Advice You - Business

Before we begin a thorough discussion of business pain, let's take a look at what it really

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

means. The words Business Pain are batted around by almost everyone I talk to in the marke

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

Examples of combination products may in

ing and sales fields. It is probably one of the more misused words when describing the help

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

a company needs to become more efficient and effective. When you try to find out what a bus

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

iness worries about, you will find that you get a different answer from each person you tal

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

Combination pro

to in the organization. That is because the "business pain" will be different for each dep

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

rtment or section. The sales force will likely tell you that the pain is not getting orders

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

out on time. The order department will say that the sales force over promises, the adminis

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

ration will say that expenses are too high, and the executive will say that there are not e

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

ough profits. All of them will be correct. So how do you determine what the real pain is?

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

f you begin with the top decision makers, they will have an overall picture of where they t

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

Following aspects would a

hink there company should be in the way of market share and profitability. This big picture

dd to the challenges in developing combination products:

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

will show you where they currently are and where they want to go. It is here that the decis

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

ons are made to make improvements. It is also here that the risk is identified and the plan

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

s to alleviate the pain are put together. If you want the true definition of business pain,

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

start with the CEO and then piece together the other parts that cause the pain as described

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

Professional from academic institutions, pharmaceutical industries, health care indust

Nothing is more thrilling than working with a company that can define what it is that the

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

y are not doing right. Unfortunately, most companies are not able to pinpoint their problem

.

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

with accuracy. They can see the symptoms but usually not the probable cause. So when you l

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

Companies that provide selfless information through particip

arn about the business pain, you should be prepared to offer solutions that fit the problem

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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Advice You - Business Pain or Business Gain?

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