Innovation Series: Strict regulators balance drug safety with development
Innovation and safety come hand in hand when you are regulating new drugs to combat untreatable diseases.
It is a process AFT Pharmaceuticals founder Hartley Atkinson knows all too well.
He said regulators had an "about right" balance of caution and encouragement towards innovation in the pharmaceutical industry.
"If you have got something new, innovative and different, you do also need to know it is safe," Atkinson said.
While computers have made data collection from clinical trials easier, medicines have only become more expensive to make, he said.
But for a heavily regulated industry, medicine remained fast moving, Atkinson said.
"It is not going to slow down, it will speed up."
He created Maxigesic, which combines paracetamol and ibuprofen in a pain relief tablet , and an antibacterial cream, Crystaderm, that does not fuel antibiotic resistance.
Atkinson has licensed a nasal spray device that delivers 20 times more medicine than current nasal sprays and could be used instead of intravenous drips in hospitals.
AFT's Hylo-Fresh eye drops are created by robots in a German factory, and Atkinson is in the process of testing a topical treatment called Pascomer to cure the rare hereditary skin condition Angiofibromas.
It was important to have innovative products in healthcare because it was profitable for pharmaceutical companies to give customers options, Atkinson said.
"There is this challenge; you are talking about business, but you are talking about people. The two are not totally divorced."
He said drug companies had been pushing to find treatments for incurable diseases in recent years.
But money is a barrier to creating new medicine, Atkinson said.
Hence AFT's decision to publicly list on the New Zealand and Australian stock exchange last year.
He said New Zealand has not appreciated his company's cost effective research and development strategy.
"We developed a drug delivery device probably with $2 million to $3m. The big guys would spent $30m or $40m and get the same result."
His research and development staff work in groups of four to five people so they can act like a start-up business, he said.
"When groups get too big, people can kill an idea."
AFT could only cure what it could afford to, Atkinson said.
No New Zealand company could ever cure cancer because it would cost too much, he said.
Time is divided between expanding Maxigesic's customer base and developing or testing new over the counter, prescription or hospital grade products.
Even small improvements could significantly change the way people were treated, Atkinson said.
Taking on the global industry from an office overlooking Auckland's Takapuna beach was not as easy as it looked, he said.
"We get treated with a lot of scepticism and negative nay sayers, which we have ever since we started.
"They said the big guys will squash you."
Atkinson preferred to work with second tier pharmaceutical companies overseas because they were not as corporate as some of the larger industry players, he said.
"A lot of corporates have a stale way of doing things, you have to keep an open mind."
Atkinson said there is no better time to be alive than in todays medical age.
"Despite all the doom and gloom, the facts show people are living longer."
The Fairfax Media business innovation series runs in partnership with Callaghan Innovation.