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I learned a valuable lesson over the holidays. I learned the real value of experience. The real difference between academics and “On –The – Job” experience. You see, our garbage disposal wen

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

t out between Christmas and New Years. I won’t use the excuse that I couldn’t find a plumber. I just figured that replacing a garbage disposal was no big deal. I am educated, smart and I can

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

Examples of combination products may in

use my hands. After all, how hard can replacing a garbage disposal be for crying out loud?

Well, as I found out, it can be very difficult if you don’t know what you’re doing or have never

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

done it before.

Off to Lowes I went to buy a replacement disposal. Much to my surprise there were no directions in the box. Of course, I bought the super upgraded model. It just didn’t look

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

like my old one. Getting the old one off was not too much of a problem other than skinned knuckles.

The new one was a little bigger. It was quite a site watching me on my back, head under

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

Combination pro

the sink, trying to attach the new disposal with Tracy sitting on my stomach trying to hold the new one in place while I tried to figure out how to attach it. After about thirty minutes of f

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

rustration, lack of success and dropping the disposal three times but grazing my head only once, we took a break. (I bled a little but didn’t need stitches) Tracy noticed a tool inside the

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

box that just happened to fit the neck ring of the new disposal. Once we figured out how to use it, attaching the new disposal was a piece of cake. I laughed at how funny and how stupid I mu

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

st have looked. I was glad none of my plumbing friends could see me.

Once I got the new disposal on, I thought I was home free. After attaching the elbow coming out of the disposal, I notic

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

ed that the pipe to the drain was too long. Must be because I bought the big one I thought. No problem. I’ll just cut the pipe, so I did. Unfortunately, I cut it a little too short but didn’

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

t notice until I had it hooked up, tuned it on and water shot everywhere as the short pipe just busted out of its connection.

Tracy now insisted for the third time that I call the plumber.

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

Following aspects would a

I wasn’t having any of that. I could do this. Tracy ran down to Lowes to get a new pipe for me since the old one was too short.

I contemplated my situation while she was gone and figured ou

dd to the challenges in developing combination products:

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

t that the original pipe wasn’t too short. I had attached the new elbow on the disposal backwards. What a revelation. I am almost too embarrassed to admit it.

Tracy returned with the new pi

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

pe and I managed to get it connected. Home free, so I thought. I turned the disposal on and it leaked. After taking it apart about four times and reassembling it without being able to stop t

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

he leak, I decided that Lowes must have sold me a defective garbage disposal. Maybe there was a washer that was left out of the box. By the way, this all took place over the course of three

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

days.

I decided to take the thing apart, take it back to Lowes and get a good one. One that wasn’t defective. Back under the sink I went for about the fifteenth time. As I looked up at th

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

Professional from academic institutions, pharmaceutical industries, health care indust

e neck of the disposal I just happened to notice that it wasn ‘t exactly fitting real snug up against the drain. After further investigation I realized that I never actually had it seated ri

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

ght and the leak wasn’t coming from the pipe but it was actually leaking from the top by the drain itself. Once I reattached it correctly, everything worked perfect.

It only took three days

.

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

, four arguments about calling a plumber with Tracy and a bloody head where the disposal scratched it as it fell.

So much for having an MBA and a Doctorate, No wonder experience over educat

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

Companies that provide selfless information through particip

ion is a deciding factor in many new hire decisions.

________________________________________

If you missed Issues #1, 2 and 3-- e-mail: rick@ceostrategist.com for copies of these issues

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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