E-Articles - Relationships

Givers in relationships are always looking for ways to help, support, give and be a benefit to their partners. They give becau

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

se it is in their nature to be generous, kind, giving or supportive.

Takers on the other hand always take - stuff, help, suppo

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

Examples of combination products may in

t, kind acts, recognition etc. They take because it is their nature to do so. Now lets put a taker in a relationship with a gi

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

er.

Givers need a taker to give to, so they tend to attract them into their life. And, takers need a giver in their relationsh

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

ip so they too tend to attract givers. This is where the problems begin for both parties in this type of a relationship. (Ple

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

Combination pro

se keep in mind that these relationships can work, they just take a lot of work)

The givers give and give and give and the tak

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

rs take and take and take. So what’s the problem? Well, after a while the givers begin to resent the takers for never giving s

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

omething, anything back and the takers also begin to resent the givers for always giving. Both parties will deal with their pe

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

sonal agendas in different ways, but the outcomes are the same. Anger, resentment, feeling taken advantage of, and often guilt

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

yes the taker will feel guilt, but for different reasons than the giver. Are you in a relationship with your opposite? Are 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 the giver or the taker? What can you do to ensure your relationship doesn’t escalate in a negative fashion? Here a few poin

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

Following aspects would a

ters.

If you are a giver:

1) Give to yourself sometimes more than your partner.

2) When you do give to him/her, do it withou

dd to the challenges in developing combination products:

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

an expectation for any type of return even a thank you.

3) Manage you expectations more honestly.

4) Learn to accept you par

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

ner for who he/she is.

5) Rise above the emotional game playing of who is giving or getting more.

6) Learn to handle taking b

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

etter.

7) Recognize that your taking partner needs you to give to them.

If you are a taker:

1) Recognize that sooner or late

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

you will begin to resent your giving partner.

2) Learn to be verbally appreciative of the giving your partner does.

3) Try t

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

Professional from academic institutions, pharmaceutical industries, health care indust

give once in a while, and don’t expect a big brass band when you do.

4) Recognize that your giving partner wants and/or needs

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

to be able to give.

5) Try little acts of thoughtfulness or kindness more often.

6) Don’t expect anything from your partner,

.

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

and when they give it see it as a real gift of themselves they are sharing.

Givers and takers are not right or wrong, it is ju

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

Companies that provide selfless information through particip

t the way they are. They can change if they choose to. So which are you? Is your partner like you or opposite in this regard

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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E-Articles - Are You A Giver Or A Taker?

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