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I spent last Thursday hosting several staff training sessions at the Hyatt Regency McCormick Place.

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

It was incredible! From the housekeepers to the bellman to the sales force, all employees at the

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

Examples of combination products may in

property made it obvious why they're one of the most profitable Hyatts in the country.

About half

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

way through one of the afternoon sessions, I noticed a man sitting in the front row. Literally<

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

i>, he was sitting IN the front row. The 6 foot 5, suit clad man casually kicked up his legs acros

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

Combination pro

s a few chairs, smiled, nodded and kept an interested eye on me at all times.

Who is this guy?<

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

/i> I wondered.

After we adjourned he approached me and said, "Scott, thanks very much for your pr

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

esentation! I've been hearing great feedback from everybody. I'm Jerry Simmons, the General Manag

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

r of this hotel."

Ohhhhhh...the GM. Wow. Didn't see that one coming.

"And I'm so glad you talke

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

d about approachability to our staff. You see, too many managers think it's wrong or 'not cool' to

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

be approachable. Like they should be isolated from the rest of the staff. But they need to be re

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

Following aspects would a

al. So I think your ideas are just what they needed to hear."

It turns out Mr. Simmons started hi

dd to the challenges in developing combination products:

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

career as a wide receiver for the Steelers, Falcons, Saints, Broncos and Bears in the 60's and 70'

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

s. Then, after a Hyatt Regency asked him to talk to their employees about leadership, he took on a

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

part time position in the off season in the hotel restaurant. Nine years later he became the Gene

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

ral Manager of one of the biggest Hyatts in the country.

What a story. What a guy. What a hotel.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Not to mention a shining example of someone who knows how to keep it real. Now I know, you've hea

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

rd the phrase "keep it real" ad nauseum. And it could mean a lot of things to a lot of people.

Bu

.

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

t to me, keeping it real (being yourself, showing vulnerability, eliminating superficial hie

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

Companies that provide selfless information through particip

rarchy and maintaining congruency in your character) is a direct indicator of one's approachability

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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Digg It - Managers Need To Keep It Real

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