Top Adding - Writing and Speaking

The most important thing you can do when you stand to speak is something physical.

it is something we don't do;
it is something we don't know to do; and

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

it is something we don't know how to do (properly).

Now that I have you totally confused, bear with me. Once I tell what 'it' is, you might say rubbish; a

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

Examples of combination products may in

lthough, for those of you who have done presentations in the past, you possibly remember running out of 'it' while speaking!

I am talking about breathing, specifically breathing with the

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

support of your diaphragm, a muscular partition below your rib cage which separates your chest from your abdomen. 99% of the population does not breathe with this support which is why w

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

e are often called lazy or shallow breathers. It is a medical fact.

There is one group of people in the world, however, who must breathe with this support -- opera singers. That is why

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

Combination pro

they are often called professional breathers. There is another group of individuals, though, who also breathe with this support and they are called newborns. Every infant breathes with

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

the support of the diaphragm, but as the child develops he/she tends to stop this practice and reverts to using only the upper portion of the chest to breathe.

All mammals have a diaphr

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

gm. All mammals breathe with the support of the diaphragm. It is only the most intelligent of the mammals who do not make use of this extraordinary muscle. If you do not believe me, g

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

o stand in front of a mirror and take a deep breath. Did you suck in your gut, lift up your shoulders and throw out your chest? If so, then you just did it wrong.

When I started my bus

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

iness back in 1989, I joined the local chamber of commerce. At a new member's orientation, we had to stand and introduce ourselves. There had to be 150 people in that room and I knew no

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

one. While sitting there waiting for my turn, it suddenly dawned on me that my introduction was my business. As one who teaches people how to improve the sound of the speaking voice, I

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

Following aspects would a

realized that if I blew that introduction, I could kiss my business goodbye, at which point I began to sweat. My heart was beating with such fervor that I could feel it in my cheeks. F

dd to the challenges in developing combination products:

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

inally it was my turn. I stood; I took a breath; and, I proceeded to say who I was and what I did. I sounded calm, collected, in control. They had no idea that I was 'dying a thousand

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

deaths.' And, I knew it worked because when I sat down, a gentlemen in the back said, "That's the Voice Lady!"

[Incidentally, if you are a woman, do you find your shoulders, neck, upper

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

back, and/or jaw sore by the end of the day? I do not. I have plenty of stress in my life but because I breathe properly, I never experience tension in those areas. Trust me -- it's all

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

in the breathing!]

Shallow breathing results in oxygen starvation which means we are not eliminating enough of the carbon dioxide in our bodies, thereby a toxic buildup occurs. And, wh

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

Professional from academic institutions, pharmaceutical industries, health care indust

ile this toxic buildup has many adverse effects, for the purposes of public speaking, it actually increases our tension, our stress. Think of the last time you gave a speech or a present

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

ation. Did the pitch of your voice go up? Did you find yourself breathless? Did you start speaking faster and faster? These are all symptoms of nervousness exacerbated by poor breath

.

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

ing habits.

So ask yourself this question. Would you like to remain part of the 99%? Or, would you like to become part of that 1% who allow their breathing to control their nervousness

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

Companies that provide selfless information through particip

as well as experiencing a host of other benefits that have nothing to do with the voice or presentation skills.

Take control of your nervousness and let it work for you, not against you

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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