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Imagine that you are a new entrepreneur. You have a great idea; you did your research, you're feeling optimistic and you just registered your company name. Experienced business people might call you

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

naive.

The phone rings and someone asks for you by your company name. Wow! - you think, customers are calling already. Hello? - ok so it is not a customer, just someone offering a free gift, no wa

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

Examples of combination products may in

it, she said two free gifts - guaranteed! Hum, something for free, this sounds interesting.

She said you filled out a form at some trade show, (didn't catch the name of the trade show). That's poss

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

ible because you have been to several trade shows. Sure you probably filled out the form she is talking about, even though you can't remember the form or the trade show.

What's that she is saying?

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

Any two prizes out of a list including a fax machine, a trip to Club Med, a new computer, a diamond pendant, (oh your wife would love that - maybe she would actually appreciate your business idea),

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

Combination pro

video camera - latest technology, a 52 inch TV (she called it an entertainment centre) - which you could trade for $8,000 in cash. There were some other prizes but you start to wonder what do I hav

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

e to do to get the prizes and how soon can I get them?

Reality Check
So far so good. Ok, what did I win? Oh, she said, the gift is contingent on a purchase of advertising.

"But I don't need a

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

dvertising - just send me my gift." I declared. At this point she hung up on me. I guess I blew the deal of the century. Stupid me, I asked too many questions. No free TV, Diamond pendant or trip to

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

Club Med. The video camera sounded nice too.

This was the third call I received like this since I registered my business name just a few months ago. I wonder, how many more of these calls will I r

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

eceive and how many people do they catch?

All three calls followed the same pattern. In none of the cases did we get to ordering. I suspect they wanted a credit card order over the phone.

The pur

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

ose was to sell a very specific order of advertising - pens with my company name - no choices, just take it or leave it. The order cost was between $200 and $300. I don't remember how many pens. She

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

Following aspects would a

did not try to allow me the details to make an educated buying decision.

They spent 95% of the time explaining the free gifts, model numbers and the features of each "prize". At no time did the ca

dd to the challenges in developing combination products:

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

ller their purpose as that of selling pens. They obliquely referred to advertising. I had to probe to get details.

Each time it was a young sounding female voice that called. "Are you married?" she

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

cooed. "Oh then your wife would love the diamond pendant." Do they use a young sounding male voice to call a female registered business?

She made a big deal out of the fact that the purchase was 1

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

00% tax deductible. She did not seem to appreciate my statement that all business advertising expenses are 100% tax deductible. Soon after I said this she hung up.

Each time they called from Montre

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

l, but they were selling in Ontario. What does that do to the verbal promises and guarantees? To contest any breach of promise would I go to court in Montreal, and how would I prove what they said o

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

Professional from academic institutions, pharmaceutical industries, health care indust

n the phone? They have a different form of law in Quebec, - different from the rest of the country. They use the French civil law in Quebec. Too bad they didn't keep that other French machinery of c

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

ivil law - the guillotine.

I know that there are many reputable specialty advertising firms in the area. When I need advertising, I will contact one of them and then I can see and touch the product

.

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

and see whom I am dealing with. I will also be able to shop around and pick the product and supplier who best suits my needs - when I am ready. In the meantime, buyer beware!

PS. The above is a tr

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

Companies that provide selfless information through particip

ue story. In each case my questions became unbearable for the caller and they hung up. It's been several months now and there have been no more calls. I still do not need pens imprinted with my name

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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Being asked to a job interview is always good news, but it often brings with it the dreaded nerves! I’ve compiled some simple job interview tips that will hopefully help you beat the nerves and land the job!

With today's longer work hours and increased cost of living, entrepreneurs often need to work a full time job while they launch their first business. Here's some tips on how to still start a business will working for someone else.

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