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On June 14, 2005 Jamaican sprinter Asafa Powell sped away with the 100-meter world record at the Super Grand Prix in Athens, Greece, clocking in at a blistering 9.77 seconds - one-hundre

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

dth of a second off the previous 100-meter record set by Maurice Green.

Asafa officially is now the fastest man in the universe. How much does it take an ordinary man,

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

Examples of combination products may in

who five years ago was practically a nobody, to accomplish this feat? It takes guts, determination, a strict training regimen, and the support of family and friends. Asafa also hasa ple

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

asant “nice-guy” attitude – on the track and off – unlike many of today’s cocky, head way up in the cloud sprinters. He also has a tremendous belief in himself – and an even greater beli

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

ef in God.

Asafa’s humble beginnings in the quiet, rural settlement of Linstead, St. Catherine, Jamaica, were a precursor to his amazing achievements on the track. Growing up, Asafa was

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

Combination pro

the product of a strict upbringing and deeply cultured family values. His parents, the Reverends William and Cislyn Powell, didn’t allow their children to go to dances and shows. It was

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

discipline and closeness of family that helped shape Asafa and his five older brothers.

The Powells have seen their fair share of set backs and suffering. Brother Michael was murdered

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

in a cab in New York City. Another brother, Vaughn, collapsed and died on a football field in Georgia. Reverend Powell himself was shot in the jaw during a robbery attempt. But the fami

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

ly’s close bond and devout belief in God have kept them going even in times of great adversity and sadness. While in high school, Asafa dreamed the great dream and wrote his goal in his

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

yearbook: To break the world record.

Asafa attended university in capital Kingston, Jamaica – turning down offers from American universities. He lives and trains there, attending church

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

every week, and staying in close contact with his parents. It’s easy to assume that the fastest man in the world would rely on a wide variety of special supplements to stay energetic an

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

Following aspects would a

d train hard. Asafa had never taken any type of vitamin up to April of 2005. “Taking Nutrilite™ Double X™ was the only change I made to how I had been training. After I started taking it

dd to the challenges in developing combination products:

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

, I felt I had more energy to train harder and run faster.”

He adds, “I am very careful about what I consume so I appreciate the balanced vitamin and mineral content plus the rich, plan

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

t-based concentrates in Double X.” He clocked 9.84 seconds in May 2005 at the Jamaica International Invitational, – at the time, the fastest time in the world that year. A month later,

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

he delivered a similar performance in the Czech Republic, with a time of 9.85 seconds. Asafa broke the world record, running 100 meters in just 9.77 seconds – in the very stadium in Ath

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

ens where he finished a disappointing fifth in the 2004 Olympics. His reaction to breaking the world record? The at ease, shy, deeply religious young man merely laughed and smiled – even

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

Professional from academic institutions, pharmaceutical industries, health care indust

during the few minutes it took for his world record time to be confirmed on the scoreboard.

“When I run, I don't think about my competition,” says the world record holder. “I just do

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

what I have to do. Nutrilite doesn't consider the competition in what they do, they just focus on being the best in their field.”

The name “Asafa” means “rising to the occasion” and I

.

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

believe we will undoubtedly see the name Asafa Powell in the sports records for many years to come. Asafa will only be 25 at the Beijing Olympic Games in 2008 – a relatively young athl

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

Companies that provide selfless information through particip

ete in the highly competitive world of track stars. Asafa’s story is one of setting and achieving goals and should serve as an aspiring story to those inside and out the athletic circle.

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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