Advice You - Business

In my early days of making presentations, I always thought that notes of presentation or speaker’s notes are

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

not necessary since I have prepared very thoroughly. But as my schedule becomes more hectic due to increasi

; 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 work commitments and projects, I begin to rely more on speaker notes (as my preparation time for my variou

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

presentations gets shorter). For most people then, having something in front of them is essential. Lets fir

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

t examine the roles of Speaker notes

Role of Speaker’s notes

a) To boost confidence. In the event you do n

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

Combination pro

t need it, having something there is a comfort and you could easily refer to when asked about statistics and

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

other information during Q&A

b) To act as a guide to what you will say and what order you will say in

c) T

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

assist you to say it in the best possible way by producing the right variety, pace, emphasis, etc as you go

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

along

The Five Immutable Laws of Developing Speaker’s Notes:

1) Legibility is essential. Imagine having no

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

es that you can’t read off from! As a guide, you must use sufficiently large type or writing and avoid addin

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

tiny, untidy embellishments. These notes must be suitable to be used standing up and you must be able to se

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

Following aspects would a

e them when they are placed on the podium or on the table (it is quite a distance when trying to read standi

dd to the challenges in developing combination products:

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

g up)

2) The material for your notes must be chosen carefully to suit your purposes. Some people favor smal

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

cards, others larger sheets. I personally favor small card or folded paper (B3 size) so that I can conceal

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

hem. Compare giving a presentation whilst holding an A4 sized paper versus cards which can be concealed in y

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

ur palm. Which one comes across as a presenter that is well prepared, confident and credible? You get the dr

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

Professional from academic institutions, pharmaceutical industries, health care indust

ft?

3) Use one side only of the card/paper. This allows amendment and addition if necessary and makes the t

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

tal package easier to follow

4) Always number the pages of your material. When “Murphy’s Law strikes, yes y

.

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

u will drop or lose your materials.

5) Separate different types of notes: for example, regarding what you i

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

Companies that provide selfless information through particip

tend to say and how (that is, emphasis etc) and remember to use colors and symbols to help you find your way

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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