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In conversations between two or more people, the more the others speak the more interesting and intelligent you’ll be.

Up to a poin

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

t. You can’t leave the other person in a vacuum while you squirm silently and stare blankly ahead.

Let me rephrase, the less you ha

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

Examples of combination products may in

ve to talk to keep up your side of a conversation, the more interesting and intelligent you’ll be. Unfortunately, saying just enoug

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

h is an art and a skill that doesn’t come naturally to most of us. Here are some guidelines you can follow.

If You Have to Speak <

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

ul>

Make questions the greatest part of your contribution. Asking good questions requires knowledge and understanding of the su

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

Combination pro

ject, but not necessarily mastery of the subject. And don’t ask questions merely in order to challenge the other person’s views 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

demonstrate your superiority. Take the attitude of a na?ve investigator. Listen intently and ask follow-up questions. Find areas of

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

agreement and mutual interest, and comment on them.

When it’s your turn to contribute, try to state your point in a sente

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

nce, and follow with a question.

When you’re invited to tell a story or give your opinion, do it in a minute or less. Of

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

fer the conversation back to the others…with a question. Go on only if you are invited to, and only for another minute or less. Don’

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

get sucked into long monologs.

What do you talk about? That takes some work. Pay attention to articles in popular magazi

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

Following aspects would a

nes, TV newsmagazines, etc. They must interest readers and viewers, or advertisers won’t pay. Pay attention to the things the others

dd to the challenges in developing combination products:

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

you’re with are talking about. Contribute when you have a legitimate contribution to make. If you don’t have a contribution and you

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

are eager to charm the others, take the time to learn something relating to their interests. Then ask good questions the next time

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

you’re together.

Keeping the Others Speaking

Inviting others to speak and to keep speaking is also an art that takes

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

skill and practice.

Face the speaker dead on. Lean forward. Make eye contact. Let the other know you’re with them—“uh-hu

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

Professional from academic institutions, pharmaceutical industries, health care indust

,” “I see what you mean,” “that’s interesting,” “I didn’t know that”….

Ask questions about things they’ve mentioned. Try i

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

n this way to find common interests and agreement. When you find them, you’ll be able to ask better questions and your interest and

.

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

enthusiasm will be real.

Repeat the other’s last words or phrase in a questioning tone of voice. That’s all it takes somet

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

Companies that provide selfless information through particip

imes to invite the other to elaborate, explain, embellish, and feel that you’re really interested. “Really interested?

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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