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Are you working as hard as you can in your area of expertise? Are you implementing creative ideas? Are you valuable to your clients? And now the tough

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

question: Does the public know about you? If you’re like most business people, you answered “Yes” to the first three questions, and then perhaps hesita

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

Examples of combination products may in

ed on the last question and may have ultimately answered “No,” or sheepishly said “Well, not as much as I’d hoped.”

Getting your name “out there” requi

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

res getting yourself “out there.” This means a very steady diet of first and foremost being visible in the business community, as well as actively “too

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

ing your own horn.” Being humble is not a virtue when one is striving to become a household name. So does this happen overnight? Of course not, but th

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

Combination pro

t’s where repetition comes into play. If your name and your accomplishments are repeatedly positioned in different ways, you become familiar to others

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

and that’s when you know you’re making inroads.

This begs the question of what’s an accomplishment. Again, if you’re in the humble category, you may m

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

nimize or downplay a project or new development. Rule #1 is that all your endeavors should be viewed as accomplishments. Then it becomes a matter of s

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

reading the news. Let’s say for example that you are offering a workshop in your local community and though to you it may be “old hat,” it marks an opp

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

ortunity to let the public know about it. This can range from telling family and friends, posting it on your website, sending postcard announcements to

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

ormer clients, submitting it to newspapers and trade publications as well as local Chambers of Commerce; in fact, the more the merrier. While we’re on

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

Following aspects would a

he subject of print media, why not take this idea to the next level? You can email or telephone feature reporters in your local newspaper to let them kn

dd to the challenges in developing combination products:

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

ow when and where your class will be conducted and use your skills to entice them as to why this would be a great story, photos and all. It may not be

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

the right time the first time, but if you stay the course and remember your goal (to get your name out there), eventually it will happen.

While print m

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

dia is phenomenal exposure, you don’t want to overlook radio and television. In this instance the approach is to offer to be a guest to either take que

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

stions from viewers or to do an interview. The key here is to be prepared with “your hook.” In other words, think through why your subject is of inter

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

Professional from academic institutions, pharmaceutical industries, health care indust

st to the audience, how you can be a resource, the timeliness of your call (e.g. offering your professional opinion about the effectiveness of a politic

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

an who’s running for office). You may want to approach it like a puzzle and determine where you best fit.

You may be wondering what the payoff is for

.

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

all your perseverance. Once you do break through and get that well-earned publicity, it catches on like wildfire. Suddenly, you’re “out there” like a

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

Companies that provide selfless information through particip

ousehold word, the world is your oyster…and the phone is ringing off the wall. That means only one thing which is you’ve got publicity. Now keep going

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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