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Here today. Gone tomorrow. This is obviously something most businesses do not want to think about, but should for the benefit of a busine

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

ss carrying on after the loss of key employees or owners.

Succession planning refers to the development of a comprehensive and coordinat

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

Examples of combination products may in

ed plan designed to insure an orderly replacement of key members of an organization when they are lost to the organization for any reason

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

. It reminds many of the idea of royal succession. Who is next in line for the throne? However, this is not exactly right. History showed

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

that too often the Prince was not properly prepared to assume the responsibilities of King with very serious results. The business succes

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

Combination pro

sion plan not only names the replacements but provides for their training and mentoring.

Within a Corporation, a good succession plan is

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

not only wise from a good business point of view, but is also part of the obligation of the Corporation to protect the best interests of

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

its stockholders. The history of business is full of examples of organizations that did not survive the loss of a key person. The success

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

ion plan must identify all key personnel and begin to groom their replacements so that an orderly transfer of responsibility takes place.

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

Key personnel can be lost for a number of reasons. The easy one is retirement. This is usually anticipated and there is plenty of time

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

o groom the replacement. However, retirement is not the only concern. Key personnel can be lost to death. They can be lured away by anoth

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

Following aspects would a

er Company. They might become ill and unable to perform their duties. They might even need to be replaced because of failure to perform t

dd to the challenges in developing combination products:

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

o an acceptable standard. All of these cases can create chaos within an organization unless a succession plan has been in operation.

Man

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

y organizations have Succession Insurance policies that are designed to provide the necessary funds for the recruitment and training of n

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

w personnel in the event of a sudden loss of a key member of the organization. This is one indication of how serious this issue can be to

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

a large business. It is a part of the risk management element of the overall business financial plan.

It is not just large Corporations

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

Professional from academic institutions, pharmaceutical industries, health care indust

that need succession planning. In fact, smaller business concerns can be even more adversely impacted by the loss of a key member of the

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

organization. It is a general rule that the smaller the business, the more important each individual member is to its success. While a la

.

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

rger organization might more easily adsorb the loss of a key member, the smaller organization may be totally devastated. Succession Plann

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

Companies that provide selfless information through particip

ing is the means to reduce this risk and is considered as important as any other form of insurance in the overall risk management picture

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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Many government regulators believe that no industry can police itself and yet having been involved in a franchising industry I see that the industry itself due to its very nature and structure causes cooperation between franchisees who are the investors, and the Franchisors who want to expand their brand name.

You may recall the scene in the film, “The Lion King,” in which Simba, having been banished from his murdered father’s kingdom, is floundering in the forest looking for sympathy from anyone who would listen to his sad tale of self-pity. He comes to a stream and, as he gazes into the waters, the form of his father appears and says: “Simba, you have forgotten who you are -- you are more than what you have become.” We all are more than what we have become. Read on to learn how to become better at what you do and who you are.

The systems model of management demonstrates that communication is what is needed for executing managerial functions and for integrating the organization with the outside world. Point of sale hardware exactly performs this function with the help of Management Information System (MIS).

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