Main Subject - Business

Let me start by defining strategic alliance. A strategic alliance is a partnership, a collaborative agreement and/or a relations

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

hip between two or more companies or organizations formed to pursue a set of agreed upon goals while remaining independent compan

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

Examples of combination products may in

ies or organizations. Strategic alliances exist in a variety of shapes and sizes and include a wide range of scopes of cooperati

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

on levels. Strategic alliances usually are most effective when the entities involved have complementary strengths.

What makes a

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

strategic alliance effective? What are the key components of effective strategic alliances? Your Strategic Thinking Coach rese

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

Combination pro

arched this and came up with ten (10) key components of effective strategic alliances. Here is my list of ten (10) key component

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

s of an effective strategic alliance.

1. A shared vision. The strategic alliance must include strategic thinkers that have deve

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

loped a shared vision for the strategic alliance, which is larger than each of their individual company visions.

2. Complete tru

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

st in one another and an agreement of why they need each other as a strategic alliance partner.

3. Mutual respect for what each

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

partner brings to the strategic alliance.

4. Faith in the belief that the synergy of the strategic alliance will create somethin

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

g bigger and better by working together than by working separately.

5. Accountability through regular reporting of progress and

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

Following aspects would a

tracking of the agreed upon goals and objectives.

6. Agreement of expectations, timelines, resources, issues of performance, co

dd to the challenges in developing combination products:

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

nfidentiality, cost sharing, etc. In other words, establish a complete understanding of ground rules for the strategic alliance

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

and put that understanding in writing.

7. Open and continuous communications among all team members of the strategic alliance.

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

8. Established goals and objectives that are measurable.

9. Commitment to the goals and objectives and to all the team members i

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

n the strategic alliance.

10. Added value to each strategic alliance partner’s ability to serve its clients in the marketplace.

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

Professional from academic institutions, pharmaceutical industries, health care indust

The most effective strategic alliances will include all the above components. The power of an effective strategic alliance exce

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

eds the sum of the power of the individual companies or organizations added together when they act outside of a strategic allianc

.

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

e. If you are interested in learning more about these strategic alliance components and how to incorporate these key components

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

Companies that provide selfless information through particip

to build effective strategic alliances with your company or organization, please contact Glenn Ebersole through his website below

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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