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Industry cannot 'over promise and under deliver' on Covid-19, says MSD's chief patient officer

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LONDON, 1 May (APM) - People need to have "realistic expectations" about the challenge of Covid-19 and the potential for the industry to deliver effective treatments and vaccines, according to Julie Gerberding, chief patient officer for MSD.
Gerberding on Thursday said that her company has previous experience developing a vaccine in an urgent situation, with Ervebo, its vaccine for Ebola virus infection. However, she noted it took several years to actually become licensed despite the pressing need (APMHE 65593).
"So we know what it takes and what the complexities are," she said in a virtual press conference hosted by IFPMA, the global trade body for the pharmaceutical industry.
Hopes for an effective treatment for Covid-19 have been raised in recent days with the U.S. National Institute of Allergy and Infectious Diseases (NIAID) publishing data showing that the use of Gilead's remdesivir can lead to a faster recovery time for people in a serious condition.
Many questions still need to be answered on the disease in general, however, said Gerberding, who is a former director of the U.S. Centers for Disease Control and Prevention (CDC).
"First of all we have to be honest that we really don't understand this disease. We're everyday learning more and more about the pathogenesis - why some people are asymptomatic or have upper airway disease, why some people get lower airway disease.
"Now we're learning about the neurologic complications, we're learning about strokes. We have so much to learn about the basic biology."
She said this means the industry is learning more about targets and opportunities for interventions. But scientists still do not really understand the body's immune response, she said.
MSD, known as Merck & Co in the U.S. and Canada, is working on this as part of a collaboration with Institute for Systems Biology in Seattle, Washington, said Gerberding (APMHE 67128). Funding will be provided by the U.S. government's Biomedical Advanced Research and Development Authority (BARDA).

More uncertainties

Other uncertainties include whether a single drug approach could be successful or if researchers will see the emergence of resistance as with other coronaviruses. This could mean combination therapies are necessary, said Gerberding.
She added: "We also don't know whether this virus will remain stable over time or whether it has the capacity to evolve and potentially escape what we are doing."
The industry is also dealing with a high bar for safety, she said.
"When people are very ill we recognise that some degree of side effects are tolerable if it can save a life. But we will potentially be needing to treat preventively in people with milder disease to prevent the more downstream complications and safety becomes a paramount importance especially since this medicine will hopefully be available for children or for people who have vulnerable underlying medical conditions."
Manufacturing a potential treatment at scale is another hurdle, said Gerberding.
"Scaling is not easy and the capital investment required is large and it takes time to make sure that the manufacturing processes are safe and simple and can meet the demand not just in the developed world but for all of the countries and environments where the medicine is necessary."
Several companies developing vaccines have announced partnerships with other firms to ramp up manufacturing capabilities to produce millions of doses of a potential vaccine in 2021 (APMHE 67176, APMHE 67142APMHE 67086).
With all of these challenges, Gerberding said "people need to have realistic expectations about the road ahead".
"What we do not want to do is over promise and under deliver."
She added that she remains "very optimistic" and that tackling Covid-19 is a "doable but daunting challenge".
"And as we step back and think about what has happened in just a few weeks it really is the finest moment of the biopharmaceutical industry. I think it demonstrates to all of our citizens around the world that the biopharmaceutical industry is a very critical pillar of our global health security and we need to appreciate that and support that industry's ongoing success."
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