Main Subject - Business

In Part 1 of this article, I laid out the importance of handling questions which stump us. Lets recap the first three strategies which we have discusse

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

d:

• Toss it Back - Repeat the question and toss it back to your audience;

• "Let me check and get back to You" - Write down the question and make su

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

Examples of combination products may in

re you revert to the questioner on the promised date and time;

• Tit for Tat - Posing another question to question the questioner for asking that ques

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

ion (a tongue twister). This method helps to diffuse the situation and adds more understanding to the topic you are presenting.

Let us examine the res

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 of the other 4 strategies:

4. "That is A Good Question"

Compliment the questioner. This will only be effective if the compliment is sincere. Somet

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

Combination pro

mes we tend to believe that we have seen and heard it all on a particular topic. But someone from somewhere will always come up with a question that we

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

have never thought of. If that happens just say "That's a great question. I've never thought about it that way. Does anyone here have any ideas on

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

hat?" (You toss back the question back to the audience). The key here is you must sound sincere. It always works when it's sincere because the audien

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

ce love to be complimented. If no one in the audience steps forward with a reply, just use the "Let me check and get back to you" technique.

5. "Any E

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

perts Here?"

What do you do when a question falls out of your area of expertise? You may be a marketing expert but the question asked deals with the

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

technical aspects of a product. This is a question that requires the input of say an engineer. If you know that there is an engineer in the room you

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

Following aspects would a

could say, "Peter, you are an engineer. Can we tap on your experience for this question?" If there are no engineers in the room, tell the questioner

dd to the challenges in developing combination products:

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

hat you will confer with an engineer and get back to them (technique 2).

6. Offer Similar Answers

If you don't know the exact answer to a question, o

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

ffer what you do know quickly to demonstrate some credibility. Then use the "I'll get back to you" technique. Refrain from droning on and on about your

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

parallel knowledge or you will be accused of beating round the bush! This hurts your credibility.

7. Lay the Ground Rules

You can avoid many difficul

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

t questions simply by laying the ground rules for questions in the beginning. Whenever you present to a group, you are the leader. You are accountable

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

Professional from academic institutions, pharmaceutical industries, health care indust

or everything, so lead. My experience is that if you set rules and follow them, the audience respects you. If you make rules up as you go along, you l

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

ose credibility. The number of rules you set will vary depending on the topic. If your presentation is very technical, you can use "I welcome general

.

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

questions at any time about anything on the agenda. If you have a specific question please see me at a break for a private consultation. Since we hav

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

Companies that provide selfless information through particip

e limited time, I reserve the right to stop taking questions and comments. This is to make sure that we cover everything today." This line always works

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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