once again be a mother to her children but many will praise her for her braze decision to undergo surgery a

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

nd will see her surgery as an inspiration in their own efforts to tackle morbid obesity.

But was the Renee Williams gastric bypass really

.

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

wise course of action for both Renee and her surgeons? This is clearly something that will be debated for a long time to come but, whateve

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

Companies that provide selfless information through particip

r, your own thoughts, there can be little doubt that it will serve as a warning to us all of the dangers involved in gastric bypass surgery

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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