Main Subject - Business

To fail to prepare is to prepare to fail. Great presentations require much preparation. A good presentation starts out with introductions and an

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

icebreaker such as a story, interesting statement or fact, joke, quotation, or an activity to get the group warmed up. The introduction also ne

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

Examples of combination products may in

ds an objective, that is, the purpose or goal of the presentation. This not only tells you what you will talk about, but it also informs the aud

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

ience of the purpose of the presentation.

Next, is the body of the presentation. Do NOT write it out word for word. All you want is an outline.

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

By jotting down the main points on a set of index cards, you not only have your outline, but also a memory jogger for the actual presentation. T

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

Combination pro

prepare the presentation, ask yourself the following:

1) What is the purpose of you making this presentation?
2) Who will be attending?<

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

br> 3) Does the audience already know about the subject? If so how much do they know?
4) What do you think will be the audience's attitud

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

towards you (e.g. hostile, friendly)?

As a guide, a 45 minutes presentation should have no more than about five main points. This may not seem

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

like very many, but if you are to leave the audience with a clear picture of what you have said, you cannot expect them to remember much more th

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

an that. There are several options for structuring the presentation:

• Timeline: points that are arranged in sequential order.

• Climax: The

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

main points are presented in increasing order of importance.

• Problem/Solution: A problem is presented and you offer a suggested solution whi

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

Following aspects would a

e also mentioning the benefits that come with it.

• Classification: You can classify and present important items as major points in the presen

dd to the challenges in developing combination products:

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

tation.

• Simple to complex: Points are listed from the simplest to the most complex. Can also be done in reverse order.

You want to include

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

ome visual information that will help the audience understand your presentation such as putting out charts, graphs, slides, handouts, etc.

Afte

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

the body, comes the closing. This is where you ask for questions, provide a wrap-up (summary), and thank the participants for attending.

And f

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

inally, the important part - practice, practice, practice. The main purpose of creating an outline is to develop a coherent plan of what you wan

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

Professional from academic institutions, pharmaceutical industries, health care indust

to talk about. You should know your presentation so well, that during the actual presentation, you should only have to briefly glance at your n

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

tes to ensure you are staying on track. Your practice session should include a "live" session by practicing in front of coworkers, family, or fr

.

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

iends (or Devil Advocates as I call them in my ebook). They can be valuable at providing feedback and it gives you a chance to practice controll

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

Companies that provide selfless information through particip

ng your nerves. Another great feedback technique is to make a video or audio tape of your presentation and review it critically with a colleague

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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