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Two dogs share our lives. Luigi is a tiny Shih Tzu stray we found running along a road some years back. Hugo is a giant Newfoundland and Golden Retri

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

ever mutt whose sweet face beckoned us from the web page of a nearby animal shelter. These two dogs couldn’t be more different---in personality as wel

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

Examples of combination products may in

l as scale. Together, though, the two of them have taught me some important lessons about conflict and its resolution. Here are five.

Bark if you

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

must, but wag your tail, too.
Luigi is always the first to bark loudly at anyone approaching during our walks. And his bark is always accomp

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

anied by an enthusiastically wagging tail that says, “Hey, I'm on alert here but I’m also a friendly guy.” I think Luigi’s got something here…take on t

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

Combination pro

he difficult conversations in life while also making our friendly side clearly visible. Confronting and being nice are not mutually exclusive.

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

The person who makes us mad is more than the sum of his errors.
When someone does us wrong, most of us have a tendency to view them throu

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

gh a narrow lens, one that focuses on their “wrong-ness.” Hugo has been known to break the rules on occasion (sneaking up on the bed while we’re out i

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

s a favorite vice). He’s also very good at reminding me, in the midst of my chagrin at black dog hair on the comforter, that there’s much more to him

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

than just the sum of his errors. He makes me laugh with some of his “goofy Newfie” behaviors and I realize once again that his rule-breaking is just o

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

ne small part of a funny, loving dog.

Be persistent…when it matters.
Most people who’ve met Luigi see right away that he doesn’t lack asse

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

Following aspects would a

rtiveness. We call him Mr. Clear Channel. At the same time, he doesn’t bother himself with the little things in life. He’s persistent about the import

dd to the challenges in developing combination products:

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

ant things: a warm dog bed, asparagus snacks (yes, indeed), a game of fetch, lots of lap time. He lets go of the little things that clutter both energy

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

and time. You and I should aspire to do that with conflict in home and workplace relationships.

Turn the other lip…er, cheek.
Hugo’s lip

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

s are standard Newfie fare and he has enough extra that we joke about getting him a lip tuck. Luigi, the canine boss in our house, has been known to g

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

rab onto Hugo’s lip and tug when Hugo isn’t being sufficiently submissive. Hugo could use his massive size to bring an end to this, but he never does.

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

Professional from academic institutions, pharmaceutical industries, health care indust

He’s a gentle, peaceful soul through and through. Though his canine reasons for turning the other lip may be different than for a human who turns th

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

e other cheek, his ability to do this is a good reminder to end the stupid little arguments that can crop up any given day. When we look back on our l

.

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

ives when we're 100, what disagreements will we care about? Let go of the others and move on.

A good game of fetch always de-escalates tension.

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

Companies that provide selfless information through particip

Luigi and Hugo are masters at bringing the ball for play when they sense tensions rising. We could all use a little redirecting now then, right?

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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Engineering is a highly technical field, and all engineers should undertake structured professional development in order to maintain their personal and professional expertise. Many professional development institutes encourage and enable engineers to remain professionally competent through proper advice, guidance and support services.

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