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Digg It - Think Before You Talk
What you say to other people can make or break you and it can happen without you even knowing about it. That old saying “loose lips sink ships” is oh so true in busi
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
ness. If you like to gossip as most people do, learn to listen rather than participate. Oh, you’re saying to yourself that yes maybe you do talk about the job or you
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
r co workers, but never to anyone who’s involved outside your work.
That’s the kind of thinking that enabled my friend Susan to land that $50.00 an hour teaching con
That’s the kind of thinking that enabled my friend Susan to land that $50.00 an hour teaching con
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ract with one of the local businesses. You see, I happen to be at lunch with a person who was casually talking about her job. After all, I had nothing to do with he
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
r company. I was just a computer consultant that was going to send her business. How could I be a threat?
This is how it happened. At the time, we were working on
This is how it happened. At the time, we were working on
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
Susan’s game plan to become a teacher. I had a client that wanted me to teach 15 of their employees. Since my company didn't do classroom training, I referred them
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
to a computer school. Upon class registration, they mentioned who referred them. The Director of Training, Colleen, then called and spoke with me. I advised her tha
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
my company only did one-on-one training and maybe we could trade business. That’s when she invited me to lunch.
The first lunch was merely a business meeting and w
The first lunch was merely a business meeting and w
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
e exchanged business cards. However, the second lunch a few weeks later was quite different. Colleen gave me a new business card and explained she just changed jobs.
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
I knew her former employer had a reputation for suing past employees because of a no compete clause. Therefore, I questioned her about this. She then began to fill m
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
e in on all the latest legal gossip at her new place of employment concerning her former employer. I didn’t say a word.
Through legal means, her former employer ob
Through legal means, her former employer ob
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
tained an order that forbid Colleen or her current employer to solicit or train former clients. I calmly asked.
“What former clients?” She started naming them as I
“What former clients?” She started naming them as I
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
istened.
“Does this mean that those clients are no longer being trained by either company?” I interrupted.
“Well, my former employer has sent letters to them to ge
“Does this mean that those clients are no longer being trained by either company?” I interrupted.
“Well, my former employer has sent letters to them to ge
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
t them to sign affidavits for the upcoming court battle.” She quickly replied.
I knew right then I had something. No client wants to be dragged into court. When I
I knew right then I had something. No client wants to be dragged into court. When I
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ot back to my office, I called one of the clients she mentioned, and asked about their employee training. They already knew me as a consultant and asked if I knew 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
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
any independent teachers. Guess who got the contract - that’s right Susan.
Colleen never found out about my association with Susan. Colleen called me a few weeks
Colleen never found out about my association with Susan. Colleen called me a few weeks
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
ater and went on and on about this new company (Susan’s of course) that came out of the wood work and stole three of their biggest clients. Again, I quietly listened
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
.
That Director of Training’s mistake was, although my company did not want her clients, I knew people who did. She didn’t realize how well connected I was in the c
That Director of Training’s mistake was, although my company did not want her clients, I knew people who did. She didn’t realize how well connected I was in the c
.
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
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
mputer community. Being in the business for nine years, I had met most of her associates and my husband knew her current employer. You just don’t know who is sittin
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
g in the booth next to you at lunch or hanging on every word of that cell phone conversation. Therefore, think before you talk!
### Gina Novelle (copyright 12-2004
### Gina Novelle (copyright 12-2004
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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