3 key lessons industry leaders have learned from the latest Ebola crisis
On April 15, the National Foundation for Infectious Diseases (NFID) concluded its 18th Annual Conference on Vaccine Research in Bethesda, MD. The conference's concluding panel centered on one of the most important infectious disease events of the decade: The Ebola crisis in West Africa and the global biopharmaceutical industry's response to it.
The epidemic is beginning to wane, and the decline in cases brings with it a unique set of problems, considering there have still been no fully approved therapies, vaccine or otherwise, for Ebola. This reality underscores the difficulty of manufacturing such complex therapies while racing against time—a topic that came up time and time again during the discussion.
The expert panel featured officials from large pharma companies intimately involved in Ebola vaccine research and development, including executives from Novavax, GlaxoSmithKline, Merck, Johonson & Johnson, the NIH, and the FDA. Here are four important lessons that these experts say they've gleaned from the crisis:
1) Among infectious diseases, Ebola presents unique challenges
From the complexities of creating a proper vector for an Ebola vaccine to the fundamental issue of determining what true efficacy looks like, Ebola drug development comes with a set of challenges separate from even other infectious disease research. Part of that stems from the lack of appreciable cases up until this latest epidemic.
"There are some unique issues that have hampered our ability," said Michael Kurilla, an NIH director at the Office of BioDefense and NIAID. "Since this virus was identified in 1976, we have averaged, until this outbreak, 40 patients a year with this disease, of which slightly more than half of them died. So the number of human cases of Ebola even available for study, to identify what the natural history is, and even what the survivors look like, in terms of what successful immune response is, is extremely limiting."
That left researchers in the unenviable position of having to come up with therapeutic solutions based largely on animal trials. Another complication was the daylight between lab testing and actual human responses to proposed therapies.
"[I]n the last 20 years, we've known that a monoclonal antibody against Ebola was isolated from a human that survived," said Kurilla. "[It] showed neutralizing activity in vitro, but failed to protect in vivo."
Given struggles such as this, it's no mean feat that pharma companies, with the assistanc of government authorities and regulatory agencies, have been able to usher a number of promising treatments into phase II and phase III studies.
"We don't have a licensed Ebola vaccine, but I think it's important to recognize that we have a large armamentarium of Ebola vaccine candidates that are slowly moving through the approval process at a variety of stages," said Kurilla. "The difficulty of identifying what a successful human response would look like... has been a major impediment. [But] we feel very confident that we are on the right track."
2) Regulators', and the industry's, response to the crisis has surprised biopharma execs (in a good way)
Almost every panelist at the NFID panel hailed regulators' and the global pharmaceutical community's response to the epidemic.
"I think my biggest surprise is in the context of the success of the collaboration," said Ripley Ballou, head of Ebola vaccine research at GlaxoSmithKline. "I don't mean that we were surprised that we were able to do it, but I am surprised at what people did."
Ballou then pointed to the stunningly fast successes of researchers like the University of Marlyand's Mike Levine, who, alongside his fellow scientists, was able to introduce "brand new vector technology and have it reviewed by multiple layers of scientific and ethical review, and have this protocol reviewed in just 10 days," said Ballou.
"It really shows what can be done when people put their minds to it."
"It's heartening to actually see [the collaboration]," agreed Merck Vaccines VP and Chief Public Health and Science Officer Mark Feinberg.
"You don't know what to expect when you enter into a complicated situation like this. What was most gratifying about it is how many different people from different organizations really stepped up to the plate to make major commitments and delivered outstanding results in a very short period of time... NIAID, WHO, whether it's the FDA or other regulators who have been very good, proactive harbors in thinking about how this process can move forward as quickly and as effectively as possible. It's nice to see those things which you can't necessarily count on."
This "proactive thinking" on the part of regulators and the willingness of business adversaries to band together, in particular, drew praise from pharma executives on the panel.
"I think the surprise is... the proactive thinking of the regulatory authorities, even advising us on what to submit in order to make the process faster," said Johnson & Johnson SVP Hanneke Schuitemaker. "It's really amazing.
"The other thing that I would like to emphasize is that the the public health issue was always the highest priority... Even though we're sitting here across the community of pharma, there has always been an eye for potential need for collaboration, and I really like that spirit. Although we want, of course, our product to succeed," the pharma community has concentrated on collaborations to make things go faster and be more successful, according to Schuitemaker.
3) Efficacy is important. So is durability.
One of the most deflating aspects of the search for an Ebola vaccine and treatments has been the difficulty of conducting trials amid a waning epidemic. That's what makes the involvement of even relatively small, private pharma companies like Tekmira and Mapp Biopharma so important, as an eventual vaccine or treatment will require an all-hands-on-deck approach.
"I think it's very positive that so many private sector companies have gotten involved," said Feinberg. "It's not enough to simply think about developing vaccines. There needs to be models for how stockpiles will be generated, how vaccines might be deployed... If people start backing away from this goal because they see the epidemic waning, then that will make it very de-motivating and make it difficult."
In the closest thing to a contentious moment during the plenary session, one audience member asked why companies developing Ebola treatments are focusing on durability when the real focus should be deployability.
"I think we focus on both," answered Ballou. "A good vaccine is a durable vaccine... And this comes up in discussion: How would you use an Ebola vaccine? And you're right, if all you wanted to do was to go and stamp it out in an outward setting, you don't need a durable vaccine, you need a deployable vaccine.
"But I think when you look at the Ebola epidemic, this disease is endemic now in West Africa. It will emerge again. And you could envision some scenarios where you'd want to introduce selective immunization for healthcare workers, and you would like to have durable protection for those workers the next time this happens."
"The current outbreak is now ongoing for more than a year, so if you had had a vaccine that gives protection for half a year, then people that were vaccinated at the beginning of the outbreak would have become sensitive again to the infection," Schuitemaker expounded. "So I think you need the vaccine to give you at least two, three years of protection."