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Like any major project, creating a business plan requires many different disciplines and resources. Here, four different plan considerations will be discussed. They are: 1) creat

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

ion team members, 2) partitioning the plan parts, 3) assigning team member hierarchy and 4) writing and editing the plan. Each of these areas is of great importance.

First, appro

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

Examples of combination products may in

priate team members must be assembled that have the expertise to address the plan parts. While it isn't necessary that every one be a skilled writer, they should possess the knowl

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

dge needed to create the plan parts. That knowledge can be explicit (e.g., accounting or business management) or process oriented (e.g., internet researcher or editor). Another v

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

ery important consideration for a member is to assure they are committed to the plan process. The business plan creation process is complex, arduous, stressful and time consuming.

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

Combination pro

Each potential team member must be assessed during an interview to make sure they are a willing and enthusiastic candidate and that they have the ability to work with the team to

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

complete the desired plan.

Next, once the business plan creation team has been selected, it will be necessary to partition the plan and assign parts to the various team members.

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

ome members will be doing research (e.g., competitor analysis or internet research), others will be creating plan pieces (e.g., financials or budgets), still others will be assembl

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

ing the plan pieces and finally someone will be required to write and edit the business plan package.

Another important element of the business plan process will be setting up the

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

team member hierarchy. The business plan creation process is complex and there are many opportunities to overlap, conflict and waste effort. It is necessary for each team member

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

to understand his or her exact duties and responsibilities.

At the top of the team hierarchy will be a member that is the integration manager. This function is to make sure the p

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

Following aspects would a

lan parts fit together and complement each other. Effectively, the integration manager is the master of the team and his/her skill will contribute to the quality, flow and complet

dd to the challenges in developing combination products:

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

ness of the plan. He/she will act as dictator, conciliator and cheerleader during the creation process.

The final complex tasks are the writing and editing processes. This daunt

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

ing process brings together all the research, development facts, financial projections and the marketing concepts into a written document. It is a process to create a clear, uniqu

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

and doable written plan for the business. It is most of all a marketing document and must talk directly to those outside entities that are to be impressed. Plans are used to obt

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

ain investors, financing and other backing. It's carefully written to address the unique organizations and individuals that will be required to help make this business succeed. I

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

Professional from academic institutions, pharmaceutical industries, health care indust

must sell them that plan documents what is needed and how the business will succeed in the accomplishment. While the financials are important the sales and marketing aspects are

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

essential in a positive presentation outcome.

In conclusion, the business plan team must have the resources, skills and desire to create a quality plan. The quality, thoroughness

.

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

and skill of the plan team will determine if the business plan presents the appropriate facts, sells the business opportunity and demonstrates a mastery of the business environment

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

Companies that provide selfless information through particip

necessary to be successful. It doesn't matter how wonderful the product or service is, someone must get it to those in need--The business plan gets this process started correctly

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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