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Twenty seven years ago, my wife and I were looking for a peaceful beach vacation. We dreamed of a quiet place where we could get away from it all. Our good friend Alan Schleimer operated a small business in Cleveland, Ohio called Condo Search. He recommend

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

ed a little known Gulf Coast island resort called Palm Island. Palm Island is located in Cape Haze Florida, on Lemon Bay near Englewood Florida.

Once arriving at Palm Island, also known as Little Gasparilla island, we quickly learned that an island vacation

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

Examples of combination products may in

s just a little bit different. Palm Island has one restaurant, which also houses a very small general store about the size of pickup truck. Our Island paradise did not allow cars, and since Palm Island is one of the true developed Florida islands without a

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

land bridge, the only way to get their was by ferry.

The ferry to Palm Island left every hour on the hour and returned to the mainland on the half-hour. The 20 minute ferry ride, dropped us off at Rum Bay Restaurant dock, where the first mate led us to a tro

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

ley car and preceded to take us to our condominium unit. The trolley made its trip around the island every hour also, so while getting on and off the island was very easy… it took about 45 minutes to get off.

Since we were too young, and too poor to rent a g

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

Combination pro

lf cart, Kathy and I opted for bicycles as our transportation. On the second or third morning, we continued exploring our new island. We had seen plenty of great beaches, but were simply not prepared for the beauty to be discovered as we came upon an estuary

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

where Rum Bay met Stump Pass. Since it was low tide, we were able to wade through the shallows and discover bunches of unusual creatures that we had never before seen.

Among other species, we saw live star fish, numerous mollusks, something we called sea cu

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

umbers, many schools of bait fish, lots of crabs, and all sorts of shells. Not more than 20 yards away a great blue heron was stealing shrimp from a fisherman’s bucket. There were all sorts of sea birds, osprey, cormorants, and others the likes of which we h

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

d never seen before.

Watching one of the fisherman pull in a yellow-tail jack off the surf, stimulated me to give fishing a try myself. Fortunately, Palm Island Resort was able to rent me a fishing pole with some tackle for $10. During the remainder of our

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

island vacation, I was able to try fishing almost every day, and managed to catch a few fish, but I really didn’t have much luck.

Over a period of several years and several return visits, we “discovered” many enchanting aspects of Palm Island, and the surrou

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

ding area. But it wasn’t until I decided to hire a fishing guide in hopes of actually catching some fish in Lemon Bay, that my love affair with fishing the back waters of Southwest Florida began.

Most of the well known area fishing guides were already booke

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

Following aspects would a

on my available days. One of the old timers told me about a new fishing guide who had fished the waters of Charlotte Harbor his entire life, had recently got started as a part-time fishing guide, and was looking for new clients. So I gave Captain Les Hill a

dd to the challenges in developing combination products:

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

call, and arranged to have him take me out on his boat Tarpon Hunter.

I have since fished the waters of Lemon Bay, Charlotte Harbor, Gasparilla Sound, and Stump Pass with Captain Les more than 25 times over as many years. A day fishing these waters with the

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

right guide seems to be almost an existential experience. Aside from fishing, each day is filled with detailed explanations of the interaction of various fish, birds, and plant life. There are thousands of small mangrove islands, oyster beds, and deep holes

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

here fish hang out.

Except for the occasional fish that is set aside for dinner, all of our fishing is catch and release. Moreover, we generally do not use live bait.

Most of my trips to the Charlotte Harbor – Englewood Florida area include two to three day

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

s of fishing with guide Les Hill. With my son and I fishing in the boat, we have landed as many as 13 fish species over the three day span. I think this includes the fish we pulled in off the shore as well.

These include Reds, Snook, Sea Trout, Lady Fish, F

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

Professional from academic institutions, pharmaceutical industries, health care indust

ounder, Permit, Shark, Jack, Mangrove Snapper, Saltwater Sheepshead, Spanish Mackerel, Grouper, Blue, and some junk fish.

Still, we have not yet caught our first tarpon.

Most of the waters we fish range from 3 feet to 6 feet of water. The fish tend to hide

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

n the holes which are a few feet deeper. Les can spot a hole that is likely to be home to Lady Fish and Trout while running his Tarpon Hunter at full throttle, almost on demand. Because the water is deeper in the hole, you can see the difference in color. M

.

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

ost fish hang out right on the edge of these holes.

When we hunt for Redfish or Snook, Les gets up on the platform, and poles along the mangroves. Here he can usually see the Redfish or Snook tailing, well before we make our first cast into the area. This

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

Companies that provide selfless information through particip

ncreases our chances of landing a fish.

If you have ever fished as a kid, but got away from it, or if you have never spent much time doing salt water fishing, I strongly recommend that you visit the Charlotte Harbor area and find yourself a good fishing guide

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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