Summary - Relationships

“He wear no shoeshine he got toe-jam football….He got monkey finger… he shoot coca-cola…He say "I know you, you know me…."

Paul McCartne

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

y just turned 64 and he probably deserves my sincere apology for the lead-in but sometimes when I think about “community” the Beatles’ “C

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

Examples of combination products may in

me Together” plays in my brain.

To some “community” is a relatively large geographical location: the town or village where we live. To o

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

thers it’s a much smaller place where we live with others—perhaps a nursing home, assisted living site or a monastery. Regardless, commu

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

ity has to do with how we relate to those around us. There are five elements that—taken from the Buddhist definition of “sanga”—make sen

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

Combination pro

e to me as they relate to any community.

First is “commitment.” In this sense it involves examining the life we lead without the filters

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

of ego, wealth, fame, knowledge, and position. It refers to the way we are with one another; being versus having. Next is “surrender,”

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

which in this context has to do with embracing the truth about every day life. When we surrender in this way we spend less energy denyin

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

when things are not going so well while at the same time becoming more grateful and open to celebration of “the good stuff” of life. In

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

fact, we are more open to all of it -- the unknown.

The third idea on my list is “serving.” This is the concept that encourages us to do

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

what needs to be done right now and not leave any traces. It allows me to set aside my likes and dislikes and to do the dishes or pick u

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

Following aspects would a

trash beside the road with care. In this frame of mind, it’s not ‘unfair’ – it just is. Next is acceptance and harmony: an effort to a

dd to the challenges in developing combination products:

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

ccept all folks as they are and try to build trust with another human -- especially the ones who rub me the wrong way. There are experi

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

nces that are common to all of us and my community-building skills are better when I consciously look for them.

The fifth and final comp

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

nent of that Buddhist definition of “community” is “humanity and respect.” With this in mind we are asked to give up the idea of being “

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

better-equal-lesser” than another. We are human beings and can respect one another on that level, even if on no other.

I offer this as

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

Professional from academic institutions, pharmaceutical industries, health care indust

nother way to think about the ways in which each of us relates to those around us. Connections feel better than walls. In addition, whil

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

I think that, on some level, each of us is extraordinary in our own way it is important for me to remember that our “ordinariness” can 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 equally lovely. It is a reassuring thought that makes me feel connected to something bigger even when my image, status or well being f

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

Companies that provide selfless information through particip

els threatened. And that’s freedom. Thanks, Paul.

“….One thing I can tell you is you got to be free. Come together right now over me.

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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