The development of cell and gene therapies represents a breakthrough in biopharmaceuticals. Over the next five years, production is predicted to increase, development timelines to decrease, and new applications to enter the cell and gene markets.
According to Dave Tudor, outgoing VP and head of global manufacturing and supply strategy at GSK, it is the revenue opportunity that patented biopharmaceuticals offer – with high-margins and long-term value – that is “really interesting” to the larger companies.
“When you create your biopharmaceutical asset, or your cell and gene therapy asset, your viral vector, it is pretty hard for somebody to come and steal your lunch,” he told delegates at the bioProcessUK conference last month.
For Tudor, the challenging nature of biopharmaceutical development – and its high-value patent protection – marks a “big difference” between large and small molecules: “People can come and steal your lunch, and be much more aggressive about it today than they were 10 years ago, with small molecules.”
This begs the question: ‘Where should industry invest its money? “Am I going to build that biopharmaceutical plant, or am I going to re-life my small molecule network?” he asked delegates.
Ethics
Decision makers are increasingly faced with this dilemma – whether effort and money should be concentrated in small or large molecule markets – and with such a small percentage of the global population able to afford biopharmaceuticals, “probably only the top 100 million people in the world”, Tudor said this could be considered an ethical question.
“We’ve been enjoying [small molecule] penicillin in [the UK] for 60-70 years. But still, 22% of the world’s population has never taken penicillin, because they can’t afford it,” he explained at the conference.
At the same time, large pharma companies are asking themselves: “Am I going to put all my effort in that [biopharmaceutical] bucket because that’s where I can get the high margin or value?”
For Tudor, the correct answer incorporates both sectors. “There is no doubt in my opinion that in large pharma, you have to play in both [to meet small and large molecule demand]. I think it’s an ethical question.
“I think large pharma has a duty to society; we have to be able to find the mechanism for playing in both,” he added.
Partnerships
According to Tudor, partnerships and license agreements can enable big pharma to ‘play in both’ spaces.
“If it’s not strategic for the big company to be running a large number of…small molecule tablet factories then why do we do it? Why don’t we hand it out to someone else… why don’t they run it for us?” he suggested at the conference.
“We have to find a way of getting that balance and that level of optimisation. I genuinely believe that’s the direction large pharma are going in.
“If that means that we don’t make the small molecule, and [instead] give it out to somebody else under a license agreement, then that’s ok.”