Business Dump - Travel and Leisure

After our exciting round at Mystic Dunes, it was only mid-afternoon on a gorgeous day with blue skies, so we decided to take a 10 minute drive and drop

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

in on the Father Son Challenge at Champion's Gate, which has been held for the last 3 years at this golf course in the South part of Orlando. You can't

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

Examples of combination products may in

iss Champion's Gate, when you first get off exit 58 on the I-4, the impressive main entrance gates to Champion's Gate are right there.

The Father Son L

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

gend is truly a walking Hall of Fame of Golf, and it's a celebration of the sport as well as of the bonds of family. Famous golf professionals of the pr

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

sent and the past play with their talented sons and daughters, and all of them share a passion for the game.

This year's line-up included Jack and Jack

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

Combination pro

e Nicklaus, Arnold Palmer and his grandson Sam Saunders, Vijay Singh and 15 year old son Qass, Mark and Shaun O'Meara, Craig and Chris Stadler, Bob and

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

avid Charles, Raymond and Robert Floyd (Raymond has won the Father Son Challenge 5 times since 1994 together with his sons Robert and Raymond Jr.), Hale

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

and Steve Irwin, Tom and David Kite, Bernard and 15 year old Stefan Langer, Davis Love III and his 12-year old son Dru, Johnny Miller and Johnny Miller

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

II, Larry and Josh Nelson, Curtis and Tom Strange, Lee and Daniel Trevino, Fuzzy Zoeller and his daughter Gretchen.

We parked our car and approached th

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

club house. Just as we were walking towards the stands on the 18th hole, Davis Love III had finished his round and was coming towards the club house. I

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

is really an amazing experience, seeing all these world famous celebrities and icons of the sport, up so close and so relaxed in this unique tournament

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

Following aspects would a

format.

The rules of playh are based on a Scramble Format, which means that on each hole, each player drives and the best drive is selected. Each playe

dd to the challenges in developing combination products:

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

then plays a second shot from the spot where the selected drive lies, and the best second shot is selected. This process is completed uniti the hole is

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

completed.

When we were there we also saw golf greats like Vijay Singh, Mark O'Meara and Lee Trevino finish their rounds. It was great seeing Vijay, re

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

laxing after his final putt with a coffee in hand, awaiting the arrival of his son on the last hole and watching his son's last putt of the day. Because

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

this tournament pairs up the great players of golf with their sons or daughters, it really gives you a much better feeling of these professionals as hum

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

Professional from academic institutions, pharmaceutical industries, health care indust

n beings, and according to Allan Findley, General Manager of Champions Gate, many of these players truly relish this event, which allows them to celebra

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

e their sport as a family away from the pressures of the PGA Tour.

We really enjoyed the atmosphere at the Father Son Challenge, and it would have been

.

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

great to see some of the other legends of golf, like Jack Nicklaus and Arnold Palmer, in person. Unfortunately we have an extremely tight schedule and w

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

Companies that provide selfless information through particip

ll be unable to come back on a second day, but it was a great experience, getting a first person look at this "Walking Hall of Fame" of the game of golf

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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Business Dump - Golf in Orlando: Attending the Legendary Father Son Challenge Tournament at Champions Gate

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