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In the feature film Rookie of the Year, Gary Busey plays the part of a one time great major league pitcher, Chet “Rocket” Steadman who has his

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

playing time reduced.

A young pitching phenom, Henry Rowengartner is signed for the team. The reality of playing ball hasn’t set in yet with

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

Examples of combination products may in

Henry. He is thrilled to be meeting the players he has only read about and seen on TV. As a pitcher he worships “Rocket” Steadman.

Chet Stea

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

man: Do me a favor: Don't call me "Rocket".
Henry Rowengartner: Why not?
Chet Steadman: 'Cause I'm not the "Rocket" anymore.

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

Henry Rowengartner: Yeah, I don't get it, you're throwing so slow.
Chet Steadman: Well, Thank you very much.

Steadman knows his days a

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

Combination pro

e numbered. When Henry is introduced into the line-up, Steadman is asked by a reporter, “How does it feel to be out pitched by a twelve-year o

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

ld?” He replies, “I don’t care who out pitches me,” indeed all he cares about is the team. The same feeling should permeate both sports and bu

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

siness.

In the movie Steadman becomes a teacher, friend, and mentor to the youngster. Henry is only playing because a broken arm has left him

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

with an incredible fast ball. Steadman gives the rookie a piece of advice, “Henry, don't take this serious. But it’s nothing to joke about. Bu

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

t one day, your gift will be gone.”

The team supports the effort to win the division championship. At the end of the movie we know that the t

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

am has won the World Series, but we don’t see them win it. What we see is that in the championship game, both Steadman and Henry lose their gi

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

Following aspects would a

ft.

Steadman has gone through physical therapy and with one pitch late in the game he knows that his career as a pitcher is over. Henry is se

dd to the challenges in developing combination products:

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

nt in as a relief pitcher for the final inning. Walking onto the field he slips and lands on his pitching arm. We know that his gift in gone a

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

d one pathetic practice pitch proves it.

Instead of taking himself out of the game or simply throwing a few pitches to the opposing team and

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

losing the game, Henry signals for his teammates on the field to join him on the pitching mound. He explains what the problem is and asks for

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

heir assistance. He has a plan. With a little trickery and good ball handling, they win the division.

The team plays through the World Series

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

Professional from academic institutions, pharmaceutical industries, health care indust

and is victorious without the physical gifts of Steadman and Rowengartner. That is the trademark of a great team. It’s easy to win games with

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

good players. It’s easy to have successful projects with great workers, but in the end a team or a business that can win without the supersta

.

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

s has reached a level of success seen by few. A great team has players or workers that care more about the team than they do for individual at

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

Companies that provide selfless information through particip

tention. A pitcher or a salesman shouldn’t ultimately care if someone younger or newer on their team out pitches them as long as the team wins

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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