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E-Folder - Exit Strategies - You Have to Change Your Way of Thinking
To paraphrase Bear Bryant, (Past great Alabama football coach), “When we lose-it’s my fault. When
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
we win it’s their fault.” Take responsibility for the bad and pass out the glory to others. From
; 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
now on, it’s not about You...
If you’re the owner of a business that’s getting ready to be put
If you’re the owner of a business that’s getting ready to be put
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
on the market, consider these words carefully. You need to change your thought process of how the
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
business has been built and how it operates today.
The time of bragging about how you closed a
The time of bragging about how you closed a
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
deal, or remember all the best clients in your head or you have a “gut feel” for how the sales ar
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
e going, is over and done. To get the most money, the business cannot be about you.
When your co
When your co
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
pany does well, it’s because of your loyal employees or some internal sales or marketing process
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
that takes care of tracking sales or establishes constant contacts with leads. Your shipping depa
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
rtment is efficient because your warehouse people have certain pre-determined steps they use beca
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
use of their experience.
You take the blame for things that could be done better because you’re
You take the blame for things that could be done better because you’re
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
tired, or bored or wanting to move on. The Good things need to be focused on your staff or proces
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
s or market. One more time, with feeling, it’s not about You.
Remember the buyer is trying to pl
Remember the buyer is trying to pl
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
ace themselves in your position. They want to manage people and processes, not try to wear your s
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
oes. Everyone already knows no one can replace you, and sellers won’t pay top dollar if they thin
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
k they have to.
When you are trying to get the most money for your business, go in with the righ
When you are trying to get the most money for your business, go in with the righ
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
t mind-set, Bad things were my fault (and I’m getting out)...good things happen because of my tea
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
m (and they will be working with you).
Approach all the hundreds of decisions with that mindset
Approach all the hundreds of decisions with that mindset
.
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
and you will have a comfortable seller that will pay top dollar and employees that will be flatte
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
red with your trust and will stay for the new owner. Now, make it about You in your next endeavor
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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