Advice You - Business

I was watching the feature film A Gentleman’s Game on cable. It’s a great movie, but it was on the Golf Channel, so I had to

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

put up with long commercial breaks . . . and I mean long commercial breaks. I wanted to watch the movie, not the commercial b

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

Examples of combination products may in

eaks. But, if you’ve got to watch something you don’t want to see, you may as well learn something from it.

There were three

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

hosts that made comments about the movie during the breaks. There were five theater seats in each of the two rows on the set

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

Two of the hosts sat in the front row with three empty seats between them and the third host sat in the second row just off

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

Combination pro

enter for a nice, relaxing Japanese set composition.

The plot of the movie revolved around Timmy, who was a caddie for a pri

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

vate golf club. He loved the game and had a perfect golf swing.

During a commercial break the three hosts talked about golf

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

wings, and noted that they each knew many golfers who had the perfect swing and a seemingly perfect golf game, and yet they n

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

ver won tournaments. On the other hand, they saw golfers with bad swings, who won tournaments in spite of their form. Golf is

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

about failure and overcoming failure time after time they theorized.

People watch golf on TV and they always say that they

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

atch to improve their game as they see what the pros do. I think, however what these TV golf fans do is become hooked on the

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

Following aspects would a

rama . . . like watching reality TV or soap operas.

Great golfers are those who make bad shots, and then go on to the next s

dd to the challenges in developing combination products:

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

hot. All golfers make bad shots, so it’s easy to see ourselves in the roles of bad-shot golfers. And, we feel the triumph whe

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

bad-shot golfers reverse their worst moves and win.

Winners are those who have the desire and drive to win. They brush asid

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

the bad shots, the bad luck bounces, the wrong club choices; and they focus on winning. Is business any different?

How many

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

times do we fail in business? Every time a prospective client says no, we fail. Every time we offer a new product or new ser

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

Professional from academic institutions, pharmaceutical industries, health care indust

ice we take a chance of failure. Winners are those who overcome resistance. Winners alter their game plan along the way to su

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

cess. The triumph we feel is even greater when we experience it personally.

We need to continue swinging, whether the swing

.

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 perfect or not. Bad moves in business can be overcome. We make bad choices and sometimes have bad luck bounces, but busine

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

Companies that provide selfless information through particip

s winners are those who have the drive and determination to succeed. And in business that should always be par for the course

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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