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We’re approaching that wonderful once-a-year “Turkey Day”!

For me, Turkey Day memories revolve around going to the football game between The University of Texas Longhorns (yea!

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

) and the Texas A &M Aggies (boo!).

Because that game was traditionally on Thanksgiving Day, my family wouldn’t have the turkey and dressing meal but would opt for roast beef

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

Examples of combination products may in

sandwiches and potato chips eaten out of the trunk of the car in our version of a tail-gater. I love those memories! And I still love watching my Longhorns beat up on those Ag

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

gies! (Hook’em Horns!)

However, I now realize that there is something more important about this holiday than turkey and football. It is, after all, called THANKSgiving

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

! Let’s look at “thanks” a little more closely this year.

I believe that living with a thankful heart is the first step towards living a truly joyful life. It isn’t always

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

Combination pro

easy to be thankful. Sometimes real life presents challenges, hard times, trials, and circumstances for which an average person would never consider being thankful! However,

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

since you are NOT average, I believe you will appreciate this view of “thanks.”

T – “THINK”

Renew your mind. Be intentional about what direction you allow your thought

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

s to take. Don’t drift into sin. Think like God. Ask God to transform your thinking. Plug good things into your thinking: scripture, inspirational reading, devotional books and

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

stories about people who have triumphed in all manner of circumstances.

H – “HORIZON”

Take the long term view. Remember there is always a bigger picture than what you’re

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

experiencing right now. Ask God to help you have that long term perspective – to see things from His vantage point. I love the description of life being like a parade. We are on

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

the street watching the parade go by and can only see what is immediately in front of us. God, however, is up high and can see the entire parade in one instant – beginning, middl

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

Following aspects would a

e and end – so He has the big picture, the 50,000 foot view!

A – “APPRECIATE”

Appreciate what you have. Train your mind to focus on the positives in your life – the thing

dd to the challenges in developing combination products:

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

s you have that are treasures to you. Too many times we allow ourselves to focus on what everyone else has that we don’t have. We can easily have a pity party, looking only at th

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

e things that are missing from our lives. That serves no purpose other than to drain our energy and our joy and turn us into crotchety, grumpy, negative people. How much better t

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

o CHOOSE to focus on the things we do have that are positive, those undeserved gifts and blessings.

N – “NOW”

Be where you are NOW in life. Enjoy it NOW. Be what God wan

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

ts you to be today. By continually looking for “what’s next”, we overlook opportunities for today. If you don’t live “now here” – you’ll be “nowhere”.

K – “KNOW”

Know wh

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

Professional from academic institutions, pharmaceutical industries, health care indust

at is important. If you imagine yourself on your death bed, what is that you would most wish for? I guarantee it would be your spouse, your kids, your grandkids, your loved ones.

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

By knowing what is most important each and every day, all those other things that want to vie for your attention will be shoved aside.

S – “SHARE”

We expect our kids to

.

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

“be nice and share”. How about us? By sharing what God gives us (both tangible and intangible), our grip loosens and we are set free.

Think. Horizon. Appreciate. Now. Know. S

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

Companies that provide selfless information through particip

hare. THANKS!

This applies all year ‘round, not just at Thanksgiving. Let’s use this Thanksgiving as an opportunity to turn over a “new leaf” of being thankful all year long

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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