Your Space - Self Improvement

Instead of focusing on what you don't have and making it a negative, leverage it. W

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

hat you don't have, can be just as much of an asset as what you do have if you posi

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

Examples of combination products may in

tion it right.

I graduated with my first two degrees from Regis University. Regis

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

is a Jesuit school dedicated to learners becoming leaders. In addition to stressing

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

education, the university promotes community and global responsibility. The school

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

Combination pro

has received many awards and has played host to such dignitaries as Pope John Paul

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

and the Dali Lama. Recently, the school has been running television ads touting the

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

ir achievements and their outstanding education experience. What is most interestin

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

about the commercials is that at the end the narrator adds, "And we did all of thi

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

s without a football team." Instead of making the fact that Regis doesn't have a fo

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

otball team a negative, they made it a positive.

At times perspective clients expr

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

Following aspects would a

ess a concern that I don't have experience in their line of work. When this occurs,

dd to the challenges in developing combination products:

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

I point out, "And isn't that great? I don't come with any perceived ideas and I don

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

't know how it is supposed to be. I start with a clean slate." I really do believe

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

that not knowing all the background and how things are supposed to run helps me be

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

objective, ask the questions that those who know wouldn't think to ask, and come wi

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

Professional from academic institutions, pharmaceutical industries, health care indust

h a beginner's mind. I leverage the fact that I don't know.

Don't think of what yo

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

u don't have as a negative. You can leverage it. What you don't have can actually b

.

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

e a strength since it will give you a different perspective. Also, positioning what

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

Companies that provide selfless information through particip

you don't have as a positive will boost your confidence and help to make you shine

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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Your Space - Leverage What You Don't Have

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