Digg It - Business

There are a lot of business models out there for improving your management skills, but let me offer you one you’ve probably never tried. Find five dachshunds – the

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

more misbehaved the better – and take them for a walk through your neighborhood. (Do get permission from the dachshunds' people first).

I’ve had more than one oc

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

Examples of combination products may in

asion to try this technique. You see, I have two dachshunds of my own, one foster doxie, and I regularly help take care of a friend’s two during the day. So it’s a

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

timesaver for me to walk all five at the same time rather than make two separate trips. Our main goals are a) no one gets tripped or squished and b) we return with

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

the same number of people (one) and dogs (five) that we started with. So far, so good.

I have definitely learned a few lessons that translate well to managing peo

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

Combination pro

le in this process:

• Everyone does things at their own rates of speed. You can try to slow down the speediest or speed up the lollygaggers, but you’ll just have

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

n unhappy pack on your hands. Averages are good for statisticians but not for unique individuals.

• There’s a time to stop and smell the roses (and the grass and

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

the fire hydrants) and a time to haul butt and get out of the street. When a truck is barreling down on you, you’ve got to hightail it. When it’s a nice sunny day

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

nd your To-Do list is short, taking the time to breathe it all in could just rejuvenate you to the point where you start looking forward to getting back to work la

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

er.

• The lead dog changes. Instead of thinking of one alpha dog and a bunch of followers, what is more likely is that different animals lead at different times.

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

ith the dachshunds, I have one leader at the beginning of the walk because he’s all “Go, go, go” energy. Of course, that energy peters out quickly and he is replac

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

Following aspects would a

d by my “Was that a squirrel” dog who takes charge whenever there’s wildlife to be examined. And I even have a “Thank god, this walk is over” leader who always mak

dd to the challenges in developing combination products:

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

s a sprint at the finish line. If you think of all your employees as leaders in their own right, you’ll be able to encourage and maximize their strengths.

• It ne

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

er hurts to carry cookies. In an emergency, it’s best to have a way to encourage and motivate your herd to do what you need to have done – whether that’s finish a

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

project on time or allow small children to pet their heads peacefully.

• Sometimes when you least expect it a wild dog will rush out at you and destroy all sense

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

f order you thought you operated under. The leashes get tangled. Everyone’s barking and lunging. You’re screaming, “No!” as you try to get the situation back under

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

Professional from academic institutions, pharmaceutical industries, health care indust

control. No matter how much you prepare for what life may hand you, there will be those unanticipated moments when you just go with your gut instincts.

• Poop hap

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

ens. You can either be a bad citizen and pretend that it doesn’t or a good leader and pick it up. Neither way stops it from happenings, but a good pack leader unde

.

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

stands that you can’t ignore problems, you’ve got to get out your doggy bag and take care of them.

• Be thankful for small miracles. It doesn’t seem like much to

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

Companies that provide selfless information through particip

et home in one piece, but when the task is complicated, be grateful. Tell your team how good they’ve been. And hope that next time the results are just as positive

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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It’s okay to take your job seriously, to be a stickler for professionalism, and sure it’s wonderful to take your responsibilities seriously. However, you have to be a bit careful when you allow your job to become your LIFE...

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