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I have been a member of the Santa Clarita, California Rotary Club for six months now. They recently held a contest where students wrote essays about the person in their

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

life that lives by the Rotary Club’s Four-Way Test. As I listened to the winning essays being read at our meeting I thought about the way that I live my life and if I al

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

Examples of combination products may in

ways meet the Four-Way Test myself.

The Rotary Club’s Four-Way Test

Is it the TRUTH? – This one seems easy enough. If you tell the truth all the time you have

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

met the test. I thought about myself on this one. I can honestly say that I always tell the truth. It isn’t easy sometimes because you have to be careful about hurting s

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

omeone’s feelings. But I have learned to be kind and gentle with people so that I can be honest with them. When I used to teach school I always told my students that the

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

Combination pro

had to be honest with me. I told them that if they did something wrong I would fight for them but only if they told the truth. If they lied about what happened and I st

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

ood up for them, that would just make us both look bad. Telling the truth is always the best thing to do.

Is it FAIR to all concerned? – You have to look at a si

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

tuation from other people’s point of view to answer this one. If even one person will be affected in an unfair way then you cannot do what you had planned. Take another

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

look at what is happening and see if you can make it fair for everyone. If you can’t, then don’t do it. I thought about my real estate transactions over the years. There

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

were many deals that I could have made but someone would have been dealt with in an unfair way. I always passed on those transactions because I didn’t want even one oth

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

r person to feel like they had not been treated in a fair manner.

Will it build GOODWILL and BETTER FRIENDSHIPS? – Life is short and we only have an unknown amou

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

Following aspects would a

nt of time to help others. This one is part of the reason I joined the Rotary Club to begin with. I wanted to bring people together who could achieve greatness if given

dd to the challenges in developing combination products:

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

the chance. Every time I bring a guest to lunch or talk about Rotary out in my community I am building Goodwill and better friendships between people. This part of the t

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

est is my favorite part and gives me the greatest pleasure when I work towards it as a goal in my life.

Will it be BENEFICIAL to all concerned? – I had to think

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

about this one for awhile. How is it different from #2, being fair to all concerned? The way I look at it is like this: If you have 5 pounds of garbage and you give each

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

of 5 people one pound, it is fair to all concerned. But to make it beneficial to all concerned you have to have something that will have value to each person. I went to

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

Professional from academic institutions, pharmaceutical industries, health care indust

a Warrior Camp last summer. I learned there not to ask "Who has what I need?", but instead to ask "Who needs what I have?" The difference is huge. We spend our lives acc

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

umulating things that we want but don’t necessarily need. If we spent our lives finding people who need what we have then it is beneficial to all concerned and meets the

.

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

Four-Way Test. Being a Rotarian is part of who I am now. Our memberships run from year to year, but like one of our club members said to me, Why would anyone

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

Companies that provide selfless information through particip

ever quit after they became a member? I agree with him. Rotary is for life and the Four-Way Test is a way to gage if you are living your life to Rotary’s high standards

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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