05 Oct Session B – Life Sciences Track

Life Science Track – Vaccine Development: Driving Partnerships in Maryland 

Moderator:

• Marian Ewell, Sc.D., Chief Scientific Innovations Officer, The Emmes Company

Speakers:

• Subhendu Basu, Ph.D., Chief Operating Officer, Adaptive Phage Therapeutics
• Syed Husain, Senior Vice President, CDMO Business Unit Head, Emergent BioSolutions
• Helen Montag, Senior Director, Corporate Partnerships, Johns Hopkins Technology Ventures
• Sally Mossman, Ph.D., VP, Head of R&D Center, US, GSK Vaccines

So, today’s discussion we’re going to be focused primarily on COVID-19 vaccine development, but I think a lot of this discussion and the comments can be broadly applied to other vaccines, as well. 

TOPIC: So the first broad topic that we have is what are the some of the unique challenges for developing a COVID vaccine. So I’d like to start with what type of vaccines are in development.

There are really two overarching challenges in developing a COVID-19 vaccine: One is urgency, and the other is scale. In terms of urgency, we really needed a vaccine yesterday or at least as soon as possible. And for scale, we’re looking at an enormous challenge of needing to vaccinate the entire world’s population. 

We are really lucky that there’s a very diverse range of vaccine candidates in development, and they have various strengths in terms of addressing those overarching challenges as some of the candidates in development are representing very cutting edge technologies things like mRNA vaccines, like the ones from Moderna or Pfizer. And those are very exciting because they’ve been able to those companies have been able to develop design a vaccine candidates very quickly and get them into clinical trials, breaking records for how quickly they could get these into first in human testing.

On the other hand, those new platforms have never gotten to the point of being a licensed vaccine and they face challenges on the scale dimension, trying to set up manufacturing capabilities in the moment and then getting ready to distribute vaccines for which the formulation still got to be optimized. On the other hand, do you have more well established platforms represented, including the one from GSK in partnership with Sanofi Pasteur. And for many of these well-established platforms, it takes a bit longer to be able to design and develop a vaccine candidate and get them into the clinic for technical reasons. On the other hand, when it comes to scale, we have the infrastructure set up and experience with manufacturing vaccines and these platforms. So I’d say overall it’s fantastic to have such a broad range of different vaccine candidates in the pipeline. We really need as many shots on goal as possible, and ultimately will likely need more than one successful vaccine, just given the sheer numbers of people that will need to be vaccinated across the world.

QUESTION: What do you think realistic timelines are for developing a vaccine, and how can we sort through kind of what’s realistic for media hype kind of surrounding this?

I think everyone’s pulled together; The bureaucracies have been cut down and supply chains are being pried open. But there is the biology, and biology has its own timeline and it can be compressed. So, we can recruit all the patients we need, people are lining up. You know, this is the duty the clinical trials will proceed. But at the end of the day, if you’re looking at a one dose or a two dose vaccine. And then ultimately determining if it certifications. You need to have the incidents happening and then it’s going to take some time to actually establish that and this is beyond safety. I can see a vaccine coming on which is emergency-use authorized earlier, based on early efficacy. And hopefully, middle to end of next year.

Sure I mean I think you can add you can accelerate the process to be able to get to the point of entering the clinic. And we have certainly seen cases of that. There’s certainly efforts to manufacture millions of doses at risk while those clinical trials are underway, but it’s very difficult to dramatically accelerate an effective clinical trial process. I know that a lot of the trials being pursued are using adaptive trial designs and then really novel aspects of that for you. Even if you have a successful candidate coming out, I wouldn’t want to minimize the challenges of manufacturing and distributing the vaccine at the end. I think that’s when you know we haven’t faced something on this scale.

QUESTION: What type of a bar do you think they will need to pass in terms of immunology? What level of protection, what type of duration, why type of protection?  

I don’t know if we know what is a protective response. We’ve fallen back to historical knowledge. So everyone’s assuming that you need an antibody neutralizing data, which is reasonable to actually protect. But there is literature coming out that indicates that a T-cell response, And then you overlay on top of the anecdotal evidence that individuals have been infected are getting reinfected that throws a wrench in a classic understanding of the biology and what is actually protected for this vaccine. So the question is, is it masking, is it just behaving more like a common cold virus where you get repeated infections, but you don’t have a long-lasting immunity. Are you going to be able to have a classic traditional vaccine immunity we get, you know, two doses, and then protected for three years. Honestly, I don’t think we know the answer to that until we advance some of these vaccines through the clinic and do a longer follow up. 

We have to make sure that we test in a way that that meets the public trust so that once the vaccine is developed people will be willing to take it.

One aspect here is an it takes into account the last two topics Overall from an acceleration standpoint. The exciting thing is, the industry has come together. So everything that would happen sequentially. People are very open to, and they’re working on, ways to bring it to do everything in parallel. Certainly there’s always a cost risk to that but you know these are the types of things that have been kind of put to the, to the side.

That’s one of the most important elements and it certainly puts people in a situation, out of their comfort zone. But I think the way everyone’s working together, including the government including the regulatory bodies, kind of putting all their knowledge and horsepower on the table to attack this together. I think that gives a lot of merit to the fact that it will be accelerated.

QUESTION: Once we get a candidate that makes it through the safety and efficacy testing, how do we get the scale-up and manufactured to really quickly deliver that vaccine candidate to the population?

It’s all about doing it in parallel, as much as possible and in advance. It’s essentially putting everything on an all-hands-on-deck fashion and really assessing the state of the process on the supply chain and getting the facilities ready at a rapid pace. To start, essentially immediately going into large scale manufacturing but I think it. It all comes under this at risk umbrella and there’s going to be decisions that are going to be made that are being made based on phase appropriate information. There may need to be still some modifications that are made down the road. But this is where the sooner you can bring in the regulator’s into it as well. Then it’s kind of an, it’s a very transparent at risk type of process which, you know, I think is kind of makes it sound easier said than done. But, um, you know the transparency is very important here.

QUESTION: What about this administration’s idea of involving the military to get the vaccine delivered and administered.

One of the significant efforts that have been that has been put in place is the formation of Operation Warp Speed. Emergent has had an opportunity to directly interact with Operation Warp Speed, and when you look at the construct of it, there’s a scientific element focused on innovation, the science behind the vaccine, the manufacturing aspect of it, and then there’s a very strong logistical aspect to it as, as well. It all goes into this all hands on deck, and it also starts to look at everything from a parallel standpoint, so they’re already thinking about the distribution in parallel to when the manufacturing is happening. Their support has helped us accelerate timelines from a supply chain standpoint, and given their expertise in this from a logistical standpoint, it’s a great add, and I think it can only help us. Now, before we have a vaccine, they also are bringing in expertise. That is very critical.

I don’t think we give them enough credit. It’s amazing what they can do, especially because they are unencumbered by return to shareholders and shareholder value. We wouldn’t have penicillin if it weren’t for the US military. And this was in the 1920s, so when we had the influenza pandemic and the military driving penicillin. It was the military, and you know they get stuff done. And then from a distribution perspective, it’s bar none. I think we’re lucky that the military is actually stepping into this, and I’m encouraged, because they will get it done. So, I think it’s a great idea to leverage the military.  

Well I think we’ve, we’ve heard, but probably amplifying the fact that there are a lot of government nonprofits foundations and private companies that are all partnering together on this work. We’ve partnered with several government agencies conducting vaccine research at NIH National Institute of Allergy and Infectious Diseases, the Walter Reed Army Institute of research, BARDA the biomedical Advanced Research and Development Authority. We’re also working with foundations and nonprofits like Bill and Melinda Gates Foundation, the Henry Jackson foundation, and others. Historically, the governments and NGOs have played a big role in vaccine development and in really preparing for emerging infectious diseases.

From a public private partnership standpoint so many merchants have a long track record and history with working with the government and its and its agencies I mean when you look at COVID-19 right now in our collaborations with them. I mean we have collaborations on the product side where they are supporting the development of our therapeutics that we have in development. And then on the cdmo side, the public private partnership to proactively reserved capacity to pave the way for a proven us supply chain for these vaccine candidates as well as expand capabilities as well. It kind of it comes to a spotlight right now during the pandemic. But there have been years and years of investment and collaboration and preparedness, as well as solving other public health threats as well.

QUESTION. What unique aspects of Maryland are furthering these partnerships?

We certainly have a broad array of universities that are actively involved in trying to work closely with all the industry partners in the state. It’s a small state, but we are close to the federal government so we have the advantage of knowing really knowing each other. It’s kind of a small network.