By Cassie Kuhn

For the Enquirer

A pharmacology and chemistry expert from Priceville helped develop a monoclonal antibody treatment that shows promise in its ability to prevent those with mild cases of COVID-19 from developing complications and requiring hospitalization.

Carl Garner, vice president of global regulatory affairs for pharmaceutical company Eli Lilly and Co., said it typically takes between 18-24 months to identify an antibody, conduct research and begin testing it on humans.

“We did it in about 2.5 months,” Garner said. “The reason why was not that we cut corners or did anything that would put patients at risk. We put the full force of 145 years of expertise and hundreds of resources toward a single problem in a very focused way.”

Garner, a Priceville native, said the antibody used in bamlanivimab was identified in a COVID-19 patient from Washington, who is among the first in the country known to have recovered from the virus.

“We were able to take that sample from that patient that had recovered from the disease and try to understand what it was about that person, and that person’s immune system, that allowed them to win,” Garner said.

Eli Lilly and Company partnered with AbCellera, a Vancouver-based biotechnology firm, in its efforts to identify, research and test bamlanivimab. The antibody was identified in April, and human testing began the first of June, Garner said.

“It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19,” an Eli Lilly news release explained.

Garner said in one small trial of the treatment, more than 70 percent of patients “who would have progressed into the hospital” were able to stay out of the hospital.

The Food and Drug Administration approved the use of bamlanivimab under an emergency use authorization Nov. 9. Since then, the treatment has been distributed to hospitals around the country. Garner said Alabama received more than 1,000 doses of the treatment during the first week after its approval.

According to Eli Lilly, the drug still needs to be approved under a Biologics License Application and is an “investigational drug.”

“We’re making it as fast as we can,” Garner said. “We invested hundreds of millions of dollars into manufacturing a molecule that would be given to patients before we ever knew whether the drug would work, and that paid off because once we found out it worked, we were able to then make it available to many, many patients, including those in the state of Alabama.”

Garner said Eli Lilly sells the treatment to the United States government, which then allocates it to states.

Local availability

“The Alabama Department of Public Health then determines which hospitals it goes to, based upon the needs in the state, so I love the model,” Garner said. “We’re pushing the decision-making of who needs the drug down to the state level and the local hospital level.”

Decatur Morgan Hospital director of pharmacy Jeanna Boothe said the hospital had administered 31 doses of bamlanivimab as of Thursday.

“We request this once a week from the state. We don’t get all of the doses we ask for because it is in very short supply and it’s allocated, so we get what we get, and we’re happy with it,” Boothe said.

Boothe said bamlanivimab is an outpatient infusion that is administered at the hospital – but is not for patients who have been hospitalized from COVID-19.

Patients need to receive a referral and meet certain criteria to receive the treatment.

“Information is sent out to the medical staff and the medical community … on how they could refer a patient to the infusion center because the patient needs to meet criteria and qualify for it,” Boothe said. “A patient can’t just show up at say, the ER, and ask for this infusion. That’s not how it works.”

Qualifying patients have tested positive for COVID-19 and are at high risk for developing complications or needing to be hospitalized but are not to the point of requiring hospitalization.

“Very importantly, it needs to be given within 10 days of onset of COVID symptoms,” Boothe said. “If you wait too long, it’s not providing any benefit.”

Both Boothe and Garner said other monoclonal antibody treatments like bamlanivimab are also in the works. Boothe said this could improve the supply of treatment available to patients at Decatur Morgan.

Boothe said bamlanivimab is a one-hour intravenous infusion, but the process can take a couple of hours.

“They need to be able to stay and be observed for another hour and make sure they’re doing fine, so you have to plan on several hours if you’re getting the infusion,” she said. “It does take us about 30 minutes to prepare it, so you’re looking at a good part of the day.”

Dr. Sonya Heath of the University of Alabama at Birmingham’s Division of Infectious Diseases said UAB has also administered bamlanivimab to high-risk patients.

“At this time, it seems effective,” Heath said earlier this month.

Public health

Garner said bamlanivimab has the potential to benefit patients on an individual level by preventing cases of COVID-19 from progressing to the point where a patient develops complications and requires hospitalization.

More generally, though, Garner said the drug has the potential to decrease the burden the pandemic has placed on healthcare providers throughout the country.

“Dr. Davis Thrasher, who is a pulmonologist in Montgomery, is treating hundreds of patients at Baptist (Medical Center) South in Montgomery, and his hospital’s full all the time,” Garner said. “He really is optimistic that this therapy could hold the promise to minimize and slow down the rate of people needing to go in the hospital.”

Garner said preventing those with COVID-19 from requiring hospitalization will keep beds open for patients with heart attacks, cancer, strokes and other serious diseases.

Additionally, Garner said if a patient’s recovery time is quickened from bamlanivimab, they might be contagious for a shorter period of time – which, of course, means “you minimize the risk of transmission and can further arrest the spread of the disease, beyond the individual person,” Garner said.

Garner said the FDA is not cutting corners to make COVID-19 treatments and vaccines available to the public.

“The FDA is doing their job, and they’re making sure anything they approve is safe for U.S. citizens – and that holds for our drug, but it will hold for vaccines as well,” Garner said. “I really want people to know the FDA’s not cutting any corners here, and you can count on the FDA to have done the same rigorous review for a vaccine for COVID that they would do for an influenza virus.”

Garner also said he wants people to listen to science. He compared the fight against COVID-19 with the steps that were taken to eradicate polio.

“People ought to trust the science behind the vaccines because if people aren’t willing to take the vaccine and help us get through this pandemic like we did with polio back in the ’50s, then all the work the scientists have done is for naught,” he said.

Priceville

Garner grew up in Priceville, where he attended Priceville Elementary.

“I love my hometown,” said Garner, who now lives in Indianapolis. “This time of year, I miss Alabama more and more because it’s cold here.

“I grew up in Priceville up on Priceville Mountain on a cattle farm up there. My parents were farmers and worked for the U.S. Army at Redstone Arsenal.”

Garner’s sister, Cherie Humphries, is the director of elementary education for Morgan County Schools. Humphries said Garner was honored recently for his role in researching the treatment.

“He received the International Quality of Life Award for his work with COVID research and treatment. This is through Auburn University College of Health and Sciences,” Humphries said.

After graduating from Hartselle High School in 1988, Garner earned a bachelor’s degree in chemistry from Auburn University. He received both a master’s and Ph.D. in chemistry and pharmacology from Vanderbilt University.

Garner started out as a researcher for Eli Lilly, studying treatments for various neurological diseases, before moving into management positions.

He has held the position of vice president of global regulatory affairs for nearly four years.