Gilead’s Parsey sees a rising bar for innovation, with positives despite challenges
Gilead CMO expands on his pipeline rationale, biotech challenges and where step changes might come: The BioCentury Show
The days of incremental benefit are numbered, said Gilead CMO Merdad Parsey, and drug developers have to bring something that will move the needle significantly to bring meaningful benefit to patients. That’s the consequence of the success and advances the industry has made in the past decades, which have raised the bar and changed the strategy for how drugs are developed.
“As we innovate, as new treatments come out, the bar continues to get higher — that’s a good thing,” said Parsey on The BioCentury Show.
He discussed the challenges facing small biotechs who must now meet requirements — such as diversity in clinical trials or dose optimization studies for some cancer treatments — which can be burdensome from a cost and logistics perspective.
Those FDA directives do mean it can be harder for small companies to generate differentiated data, an issue Parsey is sympathetic to, having spent part of his career in small biotechs. Still, he said, those changes are appropriate for patients. “I think we have to accept that’s going to take a more intensive effort, and often that’ll mean earlier partnership.”
He also outlined the strategy for Gilead Sciences Inc. (NASDAQ:GILD) in R&D, in particular how it plans to grow its oncology pipeline and what its priorities are in HIV.
Parsey said Gilead is about “half way” on its planned goal for oncology, and that having scored some wins in the late-stage pipeline via its CAR T product Yescarta axicabtagene ciloleucel and its antibody-drug conjugate Trodelvy sacituzumab govitecan-hziy, it is now looking to invest in particular in the early pipeline.
Parsey discussed some of the hurdles across the field in tackling checkpoint inhibitors now that PD-1 and PD-L1 inhibitors have raised the bar. But he retains high hopes for the target TIGIT broadly, and for Gilead’s Phase II candidate domvanalimab, which is partnered with Arcus Biosciences Inc. (NYSE:RCUS), as well as its Phase III CD47-targeting mAb magrolimab, obtained through its acquisition of Forty Seven Inc.
He also discussed Gilead’s ongoing activity in HIV, including where the unmet need remains, and why a long-acting agent is important.