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If you actively work a lot of joint venture deals, or are planning to do

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

joint ventures in the future, then it's just a matter of time before some

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

Examples of combination products may in

one tries to cheat you out of money one way or another.

That doesn't mea

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

n you shouldn't do joint ventures, but fact is if you do enough of them,

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

ith enough different people, it's only a matter of time. Especially when

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

Combination pro

big money is involved and people start acting differently.

And if you t

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

hink people aren't going to act differently when big money is involved yo

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 kidding yourself. It happens all the time. Even to people who most

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

of us would think are immune to such forces.

But, there is a way to almo

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

st completely avoid getting cheated out of money with a joint venture par

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

ner that is actually pretty simple. So simple, almost nobody I know does

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

Following aspects would a

this, and yet, it will help you sleep like a baby at night knowing you h

dd to the challenges in developing combination products:

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

ave your bases covered.

What you do is get people you do joint ventures

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

with in a habit where you are reviewing their books with them on at least

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

a monthly basis.

And...you want to start doing that upfront, before you

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

sign any agreements or contracts.

That way, if they have that expectatio

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

Professional from academic institutions, pharmaceutical industries, health care indust

n where they know you're going to be combing the books with them every mo

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

th, the chances of them trying to "cook the books" go way down.

In fact,

.

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

in order to pull off cheating you, they will have to get real creative w

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

Companies that provide selfless information through particip

ith the books and will most likely not be worth the time, effort and risk

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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