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Whenever my buddy Johnny Karloff looks into something written about Borovets he is flying off the handle. “Look at those dumb heads. What is with them to write the same garbage over and over again? Borovets is the oldest Bulgarian ski resort

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

, right.., so what? When you go skiing do you want a 1948 vintage chair lift hanging from a rusted cable? Borovets is located in pristine pine woods and the air is healthy and pollution free.” Johnny goes on mocking some hotel flyer. “It bet

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

Examples of combination products may in

ter be, with all the cigarette smoke and alcohol in your system, you don’t want to inhale tail pipe exhaust walking back to your new ski apartment at 2 a.m., do you?”

Unlike Bansko, Borovets is not an old Bulgarian village exhibiting its ne

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

w ski resort and property investment ambitions. Numerous new developments and ski condos are going up as we speak but everything is more spread out and subdued. And there are the old bourgeois villas from the time when it was called Chamkori

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

a, the time when Simeon’s dad Boris and his grand daddy Ferdinand were running a place called the Kingdom of Bulgaria. Sometimes difficult to spot, these mountain chalets, hidden between the huge pine trees, feature cozy private apartments,

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

Combination pro

sunny porches decorated with nicely sculpted porticos. And then unmistakably for the trained eye, voil?… the palaces of the nowadays Bulgaria rich. Minimalist simplicity is not their thing. Some of their owners didn’t live enough to raise ch

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

ildren and grand children among the balustraded terraces tastefully adorned with golden lions and gargoyles. Mortality rate tends to run high among the palace owners, shot on purpose or by accident. Bad luck? The Borovets tourist guides are

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

clueless on the subject. (Click here for the Borovets map)

Borovets is a short one-hour drive away from Sofia airport on a two-line well main

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

tained road following the Iskar river for the most part. Then you enter the vast potato landscape of the Samokov plain. There is little to see in Samokov with the exception of the old Bairakli mosque. It’s a jewel built in the 15th century d

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

uring the Ottoman times and reconstructed in the 19th century by local craftsmen. The exterior and interiors are lavishly decorated in the architectural tradition of that time with a spiral minaret pointing into the sky. Looking around that

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

marvelous structure one can not help but feel regret for the past glory of the town. It seems the wild Ottoman era marked an apogee and from there on it was all downhill for the local builders: ugly defaced five-storey concrete buildings, pe

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

Following aspects would a

eling paint, cubical nightmare of unhuman proportions.

Drive 10km up in the Rila mountains and there is Borovets. Above the tree line or deep into the pine woods, winter or summer, on foot or on skis, the scenery is majestic. There is a gon

dd to the challenges in developing combination products:

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

dola lift that takes you almost to the top and a speedy quad chair to the lower pistes. The 20 minute gondola ride is well worth even for non skiers. The view from the Yastrebets peak where you get off is truly breathtaking. This is the depa

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

rture for several ski runs called the Markudjik, offering various levels of difficulty from beginner to advanced. The experts can try the Yastrebets run that takes them back to the resort but on the western part where they can use an other n

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

ew and fast quad chair. When the gondola was built in the 80-ies, it had two major drawbacks, the waiting line and the wind. Since the upper part of the mountain is often exposed to strong winds, the gondola has to shut and the skiers have n

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 choice but to opt for the second best, the lower pistes. When the weather conditions are good however, you may still run into waiting lines up to 200m long outside of the gondola station, at least in the morning.

That’s where some deep-po

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

Professional from academic institutions, pharmaceutical industries, health care indust

cketed real estate investors are coming in. Two months ago an investment fund from the UK announced a partnership with the Samokov municipality to resurrect the Super Borovets project after the death of one of its first proponents the banker

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

Kyulev (shot dead in Sofia last year). The Super Borovets development is actually an ambitious plan to change dramatically the face of the old Chamkoria. 80km of new ski runs and as many as three new cable cars will serve skiers and mountai

.

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

n lovers. The real estate market is on the rise and Borovets, with its quick access to Sofia airport, will give Bansko a run for its money. Still developers will have to focus on improving off season services in order to boost occupancy rate

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

Companies that provide selfless information through particip

s.

Borovets may as well become the Sofia favorite week-end playground when the Jack Nicklaus-designed golf course is completed and the spa and wellness centers around the mineral hot springs of Dolna Bania and Pchelin get a decent facelift.

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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