Medical advances made despite big business

Scientists find alternative routes to market
Samba time: Dr Helen Lee with her simple testing device © Heinz Troll

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‘We wanted something that anyone who can cook can use,” says Helen Lee, winner of the popular prize in the European Inventor Awards. The head of Diagnostics for the Real World holds a series of patents for devices that allow simple “point of care” detection and monitoring of infections including HIV in remote parts of lower income countries.

The Samba (simple amplification-based assay) technology she has developed involves complex chemical testing using nucleic acid. Yet it delivers an uncomplicated result in the form of one or two easy-to-read lines from a device resembling a coffee machine with simple cartridges. Mobile phones share the findings. “Rather than force-feeding developed world technology into the developing world, we set it up the other way round — although it is designed to be good enough for use in richer countries,” says Dr Lee.

European patents are dominated by innovations in the medical sector, but it is not just about drugs and diagnostics. The implementation is as important as the innovation itself. “The patent is just one part of the chain,” says Dr Lee. “It only takes one weak link and it will not work. I always said engineers can’t develop something without visiting the clinics where it functions.”

Alongside the difficulties in poor countries of electricity outages and voltage surges, she highlights extreme temperature ranges — from above 38 degrees centigrade in Malawi, to the chilly conditions of Johannesburg in winter. The new Samba II device under test is designed for such a greater range.

“One of the biggest constraints is dust,” says Dr Lee. “It’s pervasive and clogs up the electronics.” She also cites the problems of spare parts — one reason she developed a filter that can be washed and reused.

Dr Lee previously worked at Abbott Laboratories, the US healthcare products group. But she explains that the time and nature of the diagnostic would have been difficult to develop in a large company, so she created her own. “If I’d still been at Abbott I would have been fired a long time ago. In fact, I would have fired myself because you can’t do this in two to three years.”

Working outside large companies has also been key for Tore Curstedt from the Karolinksa Institute in Sweden, who, together with fellow researcher Bengt Robertson, developed a treatment to prevent the lungs of premature babies from collapsing. Key to this was Mr Curstedt’s initial work in the 1960s on phospholipids, a component of cell membranes, and in the early 1980s he joined with Mr Robertson to explore the potential for surfactants — naturally occurring substances in the alveoli of the lungs.

They concentrated on the potential to treat neonatal respiratory distress syndrome; their surfactant preparation has been administered to 3m newborns over the quarter of a century since its launch. “We became very focused, building a network of neonatal doctors and holding expert meetings every year,” he says.

The surfactant is extracted from pigs’ lungs and prepared in their laboratory. The academics needed an industrial partner, but Mr Curstedt says that Pharmacia, a Swedish drugs company which has since become part of Pfizer, felt “the sales were too small and the marketing costs too high”.

Instead they came across Chiesi, a small Italian pharmaceuticals business. “It was an important product in a small company instead of a marginal product in a big one,” he says. The company named the surfactant Curosurf after the two inventors and continues to dominate production.

Robert Langer, a professor at the Massachusetts Institute of Technology, has won the European Patent Office’s non-European award for a system that envelops anti-cancer drugs in biodegradable plastics to give them maximum impact. He recalls early in his career being the only engineer in a hospital. “I was so naive at first. I thought if I published papers, people would read them and that would lead to products . . . The big companies didn’t use them, so I started small companies to develop them.”

He remains committed to a series of projects: targeted delivery of therapies; tissue engineering; and exploring longer term release of drugs and vaccines to ensure patients more reliably follow treatments in lower income countries. “I want to take first world technology to the third world,” he says. He argues that “the patent system is critical. Without protection, investors would certainly not put significant money into my area, biotechnology.”

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