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It was the fall of 1998 when I had just started my first business as a marketing communications writer. Most of my clients hired me for newsletters, brochures, and sal

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

es materials, but I would get the occasional request for something different. At the time I was too naive to consider saying "no" to any project that didn't fit me per

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

Examples of combination products may in

fectly.

A perfect example of this was when a colleague named Chip asked if I could write a short script for a customer service training video. "Wow," I said. "Video!

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

hat sounds like fun. Sure thing. I'll take it on!"

Big mistake.

Sure, at first it seemed exciting. But after I got into it, I was miserable. Not only did I sp

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

end three times as many hours as I'd planned JUST on figuring out what they wanted, but I honestly didn't know what I was doing. I'd never written a video script in my

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

Combination pro

life! I thought it would be simple, but it was a whole other world.

This thing not only sucked up all my time, taking me away from my best clients, but it also draine

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 my energy and my confidence. I felt sick every time I looked at that project folder. I lost sleep worrying that I wasn't doing a good job on it, and worst of all, my

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

fears were confirmed...

One day Chip left a message on my answering machine that MORE major revisions were needed. Then, it sounded like he hung up the phone, because

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

there was a soft click. But then I heard him start to talk about me with his partner (obviously unaware that his speaker-phone was still on).

At first I stopped the

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

essage from playing, because I knew I was not supposed to be privy to this conversation. But I wanted to know the truth, so I listened. My heart sank as I heard things

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

like, "This writer doesn't know what she's doing on this... we should have hired a real video writer... I feel bad she's trying so hard, but this isn't getting better

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

Following aspects would a

."

I got so ANGRY!

Not at Chip, but at myself.

Here I was... an award-winning writer for marketing communications. Marketing communications! That mean

dd to the challenges in developing combination products:

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

marketing materials. NOT training videos!

So why had I taken on that project?

My good friend Melanie Strick, "The Entrepreneur's Success Coach", calls this

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

"bright, shiny object syndrome", and it happens to many entrepreneurs. You see, we love ideas! We enjoy moving from idea to idea, and it's easy to get distracted by so

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

ething that seems new and exciting.

Especially when you start experiencing success, it's as if every opportunity in the world starts falling in your lap. You have to

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

become a master of saying "no". That was very hard for me.

But by sticking with what you KNOW you are good at, you are always confident and calm in your work. You

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

Professional from academic institutions, pharmaceutical industries, health care indust

now how to market yourself, and you know who you're marketing to!

I've become so clear now at what I'm amazing at, what I offer, who I'm marketing to, and how I w

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

ant my life to look like, that any business or life decision is crystal clear. I know exactly what to say "no" to.

(And they say for every "no" you give, a better "ye

.

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

" comes along!)

So today, make a list of what you are good at, what you're confident in doing, what you want to do, and who you do it for. And then practice saying, "

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

Companies that provide selfless information through particip

No!" to anything else.

You'll find that your marketing and your business will magically become easier, more enjoyable, and more successful!

© 2005 Alexandria K. Brow

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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So you've graduated from college. Congratulations, that's no small feat. Now it's time to roll out the resume and dive headfirst into the job market. Chances are you'll endure your share of interviews and meet a few nice and not-so-nice people along the way before you get that first job offer.

From major-league pitcher to launching a business magazine, Bob Meyer's enthusiasm has made the transition seem effortless. His niche publication, BarterNews, has become an interesting and valuable source for businesses interested in trading and barter.

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