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ONCE UPON A TIME, there were three Knights. They were the Knight of Marketing, the Knight of Sales and the Kinght of Exhibits.

T

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

hough they were adjacent in the same country, each had a fiefdom that was defended with tenacity and guile. When the King agreed

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

Examples of combination products may in

o participate in a Royal Market Event, the three Knights vied for position and glory.

The Knight of Marketing sent messengers to

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

the vast lands to herald the goods of the Kingdom, to entice seekers of good deals and buyers with real money, to visit the Royal

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

Enclave. Riders went out, pamphlets were delivered and subjects spread the word to come see the Kingdom’s wares. The Marketing F

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

Combination pro

efdom was secure.

The Knight of Sales planned to receive the gold and loot from the Event. This Knight drew his Knaves together

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

nd said – We must band together. We are the most important fiefdom because we strive to know of those who might possess gold and

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

loot to give to this Kingdom, rather than a neighboring Kingdom competing for such wealth and fealty. The Sales Fiefdom was secur

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

.

The Knight of Exhibits was expected to be the Bridge – to fill the Gap – between the Knights of Marketing and Sales. His role

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

as equally important as he coordinated the Event, designed the enticing Tent and cleaned up after the horses. The Exhibits Fiefdo

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

was secure.

THE KING WAS SAD. The Event occurred. The Tent was lovely. The messengers spread the word. The appearance of gold a

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

Following aspects would a

nd loot was disappointing. The Knights were called in to report to the King.

What went wrong? FIEFDOMS DO NOT EQUAL GOLD

This

dd to the challenges in developing combination products:

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

vent was a marketing event – part of the continuum of letting the people know about products and services. It was not just One Ev

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

nt. It was an opportunity for the entire Kingdom to be judged and receive gold and fealty for months to come.

Competition among

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

fiefdoms divided the final goal. Communications amongst these three – or any number – of Knights is the key to success at any Eve

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

t.

The King wanted to expand the influence of his Realm, but Knights of Fiefdoms may have diluted the message because of ego. Th

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

Professional from academic institutions, pharmaceutical industries, health care indust

magnitude required to overcome the individual ego of the Knights requires not only the King’s impart, but also a round table of

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

effort by every level involved.

LESSON LEARNED

An Event of the Realm is very important to the King and eventually all his subje

.

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

ts. The King does not want to be a Micro-Ruler but expects all Knights to be cognizant of the importance of the Realm over the in

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

Companies that provide selfless information through particip

ividual Fiefdoms.

IN OTHER WORDS – People come to a trade show to see the Company, not the Individuals employed by the Company

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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