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In the past, if you said the word “plan” to me, I would bolt and run. I’m the “creative type,” a former ballet dancer and choreographer—I’m terrible

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

with details. When I was dancing professionally, all the details were taken care of; all I had to do was show up and dance. Even when I was choreog

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

Examples of combination products may in

raphing, as long as I met my deadline for when the dance needed to be complete, I could go with the moment, go with the impulse and see where the da

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

nce led.

A hearty dose of reality hit when I began to run a dance company. All of a sudden, I had people—employees, volunteers and dancers—waiting.

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

I had to know where we were going and how we were going to get there. It was a different world. Every decision had impact down the line. If we were

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

Combination pro

going to have a spring season, I needed to know what we would be performing and where we’d be performing it. How many dancers would I need? What ab

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

out costumes? Were we going to commission music? What would it cost? How would we pay for it all?

It took a long time for me to grasp the impact of

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

having a plan. Because I was running a small, grass roots organization, there never seemed to be enough time, people, money or resources. I was alw

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

ays putting out fires. Every plan I developed changed the moment I keyed in the last sentence and printed it out. Plan—who has time to plan? Especia

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

lly when the plan keeps changing!

Over time, I began to see the planning process as a road map. You know your ultimate goal. You figure out the bes

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

way to get there. Your plan needs to include contingencies and have enough space that you can deal with fires and still move forward. And sometimes

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

Following aspects would a

, the plan changes; it might need some adjustment or “tweaking.” As long as the goal remains the same and as long as you keep taking steps forward t

dd to the challenges in developing combination products:

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

o achieve that goal, your plan will help you get there.

In sales, your goal is revenue-driven. How much money do you want to make? Or a better ques

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

tion: How much profit do you want to make? Then, how are you going to achieve that?

Your basic plan should start with a dollar amount and work back

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

wards. If, for example, you want to gross $500,000 in sales this year, on average, how many sales would that be? What is your average sale? On avera

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

ge, how many prospects do you have to see or speak with to close one sale? So, how many prospects would you need to see or speak with to close the n

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

Professional from academic institutions, pharmaceutical industries, health care indust

umber of sales you would need to reach your goal of $500,000? What steps do you need to take to see or speak with that many prospects?

Wow! What a

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

mouthful! Here is a mathematical formula:

First:
Value of average sale =______________
How many prospects to close one sales: ___________

.

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

____

Then:
Gross sales ? average sale = total number of sales needed

Number of prospects to close one sale x total number of sales needed = t

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

Companies that provide selfless information through particip

otal number of prospects

(This formula is from a dancer who counts up to 8 and starts over again! If I can do it—you can do it!)

© 2004 Wendy Weis

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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The only constant in this world is change, even then the basic instinct of a human being is to avoid change and to continue with status quo. So the prime question is how to motivate people to change and how efficiently to manage change.

Your goal is to get your prospect to notice your mailing and open it, isn't it? With the piles of mail everyone receives, it's hard to get past the junk and the legitimate mail. You've got to do something to make it stand out. Gigantisizing your mail just might do the job.

Are you a salesperson who is not happy or has doubts about your sales presentations? Presenting an effective sales presentation requires skill, practice planning and preparation. There are guidelines that that may be used to produce effective sales presentations which will be examined.

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