Main Subject - Business

I have a confession to make. The other day I was stocking up on ne

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

cessities at my local supermarket when I came face to face with Du

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

gie, who I haven't seen for years. We went through all the - "How

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

re you, what have you been up to, what're you doing now" kind of s

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

uff.

Duggie then says - "Alan, can I have one or two of your busi

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ess cards in case I need to get in touch and to pass to other peop

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."

Now, I'm always nagging other people about never leaving home

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

without business cards. Don't even take out the garbage without a

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

business card in your pocket. And guess what - I had no business c

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

rds to give to Duggie.

He then tells me that he was at a Dinner th

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

previous evening and he met several new contacts - however, he'd

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

lso forgotten his business cards. Duggie has his own business and

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

he's always looking for new clients.

So let me say it again (and I

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

m also talking to myself) - never, never, never leave home without

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

business cards. Don't even dig the garden, wash the car or visit

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

he supermarket without business cards.

There's always a chance th

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

t you'll meet someone who says - "And what do you do?" or "It's a

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

es since I've seen you, what sort of business are you in now?"

B

.

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

aware - new customers and clients are the lifeblood of any busine

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

s so make sure you never miss an opportunity to make a new contact

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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