Advice You - Business

Truly memorable disasters don’t just happen. They require a special blend of misunderstanding and m

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

isguided effort. Here are three ways to guarantee a disaster in your next presentation, and how to

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

Examples of combination products may in

avoid them.

Mistake #1: Believe in Magic

Show up hoping that a coherent, eloquent, useful present

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

ation will magically appear once you start speaking. Avoid any type of preparation. Just wing it.

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

> What Happens

Everyone is amazed by the presentation because they expected more. They are also

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

Combination pro

bored and disappointed. They may even become upset because an unprepared presentation insults t

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

he audience by wasting their time. Unprepared presentations sound like, well, unprepared presenta

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

tions.

> Instead

Prepare. Identify the goal for your talk. Design a presentation that achieves th

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

at goal. Talk with key members of the audience about their expectations. Rehearse.

Mistake #2: M

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

emorize your speech.

Spend untold hours committing every precious word to memory so that you can

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

recite it even if awakened in the middle of the night.

> What Happens

You sound like a machine.

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

Following aspects would a

And if you stumble on a word, you can become stuck-- speechless. I've seen this happen, and it's p

dd to the challenges in developing combination products:

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

ainful.

> Instead

Learn your presentation. Yes, write a script. Memorize the first and last sente

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

nces and then practice giving the presentation without looking at the script. Practice many tim

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

es. Eventually, you will learn how to convey the key ideas in a natural, normal way.

Mistake #3:

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

Talk About Yourself

Focus entirely on yourself. Tell about your background, your credentials, and

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

Professional from academic institutions, pharmaceutical industries, health care indust

your history. Tell your story. Just talk about yourself. Make the presentation all about you,

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

yourself, and your life.

> What Happens

They listen politely. If you manage to be entertaining en

.

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

ough, they may actually pay attention. Otherwise, the audience reacts by thinking, "So what?"

>

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

Companies that provide selfless information through particip

Instead

Talk about the audience. That is, talk about what they need and how they can achieve 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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As a small business owner you need to be concerned about hazards and the risk assessment requirements, within your workplace. This is now a legal requirement.

Columnist Nan Russell shares career insights learned over 20 years in the corporate world, including as a Vice President at QVC...

The reputation of a company or organization is an intangible asset, but it is an extremely important and valuable asset. Some people believe and have written that a good reputation is an organization's most priceless asset. Unfortunately businesses face inevitable crisis situations with the potential to seriously damage a good reputation.

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