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Inevitably, it happens. Almost every time I’ve gone out street preaching

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

I get the question asked, “Don’t you think you’re offending more people 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

n you are helping hear your message?” I’ve developed a nice answer to tha

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

which I’ll explain in another post. But right now I want to focus on one

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

thing.

Often, somewhere in my response I’ll say, “What do you think, ‘Go,

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

Combination pro

preach the gospel’ is supposed to look like? It certainly isn’t sitting in

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

a church pew Sunday after Sunday hoping new people show up.” Somewhere in

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

the past 2000 years we’ve twisted the commission of Jesus to the point whe

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

e it’s completely opposite to what He originally said.

We’ve changed 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

ommission from “Go and tell”, to “Come and listen”. If you drive around t

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

wn you see billboards and other ads inviting people to come into church an

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

Following aspects would a

d listen to a message instead of people on the street corners proclaiming

dd to the challenges in developing combination products:

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

he gospel. It’s like the people of the church have said, “Instead of us g

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

ing to them, why don’t we tell them to come to us.” So they put up these

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

illboards and signs and then drive to church on Sunday anxiously waiting a

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

d wondering if it worked!

Look, I know there may be better ways to preach

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

Professional from academic institutions, pharmaceutical industries, health care indust

the gospel to the world, but I know for sure that the “Come and listen” mi

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

dset isn’t the right attitude.

I would suggest reading the gospels and fi

.

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

ding out how Jesus went about preaching the gospel and how He intended His

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

Companies that provide selfless information through particip

followers to do the same. You may be quite encouraged.

What do you think

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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Answers - Lessons From Street Preaching - It’s Go And Tell, Not Come And Listen

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