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This month’s column is all about surprises and lessons learned. It comes from a letter written by Nicole who just got a new horse and with that horse came a little surprise. There are many lessons to be learned from Nicole’s situation. Below is a piece of her letter.

“Hello, I am

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

17 and purchased a Morgan mare just two weeks ago. I was told she had a small clipping problem but had no idea just what a problem it was until today. She is a very calm mare for the most part. Plastic bags, loud noises, or any other typically scary horse things don't bother her

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

Examples of combination products may in

t all, but oh boy does she hate clippers! I went really slow with her today because as soon as I even turned them on she almost jumped through the roof. I can rub them all over her body when they are off, but as soon as they get clicked on she goes crazy. I thought we were improvi

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

ng when after a while she would touch them with her nose and then I would take them away as a reward. I could gradually do it for longer and longer and actually clipped a few of her hairs. Then, however, for some reason, instead of letting me rub her with them, she starting trying

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

o bite the clippers and me a few times when ever they got near her! I patiently tried to rub them down her neck or side, but she won't let me bring them past her head without trying to break out of the cross ties. I know that this problem is going to take some time to solve, but af

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

Combination pro

ter reading your article, I wanted to make sure that I wasn't just creating a bigger problem than I already have on my hands. Any advice would be greatly appreciated! Nicole”

Lesson # 1. What most interested me about Nicole’s letter was the fact that while shopping for the horse,

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

he was warned about the “small clipping problem.” I would like to suggest to everyone who is shopping for your next horse, car or husband, that when faced with that statement, or any statement that suggests any kind of a little problem, ask the horse owner to bring out a set of cli

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

ppers and turn them on so you are well informed about the “small clipping problem.” So often, my definition of a small clipper problem is going to be radically different than your definition of a small clipper problem. I’m not suggesting that the clipper issue would or should be a

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

eal breaker, but safety is everything and the better informed you are about the horse (car, husband, house, etc) you are considering spending 20 years with, the better.

Lesson # 2. Nicole is smart enough at 17, to have already figured out that you can’t solve a problem if you don’

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

t understand what is causing it or if you don’t have enough information to approach it with confidence. She also figured out very quickly that taking a stab at a solution when you are really unsure of what you are doing, not only doesn’t solve the problem, but you can make it worse.

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

I sent Nicole a very detailed, very long, three-day program for solving the problem and if anyone is having a similar problem, shoot me an e-mail and I would be happy to e-mail the entire answer to you as well. Due to space constraints here, I can’t include it in the column, but le

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

Following aspects would a

me just say it worked. Below is a follow-up note from Nicole:

“Thanks a lot for your advice on my Morgan mare! After three days of slowly getting her used to them and their noise, she stood completely still for three hours today (with plenty of treats at hand) and let us body cli

dd to the challenges in developing combination products:

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

p her everywhere besides her head. She has no other problems with head shyness, so I am assuming that whatever bad experience she had with clippers must have been on her face. Everyone at our barn was amazed to see the horse that wouldn't let clippers get within five feet of her la

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

t Sunday being sheared from head to tail like she had been doing it her whole life! She didn't fidget, nip anyone, or make a fuss about it at all. So once we can get her comfortable with them around her face, I think she will be a great horse to clip! Thanx again for your helpful

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

advice! Nicole”

Surprise # 2. I was smiling as I read Nicole’s follow-up note because I was very surprised to read that she was so thrilled by her success that she body clipped her horse. I should mention that I received Nicole’s letter in November which is not the most common mo

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

th of the year to body clip a horse.

Lesson # 3 This is the most important lesson of all. Nicole is 17 years old and was able to understand and apply safe, responsible training techniques to her horse. In addition to solving the clipper problem, she also increased her “trust bank

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

Professional from academic institutions, pharmaceutical industries, health care indust

account” between herself and her horse. She also increased her training understanding and logic and that will pay big dividends for the rest of her life and she also learned that there are many solutions to any given problem and the right one is always the one that is safe for handl

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

r and horse, makes sense, gets the job done and doesn’t cause any new problems in the process. Quick is only valuable if you are getting paid by the hour!

I want to hear from you! If you have any questions, comments or suggestions that you would like to share with the rest of us,

.

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

drop me a line at:

Bonnie Marlewski-Probert
P.O. Box 548
Yellville, AR 72687

Or you can contact me directly on the Internet at BRMP@AOL.com or by visiting our web site, TheCompletePet.com

For more information on any of Bonnie’s books,

A Parent’s Guide to Buying That Fi

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

Companies that provide selfless information through particip

st Horse
Debugging Your Horse
The Animal Lover’s Guide to the Internet
Horse Tales for the Soul, Volumes 1 – 5
Dog Tales for the Soul, Volume 1

Or for her videos,

Debugging Your Horse and
Trail Riding, Rules of the road
Visit, http://TheCompletePet.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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