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There are times during a presentation when you really do not know the answer to a question posed to you. What do you do? Do you look at the person w

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

ith killer eyes? Do you sweat and say errrrr…

At this moment, the key is to be honest. However, admitting, “I don't know”, in response to a direct

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

Examples of combination products may in

question from the audience can ruin you immediately. What we want to do is to maintain credibility and integrity. Remember, no one can know the ans

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

wer to every question. The audience does understand. It is how such situation is handled that separates great presenters from the amateurs. I have

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

dentified the following seven strategies that you can follow to handle even the toughest questions with confidence. In Part 1 article, I will touch

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

Combination pro

on three of them.

1. Toss it Back

Repeat the question again and toss it back to your audience, “Good question. Anyone here have any experience wit

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

h that?” When you allow the audience to help you, they will save you without ever realizing it. This is not passing the buck but tapping on the kno

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

ledge and energy of the audience. Besides from experience, the audience loves this because they like to get involved and for some they love to show

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

off their knowledge. After getting the contributions from the audience, make sure you summarize the discussion. Always always add your own ideas so

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

that you continue to portray as the expert in that topic (you should use the short moments when the audience are airing their insights to quickly ch

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

rn out ideas). If its done properly, it will help you maintain control and authority.

2. Let me check and get back to you

This is the most common

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

Following aspects would a

saver and it works well if you do three things. First, write the question down. Show them. Make sure everyone knows you are writing the question d

dd to the challenges in developing combination products:

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

own. Second, tell the questioner exactly when you will get back to them. Give them the exact time and date. Can you get back to them by the end of

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

the day? Can you get back to them after lunch? You must and I stress, you must get back to them at your promised date and time. Or else there goes y

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

ur credibility. Third, be sure to get the questioner’s contact information if you don’t have it. Again, write it down and make sure everyone sees 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

t. These three actions make this strategy very powerful. It is not trying to put up a “smoke screen”. What we want to do is to show that we too wan

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

Professional from academic institutions, pharmaceutical industries, health care indust

t to learn more and in the process impress the audience.

3. Tit for Tat

Ok, what I mean by Tit for Tat is that you answer the question with anothe

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

question. Yes! Sometimes questions are too narrow or too general to answer. Reserve the right, as the expert, to open a question up or close it do

.

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

wn by asking a question in response. Questions like "What do you gain by knowing this?" "What is your objective with this question? If you require

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

Companies that provide selfless information through particip

a certain function, product, (fill in the blanks), I can help you in this way". Such questions normally diffuse that difficult moment you are facing

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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Intellectual Property Rights (IPR) is one the most important tools in the recent few years for technology and innovation protection. Patent is one of the IPR and is most important from all other rights. It contains most uptodate technological information and effective use to patent information of technological and competitive intelligence is an art. A lot of Indian firms are providing the global quality IP services.

On my mind and the minds of a lot of my clients recently is marketing. Whether you run a small business, are self-employed, work for someone else or are on the job hunt, MARKETING IS KEY.

When you are starting a business, it is hard to find money to hire business consultants. But hiring a good business consultant will be the best money you will spend. A trial-and-error method will be more expensive than the cost of getting a good consultant a soon as you need one. Be sure you hire consultants that you can trust.

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