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"All things bright and beautiful, all creatures great and small, all things wise and wonderful, the Lord God made them all" - Refrain from a hymn sang in British school assemblies during the 1960's.

Life is preciou

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

s and young life is most precious as it embodies the future and the chance to create a brighter and wiser world. So when a young life is taken we mourn the loss of potential as much as the devastating personal tragedy. Abe

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

Examples of combination products may in

fan is the story of the tragic waste of young life on a monumental scale.

For most people born before 1960 in America they can remember what they were doing when they heard President Kennedy got shot. For the same generat

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

on living in Britain at the time, you were more likely to remember what you were doing when you heard about Aberfan.

On the morning of 21st October 1966, 144 people, 116 of them children, were killed when a tip of coal wa

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

te slid onto the village of Aberfan in South Wales. One of the first structures in the path of the slag slide was the village school. In just a few short minutes the future of this small welsh community was erased.

Aberfa

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

Combination pro

tormented and shrouded Britain for many months after.

Parents found the haunting images in the newspapers and on TV difficult to confront. The inconsolable father who lost his whole family. The mother still waiting at th

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

door for her child to return home from school... but who never will. Just when you thought the stories could get no more tragic... they did.

Surviving children in Aberfan were prized - they were hugged and protected.

En

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

lish poet and essayist Laurie Lee visited Aberfan one year after the disaster and wrote a poignant essay describing the lingering devastation on the community he found. The fields of tiny graves visited daily by parents, t

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

e sound of silence on the playgrounds, and the scarcity of children's garments drying on wash lines. They all told the story of a village that had lost its children.

Within a few hours of the disaster people came from mil

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

s around with their picks and shovels to dig out survivors... but it was futile. No survivors were found after 11:00am. Grown men openly wept as they uncovered the bodies of still children surrounded by black mud-laden boo

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

s and toys.

The slag that engulfed the village was a by-product of the local mine. After many years the tips grew to be mountains... but without a solid foundation. One of the tips had a spring underneath it, and it was j

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

Following aspects would a

ust a question of time before the saturation shifted its core and created the unstoppable landslide.

Coal mining disasters in south Wales were not unusual. It was part of the price for the work it brought to the region.

dd to the challenges in developing combination products:

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

nd it was hard and dangerous work for the men of the village, and they lived daily with the knowledge an accident could shatter the fortunes of a family. But never for a minute did anybody think the price would include the

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

r children.

Aberfan has long slipped into the English language. One word that when spoken evokes instant sadness and remorse for a day in the 1960s that changed a village forever.

At the time the mines were owned and run

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

by the National Coal Board, and after a few days of mourning the miners were required to return to work. Nationalization of the Coal industry was originally welcomed in the hope that the years of exploitation of the miners

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

would be redressed. But even after the Aberfan disaster life in the South Wales valleys remained hard; collieries closed regularly, unemployment remained high, and nothing came in to fill the widening economic gap.

Today

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

Professional from academic institutions, pharmaceutical industries, health care indust

he colliery is closed and the site of the destroyed school is a memorial garden.

The Aberfan tragedy is part of a history that still casts its long shadow over the south Wales coalfield. We all carry our own "Aberfan" wit

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

us - some event that overwhelms us with grief and makes us question the injustice of life.

By October 1966 I had left school for good and was no longer required to sing hymns as part of my life. I'm not what most would c

.

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

ll a religious person, but when I heard the news of Aberfan the hymn's refrain I quoted at the beginning occupied my thoughts for days. To this day when I hear the hymn I think of Aberfan and a lost generation in south Wal

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

Companies that provide selfless information through particip

s.

I give my children plenty of hugs and protection - they are precious and I know why...

"All things bright and beautiful, all creatures great and small, all things wise and wonderful, the Lord God made them all."

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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