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Live and Work in the Mountains of Tennessee
If you have ever wanted to get away from office politics, live in the serenity of nature, and still hold down a high-payi

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

ng job, the time has come. A revolutionary residential development concept is coming together in the Mountains, high on the Cumberland Plateau near the resort town of Monteagle.

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

Examples of combination products may in

So says Grant Miller, developer of the Village on Sewanee Creek, a Spa Lifestyle community anchored by a luxury medical spa and a community amphitheater with a 30-foot-wide scr

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

en that is wired for the future.

The Village has high-speed DSL that would enable a minimally tech-familiar executive to easily set up a home office and begin telecommuting fro

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

m his Tennessee mountain paradise. Miller is working with the local telephone co-op to be the first development on the mountain to bring fiber optics directly to the home. That'

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

Combination pro

s like plugging directly into the Internet trunk line with not only SUPER-high band width, but also high-definition TV and video-on-demand delivered over bullet-proof fiber opti

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

s, not cable. This is state-of-the-art stuff in the middle of the woods. Finally, we’re starting to realize the benefits of technology to make our lives more livable.

Grant

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

Miller, Developer of the Village on Sewanee Creek
In his earlier corporate life as an international division president, Grant Miller oversaw employees and franchisees 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 over 50 countries for big name retailers like Blockbuster, 7-Eleven, Dunkin’ Donuts, Baskin-Robbins, and Papa John’s. For over fifteen years he used the Internet for real-time

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

video conferencing, desktop sharing, and Voice over Internet Protocol (VoIP) in a virtual home office environment, so he not only understands the technology that is now commonpl

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

ace, but more importantly, how to make it work in the corporate world. Miller says, “The Internet is an incredible productivity tool that helped me reduce costs, local commute t

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

Following aspects would a

ime, and international flights while I worked, sometimes strange hours, from the comfort of my home office. It played a valuable role in keeping my communications fresh and curr

dd to the challenges in developing combination products:

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

nt across long distances and changing time zones. The productivity boost was essential; the flexibility it gave me to be with my family, to do what I wanted, and to be where I w

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

anted made life worth living.” Now, with fiber optics reaching remote locations, one can really live.

Proximity to Nashville, Chattanooga, and Huntsville
Miller say

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

s, “I chose the location of the Village for a lot of reasons beyond its breathtaking natural beauty. I wanted to develop a community that would attract not only retirees, but al

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

o young, active, working families. I knew we would already have high-speed DSL, but equally important to the Village is proximity to Nashville, Chattanooga, and Huntsville. Thei

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

Professional from academic institutions, pharmaceutical industries, health care indust

r airports are all about an hour away. When I lived in Atlanta and Los Angeles my airport commute time was at least that long across town. The combination of high-speed Internet

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

and sizeable airports makes it possible for most executives to work from paradise--if you know how. Close proximity to the University of the South brings the cultural element t

.

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

at an upwardly mobile executive craves. This is the Sweet Spot.”

For anyone ready to make the leap, Miller is offering a 15-minute, live, online demonstration of both the techn

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

Companies that provide selfless information through particip

ology and the Village. For those who become neighbors in the Village, Miller is a resident and says he’s happy to be both productivity and lifestyle coach.”

WOW, pack your bags

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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