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However, in this new Internet age, strategic alliances between companies that are direct competitors are taking place. In such cases, one company agrees to buy services from the 2nd company to resell at a higher cost to company one’s end cu

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

stomers. In such a case, a company located in a low cost country (like India, China, etc.) or that has offices in a low cost country, forms an alliance with a company located in a high cost country (like the US, UK, etc).

In such cases,

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

Examples of combination products may in

oth companies are selling the same services. But they are bound by an agreement that prevents the company selling the services (from a low cost country) to directly interact with clients of the company buying the services (in a high cost co

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

ntry like the US).

The company that is buying the services also has the added benefit of getting diversity in skill set and flexibility to add or reduce resources without the disadvantages associated with hiring and firing people to accomm

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

date peaks and valleys in business.

Why form Strategic Alliances?

Regardless of the type of strategic alliances that are formed, there are many advantages to both companies involved in an alliance. Strategic alliances al

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

Combination pro

ow businesses to gain a competitive edge by leveraging partner resources such as marketing, technology, capital investments, and people. It also benefits both companies by allowing them to brainstorm ideas, leverage skills, and leverage con

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

ections to take the business to the next level. By forming strategic alliances, companies can add complementary skills to diversify offerings without the added cost of finding talent with new skills, ongoing training, and the need to mainta

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

n employee overhead costs.

All these allow companies to boost productivity while saving time and effort due to the ready set of skills that are available at their disposal. The company selling the services can benefit from the alliance du

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

to the fact that it opens the door for ongoing work thus allowing them to focus on employee development and retention.

Both companies benefit from having strategic discussions on what to focus on next, from brainstorming ideas together, c

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

nducting joint marketing, and in general from using resources that are readily available through the alliance.

The internet has created a global marketplace but it has also brought more competition that if the market place had been geograp

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

ically limiting. Therefore, companies need to be more and more creative in terms of how to grow and gain an edge over their competition. Strategic alliances help them do just that.

How to form a successful Strategic Alliance?
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
rong>

From experience I’ll tell you that it’s tough entering into a strategic alliance. Generally I’ve found that companies that lack a strategic plan and vision don’t necessarily get the concept of what a strategic alliance means. They a
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
so perceive the requesting company as a threat and in general shy away from even discussing

Sometimes, you may proceed along fine until you begin to discuss revenue sharing or commission structures. This derails a nicely progressing relati
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
nship when both companies cannot agree to the commercial arrangement proposed by one or the other.

Therefore, before approaching a strategic alliance, here are some steps that may help you:

? Define goals and objectives for both com
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
anies

? Define success measures – that means that both companies should list what they would consider a successful outcome from that strategic alliance

? Clarify what each company will do and clearly document roles and respons
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
bilities

? Define or create an operating agreement to plan what needs to be done, by whom, by when, etc.

? Document commercial agreement related to individual costs, revenue sharing, commission structures, operational overruns
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
marketing costs, etc.

? Define exit clauses in the event that the strategic alliance just doesn’t work out for any reason

? Make sure you never operate on just a verbal agreement, document everything to protect both parties

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
Lastly, protect intellectual property because lets face it, we’re dealing with human beings and although a relationship can begin with trust, it takes no time for that trust to change into betrayal.

In summary, we know that most l
.

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
rge companies have understood and successfully created strategic alliances. What amazes me is that small companies and mid sized companies are still moons behind embracing this philosophy and thus are ill-equipped to sustain growth in the
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
ace of rising competition.

Jenesys Group, LLC has formed many successful strategic alliances with companies across the globe in the UK, Central America, US, Canada, and Mexico. You may see our services at www.jenesysgroup.com/services.ph

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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