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What is the biggest advantage of forming an alliance?

Everyone has their own de

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

finition of an alliance. I had a potential alliance with a person that was start

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

Examples of combination products may in

ng his own business. He came to my residence with his partner and I brought in 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.

couple of friends and business associates to discuss the possibilities. He gave

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

us a fabulous demonstration of his company offerings. I really liked what he had

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

Combination pro

to offer and was willing to pass leads on to him. He was excited about the poss

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

bilities. He next mentioned that he would love to work with our current client b

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

ase. I asked how he saw the relationship working and his reply was that he would

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

piggyback on our current sales effort. I then asked him how we would be able to

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

capitalize on his client base and how he would help sell our services.

Guess wh

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

t? He only wanted a one-way relationship: we would make money on sales we did fo

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

Following aspects would a

him! This would certainly take us away from our core business; take us into ano

dd to the challenges in developing combination products:

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

ther area which might fit within our focus in some respects, but not entirely at

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

all. Needless to say, this potential alliance did not get put on paper, even tho

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

ugh his offerings were good. You see, an alliance has to be a two-way street. Ea

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

h member must have a benefit to forming it.

In this example, the business prese

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

Professional from academic institutions, pharmaceutical industries, health care indust

nted would not be a good choice for an alliance. We needed to have a company tha

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

provided us with services we could offer in addition to our own services. The a

.

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

llied company would also have the opportunity to sell our services as an add-on.

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

Companies that provide selfless information through particip

The important thing to remember is that you must carefully choose your alliances

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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