Just Answers - Writing and Speaking

1. - Your speech needs to have a logical order. Make sure you have your speech blueprint written down into sections under the following headings;

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

Beginning; Middle; End.

2. Under each of these sections write a few ideas that you’d like to say. Some ideas about what to write could be;

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

Examples of combination products may in

a. what do you know about the groom? (things that make good stories),
b. little known stories about the groom,
c. their interests,

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

> d. date of birth and
e. famous people that share the same birthday etc…

3. You will need to introduce yourself to the audience. Do you

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

know them, or will they be mainly strangers? As most people may not know who you are, be sure to give an introduction that is funny, catches thei

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

Combination pro

r attention, and depicts the relationship that you have with the groom. You may also like to say a few words thanking the people hosting the wedd

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

ng here, but that is entirely up to you.

4. Write down all the points and stories in the body of the speech. I generally like to do this first.

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

Remember, in a 10 minute speech, you’ll have time for two stories only. In a 15 minute speech, you’ll only be able to cover 3 points max… so mak

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

sure they are short, to the point, and entertaining anecdotes about the groom. It helps if they are little known points about the groom, that wa

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

y you don’t bore the audience with stuff that they already know and take for granted about the groom.

5. For the closing, it's hard to go wrong w

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

th a traditional toast or blessing for the couple. Make your toast loud impressive and short. Don't forget to have a full glass around, and drink

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

Following aspects would a

o your toast yourself. For a good collection of wedding toasts, go to www.classicspeeches.com

6. When giving the speech, talk to the whole audie

dd to the challenges in developing combination products:

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

nce. Life your head up, speak loud and clearly. Make sure everyone hears you and sees you and never speak to the floor. If you are addressing i

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

dividual people like bridesmaids, it helps to talk directly to them in the first person. This will help to build trust and a relationship with th

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

e listeners. Use good vocal variety and pause for maximum impact for the speech. DO NOT use umms and ahhs, as they detract from your message.

7.

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

Take your time speaking. You should have practiced your speech at least three times before the big day so you know the content and have the timing

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

Professional from academic institutions, pharmaceutical industries, health care indust

and pauses well rehursed. This will also help your confidence with this public speaking engagement. It is common for people to speak too rapidl

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

when nervous. Try to avoid this by consciously speaking in a calm, relaxed tone. Don't be too quiet, especially if you don't have a microphone.

.

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

8. At the very least, you must memorize the introduction and the toast. You don’t want to spoil a good speech by reading a paper from beginning t

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

Companies that provide selfless information through particip

end. You can have the structure on a note card and practice delivering the speech a few times in front of a mirror. And most of all… ENJOY IT!!

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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