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At Summerhill, tradition meets the mystical to create a winery experience that is somewhat out of the ordinary. Visitors may try s

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

ome of Summerhill’s many wines in the wine shop before heading out on one of the many tours that are conducted throughout the day.

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

Examples of combination products may in

The winery also features Sunset Bistro, a restaurant at the winery’s front with an ample patio and view of Okanagan Lake. Before

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

entering the winery, visitors can also take in the World Peace Park with a waterfall, lovely vista, and koi pond to boot.

Immedia

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

tely upon entering Summerhill’s grounds, visitors will notice a white concrete pyramid. This is the jewel in the winery’s crown an

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

Combination pro

d the place where many of Summerhill’s wines are aged. It is thought that the aging of good wines in the ‘sacred geometry’ of the

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

pyramid has a positive, flavour-enhancing affect on them (tastings conducted in the pyramid revealed that 9 of 10 tasters preferre

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

d pyramid-aged wines).

During the tour of the cellar, which somewhat resembled a s?ance, we were informed that the pyramid could

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

also strengthen one’s life-force. At the very least, the carefully constructed building keeps the wines at a cool temperature (11?

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

-15? C) and provides welcome relief from the hot Okanagan sun outside.

Wines:

Summerhill derives its grapes from 45 acres of org

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

nic vineyard as well as from growers up and down the valley. The winery gained early attention for its sparkling wines, particular

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

Following aspects would a

ly the Cipes Brut, which has won awards internationally against sparkling wines from Champagne. The winery tour includes an explan

dd to the challenges in developing combination products:

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

ation of the sparkling wine vinification process. There are several lines of Summerhill wines, including Pyramid wines, Star Galax

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

y, Summerhill Organic, Enchanted Vines (featuring folklore artwork and organic grapes) and Summerhill Estate.

Summerhill currentl

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

y produces an array of wines too wide to list in its entirety. We have included a selection of some of its best-sellers:

Cipes Br

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

ut N/V
Pyramid Ehrenfelser (quite popular according to tasting staff)
Pyramid Gew?rztraminer
Pyramid Cabernet Franc

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

Professional from academic institutions, pharmaceutical industries, health care indust

Organic Pinot Blanc
Organic Gew?rztraminer
Late Harvest Riesling
Riesling Icewine

Notes on Tastings:

Summer

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

hill has a well-equipped tasting room with a long tasting bar. Some staff members are fluent in Cantonese or Mandarin. The winery

.

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

is often very busy in the summer, sometimes with several tour busses passing through at a time. Up to four wines can be tasted fre

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

Companies that provide selfless information through particip

e of charge.

Last Word:

Did we feel the Pyramid’s energy?- Perhaps. We recommend that you visit this winery and see for yourself

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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