Main Subject - Business

It seemed like a good decision at the time. A 10-percent raise, an easier commute and a chance to move up the corporate ladder.

Now, six weeks into the new job

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 know in your gut and sleepless nights that maybe, just maybe, you’ve made the biggest mistake of your career. Your new company is a 180-degree change from

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

Examples of combination products may in

your former one.

Are you finding any of the following? Your new company hardly holds meetings while your former company had constant meetings. You’re now faced

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

with status-quo thinking when you’re accustomed to innovation and change. You’re bored! Before, you were constantly challenged. There’s an Old Boys Club going

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

n, whereas you were once on an almost level playing field. Management has unreasonably high expectations and an autocratic style when you previously thrived wit

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

Combination pro

h realistic expectations couched in consultative management. And here’s a new expectation: golf on Friday afternoons.

So how are you going to fit in? Did you m

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

ake the right choice? Should and can you leave?

If you are in this situation, start by:

*Asking a trusted friend to help you write down specifically what the

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

differences are between your former company and new one, using the above as a guide;

*Determining how to bridge the differences and if it’s worth it to you and

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

your career to do so;

*Making three-month, six-month and one-year goals to benchmark your satisfaction and value within the company. For example, “In three mon

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

ths, I will be on two cross functional committees, leading one of them.”

*Identifying the top 10 positive experiences you’d want to undergo if you had 24 hours

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

to live. (Read “Choice Points,” by Sidney Rice, and the Top 10 exercises from the PaperRoom Process.) Then, you ask yourself why you chose each and translate t

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

Following aspects would a

he items into your core needs – that is, what do you need at work to bring out your best. The Top 10 fall into four categories – challenge, recognition, social

dd to the challenges in developing combination products:

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

onnections and achievement – connected to your values. You can see what’s missing and devise ways to fill the gap.

For example, if you are missing achievement

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

and recognition because your change initiatives are nowhere near completion, give yourself several simpler projects to complete, even something at home.

If you

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

are missing social connections, ask yourself, “What specifically does that mean to me?” You might realize that the location of your new company interferes with

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

your ability to connect with industry contacts. Map a plan to network twice a month, drop a note to industry contacts periodically, and attend a new conference

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

Professional from academic institutions, pharmaceutical industries, health care indust

to increase your connections in your field.

When you change companies, you’ll almost always encounter a change in culture, sometimes mild, sometimes severe. Be

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

fore you make a move, check out the company’s culture as well as its financial statements and the specifics of the job offer. If you’ve already made a move and

.

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

you’re not sure it’s the right one, these suggestions may help you decide with greater confidence whether to stay or go.

You Are Welcome To Reprint This Art

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

Companies that provide selfless information through particip

icle Please include the following text on your reprint:

Copied with permission of the author, Barbara Callan-Bogia. Source: www.Callanconsulting.com

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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Main Subject - New Job, New Culture: Do You Fit In?

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