Michael Bigham, US pharmaceutical expert, talks about Coronavirus research

by Lilly Drumeva-O’Reilly

The earth stands still, waiting for a cure for COVID-19. We hope the cure will be discovered in a country like the USA, Germany, the UK, Japan, Israel etc. Some of the USA’s leading pharmaceutical companies are already testing various medications and conducting clinical research. With regards to this, I spoke to Michael Bigham, former vice-president of Gilead Sciences.

Mr. Bigham, is there a chance for us to discover a cure for the coronavirus any time soon?

Much is known already about this corona virus, SARS-CoV-2, and more is being learned on a “real time” basis. This virus is widely believed to be the cause of the infection COVID-19. Several potential treatments are currently being evaluated with many more coming. It is too early to tell what may or may not work. It is likely that some combination of treatments may be the most effective, as we have seen with other viral infections, for example the triple therapy used to treat AIDS. And some treatments may only work well early in the infection while others will hopefully work even with severe infections. We just do not know yet.

We should hear about early clinical data on a few potential treatments in the months ahead. One of the more promising potential treatments is Remdesivir, a drug being developed by my former company, Gilead Sciences. It targets an enzyme called RNA polymerase that is used by many viruses to replicate. There is published data suggesting it works against other corona viruses, but those tests were only in lab dishes. The first clinical data should become available sometime this month.

One can go online at COVID-19 ClinicalTrials.gov to see a summary of the extensive list of treatments under active consideration.

The main goal of most treatments for viral infections involves stopping the virus from replicating. This has two main benefits: first, it enables the immune system to neutralize the virus more easily as there are fewer viruses to attack. Secondly, it reduces the possibility that the virus will mutate over time into a potentially more dangerous form.

What research is being conducted in the companies you’ve worked in over the years?

My former company, Gilead Sciences, is developing one of the most promising potential treatments, Remdesivir, mentioned above. Many other treatments/treatment regimens being evaluated or soon to be evaluated can be seen on the website mentioned above.

One challenge with any viral infection, such as COVID-19, is the potential for patients to develop secondary bacterial infections. The data to date suggests that patients with COVID-19 who also develop secondary bacterial infections suffer higher rates of both morbidity and mortality. My current company, Paratek Pharmaceuticals, developed a broad-spectrum antibiotic that is approved in the U.S. to treat bacterial pneumonia. The drug is called NUZYRA. We believe it can play an active role in treating the secondary infections that can accompany COVID-19 infections.

How far are we from developing a vaccine?

Arguably the quickest and safest way for our communities to develop “herd immunity” is a safe and effective vaccine. Dr. Anthony Fauci, director of the NIAID, called the development of a COVID-19 vaccine “an urgent public health priority”. Several potential vaccines are under active development. J+J recently announced their plans to start clinical trials on a potential vaccine this fall. Pfizer announced plans to start clinical studies on a potential vaccine in the next several weeks. The NIH, working with Moderna Inc., has already started a Phase 1 clinical study with a potential vaccine.

Developing a safe, effective vaccine will take time but it appears that both industry and regulators are working in tandem to make the process as efficient as possible. The sense of urgency is real. The exact timing of when a vaccine may become available is hard to predict today as we have no data on what may or may not work. If one or more of the vaccines being developed demonstrate appropriate safety and efficacy soon it is possible that a vaccine/vaccines could be available as early as the first half of 2021.

Manufacturing the large number of vaccines needed is a secondary challenge. One can expect that the first vaccines available will likely be prioritized to health care providers and those considered at “high risk” of developing a severe infection. But efforts are no doubt underway to anticipate the manufacture of high volumes of vaccine as soon as possible.

Numerous medications are sold which alleviate COVID-19 symptoms – medications based on quinine which are effective against malaria; the antibiotic Azithromycin, which is very useful against pneumonia; a tuberculosis vaccine which gives additional resistance; various supplements, like ginger. Could you comment on these treatment options or do we have to explore in different directions?

The scientific and clinical communities must explore many directions in parallel to find “what works.” There is some rationale for the approaches mentioned, but without proper clinical studies one cannot know definitively what does or does not work.

How dangerous is COVID-19 really? It seems to me that there are many differing opinions and an unknown factor. For example, why is it that some people fall ill and others do not; some have serious complications and others – very mild symptoms, as if scientists are missing something?

This is a “new” virus; much remains to be learned. It appears to cause symptoms similar to both a bad head cold (normally caused by less lethal corona virus strains) as well as influenza. It is also becoming clear that this virus settles deep in the lungs as opposed to influenza which typically settles higher in the lungs. There is also growing evidence that this virus may have cardiovascular effects not typically seen with other viral infections. Overall, it is currently believed that people over age 60 and those with pre-existing co-morbidities are the ones at highest risk. The fatalities to date have been concentrated in these groups, though not exclusively.

Many sectors of the economy are completely stunted, while some, for example the pharmaceutical industry, are flourishing. People are hoarding medication and some prices have skyrocketed. How do you envisage the development of pharmaceutical companies in the context of the crisis and after it? How can they be more useful to people?

Drug and vaccine development are complex, time-consuming activities that typically require many years of research and development. The failure rates are high, and the costs of development – significant. Manufacturing a drug or vaccine is equally complex, time-consuming and costly. Accelerating these processes is difficult.

Pandemics present a unique challenge as they are often hard to predict with accuracy. The best “treatment” is early detection; to catch any potential pandemic early and isolate it. Prevention is by far the best “medicine”.

It is also essential to establish significant stockpiles of protective gear such as masks, gowns and gloves. And, to stockpile any essential equipment likely to be needed in any pandemic, such as ventilators.

Developing appropriate treatments and vaccines for a pandemic take longer because the infectious agent must first be identified and characterized. However, creating stockpiles of drugs that are most likely to be needed in any pandemic also makes sense: antibiotics; anti-inflammatory agents; pain medications, for example. This will help alleviate any shortages that might otherwise arise, as well as minimize the temptation for some to “hoard”.

How do you envisage life after COVID-19? What can we learn from this crisis, what conclusions can we draw?

We are fortunate that this virus is not more lethal than it is; otherwise this pandemic would be far worse. The so-called Spanish Flu of 1918-20 was more lethal [I recommend the book “The Great Influenza”, which describes that pandemic well]. And the great plagues caused by bacterial infections in the middle ages were even more lethal with mortality estimates as high as 50%. But this does not lessen the human tragedy unfolding around us.

Processes must be adopted to improve “early detection” and isolation of potential pandemics.

Processes by which societies implement “shelter at home” and quarantines must be better communicated across communities for rapid adoption. Practices such as the “wet” markets in Asia must be eliminated; they are perfect breeding grounds for future pandemics. And societies must stockpile those items most likely to be used in any pandemic to improve initial responses, protect our healthcare providers and discourage “hoarding” behavior.

Our “global” economy provides unique opportunities for pandemics to spread and spread quickly. There will be more if we are not more diligent and better prepared.

Life will eventually return to something very much like the “normal” we experienced prior to this pandemic. However, it will take time for us to feel comfortable again being around others. It may well not be possible on any real scale until a treatment is available to prevent or reverse serious illness from the infection. A safe and effective vaccine is the very best option. Once we feel “safe” I would expect that we will actively return to our native form: we are a very “social” species.

Mr. Bigham, thank you for this interview. Good luck and all the best!

Michael Bigham has held leading positions in some of the largest pharmaceutical companies and has developed cancer treatment medication as well as some of the newest and strongest antibiotics. He is a true guru in the pharmaceutical and medical industry in the USA. Additionally, he is a very successful businessman, entrepreneur and investor. 

Michael F. Bigham was appointed Chief Executive Officer and Chairman of Paratek Pharmaceuticals’ Board of Directors in October 2014. He has more than 25 years of senior leadership experience in the biopharmaceutical industry. He currently serves as a member of the board of directors of InMediata and has held several directorships, including at Avila Therapeutics, Magellan Biosciences, Portola Pharmaceuticals, Supernus Pharmaceuticals, Avedro and Valeritas.

Mr. Bigham was formerly Vice Chairman of Corixa Corporation, a publicly traded biotechnology company, and was President and Chief Executive of Coulter Pharmaceuticals, a publicly-traded oncology company, until it merged into Corixa. Previously, he was an early employee at Gilead Sciences where he served in various capacities, including Executive Vice President of Operations and Chief Financial Officer. Before joining Gilead Sciences, Mr. Bigham was a Partner at Hambrecht & Quist where he became Co-Head of Healthcare Investment Banking. Mr. Bigham received his B.S. from the University of Virginia and qualified as a C.P.A. before completing his M.B.A. at Stanford University.

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