Advice You - Business

How far can you go based on your relationship with an alliance partner?

The imagi

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

nary line you draw in the sand will let you know when an alliance is getting close

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

Examples of combination products may in

to failing. I would suggest setting the line a little higher than the disaster po

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

nt. As a matter of fact, the line should sit around the seventy-five percent posit

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

ion. This way you can work with the partner before the relationship dips too far d

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

Combination pro

wn. A partner that experiences lulls in sales may be a fairly normal occurrence, 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

ut when it is compounded by lack of communication and lack of marketing, you know

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

hat something else is the underlying problem.

Alliances and partnerships are simp

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

ly a way for you to market your goods and services. They will always have lulls an

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

marketing efforts will sometimes be lax. If you take the time to monitor all the

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

details and be consistent with your support, then the alliance partner will not fe

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

Following aspects would a

el that you have over-committed with other partners, and they will still feel that

dd to the challenges in developing combination products:

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

they are important. You should also remember that having a service level agreement

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

in place to define sales, marketing efforts and first rights of refusal will add

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

o a successful alliance. You must remember that you are the expert in the field an

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

d that they will rely on you for help and support

A word of caution when it comes

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

Professional from academic institutions, pharmaceutical industries, health care indust

to support: You should always support the customers of an alliance partner. You sh

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

ould always monitor the amount of support you give to each of your alliance partne

.

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

s. You should always educate partners that need more help than others. There alway

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

Companies that provide selfless information through particip

s needs to be a number of touch-points in order to be aware of a potential failure

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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The differences between two organizations that provide the exact same services can be HUGE! Those differnces add up to one thing: service. Think you are in a comodity business and can no longer compete? Think again. Service can differentiate you in the marketplace. This is a tale of how that looks from the customer's perspective...

Indeed, our craze for getting organized and up to date has spilled over and now; we even have real people who use the concept of planning as a job.

Sure, as tactics usually presented to business, non-profit and association managers, special events, brochures and news releases are fine.

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Advice You - Alliances: Drawing The Line

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