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When I first entered the workforce, the path for moving forward and advancing my career was steep and hierar

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

chical. In some ways, it reminded me of the steps required to ascend the temples in Chitza Nitza, Mexico. If

; 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 have ever climbed the pyramid at Chitza Nitza, you know that it’s not too bad at the lower levels, but

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

gets more challenging the higher you go. And as you might expect, it was pretty lonely at the top.

Today, 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

he organizational realm in which we work has been dramatically altered. Organizations are flatter, with fewe

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

Combination pro

r middle management positions. Those that do hold those positions now have broader spans of control with mor

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

e responsibility. Downsizing or “rightsizing” has become an accepted business practice in most companies. An

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

, we have come to know, that we all have limited -- if any -- job security.

Not to worry! There are still p

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

lenty of opportunities for those that want to move ahead and ascend the corporate ladder. It does require yo

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

u to change your perspective and develop a new vocabulary.

If you want to move ahead in your company, here

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

are a few tips to get you started:

• Develop a "Me, Inc." attitude. Identify your key assets and liabilitie

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

Following aspects would a

s. Then create a plan to leverage your assets and offset your liabilities. Involve your manager when appropr

dd to the challenges in developing combination products:

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

iate. But remember, you are responsible for your own career success.

• Invest in your "work portfolio." Dev

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

elop a wide range of experiences and desirable skills. Do this internally at your company or externally thro

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

gh volunteer work. And remember, embrace lifelong development and continuous learning by taking advantage of

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

degreed programs, industry seminars, continuing education and company training programs.

• Be a change age

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

Professional from academic institutions, pharmaceutical industries, health care indust

nt. Get comfortable with handling ongoing change. This means not only embracing change but also seeking it o

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

ut in the form of new and challenging experiences. Move around willingly and proactively. That includes up,

.

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

down, and sideways within your company, and outside of your company when necessary.

Follow these tips and y

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

Companies that provide selfless information through particip

ou can expect new avenues to open up for you. And remember, in the new world of work, up is not the only way

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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