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To run, or not to run? That is the big question for the NBA Finals as Miami battles Dallas. Actually the key will be who controls the tempo? Detroit had an explosive off

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

ense all season, then blew away the Cavaliers in their first two playoff games. Suddenly, the Cavs completely slowed down the pace, controlling the tempo, and winning 3

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

Examples of combination products may in

in a row over the stunned Pistons. The Heat also controlled the pace in slowing down Detroit in the Eastern Conference Finals.

A younger and deep Dallas lineup no doubt

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

will want to run while Miami will try and slow the tempo. Dallas has been unique and unpredictable in the postseason with respect to tempo. Against San Antonio, the Mavs

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

played the Spurs' pace in Game 1, a slow, methodical tempo won by San Antonio 87-85. However, the Mavs scrapped that style and went uptempo the rest of the series, winn

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

Combination pro

ing 3 in a row, in fact, by running.

Dallas continued to play uptempo in Game 1 against Phoenix, but lost at home 121-118. So what did Dallas do? Scrapped that plan 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

played defense the next five games, winning four of them. After scoring 121 in that first game, the Suns scored 98, 88, 106, 101 and 93 the rest of the series. After mis

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

sing most of Game 1 against Phoenix, Josh Howard averaged 22 points and 10 rebounds in the final five games. The Mavs went 4-1 with him.

So what does Dallas and Miami d

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

o now? Game 1 may have told us a lot. It makes sense for Dallas to run, not only because they are younger, but because Miami is a terrific high percentage shooting team,

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

almost solely from the low post, along with Dwyane Wade's drives. Dallas is less likely to keep Miami from shooting well (just ask the Pistons, who had no answer for Sha

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

q or Wade). But a halfcourt pace favors the Heat. After all, Shaq is 34-years old and Alonzo Mourning is a 36-year-old veteran. And we saw a low-scoring 90-80 affair in

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

Following aspects would a

Game 1, and perhaps, a bit surprisingly, a Dallas victory.

For Dallas to continue to be successful against the Heat, that could mean turning often to a group that inclu

dd to the challenges in developing combination products:

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

es Dirk Nowitzki in the middle, forcing O'Neal to defend a fellow seven-footer who has the quickness and shooting prowess of a guard. Dwyane Wade said defending the Mave

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

ricks in that scenario would become the ultimate team challenge. On the other side of the ledger, Dallas will have to decide whether or not to double team O'Neal. In the

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

regular season, the Suns had success double-teaming Shaq with smaller players at all times and daring the Heat to beat them with ball movement. Miami has been much bett

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

r in the postseason against that type of defense.

Oddly, one game really turned around Miami's season: a 112-76 loss to the Mavericks. Afterwards, Gary Payton and Udoni

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

Professional from academic institutions, pharmaceutical industries, health care indust

s Haslem addressed the Heat players. "There's nothing worse than being out on the court knowing that your teammates don't trust you and you don't trust them," Haslem sai

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

d this week. "I don't think we had 100 percent trust for one another."

Three days later, they turned things around, as the Heat rallied from a 13-point fourth-quarter d

.

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

ficit at home to beat the Pistons. Wade scored the Heat's final 17 points in that game, and it started a stretch in which the Heat won 15 of 16 games. So now Miami comes

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

Companies that provide selfless information through particip

full circle, in a sense: To thank the Mavericks for helping to turn things around? Or, to get beat again by the better, younger team? Good luck, as always...Al McMordie

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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