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Try these proven techniques during your next question and answer session.

1. Repeat the question

It is

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

helpful to repeat a question asked by a participant especially if;

1. You are speaking to a large group.

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

Examples of combination products may in

br> 2. Your session is being taped and you want the listeners to the tape to hear the question, and

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

3. The person asking the question has a low or soft voice.

2. Keep answers short-don’t lecture

It is s

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

tempting to digress. Often if asked a question that strikes right to the core of our passion we may go

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

Combination pro

n and on in giving a response. Give participants the option of staying longer or contacting you for more

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

details or discussion.

3. Respond to the entire audience

Yes, we must maintain eye contact with partici

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

ants who ask us a question. However, be careful not to answer the entire question while focusing just on

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

he person who asked the question. This is not easy. But attempt to respond at the beginning to the perso

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

who asked the question then back up a step or (if space prohibits) let your eyes meet the entire audienc

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

as you respond to the question.

4. Say, “I don’t know, but I will get back to you”, if you don’t know t

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

Following aspects would a

e answer to a question.

I am a firm believer in never, ever knowing it all. If that happens there is no

dd to the challenges in developing combination products:

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

room to learn anything new. If we fake an answer we can lose the respect of our audience.

Also, if you p

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

omise to get back to a person-do it! Develop a form (Contact me if you need one) that will record the na

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

e of the person, question and contact information. E-mail always works better for me. But not everyone i

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

online so be sure to find out the best way to contact them.

5. Be alert to the “question hog”

At times

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

Professional from academic institutions, pharmaceutical industries, health care indust

I am a “question hog” If I am excited about a topic I may forget that there are others in the room that w

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

nt to get their questions answered before the time runs out. In those instances the best thing a present

.

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

r could do is FOCUS THEIR EYES ON ANOTHER PERSON THAT HAS A QUESTION.

If they keep talking with me in a

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

Companies that provide selfless information through particip

ack and forth dialogue others can lose interest. So give these tips a try during your next presentation

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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