Advice You - Business

A joint venture (often abbreviated JV) is a legal entity formed between two or more parties to undertake economic a

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

ctivity together. The parties agree to create a new entity by both contributing equity, and they then share in the

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

Examples of combination products may in

evenues, expenses, and control of the enterprise. The venture can be for one specific project only, or a continuing

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

business relationship such as the Sony-Ericsson joint venture.

Generally, joint venture is the merging of two (or

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

more) companies, enterprise or organization towards a more profitable, mutually beneficial and stronger entity in t

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

Combination pro

e market. They may have varied goals, or may lead only to one goal. Still, the merging was completed because it pre

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

sented a win-win situation for both (or all) parties.

A joint venture may be of various kinds – temporary merging

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

r permanent partnership. This is depending on the goals or projects being covered or strategies being adopted by on

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

or more merging parties.

Organizations can also form joint ventures, for example, a child welfare organization in

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

the Midwest initiated a joint venture whose mission is to develop and service client tracking software for human s

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

rvice organizations. The five partners all sit on the joint venture corporation's board, and together have been abl

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

Following aspects would a

to provide the community with a much-needed resource.

Some countries, such as the People's Republic of China, req

dd to the challenges in developing combination products:

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

uire foreign companies to form joint ventures with domestic firms in order to enter the Chinese market. This requir

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

ment often forces technology transfers and managerial control to the domestic partner.

Reasons for forming a joint

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

venture:

Internal reasons
1. Spreading costs and risks
2. Improving access to financial resources

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

> 3. Economies of scale and advantages of size
4. Access to new technologies and customers
5. Access t

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

Professional from academic institutions, pharmaceutical industries, health care indust

innovative managerial practices

Competitive goals
1. Influencing structural evolution of the industry

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

2. Pre-empting competition
3. Defensive response to blurring industry boundaries
4. Creation of s

.

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

tronger competitive units
5. Speed to market
6. Improved agility

Strategic goals
1.

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

Companies that provide selfless information through particip

ynergies
2. Transfer of technology/skills
3. Diversification

Copyright 2007 Ismael D. Tabij

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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