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My wife and I were married last summer in a beautiful gazebo ceremony followed by an elegant reception. Close to two hundred guests attended. Everything was perfect. The we

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

ather was immaculate - breezy and comfortable. The gazebo setting was beautiful. The catering service was impeccable. And everyone was in good spirits.

Surprisingly I wasn

; 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 even nervous. I was excited and happy and felt confident throughout the entire ceremony. I knew I was marrying a great woman and had no reservations about it.

After the

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

ceremony my wife and I were reintroduced to the guests in the reception hall, danced our first dance, and settled in for what promised to be a night of celebration and fun.

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

As the waiter poured my glass of champagne I felt my first pang of nervousness. I realized it was time for the maid of honor and best man to give their speeches. You see t

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

Combination pro

he best man, Jason, is a great friend - he's very intelligent, strong willed, and a whiz with computers. However, a good writer and public speaker he is not.

To make matte

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

s worse the maid of honor was my wife's best friend - a doctoral student, a teacher, and wonderful at speaking in public. I didn't want Jason to be outclassed and embarrass

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

ed by the maid of honor. I was nervous for my friend.

As the maid of honor finished up her speech I was expecting the worst. Her speech was very good. The guests laughed,

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

ried, and even clapped at the end. I was terrified for Jason, and I assumed he was terrified too.

Then a strange thing happened. Jason took the microphone, introduced hims

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

elf, and assuredly delivered the most eloquent wedding speech I had ever heard. He was confident, funny, heartfelt, and poised. His timing was perfect and the speech itself

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

sounded as though it was written by a wordsmith.

I couldn't believe it. Later that night I asked Jason how he went about writing his speech. He wouldn't tell me at the tim

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

Following aspects would a

e, but a few months later he and his girlfriend got engaged. When Jason asked me to be the best man he finally filled me in on the resource he used to help him prepare his

dd to the challenges in developing combination products:

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

peech.

I have begun to write my speech for Jason's wedding. From my research I have come up with a few guidelines to follow when writing a wedding speech. These aren't set

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

in stone and there are probably more tips that could be added, but these are the building blocks of most great wedding speeches:

Introduce yourself to the guest

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

. Unless everyone knows you, this will help put your speech in the proper context.

Make a positive observation about the wedding.

Say something funny at

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

the groom's and/or bride's expense. Keep it clean, clean, clean.

Tell an amusing anecdote about the couple.

If you are the best man, then don't forget

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

Professional from academic institutions, pharmaceutical industries, health care indust

he bride (and visa versa). Say something nice about him/her.

Provide an insight into the bride's and groom's relationship.

Pay a sincere tribute to the

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

groom and/or bride.

End the wedding toast on a high note - express good wishes for the couple's future.

Don't forget to actually propose and execute a t

.

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

ast. Have the guests join you and lift their glasses. Then complete the toast with a "Cheers", "Salut", etc.

Do not give a wedding toast if you are drunk. This sh

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

Companies that provide selfless information through particip

ould require no explanation.

A wedding is something that will be remembered forever. Go the extra mile to craft a meaningful tribute and deliver a great speech

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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