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Moving from staff into management for the first time is exciting—but it can also be scary.

There’s so much

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

you don’t know. Somehow managing looked so easy from the outside, but now that you actually have to do it,

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

Examples of combination products may in

you realize it’s more complicated than you thought. Before, you had certain tasks to accomplish and you k

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

new you had the skills to do them. You still have responsibility for those tasks, but now you have to se

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

e that the work is done effectively by other people. That’s a whole new task in itself, and you’re not sur

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

Combination pro

e you’re up to the job.

You also find that it’s hard to concentrate on the planning that is such an importa

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

nt part of managing, because emergencies large and small seem to arise all the time and people keep runn

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

ing to you to resolve them. The expression “When you’re up to your neck in alligators, it’s hard to rememb

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

er you were trying to drain the swamp” might have been written for new managers!

In these early days, you

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

must learn not to be too hard on yourself. Management skills are not built into our human DNA—we have to

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

learn them as we go. Promise yourself you’ll learn at least one management lesson every day. Set aside a f

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

Following aspects would a

ew moments at the end of each day to think about that day’s lesson and how you’ll use it to improve your

dd to the challenges in developing combination products:

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

management skills. Sometimes these lessons will be hard, but each one will give you something to build on

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

if you are willing to learn.

Each day will bring you new challenges, new experiences—and new successes. It

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

’s easy to forget the successes and focus on all the things that didn’t go so well, so I recommend you k

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

eep a diary of all your new experiences. Then, on those days when you think becoming a manager was all a h

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

Professional from academic institutions, pharmaceutical industries, health care indust

orrible mistake, you can read over your diary and remind yourself just how far you’ve come.

Becoming a ma

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

nager is a journey. Like any journey, it offers both good and bad experiences, enjoyable and not-so-enjoya

.

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

ble aspects, positive and negative events. Just take it one stage at a time, learn from each experience—go

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

Companies that provide selfless information through particip

od or bad—and you’ll gradually find yourself becoming more and more comfortable in your management role.

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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Ever worked hard on a proposal and not been awarded the contract? When it happens to me, I say 'Thank you.' My follow-up notes read like this:

Indeed coffee shops are getting a lot popular these days. Perhaps it is because people are finally taking notice and liking the different coffee flavors quite different from the commercial ones they have at home. Or perhaps it is because wherever they may be, a coffee shop is an ideal place to converse with friends and go over recent news. A coffee shop can also be a place where you can read a good book and just take a break from your work. When located in a mall, it can also be a place where you can rest your feet while waiting for your spouse and your kids to finish shopping. Whatever the reason may be, coffee shops are proving to be a place people flock to.

In a great working environment people are productive and morale is high. Here's what a great working environment looks like.

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