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Misinformation Based Pitfalls

You could easily be guilty of underestimating the complexity of coordinating and integrating corporate resources, and overestimating your partner's abilities to achieve the end result. Self-doubt

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

and not believing you have the skills and tools to create an alliance can crop up here.

Eventually, Partnering success depends on management’s abilities, skills, commitment, aspirations and passions in assembling the pieces of the

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

Examples of combination products may in

uzzle. When unequal dependence in a relationship occurs, the partner with the least dependence could be less likely to compromise and put energy into the relationship.

Meanings assigned to words by different cultures can cause serio

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

us problems. In one culture quick delivery could mean one day and in another it could mean one month. This opens the can of worms often referred to as unrealistic expectations of a partner's capabilities. The areas commonly include t

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

chnology, research, production skills, marketing might, and financial backing.

We also have the unexpected inefficiencies or poor management practices of a partner that can be the demise of a well-intended alliance plan. Also at ris

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

Combination pro

k is the area of developing an alliance with multiple partners, who later become rivals to one another. This puts a serious strain on the integrity of the remaining alliance.

Now that you've had a view of Partnering from the downsid

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

, don't let these hurdles stop you. Be clear on what alliance partnering is not. It is not instant gratification, nor a quick fix. It is not a flavor of the month management strategy. Strategic alliances are separate entities that h

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

ave come together to solve their individual problems in a way that serves the whole mutually. It is sharing core competencies that overlap and create synergies. The struggle is a necessary part of any relationship that is valuable an

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

lasting.

To reduce the effects of Partnering pitfalls, David Elliott, senior vice president and chief administrative officer at Technicolor in Hollywood, CA shared his thoughts with me. "If a partner fails to meet their responsibil

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

ities, a clear agenda is necessary that both sides are operating from. When the agendas are different or conflicted—that’s a problem.” He went on to say, “We don't have partnering horror stories because we include an exit strategy, b

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

fore going into the relationship.”

Elliott's advice for others entering into partnering relationships is to do your homework, know the agenda of all partners in the relationship and measure against it. If after doing your homework y

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

Following aspects would a

u're still not completely sold on partnering with a company, start small. Begin your alliance by partnering with another for a simple or small promotion and get your feet wet. If you do stumble, then having the ability to regenerate

dd to the challenges in developing combination products:

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

after a fall is crucial, especially if you or a partner simply make a mistake.

Having knowledge of the alliance unknown should keep you from becoming immobilized and waiting for opportunities that could easily pass you by. Sure, the

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

e are some risks, but to lessen the effects, do your homework, know the agenda of all partners in the relationship and measure against it. If after doing your homework you're still not completely sold on an alliance relationship with

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

a company, start small. Begin your alliance by Partnering with another for a simple or small promotion and get your feet wet.

If you do stumble, having the ability to regenerate after a fall is crucial, especially if you or a partn

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

r simply makes a mistake. Be careful when events and circumstances are not what you hoped or planned for. You might go to a place of apathy. If you remain in a toxic mind-set, you'll wait and wait for things to get better before yo

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

Professional from academic institutions, pharmaceutical industries, health care indust

u move into action. The trouble is that things rarely get better until you propel yourself into a state of activity.

To be successful at partnering you must commit to functioning at a higher level. A level that will allow you to str

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

tch your comfort zone and then commit to moving into action. Without these two issues in concert, you might not get started or restart when necessary.

Once you get back in the action, you can go after small wins to reestablish your

.

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

confidence to take risks in pursuit of an even larger prize. The key is to not wait for all to be perfect before you commence. It's okay to subscribe to the idea of: ready, shoot, aim. Do though; take the time to adjust your aim aft

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

Companies that provide selfless information through particip

r you begin. Be like a commercial airline pilot and course correct regularly. Keep your future focus on the partnering journey. Keep it improving. Be decisive, and show the qualities of a leader in your industry. You will be rewarded

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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