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Advice You - Managing Change - Trust, Integrity and Change
Imagine sitting in an HR Managers office, a Director of Human Resources discussing a change project gone bad and he tells you, “I’m glad I travel, I hate people coming in to my office.” That actually happened on one project
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
and the guy worked for a big, glamour Company and was in charge of a large division of the outfit. As a partner of mine said when I was relating the story, “He must be the Director of Non-Human Resources.
Yet I see it every
Yet I see it every
; 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
where I go. In the case above the change was major, the moving of the headquarters to another site a world away. The subjects of the change were long tenured employees who loved the company and their jobs. It was being moved
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
just like the recent Halliburton announcement of going from Houston to Dubai to save money on taxes. This was similar.
Now when I come in my work is to get people at this point to move on with their lives. I tell them that
Now when I come in my work is to get people at this point to move on with their lives. I tell them that
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
‘it is what it is’. And that’s true, ‘it is what it is’. The place is moving regardless of how you or I feel about it, or whether they did a good job of handling the communications, which they rarely do. But this case hamme
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
red home a point that I see on every change project … leaders lose their integrity by failing to keep their word and insult the intelligence of their workers.
When I go in to help the people ‘move on’ the first thing I hear
When I go in to help the people ‘move on’ the first thing I hear
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
is “You can’t trust these people, they have no integrity”. So I listen. What do I find? It’s all pretty simple, you can’t trust these people. You say come on Ed they aren’t all liars. No, they aren’t, they just use situatio
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
nal truth instead of being straight up and honest to the point of if you don’t know the answers to some questions you simple say so.
As Stephen Covey so eloquently put it in his outstanding book The Seven Habits of Highly E
As Stephen Covey so eloquently put it in his outstanding book The Seven Habits of Highly E
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ffective People … your words must match your deeds. To have trust you make a commitment and you keep it. Make it, keep it. That’s a person of integrity. Simple? Apparently not. So few leaders actually do it that I can only t
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
hink it must be hard. But you and I know it isn’t.
On change projects you are upsetting the norm in the culture, so it is important to keep as much stability as you can in the form of trust. By that I mean the trust that ex
On change projects you are upsetting the norm in the culture, so it is important to keep as much stability as you can in the form of trust. By that I mean the trust that ex
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ists between leaders and the ‘subjects of the change’ as human resources is so ready to call the people impacted. Trust is the direct result of making and keeping commitments and when you do that makes you a person of integr
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
ity.
In the example I above, the one where the Director of Non-Human Resources didn’t want people coming into his office, we can predict the trust that exists in that organization with one word – zero! You see words must ma
In the example I above, the one where the Director of Non-Human Resources didn’t want people coming into his office, we can predict the trust that exists in that organization with one word – zero! You see words must ma
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
tch deeds, anything less and you have no integrity. Let me tell you how their change came down.
They announced the changes, headquarters moving, and told the folks who were losing their jobs they would pay them a bonus if t
They announced the changes, headquarters moving, and told the folks who were losing their jobs they would pay them a bonus if t
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
hey stayed through the end of the transition period and that they would help them get jobs in the larger organization which had offices nearby, actually several offices. Now all that’s good, right? Then for nine months they
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
fed them pure BS with literally no information about their replacements, when their jobs would end and on-and-on.
Can you imagine the unrest in the organization at this point? No information is worse than standing up and sa
Can you imagine the unrest in the organization at this point? No information is worse than standing up and sa
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
ying ‘I don’t know’. The people lived in a vacuum and when you allow that to happen rumors fill the space and it is all bad after that. Leaders needed to keep their word and have individual transition plans for each person b
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
ut instead kept telling them either nothing or wondering amongst themselves why these ungrateful people weren’t happy with having a retention bonus to stay. They also had problems with people being recruited by other divisio
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ns in the larger company and being told ‘hands off’, we’re not ready to let them go’. All the while the clock was ticking from the employee’s point of view.
Leaders of change, well all leaders really, need to insure that th
Leaders of change, well all leaders really, need to insure that th
.
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
eir words match their deeds. They need to insure that they do what they say and are people of integrity. They need to make commitments and keep them. They need to be people of trust and integrity. The people need to be able
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
to look up to their leaders and know that what they say equals what they actually do. Anything less than that and trust, along with the success of your change project, goes down the drain and cynicism spirals out of control.
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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