Advice Pool - Health and Fitness

I have a client, I’ll call Julie. She’s a beautiful and fit woman that I’m working with on the phone. She’s polite and sweet and extremely smart. I enjoy her immensely and she’s working with me to get better social skills and so she can work better wit

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

h men.

I guess I’m pretty good at this. I grew up with a mom who had 8 brothers. My dad had 7 brothers and I have 2 brothers of my own. I have a sister too but when I was younger I was the girl in the neighborhood who would compete with the boys while

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

Examples of combination products may in

playing kickball or pickle in the front yard. I liked to win. My sister was more into crafts and sewing. I picked those up later, but was never as talented as my sister in domestic things.

I was the one who had to learn how to be feminine. I was alwa

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

s “one of the boys” until college when I realized that I wasn’t being treated special by the guys at all. They were rough and tough around me and didn’t hesitate to talk down to me either. I remember once in college I felt I’d had enough. I was a fresh

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

man and hanging out with the football players. They all liked hanging with me but when it came time to ask the girls out for a party, I was the one stuck at home. I decided to change that in the blink of an eye.

I disappeared.

I no longer went to the

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

Combination pro

cafeteria to just hang out every night. I ate at another location and basically didn’t reappear for another month. When I finally decided to make an appearance.. I was a bit coy about where I’d been. I had lost a few lbs but didn’t show up in sweats a

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

y more and didn’t laugh quite as loud as before. Guess what happened? They all asked me out!!!

I finally realized that to be treated like a QUEEN, you have to BE A QUEEN!!! It was a lesson I never forgot and it’s allowed me to be treated well in busin

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

ess and my personal life my whole adulthood. I demand to be treated well. I leave if I’m not.

So, MY lesson was how NOT to be ONE of the boys!!! The lesson my CLIENT is learning is to BE one of the guys!

First of all, what are the advantages of being

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

a woman in business who can ‘yuck it up with the guys?” Well, there are times where she’s going to be their boss. She’s going to be the one bearing bad news, or the one praising them, or the one selling to them. If she feels comfortable and can be the

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

r friend, then there won’t be the uncomfortable tension that sometimes happens between men and women in business.

Many women who didn’t have the advantage of growing up with brothers or being an athlete view men as a mystery. They haven’t figured out

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

how to talk with them (to the point and share INFORMATION, not STORIES ) and they haven’t learned how to be treated well by them. (confront them for bad behavior or dump them!)

But how can a woman, who is used to being so feminine get to the point whe

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

Following aspects would a

re she is comfortable with the men?

I read a passage from a great book to my client today. It’s from “Women who Run with the Wolves” by Clarissa Pinkola Estes.

“Within every woman there is a wild and natural creature, a powerful force, filled with go

dd to the challenges in developing combination products:

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

d instincts, passionate creativity, and ageless knowing. Her name is Wild Woman, but she is an endangered species. Though the gifts of wildish nature come to us at birth, society’s attempt to “civilize” us into rigid roles has plundered this treasure,

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

and muffled the deep, life-giving messages of our own souls. Without Wild Woman, we become over-domesticated, fearful, uncreative, trapped.”

YES!! This is what she needed to hear. I actually told her she could try being more MASCULINE. I challenged he

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

r to go to a few rodeos, whoop it up with some cowboys who ride bulls, go to a few sports games and sit with the rowdy folks, wear jeans, drink beer, go camping, get her hands dirty, take pottery lessons, and do some loud belly laughing!

She was amaze

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

! No one had EVER told her that she could try being more MASCULINE in order to get along better with men. I assured her that there would be NO way that she’d turn into a man eating monster but that she’d just get the “feel” for what its like to be more

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

Professional from academic institutions, pharmaceutical industries, health care indust

comfortable with that wild part of her nature that she wanted to nurture.

She loved it. I did too. It’s something I’d never really coached on but it was definitely a lesson that I’d like to give to women who are too stuffy, too conservative, too supp

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

ressed, too domesticated or TOO FEMININE.

Being feminine lady is a wonderful thing…. but abandoning your ‘masculine side’ will make you slightly uncomfortable and fearful in the presence of others. While men will appreciate your sophistication at a di

.

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

ner party, they may avoid you while cutting lose. We’ve all heard how much business is done on the golf course. That’s because people do business when they feel comfortable with others.

So ask yourself.. are you comfortable with others in every situat

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

Companies that provide selfless information through particip

ion? If not, then push yourself to be in situations that potentially make you uncomfortable. When you can be comfortable with being uncomfortable, you are on your way to making others comfortable too.

And that is the BEST trait of a sophisticated lady

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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