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“Too often the great decisions are originated and given form in bodies made up wholly of men, or so completely dominated by them that whatever of special value wome

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

n have to offer is shunted aside without expression.” Eleanor Roosevelt

After dealing with crazy people in your organization, and the demands of customer

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

Examples of combination products may in

s, you may wonder if leadership is worth the trouble. Leader, leadership is a journey. Let’s explore one life-changing experience for me. As you may understand from my

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

columns, I am a research junkie. It fires me up! Too much information is not good, however. For example, one co-worker raved about a new research tool; however, some i

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

ndividuals were spending several hours using it. Isn’t technology wonderful? It’s an outstanding resource, but I found it unhelpful for me at this stage. I have gotte

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

Combination pro

n information overload during major projects. As a result of this information saturation, I then simplified my approach in conducting my research. I now use some basic

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

research tools. I’ve learned that having information isn’t enough to excel in my leadership journey. Albert Einstein once said, “Information is not knowledge.” From th

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

is experience, I learned that effective leaders are flexible.

Let’s explore another life-changing experience. It’s recognizing that I don’t know—about me and my path

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

forward. Do you know your path, Leader? Going through this leadership journey has challenged my vision. What if your abilities were designed for another purpose? Are y

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

u then making the right decisions for your life? These thoughts can generate anxiety and fear because you are now facing the unknown. Like the biblical figure Moses, y

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

ou may be only sojourning in Pharaoh’s court for a short time for training; however, you won’t ever become a royal prince or princess in Pharaoh’s court. Not knowing w

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

Following aspects would a

hat I am becoming is a frustration. Are you frustrated also? Nevertheless, you must run this leadership race with confidence because this is your mission. Do you know

dd to the challenges in developing combination products:

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

your leadership mission? I Corinthian 9:24 reads, “Do you not know that in a race all the runners run, but only one gets the prize? Run in such a way as to get the p

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

rize.”

Finally, leaders should not be side-tracked with minor issues in their organizations. What is the most important reason you are leading? Do you feel you are di

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

vinely called to lead or just holding a place in your organization? Those are important questions to consider if you are going to be effective. If you are divinely cal

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

ed to serve, you will also be equipped divinely to lead. Psalm 121:1, 2 reads, “I will lift up my eyes to the hills—From whence comes my help? My help comes from the L

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

Professional from academic institutions, pharmaceutical industries, health care indust

ORD, Who made heaven and earth.” With that said, let this growth process continue. In summary, run your own leadership race with confidence. Run this race to win bec

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

ause you are divinely called to lead. Are you running like a winner in front or you lagging behind? You should know this fact, Leader! Plan ahead. Prepare yourself f

.

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

r life’s obstacles. Run the race with a sense of urgency and purpose. Start today!

Reference:

Brain Quote (2005). Received on November 15, 2005 from elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

" href="http://www.brainyquote.com/quotes/authors/a/albert_einstein.html">http://www.brainyquote.com/quotes/authors/a/albert_einstein.html

© 2006 by Daryl D. Gree

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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When you are in the process of creating information products, the more you write, the easier it becomes. I can literally sit down some days and crank out 15,000 words – and when I first started, it was tough to do much more than a few thousand. What is the difference? It just gets easier with time – not just in the creative department, but in the discipline department.

Should people who want to buy property think of investing in foreclosed assets? Yes because most of these have clear titles and ownership rights, which saves time in doing the research. Another benefit is the fact that most of the foreclosed property is sold 10 to 20% off the current market value. It is like buying a 2006 Nissan Altima that was only used for less than 3 months.

How many break-ups also result in feelings of guilt amongst partners? Please take care of guilt before you break-up. Guilt can be a very damaging feeling and can make any life hell. Those who are full of guilt undergo lot of pain asking for forgiveness everywhere, but fail to forgive themselves.

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