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A few weekends back, the Brobdingnagian Bards performed at the Austin Celtic Festival. We shared the stage

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

with some amazing bands, but at the very top of my list were The Rogues.

We first met The Rogues last ye

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

Examples of combination products may in

ar at the Texas Renaissance Festival. Since then I've been a big fan of not only their killer bagpipes and

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

drums, but their phenomenal ability to sell CDs. They work magic on and off stage and sell tons of CDs.

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

What do they do that is so special?

Well, The Rogues are very proactive when it comes to selling. While m

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

Combination pro

any bands will setup a table and say, "go to our table and buy our CDs", The Rogues take it a step further

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

. They send their sales ladies to their fans.

I remember at the Kansas City Renaissance Festival when the

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

y played the Pub Sing. They began playing music. Their Sales Ladies danced to the music. Then they picked

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

up their baskets of CDs, grabbed a couple, held them high, while The Rogues invited the audience to, "Go b

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

uy our CDs." Then the lasses walked through the aisles through the rest of the entire performance.

While

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

the rest of us were on stage watching with shocked amazement at our own untouched sales table, The Rogues

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

Following aspects would a

sold a dozen CDs! They repeated that performance at the Austin Celtic Festival.

We shared a booth with Th

dd to the challenges in developing combination products:

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

e Rogues at the festival, and I asked Sharon about how they do it. She told me it varies in different part

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

s of the country. In Texas, this direct approach works magic. In Florida, an older recreational audience g

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

ets angry if sales people disturb their show. But the key is to realize that your sales team is a PART of

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 show!

They don't just stand up there silently holding up CDs. If they do, they disappear. We learned

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

Professional from academic institutions, pharmaceutical industries, health care indust

that during our first show this weekend. Integrate your sales people into your show. Get them to dance in

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

the isles, clap their hands, sing-a-long. If they do, the audience will follow their lead. This will help

.

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

them to attract attention to the CDs, and you will sell more.

Be proactive. Don't wait for your fans to c

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

Companies that provide selfless information through particip

ome to you, or they may never! If you go to them, you'll sell more CDs, and make more fans in the process.

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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