Others - Writing and Speaking

Why is it that when we make a mistake, we tend to kick ourselves in the head over and over, cursing ourselves, feeling crummy and discouraged? Do

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

we really think that that's going to help us in some way?

Last week my husband and I went to hear my friend Tom play at a jazz club in Santa Rosa

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

Examples of combination products may in

. Tom plays bass in my jazz trio, but this night he was playing bass with his own trio made up of a pianist and a drummer.

As we were sitting 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.

re, listening to the music, sipping Zinfandel and contemplating the menu, Tom called me up to sing a few tunes. An invitation to sing! My favorite

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

thing. So, jumped up and sang a Cole Porter tune, which went very well. What fun!

The trouble started in the second set when Tom asked me to com

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

Combination pro

e up and sing again. Sure, you betcha! As the pianist launched into the tune, "Skylark," I couldn't really hear my first note from his introductio

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

n but I just opened my mouth and took a guess. A wrong guess. I started wrong, quickly found my way to the right pitch, and the rest of the song w

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

ent beautifully.

Ah, but that first note! The very first one! To screw that up, ugh!

Even though I went on to sing a fun duet with Tom, even tho

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

ugh I had sung well all night, I couldn't stop mulling over my previous mistake. Damn, that first note of "Skylark."

Now, if you were me and that

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

had happened to you, I would be squawking at you, saying, "One bad note? How many other notes did you sing perfectly? What about how much fun you

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

had singing? What about how well you interpreted that song and all the others? And what about how quickly you recovered and went on to nail that t

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

Following aspects would a

une? How come you're not focusing and replaying all of that?"

Yeah, how come?

Here's the deal. When you keep replaying your mistake and feeling

dd to the challenges in developing combination products:

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

badly about it, you are not helping yourself. In fact, you are actually increasing your chances of it, or something worse, happening again. Why? B

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

ecause you are feeding it with your attention. You are reinforcing it in your experience. It's as if you are mentally practicing your mistake. You

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

are also feeding your doubt, anxiety and fear, which are three monsters you don't want to feed.

Stop it!

Do this instead. After every public sp

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

eaking experience, take a long inventory of all the things that went well, all the things you loved, all the things you want to do again. Then, on

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

Professional from academic institutions, pharmaceutical industries, health care indust

ly after you've appreciated everything that went well, take note of what you want to change, what you would have done differently. Then sit and re

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

create that experience in your mind, except this time let it unfold exactly as you want it to go.

When you do this after every performance or spe

.

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

ech, you pre-pave the way for the next experience to be all the more wonderful and satisfying. You reinforce and give energy to what you do want,

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

Companies that provide selfless information through particip

rather then empower what you don't want. You connect to your confidence, your capacity, and your greatness, rather than your doubt, worry and fear

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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