The BioCentury Show: Oyler advises CEOs to face home truths as they navigate the capital crunch
BeiGene CEO discusses the future of China biotech, global innovation and PD-1s
By C. Simone Fishburn, Editor in Chief
February 10, 2022 3:54 AM UTC
BioCentury
CEOs new to a down market will have to face hard truths as they consider resources and navigate the capital crunch, at the same time as managing a workforce exhausted from the pandemic, which has had a profound impact on the way people think about work, said BeiGene’s John Oyler on the recently launched The BioCentury Show.
In a wide-ranging conversation on the second episode of the show, Oyler talked about navigating the next year, which he says will be a hard one, and how he thinks the future of China’s ecosystem will play out. He also addressed PD-1s, global trials and pricing.
Oyler, who is co-founder, chairman and CEO of BeiGene Ltd. (NASDAQ:BGNE; HKEX:6160; Shanghai:688235), talked about a tough year facing all CEOs, with a game of musical chairs where many investors have rotated out of the sector taking chairs with them. The question CEOs have to ask themselves, he said, is “How long is the music playing for you.”
Oyler also believes the China ecosystem, whose marked growth he has witnessed first-hand, will settle down to the pattern seen in the U.S., Europe, South Korea and Japan. “There’ll be several A players, several B players, and everyone else is going to have a much smaller commercial footprint and really have a small portion of market share.”
While that’s no surprise to industry veterans, he said, that will take some adjustment for others to absorb. “For a while there was a misunderstanding that every Chinese company doing research was going to be a commercial organization.”
Oyler also responded to comments made last week by FDA Director of the Oncology Center of Excellence Richard Pazdur, who argued in The Lancet and in comments to BioCentury that FDA will not look favorably on China-only or single-region clinical trials for anti-PD-1 mAbs or other drugs where there are already similar drugs on the market in the U.S. Instead, Pazdur says sponsors will need to show data from a patient cohort that represents the U.S. population.
“These are all fair questions for the FDA to ask,” said Oyler, noting that requiring a representative population, or data showing patients are dosed at the same stage of the disease is standard. “These are scientific questions,” he said.
Oyler himself is a big advocate of multiregion clinical trials, which are core to BeiGene’s business model. Its tislelizumab is an anti-PD-1 mAb partnered with Novartis AG (SIX:NOVN; NYSE:NVS) to treat esophageal squamous cell carcinoma, is based on global trials, and has a PDUFA date of July 12.
However, he warned that there are downsides in creating too many hurdles because it can discourage development of best-in-class drugs. “The third, fourth, fifth or sixth may be the best,” said Oyler, citing Lipitor as an example. “It’s very important not to create a framework that makes it so difficult, you couldn’t get a best-in-class medicine to patients.”
The BioCentury Show, which posts every two weeks, is an open-access program of in-depth one-on-one interviews with leaders across the biopharma ecosystem.
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