A new medicine can have an instant, positive impact on many lives. When Mark Sullivan started Medicines Development in 2005, his mission was not only to develop new medicines but to put them in the hands of those who need them most.
Medicines Development is one of a rare breed of not-for-profit (NFP) pharmaceutical companies – though Sullivan prefers the term “social enterprise”.
“We’re as focused on making a profit as any commercial organisation,” he says. “The difference is that our profits stay within the business to help us meet our goals of delivering new medicines, reducing their cost and donating them to people who can’t afford them.”
One of only four similar groups in the world – and the only one that is totally independent – Medicines Development has been self-sustaining since it was launched.
“We have never received a donation,” says Sullivan. “We focus on developing drugs with a potential impact on higher-income countries as well as low and middle-income countries because we have identified this as a realistic way of generating sustainable revenue.”
The business model is particularly impressive given the huge costs associated with their work. “Research and development are generally lumped together as ‘R&D’ but they’re actually two very different things,” he says. “And, when you reach the development stage, the costs increase exponentially. For every $5-10 million invested in research you are likely to need $100-500 million for development.”
The regulatory authorities are very rigorous and require a specific and transparent process. “This is exactly what you would hope for in a pharmaceutical environment but it does make development very expensive. For example, we’re in the process of registering moxidectin, the drug we license from the World Health Organisation, for the treatment of a parasitic disease known as river blindness.
“We’ve reached the stage of making three identical, commercial-scale registration batches under what’s called Good Manufacturing Practice. They must be kept under very different ambient conditions for at least two years to test their stability and then they will be thrown away. Again, this is important in terms of safety but it will use up $2.5 million of our $10 million budget. Registering a drug is a big milestone in anyone’s career. The amount of effort, work and money involved in it is enormous.”
A new frontier
Two years ago the company’s biggest challenge was generating sustainable income. Today, it is the process of registering moxidectin. Tomorrow it could be managing the transformation of a small, Melbourne-based group into to a serious global player.
“There is an American scheme called the Priority Review Voucher that rewards people who are developing drugs for neglected diseases,” Sullivan explains. “The value of the voucher is incredibly high – hundreds of millions of dollars – and it seems likely that we will qualify for one in about two years’ time.
“This is a very significant point in our history and right now my focus is making sure we are very well prepared for these changes should they occur. If they don’t that’s fine, we are still in a very good position to progress with our current work, but we need to proceed on the basis that they will.”
Sullivan’s strategy includes searching for people with skills that will support his own.“I’m very confident with the process of developing medicines and I know how to do things like bring teams together, so everything I’ve done so far has been well within my range of experience,” he says. “This is on a totally different level so I’m surrounding myself with people who can provide help wherever I need it.”
He also draws support from his board. “I look to the board for a range of perspectives and connections as well as governance,” he says. “Our chair, Lorna Meldrum, is a very experienced pharmaceutical scientist who is currently working with a local company, bioCSL, and she acts as an invaluable sounding board for me.”
The board is small – just four members including Sullivan. “I prefer smaller groups because they allow really fresh and frank discussions,” he says. “We may need to expand the board in future if different skills are required but I don’t imagine we’ll ever have more than six people around the table.”
Sullivan started his career in England. “I studied microbiology and biochemistry at Deakin University in Victoria and, at the end of my second year, I had the opportunity to be part of an overseas placement scheme,” he says. “I spent two months working at Johnson Matthey near Oxford in the UK and they offered me a job when I finished my degree. I went back as a research microbiologist then switched over to Glaxo (now GSK) for a role in drug development and clinical research. I hadn’t expected to like London but I loved it and ended up staying there for 10 years.”
After two years with Gilead Sciences at their head office in San Francisco, he returned to Australia. “I have always worked in infectious diseases and I had a particular interest in viral diseases so I was very keen to work on an HIV vaccine program,” he says.
“The role was in a semi-academic setting and I could see that the skillset I had built up in developing new medicines and vaccines could be very useful in an academic environment. That was when I decided to set up an NFP organisation.”
The move to an NFP structure did not reflect a change in his underlying motivation. “Whatever we hear about ‘big pharma’, most of the people who work at the coalface are driven by wanting to help, wanting to make a difference and knowing that a new medicine is an incredibly important tool in the management of disease,” he says. “I have worked on several new medicines that are currently being used to treat diseases that were previously fatal. My colleagues and I find it incredibly rewarding to know that we have played even a small part in improving someone’s life outcome.”
A role in global health
In 10 years’ time, Sullivan would like Medicines Development to have a number of different products on the market and more in development. “My goal is for us to play a really important role in global health,” he says.
He also plans to do a PhD when he finally emerges from the tunnel of hard work. “One of my biggest personal challenges has been not having a PhD or a medical degree,” he says. “It hasn’t been a barrier but I think either of those qualifications would have made it a bit easier to move ahead in my chosen field. I’d like to do a PhD because I love science. I’ve never lost my thirst for knowledge and there are areas I’d really like to explore in depth.”
Meanwhile, in his brief moments of relaxation, he enjoys music, literature and art – things he describes as the opposite of science. He also enjoys travel but says, at the moment, the more time he can spend at home the happier he is. “I’ve become much more focused on preciousness of being able to tune out at home,” he says. “It’s rare, but that’s what I look forward to most.”