Shepparton woman helping to change global health landscape

It’s here that her love of science first emerged.

“We used to camp a lot and go yabbying, and I was always intrigued by the world around me,” Ms Handley said.

At high school, she had two science teachers who fostered her love for the subject, finding creative ways to engage their classes.

“We did experiments that weren’t in the books,” she said.

Now, Ms Handley is part of a small Australian not-for-profit pharmaceutical company, Medicines Development for Global Health, focused on ensuring that poverty doesn’t prevent people from receiving medical treatment.

The group did the unthinkable in 2018, when it achieved approval from the US Food and Drug Administration for a new drug.

US FDA approval is seen as the gold standard in the stringent drug regulation environment, but it is a lengthy and costly process that’s normally only attempted by the giants in the field.

“Being a not-for-profit pharmaceutical company is pretty rare,” Ms Handley said.

“We were the first not-for-profit to achieve US FDA approval in history,” she said.

The drug — moxidectin — was approved to treat river blindness.

River blindness is a disease caused by a parasitic worm that affects roughly 20 million people, many living in sub-Saharan Africa.

It’s classified as a ‘neglected’ disease because it, like many others with that classification, often affects people in impoverished communities and is largely absent from the global health agenda.

It’s not the kind of disease that large pharmaceutical companies have historically developed treatments for — it’s not a profit-rich endeavour.

But Ms Handley said focusing on treating these kinds of diseases was a major goal when MDGH was founded by Mark Sullivan about 20 years ago.

“Health inequity was something that really bugged all of us,” Ms Handley said.

“Everyone’s basic human right is to have access to good medicine.”

The drug approval in 2018 was a huge milestone.

Then, this month — after several more years of trials, and one global pandemic — Ms Handley and her colleagues were able to see their goals realised as hundreds of thousands of doses of moxidectin began filtering out to community members in Ghana through a mass drug administration.

“I did cry a bit because I was so proud,” Ms Handley said.

The revolutionary approach MDGH took to have its drug approved by the US FDA is something Ms Handley is hoping other not-for-profits and charities could replicate.

The group took advantage of the US FDA’s Priority Review Voucher Program.

The vouchers cut processing time for drug applications by about six months, something that’s valuable to companies trying to beat competitors to market.

They’re available to anyone who can get a drug approved for a neglected disease, and the holder of the voucher is allowed to sell it.

“It’s like a golden ticket,” Ms Handley said.

MDGH sold its priority review voucher for about $100 million, she said, allowing the company to bring its drug to market and pay investors.

She is hopeful that others will do the same.

“Every time a drug is approved for a neglected disease it means people have access to a medicine and it means we may be able to eradicate a disease,” she said.

Ms Handley said she and her colleagues were now focused on bringing a treatment for type 2 leprosy reactions to market.

As she continues the battle to ensure good medicines are available to all, regardless of location or means, her message to budding scientists in her home town, especially women, is to persevere.

“When it gets challenging, don’t put it down and give it up, because you can really grow when you’re challenged,” she said.

“Stay with it.”