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Whenever I write, inevitably I get to a place where my creative well seems to not only dry up, but cave in on me. This is usually around page one-

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

hundred; right after my story has gone off like a shot.

I’m not alone in this discovery, am I?

Many other writers have experienced this exact sam

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

Examples of combination products may in

e phenomena. That’s why we come up with artful ways to describe what happens – the sagging middle, muse-go-bye-bye, and worst of all—Writers Block

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

.

The problem, as I see it, is far simpler and less traumatic than those phrases make it out to be.

Writers frequently sit down to write because

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

we had a great idea for a story. In actuality, what we had was a great idea for a scene. We rush to our keyboards or paper frantic to begin the p

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

Combination pro

rocess. After you’ve expended all your energy on the brilliant scene you realize, you have to tie that scene to a beginning and an end.

My friend

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 a scene does not a story make.

At this point is where the real work of being a writer begins. Anyone can create a scene, only writers know how

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

to craft those few ideas into a masterpiece.

When you reach the “I’m stuck” place, ask yourself these questions:

• Do I know where to begin?

• D

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

o I know where to end?

• Do I have one great climactic scene to anchor all the others?

• Do I have several smaller climax scenes leading to the b

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

ig scene?

My guess is the answer to at least one of the questions will be, no. In addition, I bet the question most frequently creating obstacles

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

is the last.

We know we have to open by introducing the characters in their natural habitat. We know we have to wrap everything up at the end.

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

Following aspects would a

The huge crisis scene is what set us off on this adventure in the first place. What’s left are the foothills leading to the mountain.

The foothil

dd to the challenges in developing combination products:

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

ls are the trickiest because they have to do with A) motivation—what drove the person who kills twelve people in the final spectacular scene to tha

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

t point? (which is usually straight forward) and B) conflict—this seems to be the hardest. After all, you’ve spent a lot of time giving birth to

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

these characters, and making them decent people. Then you have to torment them. What kind of a monster are you?

It’s okay. It’s your job to tor

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

ment your characters, and their job to suffer.

If plot is a four-letter word to you, then mull over the dilemma, let it simmer until you know all

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

Professional from academic institutions, pharmaceutical industries, health care indust

the scenes that build your story. If you’re a plotter, send your charting skills into high-gear, and map out what you need to do to get from a to

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

b to c.

Whether your process is organic or mechanical, don’t force the answers. If you do, the results will ultimately be stale and predictable.

.

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

Take your time and wait for the answers to come.

Getting stuck happens, but we don’t have to treat it like it’s the end of the world. Instead, r

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

Companies that provide selfless information through particip

edefine being stuck as not yet ready to create, or an opportunity to dig deeper and discover you’re not in a dry well but a mineshaft full of gold.

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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