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Did you take some time this past week to think about and perhaps even write down your resolutions for 2007?

To be honest, I'm not exactly a fan of resolutions - really, what's so differ

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

ent about December 31 than January 1 that's going to make a dramatic difference in whether or not you keep your resolutions? If you just have a list of things you'd like to accomplish, w

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

Examples of combination products may in

ll, the answer is 'not much'. But if you have a PLAN to go along with your list, well, that can make ALL the difference.

What I've done for the past several years, as part of a much lar

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

er strategic planning process, is create what I call My Simple Business Plan. It includes just 4 goals that I want to achieve in my business within the next year. I review the previous y

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

ear's goals before setting down the next set for the upcoming year, and what I've found from doing this process over and over is this: I've reached AT LEAST those 4 goals within the year

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

Combination pro

(and usually qutie a few more). How? Because those were the ones I created a plan around to achieve.

So even though 4 goals may not seem like a lot, if it's 4 more than you usually reac

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

, wouldn't that feel great? :)

This year, instead of creating resolutions for your business, try the following steps to create your own Simple Business Plan:

1. Create your 1 year visi

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

on

One of my favorite exercises is creating a vivid vision of what I want my life to look like over the next year. I include anything and everything I can think of, letting my imaginati

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

n run wild while my fingers try to keep up with my mind.

If you've done this or a similar exercise before, review what you've written previously. Acknowledge the progress you've made, 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

t don't get stuck on the goals you didn't reach either. Move forward with your new or revised goals for the future.

2. Choose a theme

Usually from the 1-year vision exercise, a theme w

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

ll immerge about what seems most right to focus on over the next year. It may be finances, relationship-building, or a specific piece of my marketing efforts that I want to implement or

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

Following aspects would a

increase.

3. Choose 4 goals to focus on within that theme

Choose one goal that follows the overarching theme of your year to work on each quarter. For example, if your theme is 'increa

dd to the challenges in developing combination products:

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

e market reach', your first quarter goal may be to get exposure in a media outlet you haven't tapped yet. Your second quarter goal may be to develop 3 new strategic alliances.

4. Break

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

own each Quarterly Goal into monthly, weekly and daily tasks

Now that you know what you want to focus on each quarter, figure out what you need to do each month, week and day of that qu

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

arter to reach your goal. Then write down those tasks in your planner.

This step is huge - and it's also the step that most people skip. But I promise if you set aside the time to do 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

s, you will reap the rewards. Doing this will almost effortlessly PULL you forward towards reaching your goals.

5. Get support

As entrepreneurs, we have a tendency to want to go-it-alo

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

Professional from academic institutions, pharmaceutical industries, health care indust

e. But nothing will increase the likelihood of actually reaching your goals more quickly and easily than if you have someone else holding you accountable.

Buddy up with a colleague, or

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

hire a coach, to keep you on track and moving forward. Check in at least once a week to ensure forward progress. And don't forget to celebrate your victories, whether they be big or smal

.

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

, along the way.

I know this sound simple, but for some reason, we have a tendency to make everything much more difficult than it needs to be. If you follow the 5 steps I've given you,

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

Companies that provide selfless information through particip

hen this time comes next year, you'll be astounded that you actually reached, at the very least, your 4 goals of your Simple Business Plan.

© 2006 Alicia M Forest and ClientAbundance.co

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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Come on, don't deny it; we've all said that at one time or another (yes, under your breath still counts).

It's never too late to start a business, career, life or relationship journal. You would be amazed at the results it can help you achieve.

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