Useful Advices - Business

Do you know anyone whose attitude and disposition seems to drag you down? Do you know any

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

one whose outlook and energy bring the best out of you? I like to call this the Winner/

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

Examples of combination products may in

Whiner model. I like to simplify things and divide the world into two kinds of people - T

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

hose who are Above, and those who are Below the Line. I know what you're thinking, and I'

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

l bet it's... Huh??

Think of those people in life who always seem to be in charge of the

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

Combination pro

ir destiny, and maintain a great attitude no matter what they face. They are accountable

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

for their actions, they are responsible, and they can't help but be infectious. I call th

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

se folks the "Winners."

They might not be able to tell you whether their success is the

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

result of their attitude, or vice versa, but I'm here to set the record straight. These "

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

Above the Line" people are much more effective when presented with adversity, and they ar

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

almost unstoppable when things are going well. Needless to say, Salespeople in this cate

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

Following aspects would a

gory make a lot of sales. Why? Because as I've said so many times it's like an echo in my

dd to the challenges in developing combination products:

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

head: "When you make a sale, someone else has made a buy." Don't lose sight of the impor

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

tance of that relationship. If you can't connect with your customer, and make them like y

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

u, you're at a serious disadvantage.

On the flip-side of the coin, are the Whiners. Thes

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

e are the people I refer to as "Below the Line." They make excuses, they blame others, an

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

Professional from academic institutions, pharmaceutical industries, health care indust

d they are in a constant state of denial. They too, are infectious. In your personal li

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

e, and in business, it's easy to see what kind of people you'd rather associate with. You

.

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

r customers feel the same way. If you can conduct yourself "Above the Line" as often as p

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

Companies that provide selfless information through particip

ossible, more of your prospects will be willing to enter a business relationship with you

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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Useful Advices - Winner / Whiner Model

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