Advice You - Business

A couple of months ago, I was invited to speak at the Arizona State Bar for a of continuing education event. This most respected speaking engagement was the re

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

sult of a referral from Chip Lambert of Network2networth.com - a profound speaker and business man with a surly sarcastic edge that qualifies him to be a frien

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

Examples of combination products may in

d as well as a colleague.

A few weeks before the actual event, our hosts from the State Bar graciously invited the speakers to a private luncheon at the Biltm

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

ore Embassy Suites. For this special occasion, I pulled out my best conservative navy suit, wore understated jewelry and wiggled into my trusty Spanx to smooth

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

my middle and lift my ass, in order to feel the utmost professional for a couple of hours of socializing with those who interpret the law for a living.

One o

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

Combination pro

f the other speakers and luncheon guests was a polished and confident ethics expert. This expert could recite the ethics with as much passion and conviction as

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

a televangelist quoting scripture to heal the sick and drive donations. In short, she was the attorney's attorney, the go-to person for lawyers with concerns

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

around ethics, conflicts of interest or gray legal matters.

During lunch, our expert was sharing examples of attorney's who operated outside the ethical stand

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

ards of the industry and thus, found themselves in hot water with the Bar in their respective states. As the details of each story unfolded, we shook our heads

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 if to say "how foolish, any moron could see that was an ethics violation."

Then our ethics expert graced us with a story of a criminal defense attorney in

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

New York who printed a picture of a naked woman on the back of his business cards. The NY attorney wanted to encourage inmates (ie, his target market) to pass

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

Following aspects would a

his card around to others who found themselves in the unfortunate position of being incarcerated. Before she could wrap up the story and the rest of us could

dd to the challenges in developing combination products:

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

give the knowing head shake, I was so moved by the creative genius of the NY attorney and blurted out. . ."Oh My God, that is Brilliant!!! "

(Here's a little

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

tip for future reference, if you ever want to score points with an ethics attorney, avoid making any comments to imply you condone nudity as a marketing ploy.)

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

Despite the looks of disapproval and tension at the table, I stand by my outburst! A naked woman on the back of a criminal defense attorney's card is a brill

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

iant marketing move. It was not so brilliant in terms of ethics or gaining support from peers, but from a pure marketing, how to get attention and how to get p

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

Professional from academic institutions, pharmaceutical industries, health care indust

eople to talk about you - it couldn't have been any better if P.T. Barnum himself created the idea.

I am sure the attorney was fined and/or ordered to cease a

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

nd desist the distribution of the naked business cards. However, he will be known for years to come as "the attorney who had a naked woman on his business card

.

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

s." A slap on the wrist for what possibly amounts to years of recognition with his target market . . . not a bad trade if you ask me.

Think about your busines

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

Companies that provide selfless information through particip

s, is your target market talking about you and passing your business card around? If the answer is no . . .maybe its time to get naked and stir things up a bit

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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