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Your Space - What are you Afraid of?
There is someone calling to you right now – who is it?
It’s the person you want to become. Who is that person? Is this person happier? We
It’s the person you want to become. Who is that person? Is this person happier? We
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
althier? Thinner? More energetic? More powerful? Whoever this person is, this person is inside you. This person IS you.
What prevents y
What prevents y
; 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
u from becoming this person?
I once knew a young man who wanted to become an actor. He studied acting and participated in many plays at his
I once knew a young man who wanted to become an actor. He studied acting and participated in many plays at his
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
college and in his community. A director recommended that he study dance, so he did. He even took voice lessons.
Today, he still lives in
Today, he still lives in
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
is hometown. He’s married and has two kids. He frequently says “You know, I could have been an actor.” When asked why he didn’t pursue his
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
acting career, he shrugs and says it just wasn’t practical. Besides, it’s too late now.
One day, his wife decided to push him on the topic.
One day, his wife decided to push him on the topic.
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
He explained that in order to pursue acting, he’d need to relocate to a big city, like New York, Los Angeles, or Chicago, and that just wasn
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
’t practical.
“Even though it wasn’t practical, why didn’t you do it anyway?” his wife pushed.
“Because I wanted to marry you,” he said, te
“Even though it wasn’t practical, why didn’t you do it anyway?” his wife pushed.
“Because I wanted to marry you,” he said, te
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
singly, trying to get her off the topic.
“You don’t think I would have moved to a big city with you?” she asked. “Did you even ask me?”
“
“You don’t think I would have moved to a big city with you?” she asked. “Did you even ask me?”
“
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
ell, I didn’t have a job lined up. Besides, what would I do in a big city? I wouldn’t know anyone. And it’s not that easy to break into ac
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ing. There are a million starving actors waiting tables in big cities.”
“But you wouldn’t have starved if I were working,” she persisted.
“But you wouldn’t have starved if I were working,” she persisted.
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
fter more conversation along this line, he finally admitted the truth. He was terrified of failure. All through high school and college, ev
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
ryone assured him that he had the makings of a great actor. What would they think if he failed? What would he think of himself? It was jus
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
easier to let everyone think (including himself) that he chose love over fortune.
He had never admitted his fear of failure to anyone befor
He had never admitted his fear of failure to anyone befor
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
e. Naming this fear made it seem less threatening, and even a little ridiculous. He wondered why he had let his fear of what other people m
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
ght think deter him from following his passion.
He now says that if he had been more honest with himself, he may have been able to face his
He now says that if he had been more honest with himself, he may have been able to face his
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
ears. He may not have become the great actor everyone had predicted, but he would have had a chance to follow his passion.
If you can name
If you can name
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
he fear, you can face it.
Sometimes you have to ask yourself tough questions to get there. When you ask yourself “What’s holding me back?”,
Sometimes you have to ask yourself tough questions to get there. When you ask yourself “What’s holding me back?”,
.
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
don’t settle for answers like “I don’t have enough time” or “I don’t have enough money,” or “It’s not practical.” Press yourself until you d
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
scover the real reason.
When you discover the true reason for holding yourself back, you can address it and even move past it, if you choose
When you discover the true reason for holding yourself back, you can address it and even move past it, if you choose
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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