Advice You - Business

Many individuals and that includes organizations which are just groups of individuals united to achieve

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

specific goals continually seek new answers to this centuries old question: How do I change?

With to

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

Examples of combination products may in

ay's generation having more change in one year than their grandparent's experienced in their entire lif

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

etime, learning how to deal with change is critical to personal and organizational success. This is cal

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

ed change management. Yet, change is still a challenge even for those who think that they have open mi

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

Combination pro

nds.

For example, can you explain the logic of these numbers?

8 5 4 9 7 6 3 2 0

What is going throug

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

your mind? Are you adding, subtracting, multiplying to determine the logical sequence? As a business

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

coach and change management consultant, this is one of most favorite activities that I use with my cli

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

nts from young people to executive board members.

What this activity quickly demonstrates is that the

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

paradigms we use to solve problems with an an individual or as an ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

ocessspecialist.com/organizations.htm">organization force us in some cases to expend a lot of energ

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

Following aspects would a

y as well as emotions without a satisfactory answer. However, when we change how we see things, the th

dd to the challenges in developing combination products:

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

ngs we look at will change.

This change happens because we have changed within ourselves. Outside forc

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

es from motivational speakers to the newest video such as The Secret only provide opportunities

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

o see things differently.

Since we are the way we are because of years of experiences that have furthe

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

r solidify our foundational belief systems, we should not expect change to happen overnight. Change ta

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

Professional from academic institutions, pharmaceutical industries, health care indust

es time just like reading a positive affirmation statement or what I call a belief statement. When tho

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

se written statements are read out loud, heard and felt at least three times each day, we can begin to

.

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

witch our negative beliefs or attitudes for positive ones. Remember, first, we must be the change that

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

Companies that provide selfless information through particip

we are seeking.

P.S. If you cannot answer the above question, just send me an email or give me a call

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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Without a plan to distribute your cards, there's no need to print them in the first place.

It is important to have a goal. Without a goal you will never move forward. However, that goal needs to be the right goal. Your goal should be to have a rewarding career that matches your life’s purpose; not a particular job description.

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Advice You - Change Begins from Within Through Paradigm Shifts to Your Belief System

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