Main Subject - Business

Which sounds more appealing, getting up in front of a group of strangers and talking, while they all sit there looking at you l

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

ike a dog watching a ceiling fan...or gargling with Drano? It's no surprise how many would choose the Drano.

Public Speaki

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

Examples of combination products may in

g has been ranked as the "number one fear" among thousands of us. The anxiety is overwhelming, you start to sweat profu

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

sely, your knees are knocking so hard you might break a kneecap, hands tremble like you dipped them in a fryer full of hot oil, vo

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

ce starts quivering like someone dumped a bucket of ice water on your head and you can't remember what it is you are supposed to b

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

Combination pro

talking about. Why? Because you are scared to death.

I want to share with you some tips on overcoming this fear of Public Spe

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

aking.

1. Picture yourself doing it, go ahead picture yourself standing in front of all these people saying what it is you ar

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

going to be talking about. Picture yourself from start to finish. Begin with walking up to the microphone or podium, all the way

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

hru your speech, and then finally wrapping it up to a successful outcome.

2. Practice, practice, practice...do your speech 'out l

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

oud' over and over again. Now, do the same thing to a real live person..(just make sure they will be honest with you about your pr

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

sentation).

It's been said: "Repetition is the mother of all skill"...it really is and you do it everyday in your real lif

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

Following aspects would a

, because you have done the same thing over and over again. You can just about overcome any fear you have by doing it over and ove

dd to the challenges in developing combination products:

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

r again. Sports are a good example...you see NBA players almost never miss a free throw, PGA players make 20 foot putts, NFL kicke

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

s put it thru the uprights. It's not because they were born with some special skill...it's because they practiced and practiced an

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

practiced some more. The same holds true for Public Speaking.

3. Whip out the camcorder and tape yourself giving your speech. Th

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

at way you will be able to see what the audience will be watching and listening to.

4. Get a grip...just before you give your spe

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

Professional from academic institutions, pharmaceutical industries, health care indust

ch, RELAX. Take some slow deep breaths and remind yourself that all these people are here to listen to what you have to say. They

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

on't know (or really care) what your personal life is like. Honestly, they could care less about anything going on in your persona

.

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

l life that YOU feel is adding to this anxiety.

The more prepared you are, the less anxiety you'll experience, which in turn, wil

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

Companies that provide selfless information through particip

boost your confidence sky high. Then after you are all "said and done"...you will never look at a can of drano the same way again

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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Many successful businesses were started by first time entrepreneurs who never went to college. Natural talent, ambition, drive, determination, and good old dumb luck have fueled many success entrepreneurs, myself included. I don't have a degree (I drove past a college once. It looked hard, so I kept going.) Would a degree have helped make my business trek easier? Perhaps...

Many people do not like big-game hunters because they kill what they call innocent animals. However, these wild animals would not think twice about killing a human if they were in the way or threatened them. Whereas, some people think that all big-game hunters are bad they might want to consider that overpopulation of big-game can also cause problems,

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