Contributors to this programme:
Director of Real Estate Europe, Middle East and Africa, Pfizer.
Dr Steve Felstead
Head of Clinical Research, Pfizer Worldwide Pharma Therapeutics
Dr Ruth McKernan
Chief Scientific Officer and head of the Regenerative Medicine Dedicated Research Unit, Pfizer Cambridge
Business Manager, Pharmaceutical Sciences, Pfizer
Dr Declan Doogan
Chief Medical Officer, Amarin
Sir Richard Sykes
Chairman, Royal Institution
Leader of Kent County Council
Peter Day's Webcomment:
About this programme by Peter Day
I must admit I was shocked when - last February - I heard they were closing the big Pfizer research and development campus at Sandwich in Kent, with a loss of more than 2,000 highly-specialist jobs. Here was what was supposed to be one of the centres of excellence in British industry.
I spent quite a lot of time five six and seven years ago following the development of a new drug through the system, and Sandwich then seemed a secure part of the Pfizer empire. It had, after all produced the best-selling Viagra (rather by accident) a few years earlier.
I was tracking a drug then called Maraviroc, an HIV/AIDS treatment taking a new approach to blocking the virus from entering human cells.
We eavesdropped on only a few years of the whole process in order to make a series of programme called Quest for a Cure. The basic medical research had started ten years previously at one of the National Institutes of Health in the USA.
From this publicly-funded work, Pfizer’s specialists identified an approach that might inhibit HIV/AIDS if they could find the right chemical compound to do this job.
I went to see the vast library of compounds at Sandwich. Big pharmaceutical companies have been trying to speed up drug discovery by making new chemicals by the thousand in robotised labs and then storing them against future use.
When the medics have identified an approach which might make an impact on an illness, the search is on for a compound somewhere in the store that might have the desired effect.
Then the chemical compound is refined and modified to make it more effective, using different expertise from other parts of the organisation. Endless testing follows.
And then the trials begin. First the drugs are dispensed in tiny quantities to volunteers, as the scientists seek signs of side effects.
If the early trials shows some kind of promise, the candidate drug is eventually rolled out to hospitals in various parts of the world to gain data on a strictly objective basis from medical teams who have nothing to do with the drug company itself … it is called Phase Three testing.
The development team I was following got on with other things, waiting in Sandwich for the results of the “blind” tests to be disclosed.
One weekend there was a scare when news came through of apparently adverse effects on one of the test patients. It turned out to be a false alarm, but the two rival drugs to Maraviroc from other companies were cancelled or delayed in phase three testing.
But the Pfizer drug eventually came through the tests and the project was passed on to the marketing specialists to start getting ready for selling. They invented a commercial name Celsentri or Selzentry, depending on the sales territory.
There was one more stepping stone to cross: regulatory approval.
Nearly 20 years after the original ideas about treating HIV/AIDS in this way, the Pfizer team gathered in a hotel boardroom on the edge of Washington DC to put their findings about Maraviroc to a panel from the Food and Drug Administration, a mixture of specialists and lay people.
After a morning of statements and questioning, they filed back into the room with a verdict: yes, the company was granted permission to sell the new drug in the USA . Other countries followed.
It was a dramatic, fast-moving climax to a very drawn-out story.
What I wanted to find out from this long process of programme-making lasting seven or eight years was why successful drugs are said to cost a frightening $1billion to produce. Drug companies say it is more now, maybe even double that.
The price of doing Phase Three testing in many countries under very strict and independent medical supervision is one obvious reason. The huge investment in labs and highly specialised people is another.
Then there’s the high failure rate in drug development. One of the things they tell you in the labs is that most people working in big pharma will never work on a successful drug. I found that discomforting.
And my absolutely layman’s impression of those years visiting Sandwich were that these companies had developed a machine for drug invention and production that was vast, unwieldy, and difficult to manage.
This despite the fact that the drug I was tracking actually reached the marketplace, and is now a (modest) revenue generator.
Twenty years ago, many big pharmaceutical companies set up huge labs costing hundreds of millions of pounds or dollars such as the one at Sandwich, excited by the apparent possibilities of applying newly realised computer power and robotisation to the inevitably slow process of drug discovery.
They were using the profits of a golden era of drug invention to finance what they promised would be a new flow of innovative blockbuster drugs out of their awesome new laboratories.
But the model failed; the drugs did not happen.
Sandwich came up with Viagra in the 1990s, a rather accidental result of developing an angina treatment that turned out to have side effects.
But in recent years, only Maraviroc/Celsentri appeared, despite vast spending on premises and people.
(Sandwich scientists will argue that work done there may still produce results in the future. And because it takes at least 10 years for a new drug to go from invention to the marketplace, the delay makes it very difficult for outsiders to assess the efficacy of a lab or even a company.)
But the mechanisation of the drug development process rather frightened me.
I could never forget my first view of the Sandwich campus on the marshes outside the little Cinque Port town on a chilly December morning: a huge bulk rising out of the sea mist, surrounded by barbed wire to keep out the animal protestors.
Even then, it seemed incongruous. And now - like the shuttered Kentish coal mines near by - this fortress on the Kent coast is becoming a sort of memorial: to an industry that got seduced by the idea of bigness, and apparently lost its way.
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