Advice You - Business

Imagine you have just been asked to give a highly complex presentation to the Board of Directors. One of the biggest mistakes you can make at thi

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

s point is to start thinking about what you will say. Instead focus on planning.

So how might start the planning? Here is a simple but effectiv

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

Examples of combination products may in

7 step process.

Step 1: Develop Objectives

Before you do anything get clear on your objectives for the presentation. Possible objectives might

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

e:

• To inform the Board of the current financial position and future forecast

• To secure the funding for a new computer system

• To get buy-i

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

to a new performance management system

• To secure support for an increase in staff numbers

Take the time to get clear on your objectives from

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

Combination pro

he presentation.

Step 2: Assess Your Audience

Whenever you are assessing your audience, try to step into their shoes as the recipient of the pre

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

entation. Think about:

• The level of knowledge they have about the topic

• The level of resistance you are likely to encounter

• The percepti

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

ns or views they might have about you or your team

• Any insights that you have gained from others about the style or type of presentation they r

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

spond well to

Step 3: Brainstorm Ideas

A brainstorm is quite simply a dump of ideas on what you could cover. Remember the first step is to get

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

ll possible ideas down. It is not about evaluating at this stage. Keep brainstorming until you run dry on ideas.

Step 4: Identify Common Themes

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

It is likely that when brainstorming, you will have come up with similar things that you can group into an overall theme. For example, if it is

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

Following aspects would a

a financial performance presentation you might have included budgeting, forecasting, treasury and working capital that you put under a theme calle

dd to the challenges in developing combination products:

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

financial management.

Alternatively if it is a human resources presentation you might have included recruitment, selection, retention and person

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

l development that you capture under a theme called talent management.

Step 5: Produce An Outline Structure

On one piece of paper sketch out the

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

theme on each slide and the two or three messages you want to get across.

Step 6: Prepare The Presentation Materials

The key things to be aware

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

f in preparing your presentation materials are:

• The appropriate number of slides- my rule of thumb is 5-7 maximum for a 10 minute presentation

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

Professional from academic institutions, pharmaceutical industries, health care indust

• How much text to include- in my experience bullet points are best

• Use animation only if it adds something

• How you will deal with numbers-

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

n excel spreadsheet is not appropriate so you need to think of alternatives if it is numbers based presentation

Step 7: Practise Practise Practis

.

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

Running through your presentation at least twice is an essential part of your planning. Don’t neglect it as it will serve you well when it come

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

Companies that provide selfless information through particip

to the real thing

Finally, remember that most of us are not that enthusiastic about presenting and thorough planning can make all the difference

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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