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Let me be the first to admit I’m dragging my derriere this morning with respect to cold calling.

For my

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

benefit, and of course for yours, let’s analyze this little funk before I hit the phone.

There are 5 dis

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

Examples of combination products may in

tractions bogging me down, and they can get in anybody's way.

(1) I’m coming off a really nice weekend.

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

Yesterday I took a long hike at and around the beach, swam, worked out with weights, and did some karate.

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

My knee feels the strain, and the rest of me is dragging, too.

SOLUTION: Pick up the dumbbells next to m

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

Combination pro

e and get the blood pumping. Be right back…

DONE! Yep, I feel better. I topped off my 40 rep set of curl

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

s with 40 Soloflex machine reps. I’m pumped!

You may not have exercise equipment at your desk, but maybe

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

you can get some, at least a few light dumbbells. Keep them in your drawer. What I just did took half or

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

less the time of a coffee break and it changed my mood for the better.

(2) I haven’t started my calls be

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

cause MY LIST SUCKS. It is incomplete and not prioritized. I should have done today’s call planning yeste

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

rday. Shame on me, but once I get started I’ll find my niches.

(3) I’m WAITING for some calls to come in

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

Following aspects would a

. This is really stupid, because of course, they may not come in at all and I’ll twiddle away my time for

dd to the challenges in developing combination products:

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

nothing. Moreover, the positive results I’m waiting to hear may not turn out that way. If this happens, A

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

ND I’ve been idle, I’ll feel morose. Better to get on the stick and to MAKE SOMETHING HAPPEN, NOW!

(4) I

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

’m speculating about what some of my known prospects, my follow-ups will say. What an incredible waste th

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

is is. First, whether I’m right or wrong, who cares? Why pay the price of their reaction, twice? Just cal

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

Professional from academic institutions, pharmaceutical industries, health care indust

them, for gosh sakes, and end the mystery.

(5) My desk is messy, and despite what you’ve heard about th

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

is being a sure sign of genius, it isn’t my kind of genius. I need to take two seconds and put this clutt

.

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

er into piles so I can see the wood grain of my writing surface, again.

Okay, this sums it up.

Now that

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

Companies that provide selfless information through particip

I’m in touch with all of my foibles I’m good to go.

And this article helped a lot.

Thank you very much

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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