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Suzanne was accustomed to sweaty palms. Getting established on the speaker circuit, she hadn’t yet moved beyond stage fright. On one occasion, however, she was delighted to find her palms dry! What was the secret? Talking it over with her coach, she saw that her

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

topic, and this particular audience, was precisely in line with her vision of her purpose, the reply to “why I’m here”. She had been true to her professional mission statement. The experience of being aligned in this way apparently left no room for self-conscious

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

Examples of combination products may in

ess or fear of rejection.

Like Suzanne, taking the time to think about your answer to why you’re here on the planet – to articulate your mission statement – will serve you in many ways.

Being in alignment
As was true for Suzanne, when you’re doing a piece of

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

ork that’s in accordance with your mission, you may find you have such heartfelt connection with what you’re saying and the people you’re speaking to, that there is no room for self-consciousness or performance anxiety.

Wellspring of energy and inspiration
If

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

ou’re in the midst of a career search, a mission statement reminds you of the wellspring from which you draw energy and inspiration to find or create the work that’s right for you. It links together those times in your life when you’ve felt most vital and “on purp

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

Combination pro

se”, restoring you in times of confusion or discouragement.

Guidance for decision-making
In practical terms, a mission statement will guide and corroborate your process of decision-making. Like the North Star, it’s a point of reference as you move through th

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

stages of your search, helping prioritize the factors on your “want” list and sort through opportunities as they appear. It will support you in resisting what’s easy in favor of what’s important.

The format of a mission statement
A mission statement contains

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

three elements: What is my purpose? Why, or to have what impact? On whom? (Individuals? Groups?)

It completes this sentence: “I am here to _________ so that _____________ for _______________” .

Examples: “I am here to promote justice so that there will be g

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

eater economic opportunity for the disenfranchised.” The first phrase, “to serve justice”, refers to the “what”. It may represent a top priority in this person’s life, a value, or a calling. It can have an action orientation (“promote justice”) or a feeling orien

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

ation (“I am here to inspire leaders…”). The “why”, or “so that” phrase refers to why it matters, or to the impact that action or quality will have. In the example, “I am here to inspire leaders to bring out the best in people”, the impact is implied rather than

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

tated: “…so that people contribute their best.”

Creating a mission statement
To arrive at a mission statement that’s empowering requires that you commit time to creating it. People often find it useful to actually schedule some personal retreat time, leaving

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

Following aspects would a

he familiar daily obligations and distractions for a day or two. Once away you might prepare for the writing phase by taking a walk, doing some inspirational reading, or sitting quietly for a period, inviting the left brain or intuitive part of yourself to join in

dd to the challenges in developing combination products:

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

Reflect on what matters most to you. What do you want to contribute? What will bring you fulfillment to leave behind, at the end of your life? What do you most want to be remembered for? The more specific you can be, the better the statement can guide you. E

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

en if you start with generalities now – “I want to help people” – you will be able to make them more specific over time. In giving thought to what impact you want to have, and on whom, it’s often helpful to start by ruling out certain groups. You may know, for in

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

tance, that you don’t want to help people with terminal illnesses, or people who can afford to pay high prices for help.

Just remember you don’t have to “do it right” immediately. Once you’ve started, creating a mission statement may take on its own momentum, so t

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

at you find yourself thinking about it unexpectedly, or recognizing elements that should be included in decisions you make.

A word to the modest:
Here’s an important caution for those of you who are shy about THINKING BIG about yourselves. What you’re here f

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

Professional from academic institutions, pharmaceutical industries, health care indust

r is big! In one sense, it’s all there is. But it’s also not a solo endeavor. Whatever your purpose is, you’re standing on the shoulders of some who have gone before you, and you’re preparing the way for those who follow. So beware of false humility, and beware

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

of those pessimistic inner voices that say you’re being grandiose. William James has given us a fitting definition of a hero: someone who acts as if what he or she does makes a difference. Your mission statement is your claim to heroism. Be bold!

2005 © Nina Ham

.

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

All rights reserved.

Nina Ham, certified coach and licensed psychotherapist, has created Success and Me: A Game of Self Discovery™. The Game™ is a facilitated group process, lively and down-to-earth, that guides players in creating personal success visions to ser

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

Companies that provide selfless information through particip

e as a compass for navigating life’s complexities and challenges. To learn more, go to www.SuccessandMeGame.com. Or subscribe to her free e-zine for articles and tips on creating sustainable success in career or business, www.SuccessfromtheInsideOut.com/library.htm

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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