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Advice You - Leading Change; Four Principles for Staying in Control
When leading a change programme, the bare minimum requirement of a leader is to be seen to be in control.
The people you are leading will have a range of anxieties about the change which different individuals will feel to a different depth. The nature of the anxiety and the depth of the anxiety will change over time, sometimes precipitously.
The people you are leading will have a range of anxieties about the change which different individuals will feel to a different depth. The nature of the anxiety and the depth of the anxiety will change over time, sometimes precipitously.
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 leader, however, must be seen to be in control. More than that, except for the odd private lapse of confidence which bedevils the best leaders, the leader of change must be in control.
My observations from being affected by and leading change are that there are a few guiding principles for maintaining control.
Pri
My observations from being affected by and leading change are that there are a few guiding principles for maintaining control.
Pri
; 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
ciple One: Focus on the goal
Day-to-day, leaders will receive good news and bad about the activities which make up the programme of change. Some activities will be ahead of where you thought they should be, some will be falling behind, or under seemingly impossible challenge to actually be completed.
Getting excited
Day-to-day, leaders will receive good news and bad about the activities which make up the programme of change. Some activities will be ahead of where you thought they should be, some will be falling behind, or under seemingly impossible challenge to actually be completed.
Getting excited
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
about activities which are ahead of progress and getting despondent or activating a reactionary process about activities which are not going well is sure way of communicating a lack of control.
Celebrating progress in a change programme is an important part of a change programme communication strategy. However, the celebration should be for pr
Celebrating progress in a change programme is an important part of a change programme communication strategy. However, the celebration should be for pr
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
gress towards the goal. The progress should always be measured as a balance of good and poor progress against the goal, where we have come from and the challenges which lie ahead of us.
Keeping a calm focus on the goal whilst encouraging overall progress and providing specific resources and guidance to fix problematic activities will give the
Keeping a calm focus on the goal whilst encouraging overall progress and providing specific resources and guidance to fix problematic activities will give the
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
team involved in the change increased courage and determination.
Reacting positively to good news and negatively to bad news only increases anxiety.
Of course, this principle assumes that the goal is clear and well understood. If it is not, take urgent action to clarify the goal of the change, its delivery date and ensure it is communicated i
Reacting positively to good news and negatively to bad news only increases anxiety.
Of course, this principle assumes that the goal is clear and well understood. If it is not, take urgent action to clarify the goal of the change, its delivery date and ensure it is communicated i
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
the languages and styles that the recipients will be most comfortable with and the mediums they have easiest access to.
Principle Two: Understand the building blocks of the change
Any change will have some key building blocks without which the change will not be affected. Building blocks will include items,
Principle Two: Understand the building blocks of the change
Any change will have some key building blocks without which the change will not be affected. Building blocks will include items,
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
for example, such as changing the competence of people, building infrastructure, purchasing equipment, implementing software changes, changing processes, developing products or gaining market understanding.
As a leader, focus a heavier proportion of your time ensuring the key building blocks of change are given the resources and management thi
As a leader, focus a heavier proportion of your time ensuring the key building blocks of change are given the resources and management thi
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
king time necessary to make sure they are completed.
Ensure more effort is spent on planning the building blocks. Demand more rigorous understanding of the critical path to completing the building blocks on time. Be prepared to spend more budget to compete the elements when problems arise which require more resources. Insist on a detailed risk
Ensure more effort is spent on planning the building blocks. Demand more rigorous understanding of the critical path to completing the building blocks on time. Be prepared to spend more budget to compete the elements when problems arise which require more resources. Insist on a detailed risk
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
management strategy being developed and executed.
Leaders who do understand the building blocks of the change they initiated ensure not only that the organisation as a whole is seeing the wood for the trees, but will coach others to act similarly in their sphere of influence almost without knowing it.
Principle Three: Develop and exe
Leaders who do understand the building blocks of the change they initiated ensure not only that the organisation as a whole is seeing the wood for the trees, but will coach others to act similarly in their sphere of influence almost without knowing it.
Principle Three: Develop and exe
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ute a risk management strategy
If we all had a crystal ball that worked, we would not need to develop a risk management strategy. Unfortunately, for leaders of major change programmes, a working crystal ball has yet to be found. Further, change programmes, more so than any other project, are full of uncertainties and
If we all had a crystal ball that worked, we would not need to develop a risk management strategy. Unfortunately, for leaders of major change programmes, a working crystal ball has yet to be found. Further, change programmes, more so than any other project, are full of uncertainties and
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
ambiguities.
The main reason for the uncertainty and ambiguity is that change programmes always involve or impact people. They impact one or more of customers, shareholders, employees including team leading the change, public servants, governments, suppliers and the general public.
How all, or one of these groups of people will react, is not
The main reason for the uncertainty and ambiguity is that change programmes always involve or impact people. They impact one or more of customers, shareholders, employees including team leading the change, public servants, governments, suppliers and the general public.
How all, or one of these groups of people will react, is not
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
ver really known until the change programme starts to play out as it is not just the change that causes reactions nor what people do, but importantly, what people say about the change and elements in it and how they say it.
Completing a risk analysis is moderately easy. Every change programme has its nay sayers. Utilise them and a good range o
Completing a risk analysis is moderately easy. Every change programme has its nay sayers. Utilise them and a good range o
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
f experienced, inexperienced, intellectual and practical people to determine what the risks are for the change programme. Developing a robust and actionable (in time) contingency plan for those risks which are considered to be high impact, whether high or low probability, is more difficult but must be done.
Knowing your risks, building conting
Knowing your risks, building conting
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
ncy plans and making those contingency plans part of the change programme is buying insurance for a leader's ability to stay in control.
Principle Four: Communicate early and often
The simplest way for a leader to lose control of a change programme is to allow the rumour mill to develop and then run. The lead
Principle Four: Communicate early and often
The simplest way for a leader to lose control of a change programme is to allow the rumour mill to develop and then run. The lead
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
er and their team are inevitably caught up in reacting to rumours, reducing the time they can spend on the key building blocks of change. Additionally, and fatally if it is allowed to happen, the concentration of the leader, the change programme team and the organisation as a whole drops away from focusing on the goal to the minutiae of the day
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
Leaders must develop a communication strategy that encompasses all stakeholders and what it is that they want communications with them to make them feel, think and do. The communication strategy must be built on what messages, through what mediums, at what frequency, delivered by which person, will help the stakeholders feel, think and do wha
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
t will be helpful for the success of the change programme.
The communication strategy must take into account the different filters of experience, upbringing, emotional state and thinking styles that people in the organisation will apply to the receipt of communication. The filters will change over time.
Communications, therefore, need to be p
The communication strategy must take into account the different filters of experience, upbringing, emotional state and thinking styles that people in the organisation will apply to the receipt of communication. The filters will change over time.
Communications, therefore, need to be p
.
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
ural and frequent to allow people to assimilate the messages at their own speed.
If people are not told what is happening in a major change programme, their anxiety leads to them making their own conclusions based on past history, snippets of information heard in corridors, tea rooms and read in newspapers. The leaders of the change programme
If people are not told what is happening in a major change programme, their anxiety leads to them making their own conclusions based on past history, snippets of information heard in corridors, tea rooms and read in newspapers. The leaders of the change programme
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
and their team then have to react to what is not real rather than what is real.
Staying in control and being seen to stay in control is a paramount behaviour for a leader of major change. It is what they are paid for. It is difficult at times. Staying true, however, to a few key principles makes it much easier than it otherwise would have been
Staying in control and being seen to stay in control is a paramount behaviour for a leader of major change. It is what they are paid for. It is difficult at times. Staying true, however, to a few key principles makes it much easier than it otherwise would have been
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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