Advice You - Business

The ‘book of lists’ published every year in America, has accumulated and ranked a dazzling assortment of fascinating topics. Amongst them is the lis

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

t of ‘mankind’s worst fears’

Do you think that ‘death’ is our greatest fear? - No that’s tied for sixth place with ‘sickness’

In fifth place is ou

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

Examples of combination products may in

fear of ‘deep water’

In fourth place comes our fear of ‘financial problems’

In third our fear of ‘insects and bugs’

In second place is our fear

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

of ‘heights’

So what do you think ranks as our worst fear?

It is in fact, the prospect of having to stand up in front of an audience and make a sp

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

ech or give a presentation.

Interestingly, the most common problem among inexperienced presenters is the ‘fear of fear’ the feeling that they will

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

Combination pro

e unable to overcome this nervousness. This fear is normally multiplied by the number of people they are talking to.

The Value Of Nerves:

H

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

owever, the adoption of certain basic principles will help to control nerves.

You will note that I say ‘control’ rather than eradicate - which lead

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

to the first of these principles.

• Feeling nervous before and at the start of any presentation is not only natural, it is necessary. Without that

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

keyed-up feeling, the adrenaline will not flow in the presenter and therefore the presentation will be flat and unexciting.

• Remember that of the

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

three key elements in any presentation -i.e. the audience, the content & the presenter, the presenter is the least important

• Also remember that

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

ou are not alone. Nearly every great orator, whether they are a politician, an actor, an evangelist or a great sales person, feels the same nervousn

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

Following aspects would a

ss that you feel. (indeed many of them feel it worse)

In nearly every case the audience is on you side.

In Summary:

• The biggest fear is

dd to the challenges in developing combination products:

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

probably of ‘drying -up’ you will not do this if you are properly prepared with a good set of notes. If you are lost for a word, don’t worry, it wil

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

either come to you or the audience will supply it.

• Just before you are due to start, sit down in a chair and take two or three deep breaths.

•

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

ake sure you have ‘warmed-up’ your voice before rising to speak,

• Be appropriately dressed for the occasion - smart attire adds to you confidence.

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

• When you stand up, ‘stand-tall’ with feel slightly apart and well grounded on the floor.

• Don’t fidget - relax

Remember the only way to learn

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

Professional from academic institutions, pharmaceutical industries, health care indust

how to have full control of nerves is to practice making presentations whenever and however possible.

There are of course, a number of key elements

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

within a professional presentation, for example: Planning and preparation, structure, verbal delivery, physical delivery, the use of visual aids and

.

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

the management of the question and answer session. Each element is important andeach needsto be planned thoroughly.

In Part Two of this article,

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

Companies that provide selfless information through particip

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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Advice You - Planning Is Key To The Success Of A Professional Presentation

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