Main Subject - Business

"Doesn’t listening to this give you that "Big Mac' feeling? You crave it, taste it, smell it and just can’t wait til' you can bite

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

into it. A little while later, after you eat it and get it down, you start feeling tired, bloated and real sick to your stomach. Th

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

Examples of combination products may in

at's kinda' how I feel here ... a little sick and not right."

One of my project managers leaned over and said that to me in a chan

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

ge meeting when the Senior VP of Human Resources had just hijacked our change plane. It was unbelievable but true. After all this t

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

ime, with the old leader sitting nearby, this guy is delivering the goods on our work. Where has he been all this time?

We were al

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

Combination pro

l called in for a project update when up steps our Senior VP of HR. The only thing missing from this charade was Gomer, from Mayber

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

ry saying, "Surprise, surprise." This guy had no involvement in this project for the two long years of its life. Now, today, he wal

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

ks in and pronounces he's in charge. He’s not only in charge; he’s announcing everything is beautiful. I was waiting for Ray Steven

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

s to come in and sing his song by the same name.

The project in question was a PeopleSoft implementation that was a full year behi

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

nd schedule. When we were invited to this ‘update’ the email led us to believe we were coming to hear the 'Straight Talk Express".

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

ike, let’s get be honest and do what needs done to get this thing on schedule. Instead, this guy stands up, with all his compatriot

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

Following aspects would a

s in the room, including the CEO cleaning his nails, and lays some smack on us.

From the time he started talking it was clear this

dd to the challenges in developing combination products:

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

guy could jump through a bag of pretzels and come out straight. It was unbelievable. He was spewing forth more BS than Congress on

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

a good day. The old leader, the Controller, sat silently by as we heard 'all is well'. If you only heard the HR guy’s update you’d

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

have thought this baby was ready to walk. It wasn’t so.

As the change leader, you must be part Gunnery Sergeant and make things h

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

appen, part JFK and inspire people to believe, and part Intelligence Officer to insure you see things like this guy coming. You can

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

Professional from academic institutions, pharmaceutical industries, health care indust

not let a project be hijacked if you’re the leader. And when the BS starts flowing like the java on a morning stop at Starbucks, yo

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

u have to intervene. This stuff isn’t easy but it is doable. Leading change requires a ton of courage and if you don’t have it – yo

.

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

u lose.

When asked why he was a great scorer, Wayne Gretzky replied...

"I skate where the puck will be, not where it is."

As a c

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

Companies that provide selfless information through particip

hange leader you must skate where the puck of change will be, not where it is. Otherwise you will not succeed or survive.

Ed Kugle

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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