Business Dump - Travel and Leisure

It’s Wednesday night and I’m sitting in Churchill’s Pub on N.E. 2nd Avenue and 55th Street in Miami. It's ran by Dave Daniels, a Brit e

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

xpatriate and everything about it is British-- including its interior which looks like something left over from the London bombings of

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

Examples of combination products may in

World War II. Daniels describes the place on the outside wall as "sort of an English pub." It's got the Union Jack and a silhouette of

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

Churchill painted on the walls just to confuse you. And let's not forget the two derelict double-decker busses sitting in the unpaved,

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

ock strewn parking lot. The menu includes the expected pub fare of shepherd's pie and bangers and mash, but what brings me and my buds

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

Combination pro

back week after week (besides Alex and Brooklyn the gorgeous tattooed barmaids) is Wednesday Curry Night. Done "London style," it is th

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

e consensus of curry eating connoisseurs who join me that it is the hottest curry known to man.

I consider the regulars in my group me

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

bers of the "Curry Eaters Club." Only the worthy can sit with us at one of the plastic lounge tables scattered on the opposite side of

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

the dark bar. On any given Wednesday night you can find the face of Miami in this bar: Haitian, Cuban, some variety of South American,

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

WASP, and Jew. And the young and old too. If you’re not there to make your eyes water and your nose run from the curry, you’re there t

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

drink, shoot pool, hang out with your friends at the bar, watch soccer on the TVs and, later, listen to live rock music (or jazz on Mo

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

Following aspects would a

nday's) around 10 pm. In fact, Churchill’s is one of the few places left in Miami where you can hear live rock and has become legendary

dd to the challenges in developing combination products:

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

for championing new bands. Many are young kid slammers and screamers who seem to be working out their anger management issues on the p

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

ub’s minimalist stage. Still, you never know what kind of band will play that night.

I remember a couple of weeks ago, a young Alabama

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

girl carrying an acoustic guitar almost as big as she was, got up and sang songs she had written that were eerily reminiscent of folkie

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

stuff from the fifties. If it hadn’t been for the crowd sitting around the bar cheering on some obscure soccer team’s goal on TV, I wo

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

Professional from academic institutions, pharmaceutical industries, health care indust

uld have sworn I had been transported back to Greenwich Village at the height of the folk music era half-a-century ago (not that I was

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

ctually there, I only read about it). Of course, members of the Curry Eaters Club, could care less who’s playing as long as the music a

.

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

nd the entourage that follows the bands don’t interfere with our mission and very little, even a drunken rowdy crashing into our table

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

Companies that provide selfless information through particip

will cause us to pause from the club’s agenda. Oh, yeah, you're more than welcome to join us at the table, but crybabies need not apply

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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Why an artfully delivered speech can be far more persuasive than the written word

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