Amici ready for role in finding COVID vaccine: Conducting human trials

A number of New Jersey companies — including Merck and Johnson & Johnson — are part of the worldwide race to find a vaccine for COVID-19.

Another company, Raritan-based Amici Clinical Research, is eager to do its part: Provide the human trials necessary to show a potential vaccine works.

Dr. Robert Falcone.

Dr. Robert Falcone, the chief medical officer and principal investigator at Amici, said the company is preparing to conduct various COVID-19 trials this summer, many of which will be focused on developing vaccines and preventive drugs for the pandemic.

Falcone, 66, said he can’t wait for what could be a once-in-a-lifetime event — or a career-capper, as it applies to him.

“For people in this field, this is what you have been waiting for,” he said. “We’re in a really tough situation. This virus is staring us in the face.”

Falcone compared the quest for a cure to a sporting event.

“Our backs are against the wall,” he said. “It’s like you’re a baseball player batting in the bottom of the ninth in a tie game or a placekicker lining up to kick a winning field goal. When you succeed, it’s so satisfying.

“This is my last hurrah. (Having a successful trial) is a pretty good way to go out.”

Ordinary Jerseyans can play their part, too. Simply put: Amici is looking for volunteers. (Click here to register.)

Falcone said he expects between 30 and 50 patients will be needed for each trial. He also said volunteer participation rates have been encouraging. One reason: It’s not the textbook definition of volunteering.

While there is no cost to participate, compensation will be provided for time and travel — typically from $50 to $120 per office visit, depending on the study. Trials, he said, usually last 12 to 24 months.

Falcone expects no shortage of volunteers, considering the incredible — and understandable — coverage the pandemic is getting.

“COVID-19 and all the attention it has been given — for obvious reasons — has changed the whole dynamic for drug trials,” he said. “Trials are discussed all day on TV.”

Falcone, who has spent more than three decades in medicine, said the interest is unlike anything he’s seen.

“The general public is paying attention now,” he said. “They understand the importance of (trials).”

And that’s a good thing, Falcone said.

An exam room at Amici’s facility.

“Yes, developing a vaccine or drugs takes a lot of work by (the medical community), but the public has a role in this, too,” he said. “People are interested and are signing up. They want to work on it.”

Falcone said Amici’s staff of four full-time lab employees are preparing for Phase 3 in these trials. Phase 1 involves safety measures and Phase 2 is about dosage. Phase 3 demonstrates effectiveness and requires large numbers of patients.

Falcone said the studies being carried out by Amici are double-blind. This means that neither participants, nor the doctors and clinicians conducting the study will know whether participants will receive a trial vaccine or a placebo. As with most vaccine trials, approximately 50% of participants will receive a placebo. Double-blind studies ensure that the results are valid and stand up to scientific scrutiny.

The vaccine trials will admit prequalified participants on a first-come, first-served basis, Falcone said.

To prequalify, participants must be a healthy adult up to age 85. Volunteers must have never been diagnosed with presumed or confirmed COVID-19. They must not have had a fever with cough or shortness of breath in the last four months. And they must not have HIV, Hepatitis B or C or have immunodeficiency or an autoimmune disease.

“Trial participants are heroes,” Falcone said. “Without being able to confirm the effectiveness of a vaccine in human populations, we may never effectively control this virus, which would make it difficult for return to normal life as we know it,” Falcone said.

Falcone said he’s proud that the medical and pharmacy companies are working in unison.

“Too many people are first to criticize the pharmaceutical companies over greed or price-gouging,” he said. “This is a case where these drug companies are working together — and for a drug that isn’t likely to be profitable. They are putting their competitive instincts aside and coming together.”

Amici is one of very few clinical trial facilities in New Jersey. While it is difficult to know the exact number, Falcone estimates there are 765 nationwide.

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