Others - Writing and Speaking

Welcome to the era of the all-you-can-eat speaker buffet where clients have unlimited choices and the bar has been raised to the point where audiences no longer expect a speech, they expect a performance. Where do you stand in

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

the buffet line? Are you serving up potted meat when they ordered prime rib? It’s time to see your speech as more than a speech. It’s time to see it as a performance – a piece of art that touches all the emotions – a melody as

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

Examples of combination products may in

nique as its creator.

Without emotion or energy, stories, humor, or the addition of the human element, a speech would resemble a flat line – dead – just like the audience will feel after sitting there for five minutes. But we

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

have the ability as speakers to take that flat line and give it peaks and valleys – to take the audience on a journey – a journey that surprises and delights them at every turn. And it’s not as hard as you might think. It’s all

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

about changing the energy.

You must first understand the attention span of today’s audience. It’s short. And getting shorter. Your speech must change at regular intervals and there are several ways that you can do that - mainl

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

Combination pro

y in your delivery, content, and props.

But first let’s back up and review the backbone of a speech. Most speeches do four things: identify the problem, present yourself and your information as a solution to the problem, quali

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

y who you are and why they should listen to you, and tell them what they need to do. This is the part of the speech that is written first. This is what your speech is about and the basis on which everything else is formed aroun

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

d.

In addition to the basics, you will want to add other elements to your speech such as jokes, anecdotes, stories, power point presentations, interactive exercises with your audience, question and answers, or maybe even a son

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

or two. This is where we look at our speech as a melody. You will strategically place each element depending on when you need to change the energy of the piece. For example, you might want to use your joke after a particularly

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

serious segment of content. You may want to have a question and answer session when they have had to sit and listen for a while and are starting to fidget. You may want to work your way up in degrees of humor to a hilarious ap

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

x or take them on a more moderate up-and-down journey. There is no strict rule. This is your masterpiece and it will change over time or as your audience changes. You will learn to ride the swells and dips of your piece based o

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

Following aspects would a

n where you want to take your audience.

Where you place your material will not only depend on the energy of the piece, but what emotion you want to evoke from your audience. For example, here are some of the things that you ma

dd to the challenges in developing combination products:

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

want your speech to accomplish and when it should happen.

 Who am I and why I am here – beginning of your speech
 Examples of your humanity – beginning of speech
 Show your lighter side – any

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

where
 Funny Music – to open or end
 Chart or diagram – tucked in between two elements of high energy
 Explain your vision – beginning to middle
 Encourage them to take action

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

– end
 A game to play with the audience – after heavy content
 Present a problem – beginning to middle
 A story that represents a point – before the point is made. Remember when using stor

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

ies that stories come first and points come second because stories don’t reiterate your fact; the fact reiterates your story.

Sometimes it helps to map out your speech on paper and to plot where the elements of your speech sho

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

Professional from academic institutions, pharmaceutical industries, health care indust

ld be by drawing a line that travels up and down like hills and valleys. The peaks, or highest points of your speech, will be those moments of fast pace, high energy, laughter, passion, louder tone, and jokes. The middle points

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

of your speech map would be those moments in your normal tone, medium energy and pace, content, teaching, power point slides, things moving along at a normal pace, and your points. The low places will indicate when the pace re

.

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

lly slows down, material becomes poignant, your tone is softer, there is a sense of quiet urgency and you’re reaching for their heart. All the points in between will be varying degrees of these three.

Again, these are not hard

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

Companies that provide selfless information through particip

and fast rules, and the point is that you take the time to give thought to the melody of your speech – to the placement of every piece so that it shifts in tempo and tone and meets the changing attention spans of 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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