Useful Articles - Relationships

Expectations, Part 2

Does how you behave depend on how others behave? Are you reactive?

Answer the following questions?

1. Is “s

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

hould” part of your vocabulary or your criteria in decision making?
2. Do you do things for others because you have to?
3.

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

Examples of combination products may in

Can somebody else’s bad mood bring you down?
4. Do you seek approval from others before moving forward?
5. When someone y

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

ells at you , do you automatically yell back?

If you answered yes to any of those questions, you are reactive. The more numerous t

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

he yeses, the more frequently reactive behavior occurs, which means the more expectations you have placed upon yourself and others.

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

Combination pro

Most people believe they are making choices when they are really reacting. Who we are is not defined by others, therefore our acti

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

ons must be made from of our own wisdom not from reacting to each other.

“Without clear communication and an authentic commitment t

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

o personal accountability, no one has a chance.”

When we expect something from someone else but never express that expectation, you

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

are asking the other person to be a mind reader. Many times we wave a banner that says, “If you loved me you would know.” Every ti

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

me you expect a certain reaction or behavior from someone you are constructing a silent contract. Pick 3 of the closest people to y

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

u and examine your relationships. Eliminate all silent contracts you have with these people and begin to interact with them based o

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

Following aspects would a

n what you both have agreed upon. You will be amazed at the positive improvement. If you are an expert at silent contracts, seek t

dd to the challenges in developing combination products:

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

he support of a coach to help you remove the expectations you secretly have of others (and probably yourself!) and you will find you

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

spend less time being disappointed and more time enjoying your life!

Make it year to remember! 2007 is just around the corner, wh

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

at are your hopes and dreams for next year?

January is the perfect time to hire a life coach. Search the web, ask your friends or

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

take a few coaches for a test drive by arranging a free session. Most of us offer free, no strings coaching sessions and it is the

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

Professional from academic institutions, pharmaceutical industries, health care indust

only way to ensure a good fit between coach and client. We all need support and yours is just a phone call away. Look forward 6 mo

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

nths…. If nothing changes in your life will you be thrilled with the results? If you look forward and find yourself wishing, wanti

.

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

ng more……take action and make it happen! You will be amazed at how much can change in a few months. You know those changes you hav

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

Companies that provide selfless information through particip

e longed to make, you can do it! I believe in you! It is time to invest in yourself.

Wishing you a wonderful year full of success

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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