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The third base coach plays a very important role in baseball. The role that he plays i

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

n decision making is very vital for the game.

When the batter launches a double into

; 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 gap with a runner on first base, the third base coach makes the final decision. He

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

is expected to consider several factors before sending a runner home.

These factors

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

re as follows:

• Base runner's foot speed
• Outfielder's arm strength
• Rel

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

Combination pro

ay man's arm strength
• Score and inning
• Number of outs and
• The bat

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

ter on deck

In order to improve decision-making skills, the third base coach should f

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

llow the following tips:

• Pre-pitch planning should be done. It is very essential.

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

• The various possibilities in mind should be rehearsed before they happen.

• The opp

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

onent team’s moves should be well anticipated. The runner should be warned in case a p

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

rticular defensive play is suspected.

• At times, unexpected plays do occur. But, in

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

Following aspects would a

such cases, the third base coach should work with his gut. He should have the courage

dd to the challenges in developing combination products:

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

required to make the wrong call. After all, if instinct is followed, one usually never

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

goes wrong!

The role of the third base coach comes into play once the player leaves

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

he first base. The third base coach is responsible for the runner until he leaves thir

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

d to score.

It is the duty of the third base coach to maneuver himself directly into

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

Professional from academic institutions, pharmaceutical industries, health care indust

the runner's line of sight. He should remain well into foul territory at all times. Ho

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

ever, making contact with any runner while the ball is in play should be avoided.

In

.

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

short, effective third base coaches influence the outcome of many plays throughout a g

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

Companies that provide selfless information through particip

ame. To conclude, base coaches contribute a lot to a team's ability to generate runs

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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