“The reality is we can’t afford healthcare today,” outgoing VP and head of global manufacturing and supply strategy at GSK, Dave Tudor, told delegates at the annual bioProcessUK conference last month.
“The population is getting bigger and getting older, and we need more medicines. If we keep doing the same old things, manufacturing the same old way…then we won’t be able to afford it,” he added.
According to Tudor, who is leaving GSK to head up the Medicines Manufacturing Innovation Centre in Scotland, industry challenges and societal trends are impacting patients’ access to drugs, and may continue to do so in the future:
Major pharma companies are investing an increasing amount of resources into the discovery, development, and production of large molecules drugs.
Tudor told biopharmaceutical professionals at the conference that the expense of such drugs is creating a socio-economic divide: “The reality is that probably only the top 100 million people in the world will afford your products in the next thirty years.”
“It’s not cheap to make pharmaceuticals. Cell and gene therapy won’t be cheap. So, by definition, there are still going to be 5-6 billion people who are still popping pills,” he continued.
For Tudor, this problematic trend will prompt industry to consider two investment options: ‘Do we continue to invest in resource-intense products for this limited patient group of 100 million? Or, do we address the cost of tablets in basic, small molecule chemistry?’
“These are real tension points and you’re going to see segmentation of patient [groups],” he told delegates.
The march of technology
To keep up with global demand, and growing ageing populations, manufacturing technology needs to become more sophisticated to produce less waste, observed Tudor.
“We are, if I can be so blunt, still bashing metal on metal to make tablets,” he told delegates.
“It's more contained, it's more automated, it's a little bit more sophisticated, but we're making tablets today the same way we made tablets 100 years ago,” he added.
Looking to biologics, Tudor said single-use technology uptake could be increased to drive efficiencies across the sector.
“We still [make] biopharmaceuticals in big, expensive stainless vessels, as opposed to disposable technologies [and facilities such as GE’s FlexFactory].
“The technology is out there: the oil industry has been driving continuous manufacturing the last 20 years, the car industry has transformed in the UK with the drive in automation robotics,” he told delegates. “The march of technology – why is it that we are so slow to pick it up?”
A drive for efficiency
At the conference, Tudor admitted that in terms of margins and profit, the life sciences industry has been fortunate: “We’ve been able to enjoy high margins for many years.”
However, the world is changing, he warned delegates: “If you can’t see this right now, then you’re not listening or you’re not looking.”
“The idea that we will have high margins forever more is going to be a challenge in our industry – there is an expectation for efficiency,” he added.
Every step of development, manufacturing, supply, and commercialisation can be more productive, according to Tudor: “We have to drive down the waste in our process.”
“We take four years in the clinic. Four years to get a drug through the regulatory process – and 30% of that is wasted by bad planning and logistics.
“Why can’t we fix this? Why have we not been agitated to drive a much more efficient approach?” he asked.
Another global mega-trend, Tudor suggested, is society’s changing expectations. First, patients expect access to medicines: “They don’t expect there to be a shortage, and they expect to get it for a price that is reasonable,” he said.
Secondly, patients expect medicines to be ‘perfect’. “They don’t want to see contaminated tablets. They don’t want to see tablets [or biopharmaceutical solutions] that are off-colour. They want to see perfection.”
Tudor highlighted that customer complaint systems and regulatory processes are helping to raise the bar in terms of quality and standards.
“The system for bringing complaints back from patients is probably one of the most advanced we’ve had in the industry. Pharma companies are getting tens of thousands of complaints,” he said, adding that regulators are echoing an increased emphasis on quality control.
Similarly, quality control is increasing at a regulatory level: “The number of warning letters from the US Food and Drug Administration [have gone] up significantly. There is a ten-fold increase,” he added.
Dave Tudor was appointed VP, head of supply chain strategy for GSK in 2017, and since that time has represented GSK on the Medicines Manufacturing Industrial Partnership. Tudor, who is also chair of the Scottish Life Sciences Industry Leadership Group, is leaving GSK to take up the position of managing director of the Medicines Manufacturing Innovation Centre in Scotland.