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Advice You - Leading Change - Don't Make Change a Life Sentence
"Well, guys, all I can say is ... he's upright and taking nourishment, but I don’t think he'll be allowed visitors anytime soon."
That little
That little
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
ditty came from a fellow manager in response to our inquiry on one of our fellow change agents. I was visiting headquarters of a company wher
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
e I'd been working a couple years before. I was looking for a particular person who'd been working on the change project and couldn’t find him
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
anywhere. It was like he’d been banished, no one but this fellow had a clue where he might be. It had been two years and he was lost in the b
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
owels of change, career long gone, working diligently for a paycheck and wondering what he was going to do with his life.
The project he was
The project he was
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
still working on was long on life support. Senior management had given up but hadn’t pulled the plug. They were in the mode of salvaging somet
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
hing from the ship that had sunk and wasn’t coming back afloat. Each month there was fewer and fewer people working the project but no one had
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
enough compassion or guts to pull the plug and let it die.
What did that mean for the people serving their sentence on the project? It meant
What did that mean for the people serving their sentence on the project? It meant
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
that good people, who'd diligently given their careers for the sake of this work, were now nowhere to be found. Finding them was like chasing
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
down leads on the latest Osama sighting but we didn’t have Spec Op's to help. I actually ran into one guy from the project six years later and
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
he said, “Ed, you gave me a life sentence. I’m still ‘working’ parts of the project”.
You gotta’ know it's important to think through the pe
You gotta’ know it's important to think through the pe
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ople side of change before you fire the first shot. When you're asking people to put their careers aside and help you drive a change project y
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
ou need to know what will happen to them in the end. Don’t give it one of those, "Trust us; you know we'll take care of you". That’s something
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
that would come out of Washington. That’s like “I did not have sex with that woman”.
I'm sure you mean well but it doesn’t work that way and
I'm sure you mean well but it doesn’t work that way and
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
you know it. You have to work it out in advance. And if you don’t know and can't be sure you can make something happen, tell your new recruits
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
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
that up front. Most can deal with it but if they can't, then don’t put them on your team.
Real leaders don’t let their people get lost in th
Real leaders don’t let their people get lost in th
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
e jungles of change. They're up front, honest and stand up for their troops. They're enthusiastic and their people know they are going to be t
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
here with them night and day, through good times and bad. They know when things are tough their leaders will be with them.
In fact, they're a
In fact, they're a
.
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
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
lot like Chesty Puller, the most decorated Marine of his time. At the Chosin Reservoir in Korea he said, "We've gottem' right where we wantem
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
' now! We're surrounded, so they can't get away this time."
You gotta' be that pumped up and committed and your people will be too!
Ed Kugle
You gotta' be that pumped up and committed and your people will be too!
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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