Tags |
|
|
Links |
|
|
Advice You - Leading Change - Why Are We Doing This?
"I think Ed has a point."
We were in the Boardroom of a $1.5 billion consumer goods manufacturer when the CEO made that statement. Of course he was responding to what I
We were in the Boardroom of a $1.5 billion consumer goods manufacturer when the CEO made that statement. Of course he was responding to what I
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
had just said.
"If you gentlemen don't know why you’re doing this project, how on earth do you expect the rest of the company to get behind it?"
You see this outfit was
"If you gentlemen don't know why you’re doing this project, how on earth do you expect the rest of the company to get behind it?"
You see this outfit was
; 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
way behind on their promises. The same Executive Team that sat before me that day had two years previously made the decision to implement a new ERP system. You remember,
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ERP, enterprise resource planning system. They were all the rage in the nineties. That meant a lot of money for the vendor selling and a lot of headaches for the people i
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
the company on the receiving end.
Well this same group of wannabe golf pro’s, they were wanting to move the meeting along for their 1 o’clock T time, had sat in this sa
Well this same group of wannabe golf pro’s, they were wanting to move the meeting along for their 1 o’clock T time, had sat in this sa
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
me impressive, mahogany clad Boardroom and somehow chosen PeopleSoft as the system of choice. It was a solid Human Resource system but no one was choosing it for a system
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
wide implementation. Now, two years and $30 million later, they had nothing but a budget on steroids and were again asking themselves - why did we do this?
We see so man
We see so man
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
y projects fail because of a lack of leadership. In this case, a new manufacturing plant in their business would have cost $35 million to build, and they would be getting
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
a report on its progress every week. This crack crew hadn’t asked for or received a progress report on this project for over six months. As the outside guy brought in to
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
'fix' this money gobbling beast, I had to force the meeting we were now sitting in. It’s pathetic to see actions like this mistaken for leadership. But in many large comp
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
nies today their brands are strong enough it takes several years of this BS to kill it.
When you're a change leader - lead! In the meeting I’m telling you about, during
When you're a change leader - lead! In the meeting I’m telling you about, during
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
the presentation updating the reasons for a lack of progress and what was being done about it, the CEO sat at the end of the proverbial big long table cleaning his nails.
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
He never looked up once until he asked, “Why are we doing this?” If you think that is uncommon on change projects, I have some of Jimmy Hoffa’s Florida land for you to lo
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
ok at.
As the change leader you must provide unwavering direction, communications and support. You must do all three from beginning to end of the project.
1. Direction
As the change leader you must provide unwavering direction, communications and support. You must do all three from beginning to end of the project.
1. Direction
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
From the git go everyone must know where they are going, when they are going and why they are going there.
2. Communication: As the change leader you must have regular,
2. Communication: As the change leader you must have regular,
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
unwavering communication. He who blinks loses.
3. Support: You must provide continuous, visible and strong support to your change leaders.
It's simple. It's leadership
3. Support: You must provide continuous, visible and strong support to your change leaders.
It's simple. It's leadership
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
Unfortunately, leadership is as scarce today as a compliment between George Bush and Nancy Pelosi.
A wise man in an old book once wrote that blowing an uncertain trumpe
A wise man in an old book once wrote that blowing an uncertain trumpe
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
t will lead to failure. You have to be in or out with this change stuff. You can’t be kinda' pregnant. It's like raising kids. If your child can go to your spouse and get
.
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
a better deal than what you gave them, they will. There must be a common direction established upfront, then everyone climbs aboard the change bus and off you go. It’s no
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
t rocket science, its leadership.
Be a leader. Establish direction, communicate with your people and support them at every turn and you will succeed at change.
Ed Kugle
Be a leader. Establish direction, communicate with your people and support them at every turn and you will succeed at change.
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
HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.adviceyou.org.ua/article/13796/adviceyou-Leading-Change--Why-Are-We-Doing-This.html">Leading Change - Why Are We Doing This?</a>
BB link (for phorums):
[url=http://www.adviceyou.org.ua/article/13796/adviceyou-Leading-Change--Why-Are-We-Doing-This.html]Leading Change - Why Are We Doing This?[/url]
Related Articles:
Invoice Discounting For Canadian Companies
Accounting - Three Major Areas
Bookmark it:
|