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Many of you know that I ran the Philadelphia Broad Street 10-mile Run this weekend. I have never been a runner before…and still

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

don’t think other runners would consider me one now…but it was an accomplishment that I am proud of and it taught me a lesson in s

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

Examples of combination products may in

aying motivated in reaching a goal.

Regardless of whether you are self-employed or you work for someone else, staying motivated c

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

an be a challenge. When we start something new, it is always exciting and when we think about how things will be down the road, w

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

tend to dream toward the positive. Think about it…you start a new job and you fantasize about the huge bonus or taking over the

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

Combination pro

epartment or making it onto Oprah’s couch if you’re an entrepreneur like me. (In the 10-mile run scenario above, I thought I would

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

look like Elle McPherson by the time the run came around) The world is your oyster.

Then, reality sets in. Prospects don’t cal

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

back. The person who reports to you is insubordinate. Your boss is difficult. Your body doesn’t look like Elle McPherson’s. Y

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

u know the deal. Suddenly frustration starts to creep in and you start to doubt yourself, your abilities and your dreams.

Withou

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

t sounding like too much of a Pollyanna, I have truly found that the biggest breakthroughs happen in our darkest times. We learn

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

ur toughest lessons after being fired, or in a business that’s failing. Is it fun? Well, not really. But if you pay attention,

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

Following aspects would a

ou learn and you grow. Our object in life shouldn’t be to avoid failure because if we do, it means we’re not trying hard enough.

dd to the challenges in developing combination products:

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

Failure is not the end; it’s just a part of the trip. You pick up, make adjustments and you move on.

So how do you stay motivat

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

d during trying times? How do you move forward when you want to quit or just curl up in a ball and sleep? I advise my clients to

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

use these tactics:

1.Just keep putting one foot in front of the other and showing up. Continue to do one thing each day that mov

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

es you forward. If you can’t get on the treadmill for 45-minutes, get on for 10. If you can’t make 5 sales calls, make 1.

2.Tak

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

Professional from academic institutions, pharmaceutical industries, health care indust

real time away, whether you have an hour, a week or a month. Get away from the source of your frustration and focus on something

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

else. You will truly come back to things refreshed.

3.If there’s something you’ve been dreading or avoiding, get out there and d

.

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

o it or at least part of it. You know you’re living it in your head and beating yourself up over it anyway. That is worse and mo

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

Companies that provide selfless information through particip

e painful than actually doing what you’ve been avoiding. Take one step forward and you may be surprised that you get re-energized

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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