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E-Folder - Executive Brief: Pandemic Preparedness Planning
Influenza preparedness is different from other types of emergency or disaster planning and preparedness because it requires us to fortify and protect an entire system, not just a project or a tas
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
k.
These words have special meanings in the disciplines of systems engineering or systems theory or computer software development. In our everyday world the distinctions are profound as well in
These words have special meanings in the disciplines of systems engineering or systems theory or computer software development. In our everyday world the distinctions are profound as well in
; 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
the way we address disasters.
Basically, a “task” is a defined set of actions necessary and sufficient to achieve a defined, limited objective. A set of tasks form a project, which also is inten
Basically, a “task” is a defined set of actions necessary and sufficient to achieve a defined, limited objective. A set of tasks form a project, which also is inten
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ded to achieve an objective, but is broader in scope and in the resources needed for accomplishment. In essence, these terms both define activities organized to achieve ends and are distinguished
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
by their scope and complexity. One conception is to say that tasks are bundled into projects that are bundled into programs that are the building blocks of a system. That system, to function, mus
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
t have each and every part necessary to make it work do its individual work at the right time, in a way that supports every other part; that state of affairs is called “integration.”
Preparednes
Preparednes
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
s planning for an earthquake, a fire, a flood, and a snowstorm necessitate actions that deal with a societal disruption that is limited in time and geographic scope. The larger society, like the
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
uman body’s immune system, marshals resources that it feeds to the part that has been disrupted, to control damage and to repair it, so that it can re-enter the larger system as a functioning par
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
t again. But preparedness for an influenza pandemic recognizes that the “disruption” can be on a scale so massive that the larger system is itself disrupted and hampered if not incapacitated from
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
sending effective assistance to localized parts of the system. For example, a community hit by a flood receives help from city, county, state and national entities. In a pandemic, these entities
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
themselves could likely be disrupted by 25 to 40% absenteeism in every business, government and health care organization, by surging needs for health care services and supplies that outstrip our
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
capacity everywhere, by the disruption for weeks of the supply services that provide water, food, heat, light, and transportation. In short our overall method for “getting the basics” is threaten
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
ed to be broken down and pushed back to a more primitive state, one that requires us to fend for ourselves, like wilderness survivalists, rather than relying on the basic life sustaining methods
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
that we can easily take for granted.
So, as we add up what we must address to be prepared to face the implications of a pandemic, we realize that the size and scope of the task is enormous; it i
So, as we add up what we must address to be prepared to face the implications of a pandemic, we realize that the size and scope of the task is enormous; it i
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
system-wide, national, even global. And our preparations must be integrated and comprehensive, that is, the planning of what to do with the parts (such as keeping electricity running or the food
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
supply coming) requires us to address all the other parts (like health care and transportation and global trade --- because much of what we use is produced abroad --- at the same time.
An apt t
An apt t
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
hough dire analogy might be a ship at sea which at the same time quickly loses power, develops multiple large leaks, is faced by an oncoming storm and an attack by pirates, while the crew is suff
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ring from widespread debilitating and life threatening infectious disease, while their communication links are not working. There is nowhere to turn for help. The crew has to find a way to deal w
.
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
ith all these problems at once and self-reliantly.
It is this requirement for us during a pandemic to deal with the whole system that supports our modern lives that makes it so challenging and d
It is this requirement for us during a pandemic to deal with the whole system that supports our modern lives that makes it so challenging and d
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
ifficult and distinguishes it from other disasters with which we must cope. We must utilize our resources and our learning from more limited disruptions to avoid “system failure” at a large scale
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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