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A few days ago, I mentioned that an easyJet flight to Venice had pr

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

ovided me with an insight to Stelios (Haji-Ioannou), the founder o

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

Examples of combination products may in

the ground-breaking low-cost airline, which has revolutionised European a

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

r travel.

He was listing his top five things he 'wished I had known when

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

I started'.

Previously I mentioned that he wished he'd been 'clear on

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

Combination pro

is strengths and delegated the rest'. If you missed it you can find th

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

s on the 18th of November entry of my blog, through the link at the

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

bottom of the article.

Number two on his list states:-

"Don't

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

put all your eggs in one basket. Focus - on your job, on your brand."

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

This seems a bit of a contradiction to me, but the essence of the best par

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

of what he said, for me is the second bit:-

"Focus on your Brand"

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

Following aspects would a

As I see it, this can be construed two ways. It can be the brand of the

dd to the challenges in developing combination products:

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

usiness or organisation you work within, or it can be your personal

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

brand - about who you are in the work you do.

Working on any Br

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

and means initially being really clear about what it is that you repre

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

ent, where you are going in your offer and pulling all the stops out to co

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

Professional from academic institutions, pharmaceutical industries, health care indust

sistently deliver that. To be authentic - all the time.

It is about quest

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

ioning every action and measuring against the background of the

.

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

rand you personally, your business or organisation are.

Clarity and f

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

Companies that provide selfless information through particip

cus are what you must have as a constant magnet drawing you forward

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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