Main Subject - Business

Janet Green works for Data Resource Group, an IBM business partner. In her position as storage product manager, she makes decisions about highly te

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

chnical matters – and those decisions must be made quickly and accurately. Besides that, Green travels around the country putting on presentations

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

Examples of combination products may in

nd marketing products.

As an added challenge, Green does not work at company headquarters; while Data Resource Group is located in Florida, Green

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

lives in Texas. “Working 2,000 miles away from the corporate office can be tough,” Green says. “My job is hands-on, and it would be easier if compa

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

y executives could just run into my office and ask me a question.”

Whether one works in a satellite office by choice – as Green does – or because

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

Combination pro

f company mandates, it can be difficult to have a successful career while working away from your headquarters. Green, however, offers tips to overc

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

ome these challenges.

• Realize that you’ll work hard. “Probably,” Green says, “much harder than if you were working at company headquarters.”

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

br> • Make yourself available. “Because of the national scope of my job, I have customers from three time zones. That may mean phone calls at 7:30

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

a.m. or at 7:30 p.m. But, I need to make myself available to my customers.” Besides that, Green must stay in close contact with her employers. “I a

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

lways let everyone know where I am and how to reach me. I leave messages on voice mail, and I send email, as well.”
• Learn your stuff. “You m

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

st make yourself indispensable to your company. People call me because they know I can answer almost any question.”
• Continue your education.

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

Following aspects would a

“This is a never-ending battle. Attend classes in your field and learn about your competition – what their products are, which ones are successful,

dd to the challenges in developing combination products:

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

and why. Instead of reading a novel, I study computer manuals.”
• Know others in your field. “Whenever I don’t know the answer to a question,

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

I know someone who does. I first worked for IBM, where I made plenty of contacts in the technical field, and I’ve also made many contacts through n

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

tworking.”
• Be willing to travel. “My company asked me to move to Florida,” Green admits, “but I told them that I’m a Texan and so I belong i

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

n Texas. But, I’m willing to hop on a plane and be at a conference anywhere, any time – including Sundays.”
• Sharpen your communication skill

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

Professional from academic institutions, pharmaceutical industries, health care indust

. “Good verbal skills are vital when you’re so far away,” she says, “and it’s important to get information in writing, so that there is no chance o

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

miscommunication.”
• Be prepared. “I keep cheat sheets with me. So, even when I’m on the road, someone can call me, and I can help.”

Gre

.

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

en says that working successfully from a satellite office becomes easier with time. “As company executives realize how valuable you are to the comp

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

Companies that provide selfless information through particip

ny,” she says, “they’ll be more willing to work with you. Sure it’s still tough sometimes, but if you love your job, it’s worth all the challenges.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.mainsubjects.org.ua/article/9519/mainsubjects-Success-From-Satellites.html">Success From Satellites</a>

BB link (for phorums):
[url=http://www.mainsubjects.org.ua/article/9519/mainsubjects-Success-From-Satellites.html]Success From Satellites[/url]

LLCs, or limited liability companies, have become more and more popular, especially in Nevada. The primary reason for popularity of LLCs is their ability to combine the personal liability protection of corporations with attractive tax benefits and the simplicity of forging a partnership. In addition, they are extremely flexible and require less paperwork. LLCs can be set up as new entities, or converted from an existing business. Estimates reveal that Nevada, with 40,000 LLCs in 2005, has more than the corporate-friendly state of Delaware.

People are actually trying to steal your money - identity theft, fake bank accounts, phishing, and every other thing you can imagine. Here's what you need to do to prevent the theft and what to do if you're already a victim.

Here's a little story about what not to do as you carve out a name for yourself in the world of internet business.

Tags

Links

Main Subject - Success From Satellites

Related Articles: