Soon after the impact of the novel coronavirus that causes COVID-19 became apparent, academic researchers, public health institutions and private companies began the search for a vaccine to prevent infection and treatment to manage it. New trials are announced daily, and data sharing has been unprecedented. As part of efforts to encourage data sharing and progress toward vaccines and treatments, the Milken Institute’s FasterCures has developed a tool for tracking that progress. SmartBrief spoke with Executive Director Esther Krofah about the tool, and the R&D and funding landscape.
Let’s start with the COVID-19 vaccine and treatment tracker. Your team has created and is regularly updating this resource. Having looked at the landscape, how would you describe the movement toward a treatment and a vaccine?
There has been quite a significant level of activity toward development of a treatment and vaccine. I am quite heartened to see the all of the various research institutions, academic institutions and companies that are moving really rapidly to look at their libraries of compounds and identifying what could be useful for COVID-19.
And so we have a really broad landscape on the treatment side – where we are looking at antibodies, antivirals and other mechanisms of action – as well as on the vaccine front. There’s a significant amount being done.
On the treatment side, we have over 58 treatments that we are tracking and over 43 vaccine candidates that we are tracking. Of course, as we have seen in news reports, Moderna has the first clinical trial under way for a vaccine candidate, a first-in-human phase I trial, but we expect to see more coming down the pike.
Altogether, we have over 100 candidates that are being investigated for the coronavirus. Of course, attention is going to be on what can we get to patients as quickly as possible.
Can you talk about what looks most promising?
It’s quite early to talk about what is most promising. It is helpful to see how quickly we’ve been able to sequence the virus and how quickly we have been able to initiate clinical trials. Everyone is moving at breakneck speed. A vaccine of course is going to take a little bit longer. It will likely be 12 to 18 months before we see a vaccine broadly available for a general population.
I have a lot of hope in the promise of treatments in the short term, whether antibodies or antiviral treatment. If we can start to extract from convalescent patients the antibodies that they have developed after infection and use that to treat ill patients, that might be a very quick treatment in the short term. And we’re seeing a lot of activity there.
Between the clinical trials under way with remdesivir and with Regeneron’s medicines, those might really be able to help in the short term. And clinical trials are under way with hydroxychloroquine and azithromycin as a combination. These trials are being used to make sure they are safe and effective for coronavirus, as many of these therapies have already been approved for other indications
How does the regulatory process fit into this picture?
The FDA and NIH are actually working quite quickly to ensure that there are no barriers getting in the way from a clinical trial perspective. That early coordination is quite helpful and provides some guidelines to the research community and companies that are looking at this. Of course, we have a quite defined process to ensure safety and efficacy. And those standards are not being diminished. What is happening is ensuring that guidance is being brought quickly around sites of care and patient enrollment, and information is being shared quickly and clearly with the appropriate parties.
So, the coordination is happening much more quickly, but the standards are being upheld to first ensure safety and then to get the appropriate dosage before expanding upon those clinical trials.
I will also say what the FDA has been doing quite well is ensuring compassionate use where there are trials under way and there may be potential for patient benefit. We are seeing compassionate use being approved very quickly for products like remdesivir and the extraction of serum, creating a pathway for patients to get access to potential treatments with approval from the FDA and their physician. Red tape is being broken down so patients who could benefit from potential treatments are getting them as quickly as possible.
We have heard a lot of concern about patient costs. Are treatments and vaccines going to be affordable to patients?
It is too early to tell, but we do not anticipate that we will have affordability challenges or questions. This is a public health crisis, and we fully expect that companies are going to price products with that in mind.
What about research funding -- is there enough of it, and is it in the hands of those who can put it to the best use?
Funding for the trials that are happening now, particularly for the NIH, is not a significant challenge, thanks to all the efforts that are happening right now on the Hill, and thanks to other funding that is being diverted from traditional trials that cannot immediately use them.
So, funding on the clinical trials side is moving rather quickly and we have been in conversations with the Gates Foundation, which has a $125 million initiative, and with Mastercard and Wellcome Trust. Seeing the private philanthropy side step up is also quite promising.
I will say that we are going to need significant funding to ramp up manufacturing once we have an FDA-approved therapy on the market or evidence supporting an existing therapy that has a different indication. The manufacturing needs are quite real, and we need to be sure we are prepared for that. But for the clinical trials, particularly those that are run by the NIH, the funding seems to be flowing.
And finally, for individual investigators at universities, obviously they are looking for funding to scale their efforts as they typically do.
FasterCures has a long history around patient engagement and advocacy. In what ways are patients being engaged with this type of research?
There is a lot of work happening to get patients mobilized into clinical trials, and we are seeing significant participation on that front. As you see in the Seattle region, patients are quite willing to step into clinical trials, and they are quite eager to see what they can do to help ensure we can get a treatment or a vaccine quickly to market.
We are communicating and working quite closely with our disease foundations, which represent a significant portion of the community of patients that have very complex care needs. These are individuals who have chronic diseases and underlying medical conditions that make them the most vulnerable to COVID-19. What’s important for that population is getting the right information and education to them so they understand how they can protect themselves during this time and continue following the appropriate treatment protocols for their existing conditions.
Can you talk about the state of collaboration among researchers, companies and the federal government?
Yes. One example is the Biomedical Advanced Research and Development Authority, which recently issued a call to companies that want to work with them to submit applications – that is wonderful to see. We see a lot of collaboration already happening between university research institutions here in the US in collaboration with those abroad. We see NIH mobilizing their trial networks quite quickly to start clinical trials to collect evidence for treatment protocols.
Data is being shared. Even on Twitter, different scientific communities are really creating great opportunities to discuss and share data and studies in advance of being published.
So, there is a lot that is happening on the collaboration front. What we still need is greater coordination of the academic scientific community so we ensure we are not duplicating efforts. We need to have really good quarterbacking behind the scenes, whether FDA or NIH working in collaboration with the scientific community, to make sure teams have the appropriate standards, and even a master protocol for clinical trial design, which would be quite helpful during this time.
Scientists have been warning us for decades that our world was primed for a pandemic like this. What effect will this experience have on funding for emerging infectious diseases moving forward?
This is a reality check, right? The world that we predicted would happen has now come before us.
And so, my hope is that this motivates funders and policymakers to plan for long-term responses, so we are not responding continually in a crisis situation. I am quite hopeful we can get the right funding to BARDA for them to develop platform technologies and other solutions that will be helpful to turn the capability of R&D quite readily to whatever virus shows up.
We have seen a lot of quick action on the part of BARDA and others that are working in collaboration with them, but what we want to see is longer-term funding directed to BARDA, to the NIH and other parts of the federal government -- DOD and others -- that can really help us establish longer-term platforms. Now is the time to fund these agencies at sufficient levels.
Melissa Turner is director of content for health care and life sciences at SmartBrief. For more content like this delivered straight to your inbox, check out SmartBrief's Life Sciences newsletters, covering medical devices, drug development and regulation, biotech and more.