Advice You - Business

One Bad Apple

I know what you are thinking but no, I am not doing a

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

Text style="MARGIN: 0in 0in 0pt">tribute to Michael Jackson and the Jackson 5. Although I will admit that their hit song from the 70's keeps rolling around in my mind as I type this. While the Jackson Five might have believed that "One bad apple can't spoil the whole

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

Examples of combination products may in

ARGIN: 0in 0in 0pt">bunch" I don't think that they were responsible for getting high quality production results from their bunch. The fact is, in business one bad apple can make your life and the life of the people who work for you, pretty miserable, reduce production from your organization, and even cost you good employees.

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

oPlainText style="MARGIN: 0in 0in 0pt">The "one bad apple" that I'm referring to of course, is that one bad employee in your department who drags everyone down with them. I'm not talking about the employee who is temporarily struggling with their productivity. A lot of employees go through that problem from time to time. 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

th training and coaching, these

are potentially very productive employees. And I'm not talking about that the employee who is going through some personal problems and is struggling to keep their business and personal lives separate. This is also a

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

Combination pro

temporary situation that usually rectifies itself relatively quickly. Instead I'm talking about the

employee who seems to have made it their personal mission in life to be unhappy, and to ensure that everyone else around them is just as unhappy as they are.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

These "bad apples" come in various shapes and sizes, all kinds of different backgrounds, and all different levels of experience.

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

New">You have the:

· Information hog - who hides key information about their tasks and projects

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

New">· Martyr - whose assignments are always more difficult than any else

· Bully - who intimidates all those around them

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

S Mincho'">· Professional Devils Advocate - who never met a concept that they actually liked, but they will gladly take credit for any concept that actually works

· Company/Management Haters - who spend all of thei

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

free time telling anyone who will listen (and many that won't) how bad and evil the Company and Management Team really is

· Slacker - who never really seems to do anything, but is always telling everyone how busy and overworked they are

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

Following aspects would a

ext style="MARGIN: 0in 0in 0pt">

Generally speaking, it's not hard to tell if you have a bad apple in your group. They do tend to stand out. They wear their misery with p

dd to the challenges in developing combination products:

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

ide. All kinds of bad things happen to them routinely, but the problems are never their fault. And anyone who is nearby (and some who aren't so nearby) will hear about it. The problem is not that they are miserable. The problem is that they make everyone

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

n 0in 0pt">else miserable as well. Sometimes it's pretty blatant. They actively incite or intimidate those around them so that no one has a comfortable working environment. They get their power by sucking the life out of people around them and they know exactly how to do that.

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

:p>

As a leader, your team looks for you to lead and to remove obstacles that can keep them from being productive. This bad apple is an obstacle and how effectively you deal with them is a barometer that your staff will measure you by. The place to start is

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

ith Performance Management and measuring their productivity. But don't limit Performance Management to production only. Remember that all members of the team are responsible for soft skills as well

as hard skills and that an employee who produces

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

Professional from academic institutions, pharmaceutical industries, health care indust

cceptable numbers but doesn't share information, or bullies those around them is still a Performance Management problem. Manage the soft skills the same you manage the hard skills, with detailed Performance Plans. Remember, even if they play key role in your department one bad apple can spoil the whole bunch, for everyone. Work closely with your HR representative to ensure that you are in complian

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

e with both company policy and federal law, but you must remove them.

And speaking of HR reps, take a minute to think about yours. A good HR rep is worth their weight in gold. A good HR rep will help you in identifying problem employees when the

.

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

ssues go beyond straight production. They will also work with you to ensure that you are working the issues both legally and that your conclusions are based on fact and not emotion. A good HR rep is also a boon for the employees, because they will work with the employees to improve their performance by identifying problems before they become severe. If you a

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

Companies that provide selfless information through particip

e one of the lucky ones that have been blessed with a good HR rep, then take the time to thank them for their work. Being an HR rep is a thankless job, and never more so than when they are doing the right things by being actively involved in

resolving problems.

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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