Main Subject - Business

In the book Alice In Wonderland, there is a scene where Alice comes to a fork in the road, she looks down the right road as far as she can see, and sees nothing. She looks down the

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

left road as far as she can see, and sees nothing. In the center of the fork is a large oak tree with the Cheshire Cat grinning a grin as big as a grin can be. Not knowing which way

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

Examples of combination products may in

o take the fork, she asks the Cheshire Cat, “Which road should I go?” his reply; “which road do you want to go?” and Alice says “I do not rightly know which road to go.” The Cheshir

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

Cat’s response to her was, “if you do not know which road you want to go, then it makes no difference which road you go.” The moral of the scene is: If you do not have a Goal set,

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

r a direction to go, it makes no difference which way you go, nor will you know when you get there.

Planning and goal setting are essential parts of every business. A “Plan of Acti

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

Combination pro

n” must be established so that work, effort and resources are directed in a controlled and coordinated manner towards the accomplishment of these goals and objectives. A good busin

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

ss plan establishes Goals and Objectives to be reached. Good managers direct their personnel. They manage their business every day without losing sight of their Goals and Objectives

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

They make decisions and changes as required to keep the business progressing toward present goals. With goals and objectives set, the manager can now anticipate instead of reacting

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

to events; he remains in control.

Without a business plan, a business tends to run on historical experience or on a crisis management basis, constantly putting out fires, rarely fin

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

ing the person with the matches. Employees work in different directions due to lack of common goals. This creates confusion, inefficiency and, in effect, excessive costs and reducti

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

n of profits. Does this sound familiar? The lack of a business plan limits growth. Efforts are based on day-by-day situations without planning. Essentially, without a plan, you are

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

Following aspects would a

"flying blind". Although businesses cannot plan for all contingencies, planning will reduce risk and provide guidelines for staying on course.

The next step is to establish the lon

dd to the challenges in developing combination products:

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

range goals. Usually, they are done for a period of three to five years. The goals raise questions in at least three domains: labor, facilities and financial.

LABOR: Do we have th

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

personnel available to support the growth, or will we have to increase staff? If we increase, from where will they come? Are our compensation programs competitive? What will the tr

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

ining needs be? Who will do the training?

FACILITIES: Do we have the equipment and space to support the business forecast? What replacements will be required? What new or expanded

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

equipment or facilities will be required?

FINANCIAL: What are the three to five year cash requirements necessary to support the projected growth? What type of major capital expendit

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

Professional from academic institutions, pharmaceutical industries, health care indust

res will be required for additional equipment? Will long term borrowing be required? Is it available? At what costs? How will cost of living factors affect my costs? Do I have admi

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

istrative personnel and facilities to support the volume figures? Where do I acquire them? At what cost?

Planning and setting goals is the first function of your company. Whether do

.

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

umented or not, there must be a purpose to be accomplished by the business. To facilitate communication, it is desirable that the purpose be specified in writing. The first goal of

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

Companies that provide selfless information through particip

our company is to survive; the second is to grow. The prime objective is to make a profit. The success and future of your company, ultimately depends on its ability to be profitable

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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