Main Subject - Business

Have you ever noticed how untrusting people are? What is the cause of all this? Is it the media scaring people into believing that everyone is a scam artist? Is it the gove

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

rnment causing mistrust amongst the masses to further propel law enforcement agencies, which in turn make more rules and regulations to control? Is it the Internet where ev

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

Examples of combination products may in

ryone runs around using a false “pen name” as they practice deceit?

Recently, I was discussing some possible ideas for someone who wished to start their own business. They

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

asked me some questions and I asked them some questions as well. Then their wife Esmirelda asked George, why is this guy helping you; what is in it for him? I found this i

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

teresting, as since when is it wrong to simply help someone or your fellow man? The gentleman then confronted me with this question and told me his wife wanted to know.

So

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

Combination pro

I thought about it, why was I helping this man and discussing such things with him and giving him my advice that he had asked me for? I guess my goals of helping him and h

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

s family were somewhat personal; I think my reason for helping include; to keep your family together, help them start their dream small business, delete the stress of Georg

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

e, save their kids from hardship and for fun or intellectual exercise. The business was to be an education center for the arts.

For me I guess my wanting to help stemmed f

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

om some other interesting observations I had previously. It was something I saw a video on Education in the World from TED, as I think the speaker, Ken Robinson is right (s

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

ee for yourself);

http://video.google.com/videoplay?docid=-4964296663335

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

83307&q=TED&hl=en

Of course George and his wife, who questioned my integrity to help them, did not waste a minute in asking me if I would invest in their business? So,

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

Following aspects would a

I thought isn’t it interesting that they had questioned my good nature and then immediately asked me for money? Of course I told them;

I do not see myself as

dd to the challenges in developing combination products:

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

n investor as you are not where I could monitor my investment and I do not wish the stress, I am retired you see? So, no I am not interested in any stake in the company or

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

anything like that, and would not take any shares for FREE even if you offered them, I would decline.

They asked me then my advice on where to find an investo

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

or if I had any thoughts along those lines and of course I did so I said;

Sure I have lots of thoughts, but without a business plan it is ridiculous to even c

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

onsider approaching anyone who is a REAL investor for something like this. You need a business plan, proforma, artists conception, compelling reason and a good estimation o

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

Professional from academic institutions, pharmaceutical industries, health care indust

ROI (return on investment) for the business.

You know what happened next? They decided it was too much work and they decided that unless they had the money a

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

nd there was a guarantee they would get it if they wrote a business plan; they decided that it was simply too much work. Of course such a lazy attitude and lack of worth et

.

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

ic is the number two reason people fail in business, the first of course being lack of capital.

Interesting these people challenged me on my good nature to help them isn’t

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

Companies that provide selfless information through particip

it? I certainly appreciate you reading all my articles on this subject of Winning. Thanks again and Godspeed. Perhaps this article is of interest to propel thought in 2007

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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