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Technical competence alone does not make you ‘referable’, no matter how good you

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

are.

My friend Treva recently experienced a car breakdown in Los Angeles. Her ve

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

Examples of combination products may in

icle was towed to a nearby service station where the manager put her at ease with

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

his comfortable style and obvious expertise. He promised to call her the next mo

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

ning with an evaluation and an estimate.

She took the bus home. The next morning

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

Combination pro

he did not call. She called him in the afternoon. He apologized and agreed to ca

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

ll her back by the end of the day. But he didn’t. She reached him again the next

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

orning. This time he promised to call back within 45 minutes. Two hours later, he

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

still had not called.

In the end, Treva’s car was very well repaired. The manage

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

r gave her a clear explanation of what had gone wrong and charged her a very reas

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

nable price.

I asked if she would take her car to this person in the future. She

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

Following aspects would a

paused and replied, ‘Yes. I can trust him to take good care of my car. But I won’

dd to the challenges in developing combination products:

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

t refer him to anyone else. I can’t trust him to take good care of my friends or

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

y colleagues.’

Key Learning Point
----------------------------------

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

---------------------------------------------
Being technically competent is

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

not enough to build a growing business. You may be a terrific lawyer, doctor, ac

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

Professional from academic institutions, pharmaceutical industries, health care indust

ountant, broker, supplier, programmer, manufacturer or car mechanic, but if you d

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

n't keep your promises in every way, you just won't be referred.

Action St

.

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

eps
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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

--------
Promises are the foundation of reputation. Make them, and keep them

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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