Advice You - Business

"If a tree falls in the forest, and there is no one there to hear it, did it make a

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

ny noise?" That was one of the great philosophical issues we used to think about in

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

Examples of combination products may in

school. The answer is that the answer depends on how you define noise.

But my 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 to you as speakers is, "If you make a comment, and no one can hear you, what wa

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

the point of speaking?" And here the answer is clearer. There was no point, except

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

Combination pro

to hear yourself talk.

I was reminded of this recently at a seminar. Over a hundre

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

d people packed into a room with only one microphone, a stationary one mounted on t

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

e lectern. For the most part the discussion leader spoke into the mike and could be

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

heard by all in the room. Unfortunately, the audience members who commented--and I'

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

sure had interesting and valuable insights--sat and spoke in a conversational tone

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

one would use in a one-on-one discussion. They could not be heard, except by those

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

Following aspects would a

sitting near them.

Here are three lessons:

Have a microphone for the audi

dd to the challenges in developing combination products:

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

nce to use. If that is not possible, then,

As the speaker you should b

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

iefly summarize each comment so that all would know the essense of what was sa

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

d. Failing that,

You as the audience member should stand up, face the

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

ajor part of the audience, and increase your volume. These are simple, c

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

Professional from academic institutions, pharmaceutical industries, health care indust

ommon sense, easy to do techniques that make a big difference in the effectiveness

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

f the experience. Unfortunately, basic techniques are often overlooked. Remind your

.

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

elf periodically throughout your presentation that you want the audience to get val

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

Companies that provide selfless information through particip

e from what you have to say...and if they can't hear you, you're wasting their time

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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Who holds a conference in December anyway? But, since it was a paid speaking engagement, I decided what the heck. I should have had a clue as to how things would go when I sat on the runway with an engine light malfunction for two hours. Consequently, I missed my dinner engagement when that turned a 90-minute flight into one that lasted four hours. Remember when airlines distributed snacks? Forget it. We got free head phones for a flight too short for a movie. Who can eat headphones anyway?

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