Top Articles - Writing and Speaking

"I've got to be me. I've got to be me. What else can I be than what I am?"
From the song, "I've Gotta Be Me" by Walter Marks, sung by Sammy

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

Davis, Jr.

When you speak in public, do you give yourself full permission to just be yourself? Do you show up fully as you are, without feeling any

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

Examples of combination products may in

eed to be someone more articulate, more talented, more experienced, more dynamic, more interesting, more funny, more "something" than you?

Many peopl

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

e feel that if they are going to stand up and speak in front of an audience, they need to be like that electrifying, laugh-a-minute speaker they saw l

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

st week. Or they need to be an extraordinary, super-duper version of themselves.

Well, that’s nuts.

You get to be who you are. As you are. Not some

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

Combination pro

better-than-ever version of you, but who you are right now. In this moment.

Here are three reasons why you must give yourself full permission to be y

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

urself when speaking in public:

1. How Scary Can It Be?

No one knows how to be you better than you. You've got it down! You are the expert! So, how

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

nervous can you be when all you need do is be yourself, a task for which you have been practicing all your life?

Most of the anxiety around speaking

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

comes from the fallacy that in order to speak well, we need to be someone other than who we are. The objection goes something like this: “But I can’t

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

be myself! No one would want to listen to ME. I'm too (fill in the blank) and not (fill in the blank) enough." Who says? Who says you have to be any c

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

rtain way? That's all a bunch of hooey. Be real. Be who you are.

2. Faking It Doesn't Work

You've heard the old expression, "Fake it until you make

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

Following aspects would a

it." I suppose this advice made sense to someone at some time, but when it comes to speaking and being with an audience, it makes no sense at all. Why

dd to the challenges in developing combination products:

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

would you want to fake it when you can show up as an authentic, genuine person?

Besides, people can smell a fraud from a mile away. And as soon as t

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

ey get a whiff, they retract, get suspicious and choose not to pay attention. It is your willingness to be who you are that makes you worth listening

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

to. The moment you try to “fake it” you lose credibility.

3. You Get To Have Fun!

When you fully allow yourself to be who you are, in any situation

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

you get to truly enjoy yourself. You get to express yourself, say what you want to say in a way that feels easy and natural to you, rather than contr

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

Professional from academic institutions, pharmaceutical industries, health care indust

olled or contrived. You don't have to worry about doing it "wrong" because you can't go wrong when you're being real and authentic with your audience.

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

You can talk like YOU talk, move like YOU move, share what YOU know. And then receive your applause. What a blast!

Make the choice right now to give

.

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

yourself full permission to be true to you anytime you are speaking in public. Let go of that old myth that in order to be a good public speaker you h

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

Companies that provide selfless information through particip

ve to do things in a certain way. Not only will you feel more confident and at ease, you will come across as credible and trustworthy to your audience

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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