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Maybe you are one of the lucky ones, but making a speech or giving a presentation still gives me the jitters, even though I have done many over the years. My heart will start to thump away like mad and my voice often goes a little shaky when I start out. Nevertheless, like most things in life, this nervousness can be overcome and most of us can put on a decent performance, p

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

roviding we prepare properly and follow a few basic steps.

For example, I always learn my opening paragraph by heart but still write this out in full. I then start off by reading this from my cards or papers. This allows my voice time to settle down and the familiarity of the words helps to ease my nerves. Once the opening paragraph is out of the way I move on to just usin

; 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 notes for the rest of my talk. By then I'm usually fairly in control. A speech doesn't sound right if you simply read continuously, word for word, from what you have written down.

I'm probably getting a bit ahead of myself, so I'll start at the beginning of preparing for a presentation of some kind. Traditionally they are expected to have an introduction, a middle and an

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

ending. This may sound obvious but watch a lot of inexperienced speakers and you will see how they do not always follow this format. Everything can then turn into a jumble, with no real flow or continuity and often you can't be quite sure when they have actually finished, other than everything goes quiet!

Let's look at these three parts:-

#1 Introduction ~ This is

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

where you tell 'em what you are going to say.

#2 Middle or Main Body ~ Now you tell 'em

#3 Ending or Summary ~ And finally you tell 'em what you said.

To balance a talk properly 10% of your allotted time should be for the introduction, 80% for the main body and the final 10% for your summary. A thirty minute talk, for example, would have 3 minutes allocated t

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

Combination pro

both the intro and summary and 24 minutes for the main body. It is always preferable to finish a minute or two earlier than to overrun your time.

Many speakers find it difficult to guage their time. As a rough guide the speed ought not to drop below 120 words or exceed 150 words per minute, other than in exceptional circumstances.

#1 Introduction

Firstly a look at

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 introduction for the presentation (i.e. tell 'em what you are going to say). Some suggestions:-

I ~ Start with something which is particularly Interesting or unusual, something your audience may not be expecting. Try and think of a way to grab their attention

N ~ Demonstrate the Need for the audience. Try to make it personal for them all.

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

Convince them that they 'need' to give you their attention. Show the importance of the topic for each member of your audience.

T ~ Give the Title of your presentation.

R ~ Indicate the Range of your talk. Say what you will be including and what you must leave out. Tell them how long your presentation will last and whether you will be answering

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

any questions

O ~ Establish the Objectives for your talk. Explain to the audience what they will know, or will have learnt, by the time you have finished, and how you expect them to react to what you have said.

Use this introduction to set the route which you intend to navigate, so they will be aware as to what you are going to tell them.

#2 Middle or Mai

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

n Body

Now we move on to the Main Body of the talk (i.e. tell 'em). Here are a few things to consider:-

(a) The stages of the development of your theme should be very clear in your own mind.

(b) Only make those points which are fundamental to your objectives.

(c) To help you emphasise your points use (i) examples, (ii) analogies and (iii) any visual aids or objects th

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

t can be shown.

(d) Be sure that your linking summaries are both accurate and adequate for the purpose.

(e) Don't labour any arguments with repetitions. Instead illustrate and reinforce your points wherever possible (perhaps with i, ii or iii as above)

(f) Present your arguments so that only the main or important points will be remembered. Your system of priorities is imp

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

Following aspects would a

ortant.

#3 Ending or Summary

Finally we have the Summary (i.e. tell 'em what you said)

Don't end suddenly or stop too abruptly. Your finish must be part of the overall plan. The closing sentences of a well delivered talk will tend to linger in the minds of your listeners. Capitalise on this, and make this to your benefit.

Use your summary to briefly repeat and re

dd to the challenges in developing combination products:

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

state your main points, but try to vary your language. If there are any conclusions to be drawn - draw them. Do not introduce any new material, evidence or arguments in the closing stages. You are simply reiterating what you have already said.

# How Do I Say It?

What I have written above are just the bare bones of the subject, hints and tips that may be of help. L

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

et's, however, presume that you have completed the draft of your presentation. The question then arises of, 'How do I say it?'

The most successful method of preparation involves a combination of memory and reading skills.

Use your memory, as I said earlier to learn the opening paragraph. Also learn off by heart your final paragraph (remember this will tend to linger in the

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

minds of your listeners). It therefore makes sense to know exactly what you are going to say to make that final lingering impact.

Your notes are a reading aid and should be constructed as such. Whether you use cards or plain paper plan the layout. Print the words so that they are easily read and use letter sizes that will enable you to see them easily at a distance. Colo

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

red inks and sketches also help.

Regarding your notes: it is a good idea to also have one Master Sheet which sets out clearly the stages of your presentation. This enables you to be aware of the overall plan and sequence of what you saying. If you should then indulge in anything off the cuff or get side tracked, it will help you to see where your are up to and put you back

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

Professional from academic institutions, pharmaceutical industries, health care indust

on course.

Once you have prepared your talk rehearse, rehearse, rehearse! Make your friends listen, say it in front of a mirror, perhaps your dog or cat would like to hear, record it on tape and so on.

By repeating it over you may well find that you have to amend your notes. Sometimes the written word doesn't have the same effect when said aloud. It is important to stress

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

that proper preparation will create confidence. It is only a lack of confidence that prevents any of us from becoming effective speakers.

# The Delivery Of Your Presentation

I'll finish up with a few points on the delivery of your presentation. Read over your notes, not into them. Never apologise either for yourself or for the subject matter. Speak in your natura

.

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 accent and don't project your voice only to the back of the room. Talk to those in the front as well and look at your audience, talk to them and hold their eyes individually. If you are addressing a smallish group you must make eye contact with them all at sometime during your presentation. Make it a two way exchange, even if the words are only coming from you. And try t

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

Companies that provide selfless information through particip

o avoid 'umms' and 'errrs' and repeating loose phrases such as 'you know', 'you see', 'basically', 'personally speaking' etc. etc.

It's not too difficult to make a presentation or give a talk if you do your homework first. We can achieve most things in life if we really want to. It's simply a matter of effort and preparation mixed with a desire to succeed.

Good luck.

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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