The pharmaceutical industry has placed a collective foot on the accelerator in the race to stem the current public health emergency, while at the same time tapping the brakes on its usual competition-based model. Pharma’s rapid and unified response to the call for novel coronavirus treatments and vaccines has highlighted the depth of the industry’s scientific and technological strength — showcasing the true potential of an industry that, in less urgent times, has been embedded with rivalries.
But pharma’s successful pandemic response is only part of a much larger picture. Our “new future” will demand that the world rethinks its approach to pandemic preparedness.
The pharma industry is armed with the science, the technical know-how and the global platform. Now it has the experience of responding in real-time to one of the most rapidly-spreading pandemics in modern history. When the dust of COVID-19 finally settles, can pharma gather up its “lessons learned” and use them to help the industry rise as a leading voice in pandemic preparedness?
Collaborative response efforts are working
Examining the timeline between when the genome sequence of SARS-CoV-2 was shared by Chinese researchers and how fast pharma has progressed on vaccines would lead anyone with knowledge of the industry’s inner workings to conclude that pharma’s response has exceeded expectations. And the backbone of these accomplishments has been collaboration.
Recent news coverage has highlighted numerous high-profile vaccine-related partnerships involving the pharma industry, many of which are public-private pairings.
Pharma companies with promising SARS-CoV-2 vaccine candidates, including Moderna, Sanofi Pasteur and Johnson & Johnson, have announced funding grants and expanded collaborations with the Biomedical Advanced Research and Development Authority (BARDA). In mid-April, the National Institutes of Health (NIH) said it will launch a massive public-private partnership between federal researchers and 16 pharma companies, among them vaccine giants GlaxoSmithKline, Sanofi, Merck & Co. and Pfizer.
But for most larger vaccine manufacturers, a relationship with government agencies— with the end goal of preparedness for public health threats — is nothing new.
Part of Clement Lewin’s role as associate vice president Head BARDA Office & NV Stakeholder Engagement at Sanofi Pasteur involves managing Sanofi’s relationship with BARDA — which, until now, has been primarily related to pandemic influenza. The drugmaker has had what Lewin describes as a “very close and productive relationship with BARDA” that dates almost as far back as BARDA’s inception. In fact, the first product supported by BARDA to earn an approval from the U.S. Food and Drug Administration was Sanofi Pasteur’s H5N1 influenza vaccine — which, in 2007, became the nation’s first vaccine for the deadly virus.
“For [Sanofi], it’s not a new way of working, but obviously in this situation — a public health emergency — we are working even more closely with partners to move things forward quickly,” says Lewin.
Responding to the urgency of a rapidly spreading public health threat requires speed. And speed, in the pharma industry, can be achieved with strategic collaboration.
For Sanofi, the collaboration has gone beyond public-private partnerships, extending to rival vaccine maker, GlaxoSmithKline. In the recently announced pairing — one that GSK CEO, Emma Walmsley, called an “unprecedented collaboration” — Sanofi will supply its COVID-19 antigen, a genetic match to proteins in the virus, and GSK will supply its pandemic adjutant technology, which could enhance the immune response.
Perhaps most impressive about this partnership is not the fact that it unites two competitors — collaboration in the pharma industry, especially in the development stage, is certainly nothing new. In this case, the novelty is in the speed in which two rivals with a collective worth of over $200 billion, made a deal.
The World Health Organization is a specialized agency of the United Nations with the primary role of directing international health within the UN leading partners in global health responses.
The Bill & Melinda Gates Foundation is a private foundation founded by Bill and Melinda Gates with a global mission to enhance healthcare and reduce poverty, and a national focus on expanding educational opportunities and access to information technology.
The Coalition for Epidemic Preparedness Innovations is an international non-profit coalition with the goal of developing vaccines to stop future epidemics.
The National Institutes of Health, an agency of the U.S. Department of Health and Human Services (HHS), is the primary government department responsible for biomedical and public health research.
The National Institute of Allergy and Infectious Diseases, one of the 27 institutes and centers that make up NIH, conducts and supports research to better understand, treat, and ultimately prevent infectious, immunologic and allergic diseases.
Defense Advanced Research Projects Agency is an agency of the U.S. Department of Defense responsible for the development of emerging technologies for national security.
The United States Agency for International Development is an independent agency of the U.S. government that is primarily responsible for administering civilian foreign aid and development assistance, which includes a focus on combating infectious disease.
The Biomedical Advanced Research and Development Authority, part of the HHS Office of the Assistant Secretary for Preparedness and Response, was established to aid in securing the nation from chemical, biological, radiological, and nuclear threats, as well as from pandemic influenza and emerging infectious diseases.
“If you look at our partnership with GSK — it's two of the largest vaccine companies coming together very quickly to try to meet a public health emergency. In those discussions there was this spirit of collaboration because we all know how important this is,” says Lewin. “Within Sanofi, I have not heard any discussion of how much this is going to cost us or how can we profit — it’s how are we going to respond to this — and I think that speaks to the industry itself,” Lewin adds.
James Mayne, vice president of science and regulatory advocacy at Pharmaceutical Research and Manufacturers of America (PhRMA), says the increase in collaborative spirit is inspiring. “Seeing an industry that is both large and complex and, at times, competes within itself, pull together with all oars going in the same direction for a very important purpose like this has really been impressive and makes me proud to be a member of this industry,” says Mayne.
Broadening the scope of pandemic preparedness
Collaboration has been key to pharma’s exceptional pandemic response. But once the industry moves beyond reacting to a public health emergency, pandemic preparedness will be necessary to ensure the world is ready for the next outbreak — whether it be a second wave of novel coronavirus, or an entirely new threat. Will the momentum gained during COVID-19 continue, bringing about a future where pharma collaborates to create a world more prepared to respond to infectious diseases?
It could be too early to speculate.
“I think we would all agree that it will have a durable effect on industry and how we practice. Right now, the industry is in a read and react mode — an ‘action mode’ — and not so much in ‘after action’ mode of analyzing what we’ve learned from the experience,” says Mayne.
“Exactly how that learning gets synthesized and pulled into new practices, approaches and strategies — I think that book has yet to be written.”
What most can say for certain, however, is that concern over the threat of pandemic outbreak has long loomed within the industry and beyond. For years, experts from all sectors have been warning of impending pandemics. (To date, Bill Gates’ 2015 TED Talk on pandemic preparedness has 34 million views). Heeding the call of the warnings, there have been countless simulations, conferences, workshops and committees assembled to evaluate and improve global pandemic preparedness. Academia, government and private industry has had prominent seats at these tables.
Unfortunately, what the vast majority of these events have had in common was the unsettling conclusion that the world was woefully underprepared for a pandemic.
One obstacle — despite incredible advancements being made in medical science and technologies — is that planning for pandemics still involves guesswork. Many of our pandemic models and frameworks were based on the predication that the next pandemic outbreak would be a form of influenza.
In the U.S., the threat of pandemic influenza has gotten the lion’s share of attention — and funding. The 2018-2022 budget for the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) — which is the overarching coordinator of federal efforts to enhance public health emergencies preparedness — designated pandemic influenza as the largest threat-specific investment. Across National Institutes of Health (NIH), BARDA, Strategic National Stockpile (SNS), and FDA, spending on pandemic and seasonal influenza was estimated to be $5.7 billion over the five-year period.
In fact, just this past December, Sanofi Pasteur — now a major player in the race to bring a SARS-CoV-2 vaccine to market — was awarded $226 million from BARDA to expand pandemic influenza production capabilities at its Swiftwater, Pennsylvania facility.
Emerging disease pandemic preparedness outside of pandemic influenza — for coronaviruses, for example — adds logical and financial challenges.
“Facilities you would use for pandemic influenza are up and running because of seasonal influenza but when it comes to emerging infectious disease vaccines, how do you keep a plant going if you don’t utilize it?” says Lewin.
“It’s not just a financial issue, it’s that you can’t keep a factory warm without producing anything — these are biologicals, they are complex processes, so you can’t just start up the machinery overnight. Figuring out how to do this for emerging infectious diseases has proven to be challenging,” Lewin continues.
This has led government agencies, as well as non-profits such as the Coalition for Epidemic Preparedness Innovations (CEPI) and the Bill & Melinda Gates Foundation, to invest in the development of platform-based technologies that ideally could be leveraged to produce vaccines against multiple threats, including both emerging and known infectious diseases. Because these technologies would also enable standard manufacturing processes and facilities to be used for the production of non-pandemic vaccines, plants would not sit idle during non-pandemic times.
The COVID-19 vaccine development landscape consists of a broad range of technology platforms, including mRNA-based vaccines from both Moderna and a Sanofi-Translate Bio partnership. The mRNA technology platform has been particularly promising in terms of adaptability to various targets, but has yet to be tested in a large-scale clinical trial for an infectious disease.
And yet, despite the flexibility and scale that could be made possible through innovative platform-based approaches, a recent Johns Hopkins Center for Health Security project focused on vaccine platforms concluded that emerging infectious diseases “will never represent a major market with large financial rewards and minimal opportunity costs.”
Lewin adds that there’s a certain amount of funding that needs to be provided by government when asking private companies to devote resources to diseases that may not materialize as threats. “There’s no market for theoretical emerging infectious diseases,” he says.
But, as we have learned from COVID-19, that does not diminish the importance of investing in them.
Lewin speculates that the current pandemic could lead to emerging diseases carrying more weight in the future.
“It does illustrate the importance of thinking of emerging infectious disease response in the same way the U.S. and other countries have thought of pandemic influenza response. Hopefully the lesson learned is that we need to invest in the ability to respond as quickly as possible to an emerging infectious disease because we don’t want to go through this again,” he says.
Collaborating with government
As every commercial on TV will remind you, “these are unprecedented times.” Pharma has cast aside its competitive nature and has seen, first-hand, the importance of investing in infectious disease. But if the industry is to be a leader in crafting better pandemic preparedness on a global scale, efforts will have to persist long after vaccines are available and the pandemic abates.
Most agree that pharma shouldn’t go at it alone. Recent events have certainly shown that collaboration is the most efficient path to results. Dedicated, collaborative programs spearheaded by governments and philanthropies will be needed to advance future pandemic preparedness. Post pandemic, one thing we could see — and arguably should see — is an increase in public-private partnerships. But is this easier said than done?
The government has acknowledged the importance of these partnerships. According to a recent statement made by now-famed National Institute of Allergy and Infectious Diseases (NIAID) director Dr. Anthony Fauci, “We always need a pharmaceutical partner. I can’t think of a vaccine, even one in which we’ve put substantial intellectual and resource input, that was brought to the goal line without a partnership with industry.”
In the U.S., there are several government agencies and projects that can provide various degrees of funding, technical assistance or resources for pharma companies looking to engage in the emerging infectious diseases and pandemic preparedness space. Names that are now more mainstream, such as the U.S. Department of Health and Human Services’ Office of Pandemics and Emerging Threats (PET), BARDA, the Department of Defense’s Advanced Research Projects Agency (DARPA), and the U.S. Agency for International Development (USAID) are open to partnering with the pharma industry in areas such as R&D, new technologies or manufacturing.
The COVID-19 pandemic has raised the profile of a lot of these agencies, creating a larger awareness of the partnerships and funding available. Chris Stanley, president and principal consultant at Harmony Consulting, recently submitted a request to BARDA on behalf of a client and was told that BARDA had received close to 2000 COVID-19 related applications since February. This is seven times the amount of submissions the small agency — who is currently limiting requests to COVID-19 products and technologies only — receives in an average year.
But yet, in non-pandemic times, companies are not exactly lining up to partner with government agencies on pandemic preparedness and potential medical countermeasures (MCMs). “It’s usually a bit of a selling job that has to be done because, you know, working with the government presents its own challenges,” says Stanley. In his position, Stanley devotes a considerable amount of time — much more so in these past few months — to helping companies get grants from the government for medical countermeasures.
In some ways, it’s a bit of a Catch 22. In Stanley’s experience, government agencies, such as BARDA, focused on MCMs are historically more interested in repurposing existing drugs already in development, rather than investing in early stage development. And yet, the “further along a company is in development, the less interested they are in working with the government,” says Stanley. “Why would commercial stage companies want a large government contract and all the headache that comes with it?”
As such, the bulk of the partnerships Stanley ends up facilitating are clinical stage companies strapped for cash — partnerships born out of the need for non-diluted funding to keep the company afloat.
But Stanley, like many others, is hopeful that the pandemic might lift the stigma surrounding government partnerships within the pharma industry.
Aside from funding, partnering with organizations such as BARDA can offer pharma companies access to subject matter experts with long resumes of pharma experience. Through its TechWatch Program — which allow companies to pitch ideas — BARDA provides detailed feedback, including advising companies on where data may be lacking and what studies may still be required, what further discussions need to occur, and possible regulatory pathways. Importantly, BARDA also can connect companies to interagency partners within HHS, including FDA, CDC, and NIH, where the timing may be better suited to begin a working relationship.
And while timelines are accelerated right now due to the current health crisis, even during normal times, launching a partnership with BARDA is fairly efficient. “The whole process takes around to six to nine months from the time that you say, ‘Hey, I want to approach BARDA’ until the time they issue a press release saying that they have signed your contract,” says Stanley.
Pharma’s willingness to explore these types of partnerships can go a long way in terms of future pandemic preparedness in the U.S.
“There’s money and support to be had here and you can do some good for your country — maybe for the world — at the same time,” says Stanley. “I think that will appeal to a lot of pharma companies now.”
Pharma is positioned to lead
“The current coronavirus pandemic may have finally served notice on humanity that it has to take viruses seriously now, and in the future,” says Barry Holtz, former president of iBio CDMO, now serving as an industry consultant.
Awareness of the dangers surrounding infectious disease is high during a public health emergency but as treatments and vaccines progress and the world gradually returns to normalcy, the threat that pandemic preparedness will fall to the back burner looms large. Pharma is uniquely positioned to make sure this doesn’t happen.
“Pharma companies have shown that they can be agile and that they have the technical knowledge to respond quickly,” says Holtz.
And not only does the industry have the expertise, with extensive networks and operations spanning the entire world, it has the reach. Pharma taking a strong role in continuing to generate both public and political awareness will be key to future pandemic preparedness efforts.
“Pharma is best-suited to use its political influence to lead this preparedness effort, because they understand all facets of research, clinical testing and supply chain dynamics,” says Holtz.
Pharma must encourage leadership on a global level to support a continuum of research, manufacturing and distribution related to infectious disease.
“Without all of this in place, viruses will outpace our ability to respond,” says Holtz.
The current pandemic has also shown the importance of science-backed information. PhRMA, the industry’s leading trade group, has been a strong voice in disseminating information about pharma’s pandemic response efforts.
“There are a tremendous number of sources of information on this — not all of them reliable — so we’ve tried to pull together credible information and collate it in a way that allows us to speak at an industry level,” says Mayne.
In addition, PhRMA has coordinated communication between pharma and policymakers “We are on the phone weekly with leadership at R&D organizations within member companies and making sure we are coordinating efforts and communications with regulators and the administration,” says Mayne.
In order to truly push the needle on the way the world views infectious disease, conversations about the importance of medical countermeasures and pandemic preparedness will need to continue beyond the COVID-19 pandemic. And these conversations should be backed by actions, likely spearheaded by larger pharma companies, that include sustaining a level of donations, investment and collaboration.
Our new reality will have a new set of heroes. Pharma has the chance to stand among them.