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Just Other Articles - How You Impact Your Organization's Culture
Bob moved to a new company, and it wasn’t too many days before he was invited to a meeting. The meeting announcement he received said that the meeting started at 9 am in room 105. At 8:55 he walked into an empty room. Frantic he went back to his computer to see if he had
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
the details right. He checked and double checked and realized he was right – 9 am, room 105.
As he briskly walked back to the meeting room he was puzzled. He thought, “Why was the room empty, when it is almost time for the meeting to start?” He walked in at 9:02 and still
As he briskly walked back to the meeting room he was puzzled. He thought, “Why was the room empty, when it is almost time for the meeting to start?” He walked in at 9:02 and still
; 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
no one was there. He sat there for a couple of minutes when he saw someone he recognized – who also was on the invitee list – walking by the door. Bob asked if the meeting was still on and if it was still for 9 am? Susan replied that the meeting was on, that Bob was in t
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
he right place and that “meetings never start on time here.” Sure enough, about 9:15 everyone, including Susan, arrived and the meeting got started.
That night Bob told his wife the story and related how different this was from his last company. “There, everyone was there
That night Bob told his wife the story and related how different this was from his last company. “There, everyone was there
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
five minutes early, because we always started on time.”
Bob is learning – first hand – about his new organizational culture – one quite different from what he is used to.
What is it?
Organizational culture – it’s something we don’t usually talk about,
Bob is learning – first hand – about his new organizational culture – one quite different from what he is used to.
What is it?
Organizational culture – it’s something we don’t usually talk about,
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
but we feel everyday. A culture is defined by what is expected of people and what is valued. It defines the norms of behavior and “how things are done” in an organization – whether that organization is a family, a team or a business.
To be successful in any setting it is
To be successful in any setting it is
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
important to understand the culture – this understanding allows us to navigate successfully through our day and be productive. Culture is important then because it defines the boundaries of behavior and performance, which allow us to produce rather than discuss “how” to do
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
everything – it becomes a short hand way to get things done.
Cultures often develop from people’s early experiences in an organization and over time these experiences become the unspoken “rules of the road.” This is natural and usually just fine, except that sometimes wha
Cultures often develop from people’s early experiences in an organization and over time these experiences become the unspoken “rules of the road.” This is natural and usually just fine, except that sometimes wha
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
naturally develops or evolves isn’t exactly what we might want those “rules” to be. While they may have worked in the past, now they no longer serve the organization very well.
What now?
Since these rules develop gradually and become deeply engrained, what do we do
What now?
Since these rules develop gradually and become deeply engrained, what do we do
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
if we want to change them?
In most organizations, if this question is asked at all, the answer would be to point to senior management. After all, they are those in charge of the organization – if something about the culture is holding the organization back, they should be
In most organizations, if this question is asked at all, the answer would be to point to senior management. After all, they are those in charge of the organization – if something about the culture is holding the organization back, they should be
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
responsible for fixing it.
This is a logical assessment, but woefully limited in application. In reality the culture doesn’t belong to a CEO or a senior leader. It belongs to everyone. And while there are cultural norms that spread across an entire organization,
This is a logical assessment, but woefully limited in application. In reality the culture doesn’t belong to a CEO or a senior leader. It belongs to everyone. And while there are cultural norms that spread across an entire organization,
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
there often are differences within a department, a workgroup or a geographical region.
Perhaps there are things in your organization’s culture that you would like to change – Bob certainly preferred meetings that started on time, for example. So if the culture belongs to e
Perhaps there are things in your organization’s culture that you would like to change – Bob certainly preferred meetings that started on time, for example. So if the culture belongs to 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
eryone, what can you do to change it for the better? What role can you play as an individual?
What You Can Do
Have a clear picture of what you desire. If, for example, you want to build a more positive and fun work environment, you need to be able to describ
What You Can Do
Have a clear picture of what you desire. If, for example, you want to build a more positive and fun work environment, you need to be able to describ
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
e what you are looking for – not just think you will know it when you see it. Getting a clearer picture of what fun means in your situation is critical to you successfully adjusting the culture.
Understand the benefits of the change. You need to see the benefits cl
Understand the benefits of the change. You need to see the benefits cl
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
early so that you will stay motivated to change, but also because others won’t change without understanding why. Define benefits organizationally and personally.
Communicate with others. Once you have a clear picture of what and why, it is time to help others see y
Communicate with others. Once you have a clear picture of what and why, it is time to help others see y
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
our new picture. How can you expect them to buck the trend of “how things are done” if they don’t see a better way?
Model the new behavior. Want the culture to be different? It starts with you. Gandhi said, “We must be the changes we want to see in the world.” Th
Model the new behavior. Want the culture to be different? It starts with you. Gandhi said, “We must be the changes we want to see in the world.” Th
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
se five steps form a specific plan that you can use to create the changes you want to see. But this fourth step is critical – you must embody and personify the new cultural norms yourself.
Begin to expect it of others. Unfortunately, this won’t be as easy as
Begin to expect it of others. Unfortunately, this won’t be as easy as
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
flipping a light switch. It will take some time for people to get onboard with a change even if they agree that it’s a positive step. You start by encouraging them, supporting successful change and recognizing progress.
You can do these things regardless of your position
You can do these things regardless of your position
.
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
. Start small (like with yourself). Then expand it to those immediately around you. If you are a production worker your actions won’t affect the culture of your multi-national employer overnight, but they can begin to positively change your immediate work environment. Re
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
gardless of your role, you can positively impact the culture in which you work, but only if you are willing to stand up and be accountable.
Don’t shrug your shoulders; do roll up your sleeves. You are a co-owner of your organization’s culture, and you can make a difference
Don’t shrug your shoulders; do roll up your sleeves. You are a co-owner of your organization’s culture, and you can make a difference
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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