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Giving a business presentation to a nonprofit group is very similar to what a sales team d

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

oes when it pitches its services, ideas or innovations to a corporate Board of Directors.

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

Examples of combination products may in

aving done many business presentations in my life it came natural to meet when I was asked

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

to talk to a PTA or parent teacher association about an upcoming fundraiser in which my co

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

pany would be assisting the washing of cars.

It was amazing to me how the word got out ar

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

Combination pro

und town and soon I was giving presentations to nonprofit groups all throughout the commun

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

ty and surrounding communities. There of course were all sorts of objections and question

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

from parents. Such as; how many chaperones will be needed, what do you get out of it, ho

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

much money will we make, why should we do a carwash fund raiser?

The funny thing is that

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

we would make no money doing these fundraisers and yet I was defending the carwash fundrai

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

er business plan for their nonprofit group. I learned a valuable lesson that day in that i

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

Following aspects would a

sometimes not what you are selling or in this case giving away; people have to see your m

dd to the challenges in developing combination products:

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

tivation or they do not trust you.

It is the same when giving a business presentation. I

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

you offer to your products or services too low of cost and they don't see what is in it f

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

r you they are not interested because they think you are tricking them. It was amazing to

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

me that people could not see what was it for me.

Exposure for my business and a chance to

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

Professional from academic institutions, pharmaceutical industries, health care indust

give back to the community which has treated my business so well for so many years. What'

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

wrong with that? Do you know what happened after the fundraiser? They gave $200 to each

.

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

other crew-members who volunteered that day to work with the kids. Because they still cou

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

Companies that provide selfless information through particip

d not understand why we were helping the community. Go figure. Consider all this in 2006

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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