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Main Subject - Managing Change - Dealing with Underground Resistance
“I will do anything to stop this project and I expect you to do the same!” The young lady sitting before me in tears, reporting that to me, worked for the IT Director who was in charge of the systems integration for a project we were leading. She didn’t work fo
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
r me, she worked for him and he reported to me ‘dotted line’ as they say today.
We were part of a high tech company and the decision had been made, based on my recommendation, to outsource the primary warehouse of this fast growing $11 billion outfit. It was a
We were part of a high tech company and the decision had been made, based on my recommendation, to outsource the primary warehouse of this fast growing $11 billion outfit. It was a
; 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
culture clash of gigantic proportions. My team was brought in from the outside to drive change. Inside, they were all used to the best of everything.
My first order of business was to slash operating costs in the logistics function. In the warehouse in questi
My first order of business was to slash operating costs in the logistics function. In the warehouse in questi
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
n they were spending over $300,000 a year, are you ready for this, cleaning the warehouse. It wasn’t that big, a high rise facility with maybe a 150,000 square foot footprint and eight levels. They were dusting the computers up as high as they could reach – eve
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ry night!
The big guys who met in the mahogany boardroom agreed with my recommendation to outsource the function. The company was a mere fifteen years old at the time and the ‘old timers’ were outraged. We agreed to provide jobs on campus, as they called it, f
The big guys who met in the mahogany boardroom agreed with my recommendation to outsource the function. The company was a mere fifteen years old at the time and the ‘old timers’ were outraged. We agreed to provide jobs on campus, as they called it, f
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
or everyone. Nonetheless, the pockets of resistance would rival the streets of Baghdad today.
There are a few stages of resistance but I am talking about when it reaches the Gandhi stage … it goes underground. Here are a few things that began to happen …
• Al
There are a few stages of resistance but I am talking about when it reaches the Gandhi stage … it goes underground. Here are a few things that began to happen …
• Al
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
egations of wrongdoing: For me and my team it started with rumors that soon led to allegations we were in cahoots with the company selected to do the outsourcing. This was of course a major distraction to the work we were driving. We had to take time to sit dow
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
n with my boss, the CEO, the CFO and others to explain we’d never even met these people before. Lesson – it’s important to deal with what comes your way during change in a professional and upfront manner.
• Formal charges: In this company there was a person kn
• Formal charges: In this company there was a person kn
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
own as a Corporate Compliance Officer. There job was primarily to insure the company was in compliance with all laws. One morning I found out they were also in charge of following up on complaints of basic wrongdoing. Anonymous, that is how it worked; charges w
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
re filed against me and my staff for rigging the bid. That was a further distraction from the work at hand. Lesson – Make sure you make a thorough evaluation upfront of the culture and build the proper support for the effort. We had done this and after an inves
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
tigation, we were cleared of the charges.
• Underground activities: We were receiving information as our project progressed that our systems guy was going to subvert the project any way he could. Lesson – Make sure you develop a ground work of support througho
• Underground activities: We were receiving information as our project progressed that our systems guy was going to subvert the project any way he could. Lesson – Make sure you develop a ground work of support througho
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
ut the organization to receive information of what is ‘really’ happening in your project and not what leaders around you are ‘reporting’ is happening.
Fortunately for me our team had great contacts throughout the organization and the information flowed freely.
Fortunately for me our team had great contacts throughout the organization and the information flowed freely.
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
The young lady who sat in my office and reported the Director’s comments in a recent staff meeting was credible. Unfortunately, she felt she would lose her job if she went public. After much discussion, she trusted me and agreed to ‘come out’ if I talked to the
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
Senior VP of Technology, the Directors boss.
As I met the Senior VP it went something like this …
“Bob, you need to know what Harry said in his Staff meeting this week.” “What?” He gruffly mumbled.
Now he and I had had similar conversations about this guy
As I met the Senior VP it went something like this …
“Bob, you need to know what Harry said in his Staff meeting this week.” “What?” He gruffly mumbled.
Now he and I had had similar conversations about this guy
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
in the past, it was no surprise.
“He ordered his people to bury the outsourcing project in any way they could.”
I explained to him that I had a member of his staff who would walk in his office and testify to this fact but only if the Director was going to be
“He ordered his people to bury the outsourcing project in any way they could.”
I explained to him that I had a member of his staff who would walk in his office and testify to this fact but only if the Director was going to be
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
ired afterwards. Bob got angry and threw a few things around. The problem we had is that we were also in the middle of a companywide systems implementation and the Director, Harry, was THE only one on the premises who knew the old legacy logistics systems. The
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
Senior VP was in a box.
“Ed I can’t get rid of Harry … he is the only one on the campus who has a clue about our legacy systems. It would be foolhardy to me. He won’t do it. I will beat him about the head and shoulders and see to it!”
I never knew whether he
“Ed I can’t get rid of Harry … he is the only one on the campus who has a clue about our legacy systems. It would be foolhardy to me. He won’t do it. I will beat him about the head and shoulders and see to it!”
I never knew whether he
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
beat him up or not but he did it … he delivered on his promise to screw up the outsourcing. When the system was turned on between the outsource company and us, it shut down and was quite a mess. The outsource company, of course trying to please a customer and k
.
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
ep the account, kept mum about the issue behind the issue. They had to bring in very high experts from IBM to figure out what was causing every transaction to double. They found code written on our side to cause this problem on theirs. Our Director, Harry, had
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
delivered on his staff meeting promise.
Change can be ugly. Resistance is very real. When you’re managing change you must make yourself aware of everyone involved and have a network to gather ‘real information’ … and even then it might not be enough.
Ed Kugle
Change can be ugly. Resistance is very real. When you’re managing change you must make yourself aware of everyone involved and have a network to gather ‘real information’ … and even then it might not be enough.
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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