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Thesaurus - Why Walk Before You Can Run?
Do you sometimes get frustrated that others cannot see the relevance or importance of the kind of business changes you would like to make in your operation? Maybe you had great success in a previous business, developing your team, or you've done some reading and are so
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
ld on the value of doing some work on the strategy and vision of your current business.
Or is it sometimes the other way round? Do you feel frustration about people advocating change that doesn't seem appropriate for the business; like insisting on an inspiring vision
Or is it sometimes the other way round? Do you feel frustration about people advocating change that doesn't seem appropriate for the business; like insisting on an inspiring vision
; 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
statement when what's needed first is delivering a profitable quarter, or a basic reporting system?
The perspective that is missing is that businesses go through states in their development; at any given state of development, paying attention to issues beyond that sta
The perspective that is missing is that businesses go through states in their development; at any given state of development, paying attention to issues beyond that sta
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
e is irrelevant. It's not that the concern to introduce work on key business issues is wrong in itself, only that those issues are irrelevantto the current state of the business.
The Three States of a Business
The Three States of a Business
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
>State 1: Survival and Integrity
The primary focus here needs to be on making sure that the business is financially viable - that it is profitable and has positive cash flow. All your effort needs to be focused on the factors that are
The primary focus here needs to be on making sure that the business is financially viable - that it is profitable and has positive cash flow. All your effort needs to be focused on the factors that are
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
hreatening survival: poor products, poor sales revenue and too much cost. It is essential to be sure that the basic operational and financial data is present and accurate, that there aren't any skeletons in the cupboard (for example legal, safety or quality issues), an
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
that working relationships in crucial roles are in basic good shape. Concentrate on one-to-one coaching and hands-on management.
At this state of the business, it is in crisis.People need to work intensely for it to survive: it needs heroes.
State 2:<
At this state of the business, it is in crisis.People need to work intensely for it to survive: it needs heroes.
State 2:<
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
strong> Consistent Credibility and Reliability
In State 2, you need to focus primarily on developing consistent, credible results, so that the business reliably delivers on its commitments to its stakeholders. The first way to do this is to p
In State 2, you need to focus primarily on developing consistent, credible results, so that the business reliably delivers on its commitments to its stakeholders. The first way to do this is to p
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
t in place efficient business processes in the key leverage areas such as sales, product development, operations, supply chain management, financial reporting and performance management.
The second requirement at this stage of the business is to focus on the building
The second requirement at this stage of the business is to focus on the building
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
f basic competencies in management, effective teamwork and accountability. This is where group coaching and training can be effective, especially when done with intact teams, and tied to achieving specific business measures.
Processes have replaced the need for indivi
Processes have replaced the need for indivi
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ual heroes!
State 3: Business Potential and Transformation
In State 3 the focus of the business and the people in it have moved beyond solely delivering reliable and consistent results, though these are of course still essenti
State 3: Business Potential and Transformation
In State 3 the focus of the business and the people in it have moved beyond solely delivering reliable and consistent results, though these are of course still essenti
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
l. You have a choice: the business has reached a plateau and there is a danger that it can stagnate. The challenge is to move on beyond creating a well-run business as an end in itself. The focus now needs to be on creating a truly inspirational future. Work needs to b
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
done to ensurethat everyone in the business has a shared vision of an inspiring future that they can articulate concisely and compellingly - and act on!
A business like this inspires heroism in the form of leadership, which does not just exist in the senior levels of
A business like this inspires heroism in the form of leadership, which does not just exist in the senior levels of
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
management and directors but runs through the entire business. Teamwork is self-generating: teams form and become effective independent of direction from senior leaders.
At this stage of the business, focus on transformation - creating and managing new mindse
At this stage of the business, focus on transformation - creating and managing new mindse
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
s from which to operate the business, continuously developing its thinking and performance. Exploring group and individual mindsets can become a natural part of dealing with issues and obstacles to progress in the business. As a result at this stage, issues are resolve
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
and progress made very rapidly.
How to Use the Principle
It is important to remember that each state of the business's progress builds on and includes the one before. Even if your business has reached State 2 or 3, it can regress if an issue
How to Use the Principle
It is important to remember that each state of the business's progress builds on and includes the one before. Even if your business has reached State 2 or 3, it can regress if an issue
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
round business integrity or reliability arises. The important thing is to pay conscious attention to where it is at any given point in time - a business may go ‘backwards' as well as ‘onwards'!
Once you fully understand the principle we outline here, it becom
Once you fully understand the principle we outline here, it becom
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
s obvious why there is sometimes resistance to things you would like to do in your business. You cannot move ahead until you deal with the issues at each stage. They demand attention, and until they are resolved and the business can credibly be said to be operating at
.
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
he next state, there will be no tolerance for carrying out work on any further issues.
At the point where a business moves to the next state of development, issues appropriate to that state will naturally arise. The business will eventually naturally demandthe work th
At the point where a business moves to the next state of development, issues appropriate to that state will naturally arise. The business will eventually naturally demandthe work th
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
t needs to be done, there will be an appetite for doing it, and it will feel 'right' and relevant at the appropriate time.
==> for more information view the original newsletter article here <=
==> for more information view the original newsletter article here <=
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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