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The first call of the day is always the toughest.

For some reason, I get a little shy

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

and introverted before speaking to the first prospect in the morning.

But I’d say eigh

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

Examples of combination products may in

y or ninety percent of the time that initial prospect I get on the line is courteous an

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

d surprisingly receptive to my offer.

How can that be? Aren’t people supposed to be gr

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

mpy first thing in the morning?

That’s what we might tell ourselves as we start our ro

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

Combination pro

utines, but we should edit that expectation.

Instead, we should say, “This call is goi

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

g to be great!”

What if it isn’t?

Then, we can just as quickly add, “Now the first ca

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

ll is out of the way, the frogs are leaving my throat, and all’s well with the world!”

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

In other words, there’s always a positive spin that we can put on STARTING, a reward or

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

a pat on the back we can bestow, no matter how wobbly we appear to be to ourselves.

T

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

e other day, for instance, I followed up by phone with a prospect to whom I sent a prop

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

Following aspects would a

sal, but had received no feedback. When I got her on the line, frankly, I was a little

dd to the challenges in developing combination products:

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

nervous, not knowing what to expect.

My voice warbled a little, not at all filled with

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

its customary confidence.

Still, and perhaps even because I sounded genuine and perhap

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

s a little vulnerable, I revived the deal, and submitted a better proposal, one more cl

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

sely geared to what the company expected to buy.

That follow-up was my first call of t

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

Professional from academic institutions, pharmaceutical industries, health care indust

he day, and I felt great afterwards.

So, how should you prepare for the first call of

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

he day?

Relax and tell yourself you won’t be perfect, and more important, you don’t ha

.

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

ve to be in order to come out ahead.

Being in the same early morning mood, your prospe

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

Companies that provide selfless information through particip

ts and clients will empathize with you and probably go out of their way to help you out

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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You only have one time to make a good first impression. If your writing is the first thing and in most often times the only thing that a client or prospect sees of you, what impression does it make?

The other day a reporter call to interview me on the “Death of Customer Service”. My first reaction was to deny that charge and claim that customer service is very much alive and well. But upon further thought of the service I’ve received over the past few months and what others have related to me about their experiences, I had to admit that the quality and level of service has decreased. Upon further thought I realized that it has been on a decline for quite a while.

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