Answers - Real Estate

Working with tenants can be an amazing experience. (Owners and contractors are equally astounding, but those are subjects for another day.) It seems I ge

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 my most memorable anecdotes over the phone. Here are a few of the ones I’ve culled from my blog and experience and put together for your reading amazeme

; 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.

First was a late-night phone call I took:

*beeeep*

*beeeep*

*beeeep*

"Hello?"

*beeeep*

*beeeep*

*beeeep*

"Hi, my smoke alarm keeps going off."

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

*beeeep*

*beeeep*

*beeeep*

"Is there a fire?"

*beeeep*

*beeeep*

*beeeep*

"No. It does this every time I open the oven."

*beeeep*

*beeeep*

*beeeep

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

"Well have you cleaned the oven?"

*beeeep*

*beeeep*

*beeeep*

"I've opened the windows and door but it won't stop."

*beeeep*

*beeeep*

*beeeep*

"Wh

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

Combination pro

don't you wave the smoke away with a magazine?"

*beeeep*

*beeeep*

*beeeep*

"Okay, I've got the fan in the kitchen now. What did you say about the oven

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

"

*beeeep*

*beeeep*

*beeeep*

"Have you cleaned it? There's a product you can buy called EZ-Off. It's, well, pretty easy to use."

*beeeep*

*beeeep*

*

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

beeeep*

"Really? Okay, I guess I'll try that."

*beeeep*

*beeeep*

*beeeep*

"I think it may help."

"Thanks. Have a good night."

"Good night."

You'll

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

otice I didn't suggest disconnecting the battery.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

The next was a call in the late morning.

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

"Landlord for Hire."

"Terence, I have a really bad problem."

"What’s wrong?"

"There’s a bee between the door and the storm door, and I can’t get out."

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

Well, I wouldn’t swat it. It’s probably as scared as you are."

"Okay. Can you come over and open the door for me?"

"Well, I’m a half-hour drive from th

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

Following aspects would a

re. Is there someone closer you could call?"

"Not really."

"How about this: open the inside door and the storm door very quickly, and then close the in

dd to the challenges in developing combination products:

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

ide door. You’ll bring the bee out with you and it will fly away. You’ll be doing it a favor."

"What if it gets inside?"

"Be quick and it won’t – I hav

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

faith in you. Call me if you’re still stuck after you try it."

I didn’t get a call back.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

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

Springtime brought this little gem:

"Terence, it's really hot in here? Why is the heat still on?"

"Have you turned it from "Heat" to "Cold?"

"Um, no .

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

. . "

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

The last I have right now was a simple voice mail, of chilling consequences:

"Mr. Te

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

Professional from academic institutions, pharmaceutical industries, health care indust

ence, I wanted to call to let you know there’s a problem with the drain in the basement. Thank you."

"A problem" was three feet of water and human waste

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

n the basement. The tenant was late on her rent and, according to the plumber, must have endured the stench for a week or more before she screwed up 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

urage to call me. That was a rental I owned myself, and that tenant taught me a lot of the lessons I use to guide my property management philosophy, inclu

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

Companies that provide selfless information through particip

ing not selecting tenants out of fear, not accepting excuses for late rent, and always assuming that your tenants are better at understatement than you are

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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