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E-Folder - Business Process Consulting -- Corporate Team Building
Building critical thinking approaches, skills and processes into the structure of a business is an imperative of high performance, at both the individual and the corporate leadership
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
skill development level.
Effective and high performing businesses create an environment of continuous learning, where critical thinking capabilities are honed, developed and encourag
Effective and high performing businesses create an environment of continuous learning, where critical thinking capabilities are honed, developed and encourag
; 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
ed. Debate and discussion are welcomed and encouraged within a supportive and high-energy collegiate environment.
There are three fundamental elements that must be incorporated into
There are three fundamental elements that must be incorporated into
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
the culture of the businesses for this critical thinking capability to be developed.
Element One - Scan and Understand the Environment
High performance corporate teams “r
Element One - Scan and Understand the Environment
High performance corporate teams “r
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ad the times,” build assumptions about their environment and document their thinking, so that the people around them can understand precisely what they are talking about.
They ab
They ab
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
sorb knowledge from many different sources and pick trends and nuances that are emerging from both the internal and external environments within which they exist and operate. And, th
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
ey maintain single-minded focus on the needs of the business.
As individuals, they share information in a spirit of generosity, and they ask each other the hard questions, within an
As individuals, they share information in a spirit of generosity, and they ask each other the hard questions, within an
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
thos of collaboration, partnership and cooperation. They know that they are working together to the benefit of the whole business and not just for their particular part of it, or to
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
massage their own egos.
High performance corporate team building dispenses with the politics and game playing by using objective, evidenced-based data to test and analyse business as
High performance corporate team building dispenses with the politics and game playing by using objective, evidenced-based data to test and analyse business as
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
sumptions. Discussion is free flowing and energetic. Everyone treats each other with dignity and respect.
Knowing the world in which the business exists and operates allows high pe
Knowing the world in which the business exists and operates allows high pe
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
forming corporate teams to identify and think about the strategic matters that are important to the business and come up with innovative solutions to address them.
The business is th
The business is th
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
en shaped to adapt to these trends and issues that are emerging so that it can exploit and enhance them to its own advantage.
Element Two - Filter Information and Focus on the Rel
Element Two - Filter Information and Focus on the Rel
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
evant Data
In the high performance corporate team, information is reduced to its specific and particular relevance to the business.
In any given situation, most of the informati
In the high performance corporate team, information is reduced to its specific and particular relevance to the business.
In any given situation, most of the informati
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
on is irrelevant. Only 4% of the data in a given body of information, with its accompanying assumptions and emotionally laden content, is relevant to a specific management situation.
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
High performance management teams cut through this clutter and noise and home in only on the relevant information that will make a significant difference in the business.
Corporate
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
team building must include giving people the necessary tools to help them find their way through this fog, if they are to gain clarity of thought and make effective decisions.
Ele
Ele
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
ment Three - Align Rigor of Thought with Effective Action
All strategic thought must in the final analysis deliver results through well planned and well executed actions in the o
All strategic thought must in the final analysis deliver results through well planned and well executed actions in the o
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
erating environment of the business.
These actions must be undertaken using proven problem solving/conflict resolution skills in a manner that minimizes risks, maximizes opportunitie
These actions must be undertaken using proven problem solving/conflict resolution skills in a manner that minimizes risks, maximizes opportunitie
.
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
s and brings everyone along to achieve the business objectives.
All action is achieved in business with and through others. In this regard, self-awareness interpersonal communicatio
All action is achieved in business with and through others. In this regard, self-awareness interpersonal communicatio
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
n skills and capabilities are essential.
Corporate team building is about getting results for the business, and it must deliver those results based on effective thinking and analysis
Corporate team building is about getting results for the business, and it must deliver those results based on effective thinking and analysis
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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