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E-Articles - Emergency Operation
T h e U l t i m a t u m
A couple of months ago, Marc (name changed), a manager in his early 40s, called me and said: "I need your help! My superiors told me today that I get another 6-week trial period and if by then I can't show a good performance, I will be fired."
He sounded quite panicky and outrag
A couple of months ago, Marc (name changed), a manager in his early 40s, called me and said: "I need your help! My superiors told me today that I get another 6-week trial period and if by then I can't show a good performance, I will be fired."
He sounded quite panicky and outrag
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
ed, which is not surprising in such a situation. First, I helped him to calm down so that he would be able to think clearly and rationally.
Typically, my clients get coached 2 to 4 times per month. However, as this was a true emergency case, we decided to set up 2 coaching sessions per week for the first
Typically, my clients get coached 2 to 4 times per month. However, as this was a true emergency case, we decided to set up 2 coaching sessions per week for the first
; 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
weeks and then review the situation again.
It turned out that he started this job less than 6 months ago and that in the first 2 to 3 months, everything seemed to develop well. And then all of a sudden, according to him, everything turned against him:
* His boss stopped communicating properly with him,
It turned out that he started this job less than 6 months ago and that in the first 2 to 3 months, everything seemed to develop well. And then all of a sudden, according to him, everything turned against him:
* His boss stopped communicating properly with 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.
ypassed him time and again, and even annulled orders that Marc had given to his staff, thus completely eroding Marc's authority in his department.
* His staff expressed deep dissatisfaction to Marc's boss, who was the interims manager of this department for almost a year before Marc came on board. They co
* His staff expressed deep dissatisfaction to Marc's boss, who was the interims manager of this department for almost a year before Marc came on board. They co
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
plained about Marc's lack of technical competence and his leadership style.
* Colleagues from other departments became more and more skeptical about his competence and ability to perform the job, being reflected in the style of the internal communication (He showed me email where colleagues wrote things l
* Colleagues from other departments became more and more skeptical about his competence and ability to perform the job, being reflected in the style of the internal communication (He showed me email where colleagues wrote things l
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ike "… when will you ever understand who is taking care of these kinds of issues?").
W h a t H a p p e n e d ?
Looking at Marc's career, we see a person who made his way up from the bottom. His two previous positions gave me a clear indication about the root causes of the problem:
- In his second to t
W h a t H a p p e n e d ?
Looking at Marc's career, we see a person who made his way up from the bottom. His two previous positions gave me a clear indication about the root causes of the problem:
- In his second to t
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
e last position, he was working in the export department of a medium-sized company and was responsible for the sales of a certain region. He had no personnel responsibilities in this position.
- In his last position, he was responsible for setting up a sales network in Europe for a US company. At the end
- In his last position, he was responsible for setting up a sales network in Europe for a US company. At the end
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
f this appointment, he had four staff members reporting to him, all recruited by him. His boss in the US was mainly interested in the sales figures, which he successfully increased. The US team hardly got involved in what he was actually doing to achieve those.
That means, he:
... never had to "take over
That means, he:
... never had to "take over
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
existing staff.
As a consequence, he assumed that his new staff would accept him as their boss in the same way the people he employed accepted him in his previous job. He did not realize that he first has to earn the respect of his staff.
... never worked as a manager in an existing organization.
He un
As a consequence, he assumed that his new staff would accept him as their boss in the same way the people he employed accepted him in his previous job. He did not realize that he first has to earn the respect of his staff.
... never worked as a manager in an existing organization.
He un
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
derestimated the cultural aspects, as well as the dynamics and politics involved, of a grown management team.
... as a manager, never had to work closely with his boss.
Because he didn't want to do anything wrong, he initially did not make any decisions, but always asked his boss how to handle things. Wo
... as a manager, never had to work closely with his boss.
Because he didn't want to do anything wrong, he initially did not make any decisions, but always asked his boss how to handle things. Wo
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
se than that, he did not even prepare possible solutions but plainly asked what he should do.
Now, it suddenly became crystal clear to him what went wrong and that the reaction of his boss and his team was not something which happened suddenly, but that it was an inevitable consequence of his behavior.
U
Now, it suddenly became crystal clear to him what went wrong and that the reaction of his boss and his team was not something which happened suddenly, but that it was an inevitable consequence of his behavior.
U
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
fortunately, his boss was not the type who gives constant feedback on what's good and what he should improve. Instead, he was just waiting whether Marc's behavior would change over time and got more and more upset and disappointed when it did not happen.
E m e r g e n c y A c t i o n
Unfortunately, I e
E m e r g e n c y A c t i o n
Unfortunately, I e
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
tered very late in the process and it was clear to me that the chances of “saving” Marc were not good.
As always, when I coach people in difficult situations, my first target is to get them to calm down and put some distance between them and their turmoil, to enable them to think more clearly and rational
As always, when I coach people in difficult situations, my first target is to get them to calm down and put some distance between them and their turmoil, to enable them to think more clearly and rational
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
ly. I encourage them to first air their frustrations, anger and other strong emotions they may have in that situation.
Marc and I spent half of our first session doing this activity and I could feel how Marc calmed down afterwards and started to think more logically. As a next step I asked Marc to describ
Marc and I spent half of our first session doing this activity and I could feel how Marc calmed down afterwards and started to think more logically. As a next step I asked Marc to describ
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
his current situation and what led to it. Of course, in the beginning Marc could not understand how this could have happened to him. He always had good intentions, worked hard and “did nothing wrong to deserve” it.
Only when I asked him to clarify in detail what happened did Marc start to understand what
Only when I asked him to clarify in detail what happened did Marc start to understand what
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 did wrong” and what led him to this difficult situation. That was a key element of our coaching process, as understanding what went wrong was the basis of the action plan that could help rectify the situation.
In the second week, we worked out the action plan that he would present to his management to
In the second week, we worked out the action plan that he would present to his management to
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
show that he would change the way he was working so he can merit the satisfaction of his superiors.
T o o L a t e
Unfortunately, it turned out that some key people in the organization completely lost their faith in Marc—they did not believe that he would be able to change and work successfully in his p
T o o L a t e
Unfortunately, it turned out that some key people in the organization completely lost their faith in Marc—they did not believe that he would be able to change and work successfully in his p
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
osition. Hence, they were actually looking for Marc’s mistakes to have more reasons to terminate him. We realized that the ultimatum was a wish of the top management who wanted to give him a last chance, while his direct superior already “wrote him off.” In this situation, it was impossible to succeed. The
.
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
coaching process started after he had reached the point of no return.
After we realized that (3 weeks from the start of the coaching), we focused on his time after the ultimatum. Overall, Marc’s feedback on the benefits of coaching was as follows:
The coaching helped him stabilize mentally and emotionall
After we realized that (3 weeks from the start of the coaching), we focused on his time after the ultimatum. Overall, Marc’s feedback on the benefits of coaching was as follows:
The coaching helped him stabilize mentally and emotionall
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
.
The coaching came too late to save his job, but would have most likely helped him keep the job if it was started at a less critical stage.
The coaching helped him understand what went wrong, what he could have done differently, and how to be more successful in the future.
Copyright 2006 Progress-U Ltd
The coaching came too late to save his job, but would have most likely helped him keep the job if it was started at a less critical stage.
The coaching helped him understand what went wrong, what he could have done differently, and how to be more successful in the future.
Copyright 2006 Progress-U Ltd
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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