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There are five ways to predict victory. He who knows when to launch an attack and when not to will win. He who knows when to vary the size of his troops according to battle situations will win. He who is able to unite his w

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

hole army as one will win. He who is well-prepared and far-sighted and awaits his enemy will win. He who is capable and does not have to contend with the interference of his ruler will win. These are the five ways to decide if

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

a victory can be secured. – Chapter Three, Sun Zi Art of War.

As seen in the above lines, there are circumstances when one can secure victory. And they are:

1) The general knows when to attack and when not to at

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

tack. Such a general would be able to engage his enemies when there are higher odds of victory, thus does not worn out his troops easily and reduce the burden of war on the nation.

Business Application

Applying this t

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

business is, the management needs to know when to take action and when not to take action on certain decisions they have made. For instance, maybe a new factory is in the plans but building it where and when is important beca

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

use a factory is a fixed assets and a wrong move could affect the cashflow of the company. Moreover, the factory can only add manufacturing capacity to the company after a certain time lag.

2) The general must know when to va

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

y the size of his troops according to the battle situations. Knowing what the ideal size of troops is for each battle situations would be able to reduce the resources and provision needed for the military campaign, again this

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

would reduce the burden on the nation. The general must also know what type of troops to bring as well.

Business Application

The leader in a particular department or team should be able to know the strengths and weakn

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

sses of each and every individual in his department or team. From there, he should know who will complete each individual project with the best result, which person should partner with who so as to achieve synergy. This form o

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 human resource management would be analogous to management of troops during military campaign.

3) The general who is able to unite his whole army as one will win. As mentioned in the first chapter of Sun Zi Art of War, it i

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

mentioned that unity is one the determining factor of the success execution of strategy.

Business Application

This is straightforward. Again we see the mentioning of unity again. So the team leader needs to unite his

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

whole team. If the team is not united, synergy cannot be created and worse, the skills of individuals may not be able to bring out the best result because of constant bickering.

4) The general should be well prepared and far-

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

sighted and awaits his enemy. The far-sighted general would be able to anticipate and use to his advantage, the surprises enemies want to spring on them. This would render his enemies’ plans ineffective, which is the first and

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

best form of strategic attack as mentioned in the same chapter.

Business Application

In all businesses, planning and execution of plans are part and parcel of every work day. So in businesses, the one who is far-sight

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ed and detailed in their planning has higher odds of success in reaching their goals. The more detailed you are in your plans, you would be able to anticipate and resolve any emergencies that the volatile business environment

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

resents. A far-sighted general would also be able to thwart any plans or counter strategies his rival execute rendering them useless. As mentioned in Leadership, Rudolph W. Giuliani was able to plan out all contingencie

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

s plan for any emergency that happen to New York City, for example, he has contingency plans for Sarin Gas attack in the subway, bombings and building collapse.

5) The general does not have the ruler interfering on every deci

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ion he made during the military campaign. Because no matter how capable a general is, if the ruler interferes with the general’s orders and planning, the general would be equivalent to working with his hands tied up. He would

.

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

not be able to do his best because his best has been limited by the ruler.

Business Application

So as mentioned, you have the foresight of hiring the best talents that is available for the position, but have you ‘hand

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

uffed’ the talented personnel? Have you given him the room to explore his best or the organization culture has placed limitations on him? Check out your company’s systems and culture. Give your talents room to grow and explore

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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