Advice You - Business

Do you have a dream or vision for your business or organization? Do you have a personal dream or vision? How many dreams or visio

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

ns have you had in your life that you did not act upon? How many did you pursue? And what happened? If you have a dream or vision

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

Examples of combination products may in

now, do you know how to turn that dream and/or vision into reality?

In my multi-disciplinary multi-faceted professional service

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

s practice, I deal with dreams and visions of clients as a facilitator, guide and coach. I love my work, especially when it invol

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

ves helping people achieve their dreams and vision. I want to believe that you do have dreams and vision and so I want to share s

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

Combination pro

ome thoughts with you about how to turn them into reality.

First and foremost, you need to define your dream or vision. Write it

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

down on paper.

Second, you must develop a plan that will fulfill your dream or vision. We can refer to this plan as a Strategic

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

Plan for business or a Personal Strategic Plan. The plan will include a vision statement, a mission statement, a set of core val

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

ues or guiding principles and a list of short & long term goals that all relate back to the vision.

Third, you must create an ac

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

tion plan and we will call this your Strategic Action Plan for business or your Personal Strategic Action Plan. This plan will ta

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

ke the goals you defined in the second step and break each of those goals into doable and manageable tasks. Each of those tasks w

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

Following aspects would a

ill have a timeline and due date.

Fourth, you must commit to your Strategic Action Plan and hold yourself and others accountable

dd to the challenges in developing combination products:

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

for what is promised to be done. And you must look for the lessons learned from your successes and failures.

Fifth, you need to

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

celebrate your successes and communicate that success.

Sixth, you must remember the following tips to help you through all the

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

steps above.

+ overcome any fear of failure

+ focus on your goals, not the obstacles to the goals

+ be passionate

+ communica

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

te effectively and often

+ take positive risks + stay motivated

+ seek advice and recruit a coach or mentor

The truth is that

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

Professional from academic institutions, pharmaceutical industries, health care indust

YOU make the choice about taking action to turn dreams & vision into reality. Will you follow the steps outlined above or forget

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

them and leave them behind on this page or screen? Or will you “Go For It” and decide to actually follow the steps and take the a

.

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

dvice to turn your dream and/or vision into reality. The choice is yours! If you want to learn more about how to turn dreams and

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

Companies that provide selfless information through particip

visions into reality, please contact Glenn Ebersole through his website at www.businesscoach4u.com or by email at jgeprman@aol.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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Nowadays however we do have a choice, the Internet. And people, you, me and the guy around the corner, having been treated for so long as mere eyeballs, are moving to the Internet in our millions. We have no loyalty whatsoever to the Old Media, who, together with their handmaidens, The Advertising Agencies, have treated us with contempt, as nothing more than demographics, dehumanising and depersonalising us in their rush to get their hands on all those lovely advertising big bucks!

Not only does a Mastermind group support you with encouragement - you will receive different ideas that have worked with other business people, you'll develop strategic partners and even get sales faster.

How to Sell to High Tech Solutions Many companies are looking to improve upon the speed, security, and accessibility of business technologies, especially satellite and broadband connections to the in...

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Advice You - How to Go From Dreams & Vision to Reality

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