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Digg It - Are You Paralyzed by Fear
Recently I was engaged by a client because he was unable to take action. He had so much going on in his personal life and
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
in his company that he was paralyzed with fear.
In the past, he made some bad decisions and he was afraid that history wo
In the past, he made some bad decisions and he was afraid that history wo
; 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
ld repeat itself. We talked about this for several hours and I got a good understanding of his challenges. This person was
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
successful by all standards and he had a successful company. No one could have guessed at his mental turmoil.
He lacked
He lacked
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
irection and focus and he was emotionally over extended. He lost his reason for starting his own company; he lost his reas
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
on for going to work every day.
I gave him a simple assignment. I wanted him to be selfish. I wanted him to figure out wh
I gave him a simple assignment. I wanted him to be selfish. I wanted him to figure out wh
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
t kind of life he wanted and how creating his own business helped him create the life he wanted. I then asked him to make
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
one decision that would move him towards his ideal life. Sometimes being successful requires being selfish.
The next morn
The next morn
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ng I received an email from him and he outlined two decisions he made that required action. It was like a door opened for
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
him. Frankly he just needed permission to be selfish and some support to make a decision. Someone to tell him it was ok to
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
make a mistake in his selfishness. Almost any mistake can be corrected. Inaction can never be corrected except through act
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
ion.
I told him that when I am in this space, and all of us are there at sometimes in our lives, I imagine that I am in a
I told him that when I am in this space, and all of us are there at sometimes in our lives, I imagine that I am in a
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
blizzard. I make one simple decision, take one step. When I take that step there are only two things that happen. The firs
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
t is that you will hit something solid. When that happens, you can take corrective action and make another decision. The 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
cond thing that can happen is that you move through the blizzard, come out of the storm, see bright sun and blue skies. Th
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
e simple decisions that you made move you through the storm. These simple decisions are what lead you to blue skies and su
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
shine.
What simple decision can you make to move into the sunshine and blue skies? Make one decision, take one action, an
What simple decision can you make to move into the sunshine and blue skies? Make one decision, take one action, an
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
d take one step. Don’t worry about how things will work out. The purpose is to take small steps, make small decisions. Jus
.
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
know the universe will conspire to help you but the universe requires you to take action.
Every one of needs help: a coa
Every one of needs help: a coa
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
ch, a friend, or an advisor, someone to listen. Find that person, trust them, and take action. It all begins with one step
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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