Advice Pool - Relationships

Sometimes we go through life missing very important information. It is as though we see things, but in only two dimensions. The good stuff happens when we capture more as in The M

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

agic Eye artwork that from the surface seems to be a series of repetitive patterns, but when we softly focus and look through it, we discover a three dimensional picture that surp

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

Examples of combination products may in

rises and intrigues us. It seems that the same happens in relationships. We talk and listen from only two dimensions, but when we hear from the third dimension suddenly magic awar

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

eness occurs to carry us to deeper and more meaningful connectedness.

Just last night we were having an argument about making a phone call in the middle of something important. I

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

became angry and blurted accusations and as I heard myself, suddenly moved closer to the real source of upset. By then we were both defensive and I withdrew into my world of awar

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

Combination pro

eness afraid to share what was really happening for fear of appearing even crazier than I thought I was. It took all night to sort things out, but in the end I had to face that th

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

ird dimension that we all have--the place of vulnerability and fear, shame and doubt, isolation and uselessness. By the next morning, I could talk a little about it, but still fel

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

t unsafe as we tiptoed and danced around much of it. Not having much time for lengthy listening, the two-step was about all we could accomplish and then touch base by phone regula

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

rly just to say, "I love you."

Having had more time to sort through my thoughts and feelings, I realize that the anger and accusations were a cover--a repetitive pattern--to hide

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

the deeper meaning of the upset. It is much scarier to say how small and insignificant I felt at that moment of abandonment when the phone call was made; how disconnected and uni

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

portant and jealous I was that the phone call was more important than I was at that moment. Not to mention how many other times in my life I had to face aloneness, and why this pe

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

Following aspects would a

rson that had to be called at that moment could not face her own aloneness too. I had to survive without much support more times than I want to admit. The anger was strong. What c

dd to the challenges in developing combination products:

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

arried me through the muck and mire of it all was a fact that I share with people several times a week: when our negative emotions are very strong, we need to look inside for our

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

own truth--the anger may not be what it appears to be on the surface. Indeed, it was not. UGH. I hate having to practice what I preach, but there I was looking at my own stuff, ha

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

ving to confess, and afraid to confess at the same time. It is much easier to look mad or better yet self sufficient than it is to look honestly scared.

There I was and here I am

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

to write about my own weakness. Did I hate having to admit it? Yes. Was it tense and scary? Yes. Did it take courage I did not want to generate? Yes. So, I do have to practice wh

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

Professional from academic institutions, pharmaceutical industries, health care indust

at I preach as painful as it is sometimes. But I would rather see all the dimensions of the picture than hide in the space of the mundane and repetitious. So I enjoy a Magic Eye m

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

oment and breathe in the satisfaction of facing the ugliness inside, trusting that it is all our dimensions that make us and without them we are robots--patterns of predictable be

.

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

havior. No surprises and no richness. I hear the words of Johnny Nash in my ears: "I can see clearly now, the rain is gone, I can see all obstacles in my way. Gone are the dark cl

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

Companies that provide selfless information through particip

ouds that had me blind...all of the bad feelings have disappeared...Here is the rainbow I've been praying for." For magic eyes, ears that hear, and rainbows, I am forever grateful

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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