Answers - Real Estate

I admit it, I lived the so-called “American Dream.” I had a large house with 5 bedrooms, 4 baths, massive walk-in closets, a 3-car garage, pool, and within a gated community. I received a good 6 figure income from my work, traveled, dined out, and once owned ‘his and her’ Mercedes. What more could any

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

red-blooded, American want? Why, the second home in the country, of course!

We had good friends that always bragged about driving up north into the mountains to stay in their “other” home that was totally furnished and well-stocked for an instant getaway. They varied from estate-sized to modest “A”

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

Examples of combination products may in

frames. But the lure of the clean, non-polluted air, abundant wildlife, cooler summer temperatures, and scenic, pine-filled vistas, was truly intoxicating. We had spent many days and over-nighters in the area and were already convinced of the benefits. So, with a few extra bucks in the bank, we decide

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

to do some serious investigating.

It began with a budget and a plan. We wanted a cabin-like dwelling that was totally different from our current residence. So we enlisted the aid of a local high-country realtor and began the search. By the third or fourth house, we were already disillusioned. It app

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

eared that the people living in these cabins had no concept or words such as “repair” or maintenance.” Toss in “modern appliances” and “repainting,” and you get the picture, which wasn’t pretty. We had a new comprehension of what “rustic” actually meant.

Most were smallish and in need of renovation.

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

Combination pro

The agent explained that, within our price range of $100,000 to $125,000, we couldn’t expect much better. The true “log cabins” were by far, the worst. They had obvious termite damage and lacked most common amenities. But the one thing we desired most was a view, and although they all said they had on

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

e, we decided looking at large fir tree in the front yard wasn’t our idea of a view lot. So, 25 homes later, we politely thanked the realtor and headed back down the highway homeward bound and somewhat disheartened. Yet we weren’t totally dejected and still craved that impossible dream.

Weeks later,

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

I had some free time during the week and took a morning drive back to the mountain town. There, after getting a local real estate agent’s flyer, I discovered a small, new development with three models of modest sized cabins. After touring them, I found the perfect size in an affordable configuration i

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

n a two bedroom, two bath single level with a two car garage. There was also a lot available that backed onto the national forest with terrific views. I immediately slapped down a deposit and drove back home with the news. My wife came back with me, agreed on the cabin and we began building a few mont

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

hs later.

It was an exciting time. After choosing wood floors and redwood siding, we began picking out our appliances, furnishings and interior colors. By the fall, we were spending week-ends in the 1200 square foot home and enjoying our first snowfall. That spring, I planted some trees and shrubs f

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

or additional landscaping and a buddy and I built a sprawling “L-shaped” redwood deck. So, right about now you’re asking yourself, what was the pitfall of this great place?

The harsh reality began slowly and spread like a disease. But first, may I offer a bit of background material. I live near Phoen

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

Following aspects would a

ix where it’s 105 degrees most summer days and 70 in the winter. The mountain town is in the 80’s in the summer and 40’s in the winter. So, from May through October it’s a perfect temperature up north, but in the winter it gets quite cold. Nights can be in the 20’s. The purpose of the cabin was to use

dd to the challenges in developing combination products:

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

the deck and sit outside whenever possible, enjoying the view. But mid-October through March, it’s rather cold and not practical. So it really was a summer retreat. Right away, our enjoyment was limited by the climatic conditions, causing a big letdown.

In addition, although it had the wrap-around,

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

decking and satellite TV, we were bored. The outside view never changed and there was little to do in such a tiny community of 15,000. One can only take so many side trips down the highway. Sitting on the deck for hours on end was relaxing but ultimately, boring. We also had problems with visitors. W

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

hen we were gone, we allowed a few friends and family to use the cabin in our absence. Several times, we discovered things broken, the interior left dirty, and pantry food missing. Once the front door was left unlocked by an occupant for who knows, how long.

We also realized that we needed to check o

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

n the place every once and a while during the winter months we weren’t using it. That meant additional trips just to look in, on occasion. And, although there were times it wasn’t used, the mortgage, taxes, and utilities still had to be paid every month. Then, when we finally did come back, we had to

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

Professional from academic institutions, pharmaceutical industries, health care indust

spend time cleaning and doing yard work. After a rain, we had tons of weeds I was destined to pull. So it required as much maintenance as any other home. We even had to do some laundry and take out the trash. We had envisioned it as a vacation home, but, besides the cleaning, there was still the requ

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

ired shopping to restock essential products.

We owned the place for three years before we understood the real cost. For far less money, we could vacation anywhere in the world and choose different places every time. So we sold the cabin at a fair profit, invested it, and now we can take several great

.

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

luxury vacations just off the interest alone (we got back $180,000 and receive 5% interest for $9000 annually). My advise to anyone considering a similar investment would be to really think about: (a) how much it will cost, (b) how much it will be used, (c) how easy is it to get to, (d) at what cost,

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

Companies that provide selfless information through particip

i.e. gas, airplane fare, (e) will it go up in value, and finally (f) how easy would it be to sell. For us, it was a simple decision and we have a new appreciation of vacation homes. Or, as I like to call them, “temporary rustic retreats that secretly suck up expenses while offering little in return.”

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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