Tags |
|
|
Links |
|
|
Advice You - Leading Change - Being the Change
As a change leader, it is up to you to insure that people believe in the change you are leading. Gandhi is oft quoted as saying, “You must be the change you wish to see in the world.” H
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
e certainly did that as he lived as a pauper among his people and brought down the British Empire with nothing but his example. You must do the same.
It is common to see the exact oppo
It is common to see the exact oppo
; 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
site. In one company we worked where the change being shouted was massive the leaders did nothing different. While they were attempting to lead a change that would require a new system
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
in each and every part of the company, nothing changed for them. They were leaving at noon on Friday for their golf games while the masses below them were working nights and weekends to
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
keep up with their ‘day jobs’. Sometime back I was reading a book and in it was this quote, “What we do everyday is what we believe, all the rest is just talk.” That says it all.
Thes
Thes
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
e so called leaders were very diligent in listening to their consultants and conducting their ‘Town Hall’ meetings every Friday morning. They conducted their monthly ‘Update Meetings’ a
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
nd were popping the buttons off their sharp new suits at how well they were ‘managing’ the project. All the while the project was going down the proverbial tubes.
On one change project
On one change project
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
I worked with the employees that human resources determined were the ‘affected’ employees. I got my way and met with them privately, and they talked. The HR Director planned a communic
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ations meeting for the following Monday. It was his routine ‘Pizza Luncheon’. In my meetings with these ‘affected’ people one hundred percent of them told me they wouldn’t set foot in h
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
is meeting if they didn’t have to go.
Of course I asked, “Why do you have to go?
One young lady angrily replied, “If we don’t we’ll be on the list.” “The list” I asked.
Then the who
Of course I asked, “Why do you have to go?
One young lady angrily replied, “If we don’t we’ll be on the list.” “The list” I asked.
Then the who
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
e room erupted into a tirade of anger, spewing forth like protesters in a third world country, but this demonstration wasn’t staged. It was heartfelt and they knew they were right, they
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
were living it everyday. The message was consistent from group to group … there was no trust in the midst of a massive change.
At the end of the week I met privately with the HR Direc
At the end of the week I met privately with the HR Direc
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
tor they were referring to and he asked what I thought. I’m in the business of delivering truth, it was time.
“I understand you are having a meeting with the folks on Monday,” I asked
“I understand you are having a meeting with the folks on Monday,” I asked
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
like a Defense Attorney on cross, already knowing the answer.
“Oh yes, we do them monthly, to keep everyone informed.” He proudly replied with more than enough authority to make you wa
“Oh yes, we do them monthly, to keep everyone informed.” He proudly replied with more than enough authority to make you wa
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
nt to lose your lunch.
“You do realize that one hundred percent of your people do not want to attend your meeting don’t you?” I replied, emotionless, looking him straight in the eye.
“You do realize that one hundred percent of your people do not want to attend your meeting don’t you?” I replied, emotionless, looking him straight in the eye.
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
He was more than a little taken aback, insulted but professional as he said,
“Well … why wouldn’t they want to come?”
“It’s simple.” I said calmly. “Because you tell them nothing but
“It’s simple.” I said calmly. “Because you tell them nothing but
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
BS every time you get together … there is no trust.”
That was a little like tossing a hand grenade on the desk that sat between us. You can imagine how things went after that, but he n
That was a little like tossing a hand grenade on the desk that sat between us. You can imagine how things went after that, but he n
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
eeded to hear the truth. He wasn’t the change he was asking of his people, anything but. At one point he actually told me he was happy he traveled as much as he did because he didn’t li
.
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
ke ‘all those people coming in to his office complaining’.
Leaders are leaders because they are going somewhere that people want to go. They show by their every action that they are th
Leaders are leaders because they are going somewhere that people want to go. They show by their every action that they are th
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
e change of which they speak. They lead as near to what Gandhi said as possible. And their actions reflect … what we do everyday is what we believe, all the rest is just talk.
Ed Kugle
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/13812/adviceyou-Leading-Change--Being-the-Change.html">Leading Change - Being the Change</a>
BB link (for phorums):
[url=http://www.adviceyou.org.ua/article/13812/adviceyou-Leading-Change--Being-the-Change.html]Leading Change - Being the Change[/url]
Related Articles:
Advances in Wire EDM Technology
A Guide To Your Demographics And Your Endorser
Fired Before You’re Hired: Five Ways to Ruin Any Interview
Bookmark it:
|