Covid 19 disrupting Drug R and D: Caught in a Covid-19 maelstrom, Eli Lilly locks down clinical trials as multibillion-dollar R&D ops derail
The Covid-19 pandemic has derailed Eli Lilly’s $6 billion R&D operations.
The pharma giant reported Monday morning that it has decided to hit the brakes on most new study starts and pause enrollment for most ongoing studies. Lilly adds that it is continuing dosing for ongoing studies, “but with study-by-study consideration.”
The pandemic has severely disrupted healthcare systems around the globe, says Lilly, making it difficult or impossible to conduct studies at many research sites. And there’s no timeline for when it expects to get back on track.
Tim Garnett
“By delaying most new study starts and pausing enrollment of new patients or healthy volunteers in most ongoing studies, we hope to ease the burden on participating healthcare facilities and allow physicians to focus more of their efforts on combating COVID-19,” said Tim Garnett, Lilly’s chief medical officer.
The implications for the R&D industry are enormous, extending to multibillion dollar CROs and a vast array of clinical support services. Lilly had expected to spend close to $6 billion this year on one of the largest drug research efforts in the world, covering an extensive pipeline that includes experimental meds for cancer, diabetes, immunology, neurodegeneration and pain.
Over the last few days, a few small biotechs have reported moves to pause studies — something that can be easier said than done. But it was clear that a vast array of clinical trials are at risk of being shelved for now — or have been shuttered already.
On Sunday Galapagos spotlighted its plans to freeze work on a slate of mid- and late-stage trials for filgotinib, a major development effort allied with Gilead, which relies on this drug as one of its key late-stage efforts.
CEO Onno van de Stolpe sent out a memo over the weekend noting:
It was decided to pause enrollment into the filgotinib trials in order to help protect patient safety. This includes the Phase 2 and Phase 3 trials of filgotinib in Crohn’s disease (DIVERSITY), the Phase 3 in psoriatic arthritis (PENGUIN), the Phase 2 trial in uveitis, and the MANTA and MANTA-RAy trials.
We anticipate the Phase 3 program in ankylosing spondylitis will now start later this year.
This does not impact the Phase 3 SELECTION program in ulcerative colitis, as this study is fully enrolled, and we still expect results in the second quarter of this year.
I want to assure you that the Galapagos team continues to face this unprecedented situation with resilience. And as challenging as the COVID-19 crisis is, this too shall pass.
On Monday, the UK biotech investor Syncona also noted that it expects the pandemic to roil clinical trial work at its companies, with delays expected to run at least 3 months. And you can expect plenty of others to follow up in a similar vein this week.
The top 15 companies in biopharma spent more than $100 billion on research last year and were on track to do that and more in 2020.
Lilly, based in Indianapolis, was one of the first of the Big Pharmas to tell staff to work from home as the industry began a slow motion train wreck in new product development and line extensions.
Social image: Eli Lilly CMO Tim Garnett via Youtube
