As Eli Lilly hustles to make 1 million doses of its COVID-19 antibody cocktail by midyear, the company's manufacturing chief is heading for the exit.
Near 19-year Lilly veteran and current senior vice president and president of the company’s manufacturing operations, Myles O’Neill, is set to retire May 2. He'll pass the mantle to Edgardo Hernandez, Lilly’s senior vice president of global parenteral drug product and device manufacturing, Lilly said in a release.
Pfizer veteran Hernandez joined the company in 2005, advancing through several roles in engineering services and manufacturing strategy before settling into his current position overseeing Lilly’s parenteral and device manufacturing network as well as the company’s global supply chain.
Hernandez has also served as a manufacturing site lead in Puerto Rico, France and the U.S. He’ll take up his new post as manufacturing SVP and president May 2, the company said.
"Myles added to the strong foundation of Lilly manufacturing through his leadership of numerous productivity initiatives, the initiation of our new site in North Carolina and, most recently, by successfully navigating the challenges of manufacturing during the global pandemic,” CEO David Ricks said of O’Neill’s departure in a release.
Last January, Lilly laid out $470 million to build a new plant in Durham, North Carolina, to make injectable drugs and delivery devices. The move followed a series of deals for biotechs working on injected cancer drug candidates, including Lilly’s $8 billion deal for Loxo Oncology in 2019. The plant, expected to create 460 new jobs, should be complete in 2023, a Lilly spokesperson told Fierce Pharma at the time.
Hernandez faces an immediate COVID-19 challenge. Last month, Lilly and its manufacturing partner Amgen set the goal to produce 1 million doses of Lilly’s coronavirus-fighting antibody cocktail of bamlanivimab and etesevimab by the middle of the year. Meanwhile, the company has said it plans to continue scaling up production to make the treatment available in more countries around the world. The cocktail is also authorized in Italy.
The manufacturing executive swap comes at the same time as a shift in ethics and compliance leadership. Melissa Barnes, senior vice president and chief ethics and compliance officer, will retire June 27 after more than 26 years at the company. VP and deputy general counsel Alonzo Weems will step in to take her place.
Before signing on with Lilly in 1997, Weems was an attorney for the National Labor Relations Board. At the company, he’s had stints as general counsel of Lilly Canada, Lilly USA and the company’s global bio-medicines and diabetes units, where helped manage legal teams in Australia, Canada, China, Europe and Japan.
Weems now manages legal functions covering commercial transactions, litigation, regulation and human resources.
Ricks, for his part, credited Barnes’ work with the company’s strong track record in corporate ethics. In fact, Lilly has been recognized five years running as one of the world’s most ethical companies by Ethisphere, he noted.
When the FDA gave a thumbs-up to Lilly’s antibody cocktail in February, it also cleared shorter infusion times for the combo, and for bamlanivimab alone, of 21 minutes and 16 minutes, respectively, in a bid to reduce burdens on healthcare systems. That emergency green light followed an authorization for solo bamlanivimab in November, originally OK’d as an hourlong infusion.
Logistical hurdles have cast a shadow over Lilly’s antibody rollout, prompting the company to take matters into its own hands earlier this year. The company in February said it would partner with local health systems in its home state of Indiana to set up dedicated infusion centers.
"Our goal is to help gain learnings on how to effectively and quickly launch infusion sites and to share those learning with any hospital or health system willing to consider setting up their own sites,” a Lilly spokesperson told Fierce Pharma at the time.
The slow uptake of COVID-19 antibody drugs isn’t unique to Lilly, either. Society has “to do a much better job” at getting the treatments to patients, George Yancopoulos, M.D., Ph.D., R&D chief at Regeneron—with an authorized antibody cocktail of its own—said at this year’s virtual J.P. Morgan healthcare conference.
Meanwhile, former FDA chief Scott Gottlieb, M.D., in December pressed the U.S. government to ratchet up production of COVID-19 antibody therapies as an “insurance policy” against the pandemic in 2021.