The journey from growing an early-stage biotech candidate into an approved commercial pharmaceutical is one which only a fraction of companies survive.
From securing an investor, to budgeting pre-revenue capital, and managing a portfolio, each phase has hurdles – and by the end of the commercialisation track, fewer than 5 percent of startups remain standing.
But as Robert Shepherd of Dimerix points out, the right formula can see fewer trip-ups and better odds of survival.
Understanding the end-to-end work that goes into drug commercialisation is one of the biggest hurdles for startups, some of which lack the breadth to deal with financial, regulatory and manufacturing processes.
“Unless you’ve been doing that for many years, it’s hard to understand the ‘unknown unknowns’ in that scenario,” Robert said.
“There are many groups that back themselves into a corner early on, just because they weren’t aware of something they needed to do and it came back to bite them later. So having a team that understands what’s needed is a major advantage – especially when they can do so in a capital sparing manner.”
Robert said breadth of personal expertise also helps. Having worked in research for most of his career, Robert left academia to gain experience further downstream.
“I’d spent so long writing in my grant funding, about how I was working to cure various infectious diseases but didn’t understand how these things would move beyond research into the clinic, let alone into commercial success. Having experience across the spectrum certainly helps.”
Robert believes communication is important at every phase of bringing a drug to market, but says that in middle-stage clinical development, companies must become fluent in two languages.
“They need to speak that scientific language of early-stage companies – to review and bring great science forward – but also the language of capital markets, capital management, investor relations and all of those things, to actually get investment in the door,” he said.
Biotechs should also consider which real-world problems they are looking to solve and maintain that vision from conception through to clinical development.
“Having that big vision for your company and where you want to go, what sort of therapeutic area you want to serve, and making sure that that comes through in each step is so important.
“It’s something that needs to be communication with all stakeholders – be it the initial scientists, the investigators running clinical trials, patients on those trials, or the investors. You need a clear concept of why you’re taking capital to invest in a certain therapeutic area.”
Sharing more on what is needed to grow the pipeline of pharmaceuticals in Australia, Robert Shepherd will join a panel at the upcoming
Bio Connections Australia Conference, hosted by Informa.
This year’s event will be held 27 July at the Crown Promenade Melbourne.
