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Subjects - Can Your Business Run Without You?
What would happen if you decided to take an extended vacation?
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
Would you still have the same business results when you retur
; 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
ed?
I met a business owner recently who told me an interestin
I met a business owner recently who told me an interestin
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
story. His business was 15 years old and he had approximately
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
50 employees. A couple of years ago, he decided to take a vaca
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ion to Europe for a month. After all, his business had turned
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
profit every month for 13 years. He deserved it.
Off he went
Off he went
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
to enjoy the fruits of his many years of labor. He had a gran
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
time knowing all was well back home. But on his return, he di
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
covered all was not well. For the first time in 13 years his c
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
mpany lost money while he was gone.
How could that be? He had
How could that be? He had
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
50 employees to keep things going while he was gone. Why did h
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
lose money?
The sad truth is that even though he had many em
The sad truth is that even though he had many em
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
loyees to accomplish the work of his business, he was such 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
integral part of everything that got done that the business co
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
ldn't run without him.
Think about it. Can your business run
Think about it. Can your business run
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
ithout you?
Whether you're currently a business of one or 100
Whether you're currently a business of one or 100
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
now is not too soon to make sure it will. Identify the steps
.
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
ou can take to help your business be successful whether you're
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
sitting in your office or relaxing several thousand miles away
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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