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I recently completed 2 weeks of jury service and it’s an interesting and fascinating experience. Obviously I can’t tell

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

you about specific cases but I do have some thoughts on the process of being part of a jury.

In my first week, I was th

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

Examples of combination products may in

foreman of our jury and that meant facilitating the discussion and making sure everyone could express their point of vi

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

w and that we all agreed on our verdict.

During the course of our deliberations a number of things became apparent.

Ma

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

y people have prejudices that they don’t realise they have.

Many people assume their view of the world is the “right” v

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

Combination pro

ew

Many people don’t really understand the influence they have on other people – directly or indirectly.

It was quite

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

cary how some individuals were convinced of the defendants guilt purely based on a perception of who they thought they w

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

re. Whole scenarios, stories and pictures were being created about what probably happened, what they probably did, said

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

nd behaved like and what “that type” of person is like.

When I pointed out that we must only base our decisions on the

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

acts as presented to us and the law as directed by the judge, some people saw they were “making up” evidence based on th

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

ir assumptions and perceptions but others got quite irritated and couldn’t see that what they were basing their views on

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

Following aspects would a

was pure speculation, assumption and prejudice.

This got me thinking that we all make assumptions at times, which are o

dd to the challenges in developing combination products:

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

ten only based on our view of the world. This is usually not done with mal intent or consciously but purely because we s

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

the world in our own way based on our own experience through life.

However, the danger in doing this is that it can pr

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

vent us being fair, just and seeing beyond our own experiences. We might therefore miss opportunities, be blind to diffe

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 perspectives and not take a balanced view.

Have you ever assumed?

* Big companies only work with big consul

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

Professional from academic institutions, pharmaceutical industries, health care indust

ing firms

* Price is the most important thing

* It didn’t work before therefore it won’t work this time

* I don’t hav

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

time for planning

* Customers only want one thing – a deal!

* Business is a numbers game so I need to meet laods of n

.

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

w people

There are more I’m sure and I urge you to recheck your assumptions of your clients, your business and your eve

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

Companies that provide selfless information through particip

yday dealings with people. Are you being fair and just based on the facts and evidence presented or are you making it up

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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