Advice You - Business

Do you want to succeed in developing and maintaining your needed strategic alliance, collaboration or partnering relationship? Then you must be ready to overcome the pitfalls and roadblocks before they arise--before they kill your alliance. Three of these such pitfalls

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

are: Goals, Facts and Procedures Based.

Goals Based Pitfalls

In situations where a customer is the driving force behind a Partnering arrangement, you can be left holding the bag. Be sure to examine each Partnering proposal in the context of your company's overa

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

Examples of combination products may in

ll business strategy. This challenge was recently apparent to IBM and it discontinued its alliance with Somerset PowerPC and Motorola, in producing microprocessors for Apple.

When sitting down at the Partnering table a partner might find the relationship seat uncomfort

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

able. It could be that your partner has a different level of emotional and physical comfort, or sometimes it is simply a change in corporate strategy or a restructuring which leads away from a partner's product and/or technology causing the partners distress. It is impo

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

rtant that you know the short and long-term goals of your alliance partner.

When you try to partner with a potential or current customer and have them renege on the promise of purchasing from you, the disloyalty challenges that can occur can be wasteful. Be cautious, a

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

Combination pro

s there is also the possibility of your partner being unethical and attempting to capture your technology or trade secrets. This is a difficult area from which to protect yourself, but if you do your due diligence, your chances for success increase.

Facts Based Pitf

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

alls

Relinquishing some control with the expectation of greater shared returns can be a difficult waiting game. Additionally, your resources can get pulled in too many directions based on collective alliance decisions. Be certain you can spare the resources you dev

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

ote to your alliance. Otherwise you may put the success of your entire operation in harm’s way.

The lack of third-party cooperation can be a true relationship problem. All the primary members of a Partnering agreement will have to give a little for your agreement to wo

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

rk. Worse yet is your partner receiving unfavorable or harmful media coverage. This is because you are usually pulled into the picture and believed guilty by association. Real or perceived, image and reputation are critical to any company's success.

Be careful in globa

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

l alliances. Contracts with an overseas market, for instance, often take a long time to finalize. By the time you get going, in the technology industries, your competition may have already gotten started. If you are already behind and you have developed an alliance with

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

a partner organization that is weak and bleeding, they will only bring you down faster and harder.

Procedures Based Pitfalls

It is easy to underestimate how much time, energy and resources will be necessary to commit to your new alliance. Then not having acces

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

Following aspects would a

s to your alliance partner’s employees is an important issue. The closer the planned relationship between the two companies, the greater the importance of the linkages between them. You might find yourself in a situation of a small company Partnering with a large compan

dd to the challenges in developing combination products:

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

y. A challenge in working together will be that of the representatives, usually top executives of the small can make decisions on the spot. Unfortunately, the employees of the giant must take a proposal up the chain of command. This sometimes slows progress to a snail’s

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

pace.

Culture clash is a frequent Partnering challenge. The failed alliance of IBM and Apple is a typical example. The heralded early 1990s announcement promising cooperation eventually spawned Taligent Technology and Kaleida Labs. Unfortunately the two could not coex

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

ist so the alliances eventually gave way to a quiet breakup about five years later.

Putting all your alliance relationship eggs in the basket of only one executive or manager is not a smart idea. The management tenure of your alliance contact can signal success or fail

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

ure. If you have a one-person relationship, what happens if they get promoted out of the area, fired or even die? You are out of luck. Build relationships with several key contacts in the organization of your alliance partner.

What if your partner’s internal or externa

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

Professional from academic institutions, pharmaceutical industries, health care indust

l rewards structure interferes with the success of the alliance? This could apply to employees, customers or suppliers. If you are a supply partner and your partner has traditional rewards for their buyers, the buyers will only be interested in concessions and cost redu

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

ctions. On the flip side, sellers usually offer rewards for sales performance and this also can be challenging in making a relationship work.

There certainly is a difficulty in communicating across various time zones. Solving problems quickly when your Partnering facto

.

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

ry is located halfway around the world is hard enough, but when also speak a different language, that just makes it more of a formidable task.

Inertia, not having the emotional ownership in getting started is a true pitfall. Add this to chaos, seeing too many alliance

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

Companies that provide selfless information through particip

choices and ways to create an alliance, some never do get started. The two sides of the sword are, if you wait for everything to be perfect, they never will. And if you do not put enough energy into an intelligent choice, your alliance could be doomed from its inception

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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