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In 1996/7, and I can’t remember which year exactly, I met Cathy O’Dowd at a Computer Faire in Durban, South Africa. She was there to honour a sponsorship

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

by Apple. Cathy O’Dowd was a member of the first South African Everest Expedition. Her team followed the route made famous by Edmund Hillary. She reached

; 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 summit on May 25, 1996. Apple had provided some sponsorship, computers etc to the expedition. She was at the Faire to talk about her climb and to give

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

Apple some exposure.

The year 1996 was not a good year for climbing Mt Everest. During the climbing season, fifteen people died trying to reach the summi

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

t, making it the deadliest single year in the history of Mt Everest. For the novice Cathy O’Dowd, to have people dying was a terrible experience. It was a

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

Combination pro

harsh introduction as 37 year-old British team-member and photographer Bruce Herrod died on the descent.

What she suffered the most from, was people att

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

cking her and the rest of the parties who survived. The question she was constantly asked was why not more had been done to save the people who had died.

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

She maintained that there was absolutely nothing that could have been done for these people and further it would have put the lives, of the people who act

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

ually made it back, in jeopardy. Her pain in defending her stance was very apparent. She certainly did not take the loss of the team member lightly.

I ce

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

tainly do not blame Cathy O’Dowd for the death of people during her climb, or anybody else. However, I just have a question mark as to what distinguishes

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

human beings from the animal kingdom, or other aware entities. And I always think the difference is the compassion humans have towards other human beings.

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

Following aspects would a

This could be in the form of the young soldier in Iraq who threw himself onto a grenade so that the others in his team were spared. Or it could be a mot

dd to the challenges in developing combination products:

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

er giving one of her organs to her child with a disease. It could be as basic as the youngster standing up in a bus for an elderly person or the teacher i

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

n the recent United States school shooting who was killed while trying to protect his scholars.

This compassion was shown again on the latest Mt Everest

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

climbing expedition. A Nepalese climber left to die on Everest by her team was saved today by an American guide and his sherpa who happened to pass her wa

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

after returning from their successful summit.

The two gave up their oxygen for her and struggled for 12 hours to pull her down the mountain. During this

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

Professional from academic institutions, pharmaceutical industries, health care indust

ordeal they watched another woman fall 1 000m to her death. What is even more extraordinary is the fact that they didn’t actually think that the woman th

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

ey were rescuing would make it. She has in fact recovered from her ordeal.

So what does it mean to be a human being? A disregard for other people, while

.

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

n a quest and on a mission to achieve ones own goal, with a minimum consideration for the odds of somebody else’s survival? Or is it a sign of humanity if

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

Companies that provide selfless information through particip

one disregards ones own personal safety and in some cases ones own life, to help another person. I know which one I would go for if asked, what about you

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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