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Useful Advices - Entrepreneurs Have A 'Never, Ever Give Up' Attitude
One thing entrepreneurs have in common is the ability not to be stopped by problems, but to turn their
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
problems into opportunities. Where other people get stuck in problems, entrepreneurs bounce back with
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
new answers seeing a different way forward.
I once read an article on entrepreneurs in a South Africa
I once read an article on entrepreneurs in a South Africa
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
magazine. The author explained some of the characteristics of an entrepreneur and then he relates a s
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ory told to him by an entrepreneur who was asked, “What makes entrepreneurs different than the rest of
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
us?”
“Well,” the entrepreneur said, “when I think of entrepreneurs I think of a spider. I once saw a
“Well,” the entrepreneur said, “when I think of entrepreneurs I think of a spider. I once saw a
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
spider spinning his web. He would take a thread - stick it to one side and then walk with it to the ot
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
er side of where he would like to make his web.
When he came to the other side the thread broke and t
When he came to the other side the thread broke and t
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
e spider had to walk back to the place where he first stuck his thread. He then stuck his thread to th
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
place where it broke off and started walking back to where he wanted to stick the thread. And then, t
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
e same thing happened again. The thread broke. The spider went back to the same spot and stuck his thr
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ead back again from where it broke, just to start his journey all over again.
This happened about eig
This happened about eig
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
t times before the first thread was stuck from one side to the other. This, my friend,” the entreprene
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
r said, “is the hallmark of a successful entrepreneur. He is too stupid to give up. He doesn't know an
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
better but to persevere and ‘hang in’ there until it succeeds. He is not demotivated by early failure
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
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
, but he learns from them.”
Entrepreneurs have a ‘no die’ attitude. They simply don’t give up when th
Entrepreneurs have a ‘no die’ attitude. They simply don’t give up when th
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ey start to encounter opposition, difficulties or closed doors. They know they have a race to run, unt
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
l it is finished. I once heard a man said, “It is finished”, only after he has completed his whole mis
.
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
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
ion. Now that is a true entrepreneurial spirit. To understand that you will encounter difficulties, bu
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
to have an attitude that you will not, YOU WILL NOT give up until you can say, “Mission accomplished!
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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