Main Subject - Business

A strategic alliance is a partnership, a collaborative agreement and/or a relationship bet

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

ween two or more companies or organizations formed to pursue a set of agreed upon goals wh

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

Examples of combination products may in

ile remaining independent companies or organizations. Strategic alliances exist in a vari

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

ety of shapes and sizes and include a wide range of scopes of cooperation levels. Strate

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

gic alliances usually are most effective when the entities involved have complementary str

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

Combination pro

engths.

As a business coach and business owner, I have witnessed the clear and powerful b

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

enefits of carefully constructed strategic alliances and have employed and endorsed this c

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

oncept for more than 35 years. Based upon those 35 plus years of experience, here are wha

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

t I consider to be twelve (12) of the most clear and powerful benefits of developing and w

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

orking with strategic alliances.

1. increased and enhanced credibility and image of your

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

company

2. access to new skills, knowledge and experience

3. access to greater resources

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

Following aspects would a

than those of your own company or organization

4. more competitive purchasing and supply

dd to the challenges in developing combination products:

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

deals

5. enhanced marketing and sales efforts

6. added value and extra benefits to cli

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

ents and customers

7. leverage from another company or organization’s recognized and valu

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

ed brand

8. collaboration on larger and more complex projects and programs

9. increased

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

market penetration

10. increased cross-marketing possibilities

11. access to new markets

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

Professional from academic institutions, pharmaceutical industries, health care indust

and distribution channels

12. access to increased customer database

The clear and power

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

ful benefits from strategic alliances are available and can be very valuable to you and yo

.

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

ur company. The power of a strategic alliance exceeds the sum of the power of the individ

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

Companies that provide selfless information through particip

ual companies or organizations added together, but acting outside of a strategic alliance.

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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A great article that explains why it's important to focus on marketing instead of selling.

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