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E-Folder - Dealing with People that Drive You Crazy!
We all know someone who just drives us batty. Perhaps the
person is too noisy, too borish, or too flashy. Perh
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
aps the
person is too gossipy, critical, or lazy. There are hundreds of
reasons why we may not relate well to
; 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
a person.
In my case, the person was both loud and talkative. He thought he was funny; I thought he was inse
In my case, the person was both loud and talkative. He thought he was funny; I thought he was inse
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
nsitive. So I decided to just
ignore him... pretend he didn't exist. That strategy worked well
for a few mont
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
hs until a close friend accused me of being rude.
"Rude?" I scoffed. "I don't think so."
"Ignoring someone is
"Rude?" I scoffed. "I don't think so."
"Ignoring someone is
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
rude," Pat reminded me. "Acting like
someone doesn't exist is one of the worst ways you can treat
someone. Y
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
ou always told me that you hated feeling invisible
yet that is EXACTLY how you treat Earl."
"But he just driv
"But he just driv
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
es me crazy!" I said trying to defend myself.
"If I talk to him I'm just going to say something mean and
rott
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
en. Isn't that worse?"
"At least you'd be acknowledging that he's human," she persisted.
"Barely!" I said.
"At least you'd be acknowledging that he's human," she persisted.
"Barely!" I said.
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
I turned away in a red-faced huff. Pat obviously didn't
understand! Still her words lingered in my mind. No ma
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ter how
I tried to justify my behavior, I couldn't convince myself that
she was wrong.
I had to change my be
I had to change my be
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
havior.
I started with very small attempts at conversation. First I offered a basic greeting, "Hi Earl."
The
I started with very small attempts at conversation. First I offered a basic greeting, "Hi Earl."
The
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
n I asked a question and listened to the response. Before I
knew it, we were having real conversations, laughi
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
ng together,
and dare I admit, enjoying our new friendship.
Was it difficult to start talking with Earl? At f
Was it difficult to start talking with Earl? At f
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
irst, most
definitely yes. My first challenge, of course, was to climb
down off my high horse without falling
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
on my face!
But I'm glad that I dropped the mask of indifference. Earl has become a good friend. He can make
But I'm glad that I dropped the mask of indifference. Earl has become a good friend. He can make
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
me laugh at myself and the
world because he doesn't take life too seriously. Yes, Earl can
still be loud. He
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
definitely talks too much; and don't share
your secrets with him.
He still drives me batty at times, but for
He still drives me batty at times, but for
.
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
the most part, I
just laugh and enjoy our friendship. It was only after
becoming his friend that I realized
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
how exhausting it was to
ignore him. Now my energy is spent on other things... things,
like Earl, that matter
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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