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What you’ll hear in this episode:
- All about the COIVD-19 Vaccine
- What goes into the development of vaccines
- The future of vaccines
The COVID-19 vaccine seems like a light at the end of the tunnel, but it’s clouded by misinformation and a lack of understanding of the vaccine. We have two guests on this episode with extensive experience in drug formulation and delivery to help us gain a better understanding of the COVID-19 vaccine. Janet Walkow holds PhDs in Pharmaceutics and Pharmacokinetics. After owning her own pharmaceuticals company, she’s now the Executive Director and Chief Technology Officer of the Drug Dynamics Institute at the College of Pharmacy right here in Austin at the University of Texas. Timothy Sullivan is the Founder and President of Zeteo Biomedical LLC and President and CEO of Mystic Pharmaceuticals. Combined they have over 40 years of experience in the industry.
The general time span it takes to develop and release a pharmaceutical product is 10-15 years, so the fact that the COVID-19 vaccine took less than a year is astounding. We may not know what possible long-term effects there might be, but they are continuously testing the vaccine. The most important thing is it is doing what it needs to do in the short-term, which is to slow infection rates and decrease hospitalizations. Both Timothy and Janet advocate receiving the vaccine when it is possible.
We discuss what re-entry to “the normal world” could look like and the long-term ramifications of the pandemic. Janet believes that once we begin approaching herd immunity is when things will begin shifting, but the shift won’t be a return to a pre-COVID world. Both believe the COVID fight is long from over. Timothy explains that we must understand the virus’ sole purpose, which is to stay alive. What we are experiencing will have generational impacts, so we are going to have to learn to embrace the new normal to move forward.
To hear more from Janet and Timothy on the COVID-19 vaccine, the future of pharmaceutical development, and how the ACC Bioscience Incubator gives innovators a space to work, tune into this very special installment of Science in the Mall Y’all. If you enjoy the episode then be sure to share it with friends and colleagues!
Science In the Mall, Y’all is a founding_media podcast created in partnership with the ACC Bioscience Incubator.
Host: Dan Dillard, founding_media
Guest: Janet Walkow and Timothy Sullivan
Transcript:
This is a founding media podcast produced at Austin community college district.
Welcome to science in the mall. Y’all I’m your host, Dan Dillard, after the mad rush to develop the COVID vaccination in 2020, the biggest COVID 19 update of 2021 has been the emergency approval and rollout of the vaccines. Despite this positive breaking news, it’s clouded and misinformation, and lack of understanding of how vaccines work that is why this episode is all about diving deeper into the COVID vaccine and how vaccines are developed, tested, and brought to market.
We’re joined by two very qualified guests to help us learn more. Jenny Walco has a PhD in pharmaceutics and pharmacokinetics after owning her own pharmaceuticals company. She is now the executive director and chief technology officer of the drug dynamics Institute at the college of pharmacy at the university of Texas.
Our other guest, Timothy Sullivan is the founder and president of that. They’ll biomedical LLC and president and CEO of mystic pharmaceuticals. Over the past 40 years, he’s created breakthrough technologies and products in the pharmaceutical industry. Let’s jump into our conversation to get answers to all your vaccine questions.
Welcome to our podcast. Thanks for being with us. How are you guys doing today? Doing great. Thank you. Lovely day in Texas, Janet and Tim it’s. It’s wonderful to chat with you. I’m literally looking forward to our conversation, our joint conversation together, all around vaccines. Janet, before we start off and get into the nitty gritty about vaccines, will you tell the audience just a two minute version of your history and your involvement with, with vaccines and we’ll then go to Tim after that.
Thank you very much, Dan. My first involvement was in my first job, which was in the pharmaceutical industry where I headed up all the liquid semi-solid and sterile product development. And so I had experience with all sorts of injected materials and worked on several projects. And after leaving the pharmaceutical industry where I have my, my own company I got a little bit out of the actual science, but then I joined the university of Texas in 2008 where I run the drug dynamics Institute, where I’m very embedded in preclinical drug development activities.
Also for some devices and I’m heading up a lot of technology readiness types of programs at the university. Really, really cool. Tim, what about you? Well, my involvement in, in the vaccine space began about 12 or 13 years ago when we were developing packaging and delivery devices for vaccines and our focus was really around the next.
Sort of the next generational push into how to deliver vaccines across very broad populations. And so we were focused on on delivery devices that essentially enabled self administration into the nose. And we developed an entire platform for packaging and delivering vaccines in a liquid form powder form or reconstituted powder form, and being able to scale up the what’s called fill fit, finish side of the equation.
It’s one of the big challenges going on now, which is to be able to produce very large volumes of vaccines in and put them into devices that could then be deployed across large populations and actually self administered. Thank you. That was, that was really cool. And I want to dive into what you just said here.
One of the things that we’re seeing now is just, it’s just these questions about vaccines is just what are the, what are the difficult problems to get these things out. But before we dive into that what is your thought on how fast these vaccines have been developed? I feel like it’s for, for most of us in waiting while I was taking a long time, but it’s, it’s been record timing.
So what are your thoughts on the timing? Well, having been in the pharmaceutical industry for a number of years I’m very familiar with the typical lengthy time. It takes to develop a product. The average is about 10 to 14 years moving from actual discovery to commercialization and to have something like this developed in under a year to finish the early parts of a phase three trial with the kind of data that they have is just.
Remarkable. Like I said, it can take up to 14 years. It typically takes somewhere between two and $3 billion to do this. And a lot of person power. And for this to happen in this amount of time is truly a turning point, I think, in developing new ways to approach vaccines. Yeah. Tim, you and I were talking about some of the challenges just historically bringing out a new vaccine versus, you know, we’re talking about the various ways that they could be administered to the body you want to touch on, on what we’ve seen historically when it comes to vaccines.
Sure. The, you know, the typical the typical approach to administering a vaccine is typically through either an intramuscular. Subcue a subcutaneous injection. And that’s been the way it’s been done for you know you know, almost a hundred years. I mean, since we’ve really been developing them and it’s deeply embedded in, in the development process so a lot of that legacy sort of carries on over the last couple of decades though, there’s been, we’ve started to see something of a shift to sort of look at new ways new ways of administering vaccines that aren’t dependent on an injectable approach.
And the, the challenge with an injectable approach is that there’s a, there’s a lot of infrastructure required in order to be able to make that happen. Typically people can’t self administer an injection. And so you have to have some sort of healthcare infrastructure in place to facilitate that.
The, you know, the other aspect of this really revolves around the development of new forms of vaccines that can not only be administered noninvasively, but and, and can potentially be self administered, but also don’t necessarily require some of the, the cold chain infrastructure that we see today.
So there’s a lot of, there’s a lot of evolution that’s occurring very rapidly, not only in the development of the vaccines themselves, but also in the form that they take the packaging of them and the administration of them. Janet, one thing I thought was really fascinating in our earlier conversation was that even though it has fast tracked, the vaccine has fast track faster than we’ve seen before.
There are many people that are, that are gonna wait it out, kind of see more results coming, coming forward. What, what should people be asking themselves about the vaccine, even though it hasn’t been approved? I think we talked about, well, they’re still, it’s an emergency approval, so it was fast tracked.
You want to talk about more that a little bit more? Sure. You know, a lot of people are under the impression that the vaccines are formally approved and what they were approved for was for emergency use. This is very limited. Phase three data, typically you could see up to like Like 50 to a hundred thousand people in a, in a phase three trial.
And you saw much fewer in terms of the numbers. So for example, in the Pfizer trial, I don’t have the exact numbers with me, but when you hear about 95% efficacy, efficacy is different than being effective. Because what they did was, was to take a certain population is somewhere around 170 people. If I’m not mistaken and they track back how many of those people were infected with COVID-19 and, and at least were symptomatic.
So there’s another variable. They couldn’t really track the asymptomatic folks who may have had it. And then they did the calculation that in 95% of the people who had the vaccine that they were protected. So, but that’s a small population. And even when you develop. A drug using tens of thousands of people in a phase three trial, that’s still considered a very small population because until something gets out into the public sector where you literally have tens of millions of people using a medication, you don’t know which of the side effects may be prevalent.
So. What we were able to get with this is efficacy, which is a hugely important number since we don’t have the time to wait to really have the sophisticated types of trials that typically are put in place. But what we do, we will be able to tell over time how effective this is. And people should not be alarmed if it’s less than 95%, because there’s a lot of factors that aren’t in there.
I also like to remind people when they say, well, you know, some of these are only 80% effective. I go, the flu vaccine is somewhere between 40 to 60%. So I think you just have to put everything in relation to other information that we have. And I’m actually very heartened that I heard a news report this week, that more and more people are open to getting the vaccine.
I think that it was, I forget the numbers, but it’s something like. 26 million people have received at least one dose. And I believe it’s around 6 million people have had two doses and while it needs to be much higher you know, I know that the Austin public health website is being reconstructed because I think somewhere in like half a million people were trying to sign up to get their vaccines through them backlog.
For sure. Tim, one thing I thought was really fascinating in our earlier conversation was talking about the different ways to administer medicine into the body. So at, you were talking earlier, injection was one of them, but. The test itself is done via the nose. Right. And so a different kind of administration is much more efficient in, in what your experience has been.
So, so typically an intramuscular injection takes some number of weeks in order to achieve full systemic immunity. So the Pfizer and Moderna vaccines, you know, it’s a two dose regimen, right. And, and the estimates are that you achieve full systemic immunity. A couple of weeks after the second dose, you’re building immunity.
So you’re, you’re getting some level of benefit from it as you’re waiting for that to happen. There have been The, the route of infection, the typical route of infection, you know, for, COVID-19 and for influenza and for a number of these other sort of pathogens is the respiratory track. You breathe it in, you may get it on your, you know, again, you get it on your fingers and rub your eyes, but the respiratory track is the typical route of infection.
And so if you can actually initiate, if you can administer a vaccine, say intranasally as an example and, and initiate. A, an immune response in the, in the track and the respiratory track you can reduce, potentially reduce the risk of of infection. And there’s a fair amount of clinical data that exists from, with some other vaccines, not with the current COVID M RNA vaccines, but with some of the vaccines that were developed for influenza that were nasally administered, which showed that an immune risk.
Sponsor was initiated within about two days of administration intranasally and full systemic immunity was achieved actually within three or four days, so much faster onset of the immune response and an, and a very quick immune response, partial immune response, you know, in the respiratory track. And so, and so th that actually presents that that’s another one of those factors that as we look at the, some of the there’s actually now a handful of vaccines that are in development for COVID, that are being developed for intra-nasal administration.
And so as part of that process, you know, as those make it through the, the re the clinical process, and we get more data on those, we’ll be able to determine if those kinds of vaccines can also provide that same level of benefit. That would be awesome. What interests in peak? My interest the most in this is if we can compress the time that our bodies adapt to the vaccination.
Obviously then that puts a much bigger dent in the spread of, right of COVID. So exactly Janet what are your thoughts on, on intra-nasal versus injection or to have you had that experience? Oh, I’m a big believer in The better way you can deliver it, store it, ship it and access. It is the way to go.
And a lot of the folks at the college of pharmacy are working in this area. This is their specialization. They’ve worked on a lot of inhaled products and there’s so many advantages whether you’re using a powder you can also use different technologies to administer these powders that you just reduce so many barriers to access.
And I think that’s probably what we’re seeing now are these barriers to people being able to access the vaccine because of how it needs to be stored, how it needs to be administered and, and how it needs to get to these distribution points. So I’m a big fan of that and there’s a lot of research going on.
At UT in this area, that’s one thing that I wanted, hopefully get both of you guys to comment on is what we hear things on, on the news, as far as here’s, what’s happening the problems. And here’s where some of the failures are. What are your opinions on the rollout, how fast it’s happening and some of maybe the bottlenecks and how can those be improved?
It would never be fast enough. I think that we’re doing the best we can, given that there was very little direction I think would, should have happened was to create an infrastructure and a distribution plan so that every state didn’t have to figure it out on their own and then iterate and iterate again, to figure out how best to do this.
Because in the beginning, there were a lot of unused doses because they weren’t in the right places that knew how to do anything with them. With the kind of speed that you need to, to deal with, you know, getting these vaccines into people’s arms. So in terms of, you know, that that’s one of the biggest part, the distribution and, and the planning, you know, when you see websites going down, when a website opens and three hours later, no one can get an appointment when no one’s really tracking.
Who’s getting the vaccine and then shifting who is eligible for the vaccine. We want our kids in school, the teachers on our priority, you know there are very few people who I’ve talked to who have been asked to show ID and people are being able to sign up using all sorts of methods, whether they are in the one, a or one B category they may not be.
And so it’s kind of like the wild West right now in terms of how it’s being done. I do think that with the new administration, that there’s going to be more help in making this work and getting it out in a, in a better way that with all the problems, especially, I mean, I don’t know if most people understand what’s involved with the minus 80 freezer.
I’m having a new minus 80 freezer brought into the labs and you have to have a new plugin installed, which is not a simple process. It doesn’t plug into the regular wall plaque. And so it’s taking us weeks to get this work order and this isn’t for the vaccine, but you know, a lot of our stability studies we do at minus 80 degrees and it’s hard.
And Ashley right now in science, it’s a big problem. You can’t buy a refrigerator or freezer with any speed. It’s a real problem for researchers right now. So moving towards something as Tim was describing where you don’t have that cold chain storage requirement would just be huge because not only is it expensive and you, it takes up a lot of space.
That it’s just, it’s not viable for a mass distribution like we’re facing right now. Yeah. Tim, what are, what are your opinions on that? Well, you know, if you look at the countries that Have done what I would consider to be a better job of this, the, the characteristic there is that they had a top-down approach to this.
I mean, this is a massively complex undertaking from a stra a strategic perspective, you know, and, and we didn’t, unfortunately we didn’t follow that, you know, that approach in this. And so States, States, and municipalities were left to try and solve the problem at the local level. And then at the regional level and at the state level.
And a lot of those things just weren’t connected because it wasn’t driven from the top down. So my own observation, like I had to I had to schedule a vaccine appointment for my 91 year old mother. She lives in Arizona. Right. And she would have never been able to navigate. The complexity of that process on her own.
And she’s actually reasonably computer literate, but the websites didn’t work properly, you know, and we managed in fact, we ended up scheduling an appointment. They didn’t have it in their system. She showed up anyway and they gave it to her, you know, and then they had her fill out a P a piece of paper, you know, to try and lock her in.
We got it. But it was there was a lot of stress in the process. The so I think that, I think. As we go forward, the efforts that are being unfolded now, you know, we’ll, we’ll get that aligned. And this is not a, this is a long-term sort of process, right? I mean, we’re learning some lessons on this go around, but we’re going to face situations like this, you know, as a civilization going forward, this is not the last pandemic that that earth is going to face.
Right. And, and so we need to learn from this and put in place those mechanisms in you know there were, there were actually, some of this planning work was done a decade ago, following the H one N one. Pandemic now that wasn’t anywhere near as deadly as this one was, but there was a lot of infrastructure that was created, unfortunately, between the time that was created.
And the next decade that unfolded after that was put in place. A lot of that was not maintained. A lot of that thinking a lot of that planning work was re was really not maintained. And, and from a human perspective, that’s a challenging thing to do, right. W we tend to think short-term, you know, and long-term in these kinds of situations and it’s easy to make decisions about cutting funding for those kinds of putting those, that kind of infrastructure in place and maintaining it just in case, you know it’s a, it’s a very challenging thing to try and undertake.
To do, but it’s necessary. I just wanted to add to that. It’s my observation, that in countries where there is single payer nationalized health systems, it’s rolled out, it’s been rolled out totally differently or not scrambling to make an appointment. It’s something that’s been very easy to do.
Sometimes they’re the ones being contacted, but there’s another benefit. I know that Pfizer is working with, because they have a single payer system and they are they’re trading. Information Pfizer now is going to get access to their information because that’s how you really track how the process is going.
What your effective rate is, you know, with the vaccine. And you’re looking at a total population, not just pockets of a population. So some of these countries who have single payer systems are, I think, wanted to go way ahead of us. And in many ways they might have been slower to the rollout that it’s going to be much more effective because I really worry that access.
And I’ve said that once I’ve had my second vaccine in two weeks, then that’s one of the things that I want to personally work on it because there are a lot of people that, you know, if they have a phone or a computer, they could never navigate what we’re having to navigate. At least here in Texas to get an appointment.
I, I, you know, I think also that, you know, as we go forward and as some of these new technologies, for instance, we’re working on it, a room temperature, nasally administered next generation vaccine with our partner, Iowa state university, the nano vaccine Institute at Iowa state university. And they’re developing the vaccine as a Teo is developing, has developed actually the delivery system for that.
We’re in preclinical testing right now, but our target is, is to continue to advance this with the idea that it could serve as a as a next generation vaccine platform, not just for COVID, but it’s a It’s a, it’s a protein subunit vaccine and it’s a platform. And so we’re actually working on both pandemic influenza, and COVID in parallel.
And that that entire platform is set up so that we can actually very rapidly develop new vaccines, drop it into the protein. Some unit platform, drop it into our nasal delivery system and run it through the same production facility. So response time potentially goes way down. And because you have you, you don’t have ideally the cold chain requirements to manage it.
It’s a self administered device. You don’t have to deal with sharps disposals of, you know spent needles after the fact the entire system becomes, you know, dramatically simplified and a lot, a lot easier to roll out as new threats sort of emerge and we have to respond to them. That’s, that’s amazing.
I just looking at the future. Has that has anything like that been done before? Self administering vaccines. No, it’s a, it’s been somewhat controversial in the past. It’s been discussed. I was involved in, in discussions a decade ago as we were exploring different. There was scenario planning work that went on that was driven by
Right. Which is which is part of HHS. And we looked at we looked at scenarios. We did some scenario planning around that sort of a concept. It’s been tested in very small you know, small programs to sort of test out the feasibility for it. But it has not. It has not previously been rolled out broadly as a self-administered approach.
The, probably the nasal flu vaccine that people are familiar with would be a protocol flu mist, which is an AstraZeneca product. That’s for seasonal influenza, but that’s in a, that’s in a nasal delivery device, which actually has to be cold chain. And you don’t self administer. You have to go to a health care provider to get it.
They, they administer it. And that device is not really designed for self administration. Either I was going to ask what’s the big hangup on having people administer themselves. Is it the needle? Is it, if, if people aren’t using the needle, maybe it’s, maybe it’s easier to self administer whatsoever.
There’s hype, there’s, you know, high incidents of needle phobia. I mean, just, you know, the, I mean, that’s a, that’s a big aspect of it. There’s also, you know, some targeted. Places where the administration, you know, needs to take place. So you can’t just jab that needle anywhere. You also have to, you know, once, once you have administered it and you now have a biohazard, right?
So so you have to properly dispose of those needles. Right. And you know, you think of it in the context of, well, it’s just one, but you know, we’re talking about, you know, in this country, we’re going to end up with 700 million of them, right. That have to be processed and abuse of, of used syringes is a huge problem in other countries, you know, that you know, particularly in certain developing nations, there’s been large efforts, you know, to try and develop syringes that are essentially disabled themselves after use.
So they don’t get repurposed, you know, for other uses and potentially spread disease. That way. Right. So moving away from the needle generally, I think is a is going to be a, sort of a positive, you know, forward movement for this particular, if we can get to a point where it’s something as simple as stick this in your nose and push the button and then.
Throw it away and you’re done. It sounds way more efficient. It sounds like the future. So I’ve got a question for you both, and, and this is just going to be like the typical audience questions I’m talking to with family members. And the question comes up all the time is what’s the difference between the cold vaccine.
And is that because of preservatives that they’re needing a cold or is it, and the room temperature vaccine, could you guys get into the details on what the differences are? Go ahead, Tim. Sure. So, so, you know, so in the COVID world, there are types of vaccines are right, for different basic approaches to developing the vaccine.
There’s the traditional, a whole virus, which has been used for a long time. And those are typically either a they’re either live attenuated vaccines. They take the, they take the bug and they sort of, they sort of attenuated meaning that they sort of disabled aspects of it so that it, it isn’t as virulent and then they inject it and your body sort of responds to it.
And that has been used for many, many decades. That was the original approach protein subunits the MRR and a protein subunit is another approach. The AMA RNA and viral vectors are the other sort of three approaches. The, the Moderna and the Pfizer vaccines are nucleic. Asset basically M RNA vaccines.
And the advantage to that is that they’re relatively easy to produce and you can sort of make them in, you know, cost-effectively in volume, but they’re very fragile. They have to be the actual, a messenger RNA has to be wrapped in a, in a shell to protect it because it’s extremely fragile. And and so not only do you have to put it in a shell, but then you basically have to reduce all of the molecular action that’s going done on there by freezing it down at minus 80 C.
And once you thought you can’t refreeze it, okay. It’s like, it’s like chicken, you can put it in the freezer once, you know, but when you thought out you’ve got to cook it and eat it, you know, and that’s the, the M RNA vaccines are, are, this are the same way. So there’s efforts now, the, the The protein, subunit vaccines that are in development now.
And they’re by last count by our estimates, w we, we try and track all of the different vaccine programs, development programs for COVID running around the world. The last time we looked at it, which was about a week and a half ago there or something like 128 different development programs on fundings, you know, quite a few and a percentage of those are protein subunit.
And in particular, in the protein subunits space, they’re looking at formulating them they actually start out as a powder, right. And as a powder form and, and the, in that particular space, you have a, you have a bio-degradable carrier material, right. Which carries the vaccine and they load the vaccine into that.
Right. And then the original development work that we were involved in, they would, they would take that and then they would dilute it. They would basically rehydrate it in a liquid form, put it into a syringe and develop it. And so our work in that evolved that to basically look at well, can we package it and dispense it as a powder?
Well, a powder has a lot less sort of molecular activity in it than a liquid does. Right. And right now that in that particular project and in other projects going on white, that, and there are a number of them where powder is the, is the basis for the vaccine it’s packages of powder and it’s delivered as a powder.
We’re much closer to basically, you know, having room temperature based. Formulations. So, so, so whether or not the MRR and RNA vaccines can get there is you know, is a question and whether or not they could be used for it could be actually repurposed for nasal delivery is another question.
We actually also have technology which allows us to do reconstitution on the fly in a nasal device. So, so, and we’re doing some preliminary development work around that concept as well, where the vaccine may be best administered as a, as a liquid. But. To package it and to ship it into store it, it’s better off doing it in a in a powder form.
And we actually developed eight or nine years ago, a device that you can package the powder and a liquid in separate chambers inside the device. And then you just flip a switch on the device. You actually have a locket and it mixes it together and then dispenses it as a liquid. And so that’s another sort of new area that’s unfolding as a, as a potential, a way to sort of deal with this.
How do you reduce the complexity of packaging storing, deploying and using? I don’t think there’s, I don’t think it’s been publicly disclosed the difference. You know, what causes the difference between the Moderna. A vaccine in terms of cold chain requirements. I suspect it has to do probably with the fact that Janet, your colleague was working on it with Medina early on.
Right. I mean, you know, both of those were derived off of it, but you know, it’s probably the fact that it’s, that it’s that influence in that research and that, you know, th that effort behind it, which made the difference, they had more time to figure out how to reduce the you know, the storage temperature to be you know, a minus 20 C is essentially, you know, for us, it’s a standard freezer, you know?
So, hi understanding before the conversation with you, Tom, was that it was more of a preservative, but you said, no, it’s not a preservative. It’s essentially, it’s a very, very delicate the type of vaccine and the way to keep it stable is to keep it. At that temperature, is that correct? The, and I haven’t read anything to say the, the opposite, but they’re never read that one is better than the other.
They’re just different approaches to tackle the problems that. They’re actually very similar. I mean, and you know, they’re, they’re quite similar, you know, and, and, you know, with time, I mean, you know, right now Pfizer is actually working on you know, a next generation version of that, which, you know, will reduce the cold chain requirements yet to be seen sort of what, you know, what it is.
And in fact, I recently read something that they’re working on a powder version, you know, so everybody’s, everybody’s now focused on, you know, dealing with the, you know, the, the other side of the equation, the logistics side of the equation, right. That, that there just wasn’t much focus on. And that’s actually, historically, that’s always been the case.
I mean, from our experience is, you know, in, in the pharma industry, the focus has largely been on develop the therapeutic, improve it, you know, it’s safe and efficacious. It works. And we’ll worry about the rest of it later. Right. And, and but the problem is that when you have a rapidly moving problem like this, you gotta, you gotta be.
You got to think end to end, you know, or because it doesn’t matter if you’ve got a great vaccine, if you can’t get it into people, you know, efficiently, we don’t have a solution. I just want to pick up on something Tim, that you started talking about in terms of the economic impact. I think one of the differences with what we’re seeing with COVID-19 and what’s going on, you know, with the vaccines is that I don’t know one person who hasn’t had some sort of impact, it could be economic, it could be physical, it could be mental.
Everybody’s been impacted and everybody. That, who I know is just like questioning for more information about all sorts of things. And we had the public’s attention now, and I think it’s a great opportunity, not just for scientists, but for folks in public policy and communicating things effectively because I, I’m guessing that Tim also gets calls every day from friends and relatives asking questions because they want to know more.
And, and these are really intelligent people and it’s shocking how little they know. One of the biggest questions I get all the time is, or conversations I get into all the time. Is, is it safe? Cause cause people mistakenly well, I have noticed that it takes 15 years to build something. And this is built in less than a year.
And so automatically there’s this association that we rush through all of this and we didn’t do the, the work that we needed to do to get it passed. And so there’s a fear there of whether to take it or not. So I guess the way I look at it is what’s more dangerous, a side effect from a vaccination or coronavirus itself.
So how would you get comes a risk management exercise, right? I mean, you’re managing risk, risk it’s, you know, and, and you know, when you’re losing, you know, 4,000 people a day, right. You know, and it’s a legitimate concern. I mean, we did cut corners. You know and, and it’s not, it’s not like they’ve stopped testing it.
They’ve continued to test it, you know, they’re and they’re collecting data in real time. I mean, I got mine and you know, I got my first vaccine a couple of weeks ago and, you know, I, I get every day I get a survey text to me from you know, asking me, you know, for symptoms and that sort of stuff.
Right. And I assume that they’re doing that more broadly. The, you know, but the bottom line is it’s a risk, you know, it’s a risk mitigation strategy or risk management calculation. Right. And hopefully, you know, we’re not going to see any long-term sort of issues a year from now or two years from now or five years from now.
But it’s going to take some time to sort of determine that I think. Yeah, there’s always a risk with every new product. I mean, that’s why you see recalls sometimes two, three, four years down the road, but I’m very heartened by the data that people who have, or seen the vaccine are not being hospitalized.
If they, if they were to get COVID, they’re not being hospitalized, which means it’s working and it’s having a huge impact and that turning the ship that’s for sure. Absolutely. Yeah. So long-term, I don’t know. I mean, no one knows that right now the short-term is really important. It amazes me how much when everybody focuses on something, there’s a lot of solutions to it.
Sometimes we do things the old fashioned way. Cause that’s, that’s the way it’s been done, but there’s many other ways to do it, Jen. And I’m curious you working with UT and all of, are you seeing a lift in interest in this field? Field of medicine. It is dramatic. It has been dramatic from the very beginning.
When the labs were shut down on YouTube at UT at the end of March the, the first labs that were allowed to resume work or labs working on COVID-19 projects, and these range everywhere from air purifiers to the vaccine, still everything in between. And they formed kind of a loose informal group of people who were doing this.
And and in my core lab, we were working on two COVID projects, but one of the comments I really want to make this has really amplified what people are doing and would it also demonstrated almost immediately was the ability. And the desire to be able to pivot whatever research you were doing towards this problem.
And I was so heartened and we had a couple of meetings of all of us who were involved in a variety of projects. Again, it might be from a public policy standpoint down to, you know, you know, Jason McClellan who’s at the university of Texas was the one who actually identified the spike protein and has been working with no modern.
And this has been his area of study for decades. But I think the public needs to understand the intensity with which people were willing to shift what they were working on to solve this problem. Yeah has really it to me, it’s really sent a message when you’re at a public university, there’s just this plethora of research going on.
No one really knows what it is. They’re now finding out with this disease, what has been going on. But I think it’s really incumbent on our States to understand why it’s so important, not to keep taking money away from public universities, but to give it to them because the response has just been incredible on all throughout the university.
And again, it’s not just the science piece of it. It was, you know, Lauren, Lauren Meyers, you know, with the predictive analytics putting together the best way to communicate things to the public. It’s really a wonderful thing. And as Tim is describing some of the, the ways people are going to move forward, I think that has been kind of the silver lining of this pandemic.
And I’m always looking for the silver lining of anything that I think people are now have a mission to do things differently and not to do it the same old way to do things that make more sense to give access to greater numbers of people. One of our together, yes, she went into work together. The collaborations have just been incredible.
There’s a company, a spin-out of, of UT from the college of pharmacy. Gerado that’s making these Findler films. They’ve been making them for years that they can be reconstituted into vaccines so they can be shipped so easily without the requirement of, you know, the cold chain. Too all over the world means.
So people are looking at these global solutions you said earlier single-payer systems just seem to be more efficient right now because they’ve got data. They’ve got, they’ve got ways to administer and they’ve got the infrastructure. I think one thing that we’re discovering in the U S I think, well, I know that the medical profession has been disjointed for a while and people know that there’s issues there, but this spotlights, to what extent there is some, some so much disjointedness in this, in this industry to the fact that it, that people don’t talk to each other and, and it takes something like this for people to start working together and figuring out back channels of how do we, how do we build things together?
How do we more efficiently? We’ve got the brainpower. It’s just, it’s just communicating that. Yeah, no. And when you point out there also is that, you know, over recent years, hospitals were judged on. Their financials, not how great they were taking care of people. And I think as a result, we’re seeing that, especially in rural areas, but even in, in cities, they have limited capacity to do what they need to do for all the folks who are requiring hospitalization.
Speaking of working together as you know, it was a science in the mall y’all that we’re producing with in conjunction with ACC bio-sciences incubator. How did you guys work together with them? How do you work with Nancy and the folks down there? How do you have that relationship? So I’ll jump into that.
So I’ve been I’ve been working with the bio science incubator since it was an idea at ACC. We actually worked with the leadership there to help them sort of frame the idea we provided some guidance on because we had we had built a GMP. A facility in Austin, in Cedar park, actually.
We had expertise in our team. And so we have been privileged really to, you know, to be able to sort of watch this unfold over a number of years. And it has been a resounding success. I have to say, you know people like Nancy and some of the other folks who, you know, were part of the earlier the earlier evolution of it have done a phenomenal job in standing that up.
And having, having it serve as a really critical resource to the to the life science ecosystem in central Texas. Yeah. That’s what, I’m what I’m noticing as I’m talking to people that, that actually work with a CC biosensors incubators, the different companies that are coming out of there just blows my mind.
And many of them say it wouldn’t be possible without these facilities. I mean, there’s just so much that goes into it. Yeah, there, there’s not a lot of facilities. In the Austin area, I have some small, small amount of wet lab space that, that we, we share with innovators. And I’ve really enjoyed working with Nancy, her team at the buyer science incubator.
We first really got involved together when they were kind of launching before the lab was really even open and over the past several years, Nancy, and I’ve been part of a collective, we called an affinity group for folks in the. Central Texas area who are doing some of the same things. And what’s really great is that, you know, Nancy has just an amazing, you know, top shelf, you know, wonderful equipment and a setup that is accessible to so many people where they don’t have to bring in their own equipment unless they have specialized equipment.
And that’s something that innovators really need at this early stage. They don’t have the money to buy these expensive pieces of equipment. And there are several of us who have space or access to space and programs, and we all do something a little bit differently and what’s. Wonderful about the ecosystem that’s been created in Austin is that we collaborate.
We are not competitive where we all have our own things that, that work well for some innovators and not for others. And so Nancy and I, and have really worked together so well, trying to help identify, you know, sometimes one of her folks might want to come over to my space for a certain reason and vice versa.
So they have really been able to. I think attract a lot of folks into the Austin area based on the space that they have and the services that they provide and continue to expand. Yeah, I’ve been, I’ve been really, really impressed with the services, but also the people that are working there and the things that they’re working on.
And, and it’s, it’s, as I’m discussing with them having discussions, I’m like, wow, that is such a new and more efficient way of doing things for sure. And we’re all about one of the things I love is efficiency is one of the things that we were talking about earlier Tim was sometimes the inefficiencies of a system we were talking about.
The purchasers of vaccines are usually governments on large scale. And a lot of times the. Th th the people that are creating the vaccines are just going to follow the orders of what the government says, but the government’s not pushing or leading innovation. So to move from an injectable vaccine to a nasal, sometimes it’s, it’s, it’s gotta be the new innovators that are coming up with these ideas.
And then someone up in government, that’s been purchasing these for like 20, 30, 40, 50 years. It’s done this way. No, there’s a new way of doing it, but the infrastructure is already set up the old way. So that’s, that’s, that’s what I gathered. Anyway, if I crossed your words that all their time, that that’s what I thought I heard from it, is that, is that more or less the case historically, it’s been a kind of a closed loop you know, and and that seems to be changing now.
And certainly the, you know, the, the, the whole issue of a pandemic event of this magnitude has to drive different thinking. And so we’re beginning to see we’re beginning to see More funding. That’s being directed at alternative approaches to solving not just the development of the countermeasure of the vaccine itself, but also the downstream processes, the delivery systems and and, and ways to sort of reduce the impact.
On the health care infrastructure. So more of that is, you know, has started unfolding in the past year. And hopefully we will see, you know, that really take root. I mean, I think we’re on the cusp of a significant paradigm shift here of the old way, you know, and, and, you know, paradigms are paradigms are really challenging to change.
I mean, there’s really only two ways to do it either. Either you have the power to basically wave your hand and say, we’re going to do it a different way, or the system itself breaks or it explodes in some way. And then re-emerges and reorganizes itself in a, in a different, and hopefully, you know, more effective manner and you know, and you know, the ladder, the ladder approaches.
Can be pretty chaotic. And I think that’s when they’re in the midst of, I also wanted to mention, you know, just to sort of reinforce some of the comments that the Janet was making about collaboration and, and people pivoting you know, a really good example of that is back in 2003, 2004, we had the first epidemic of of a Corona virus, which was the original SARS epidemic.
And it was principally concentrated in China. And you know, a lot of people maybe don’t remember back that far, but it was, it was quite concerning. It spread very rapidly, but it obviously didn’t reach the magnitude. It was, we were able to sort of stop it. But in the intervening years, it’s been 16, 17 years.
Since that happened, nobody has developed a vaccine for it. Right. And it is, it is, it is a Corona virus. Right. And and fortunately, you know, we, we, we, as a you know, as a civilization, you know, we pivoted, you know, people work together and we, we came up with a vaccine and actually have got it out in less than a year.
I mean, that’s, that’s truly you know, the comparison of those two examples are truly amazing. Well, when Janet says it’s normally six, 13, 14, 15 years to be to roll something out, right. We get it out in less than a year. That’s really impressive. I think one of the biggest concerns now is variance, right?
How concerned are you guys about variance as opposed to what we have out now and how effective it is has that shaken your confidence at all about summertime and, and, and some of the numbers that they’re talking about in the summer. Well, I think there’s two aspects to that. Of course the variants are very concerning because we were hoping that there wouldn’t be any, which was somewhat not real logical.
There’s always variance. I mean, that’s why there’s a different flu vaccine every year. And so, but some of these tend to be what’s coming out, tend to be a little more dramatic than what we’ve been saying. So I’m very concerned about that, but I think we, to me, it, it boils down to educating people that we have to think that it’s, it’s still really important to get the current vaccine, but yes, there’s probably going to.
Be somewhat of like an annual or some sort of regular inoculation to address, you know, whatever variants come out. That’s from the vaccine technical standpoint, from a personal standpoint, I’ve had many conversations with friends and colleagues about what is reentry going to look like and how comfortable are we going to be sitting in the same room as opposed to sitting on the same screen.
Because I watch movies these days and see how people are sharing food and all this. And I’m like, Oh, I wouldn’t do that. But just a year ago. Yeah. The last thing I want to watch is something that addresses the Corona virus. Let me tell you, I want to see anything about that, you know, because we’re living yet.
But I think that I think we’re going to be seeing masks for a long time. I think that we’re all, we all have fatigue, but I think if we can hang in there until we start approaching her of unity, that’s when things are going to change, you know, I’m not sure if we’re ever going to really be back to what we did.
I mean, I started doing elbow bumps, you know, at the beginning of March last year, people kind of looked at me and I said, it’s all about health. I think handshakes might be gone for, for awhile. I agree, Tim. Yeah. Yeah. You know, I think so, so we’re very concerned about genetic, you know evolution of this.
And, and I think fundamentally what people need to understand is that you’re dealing with, you’re dealing with a live thing here, you know, that evolves and, and its purpose in life is to survive and to continue to, to exist and to thrive and to spread. Right. And so, so the fight for this, I think is going to continue in part what I mentioned before about the development of a vaccine platform, right.
That can rapidly be evolved in order to try and reduce the time it takes to respond to variants that may emerge in this as part of the solution for this. I think in a broader context When I talked about paradigm shift in the vaccine space, you know, that also applies to the broader context of, of living.
I think we’re entering, you know, PO you know, what we’ve been referring to as post-normal times, right? It’s, I think it’s, this is this, this this event that we’re living through in the midst of will have generational impacts over the next several generations. Right. And, and it goes beyond just health and into economics and things of that nature.
I mean, those are all hydro higher order impacts that are flowing out of this, this type of global health event. And so I think people need to be prepared to, you know, deal with change. I mean, you know, the, the, the, I don’t think there is going to be a return to the way it was no silver bullet, but we’re, we’re working towards right improve.
There’s a new normal that, you know, that. You know that we’re going to have to embrace and figure out how to live and be happy. And, yeah, there’s so much going on. I mean, with Tim, what you’re doing and how that’s evolving and how that can impact so many people, you know, when I look at the researchers that I’m working with, it’s, you know, for a while, we were wondering if science was going to be cool and it’s cool.
Again, the, the mission of what we’re doing with this podcast is really that just let people know what other people are doing, cause it’s really cool stuff. And the more people can hear that. And the more people can can. That’s why I was so into pointing what those problems are. Cause there’s an inefficiencies in the system.
If we can, if we can just think bottom up and innovation first we can just solve so many things much quicker. But it, it takes a lot of people hearing that message to be able to ask the right questions. So yeah, there’s an approach to, there’s an approach to that we use, you know, when we’re developing technology and it’s, it’s, it’s out there and fairly prevalent called first principles.
Right. And, and which is really defining, you have to define the root of the problem that you’re trying to solve and not a symptom of the problem. And then when you develop your solution, you know, that’s what you’re focused on and you sort of ignore all of the other ways of doing it and getting sidetracked and that, you know, that sort of thing.
And oftentimes when you take that approach, right, which is, you know you, you come up with very different. Types of strategies that, that don’t fall into the sort of the typical way of doing things. And part of this, part of the challenge that we have found is trying to break. You know, break the grip, if you will, of the existing paradigm on the way things are done in order to sort of think creatively and strategically about how to solve these kinds of problems in a different way.
You know, Tim, that’s really interesting because when I came to UT in 2008 and I’d have graduate students come up to me saying, Hey, what do you think this idea? Because I knew I’d been in pharma and I’d say, what problem does it solve? Yeah, well, but this is unique and I can patent it. And I remember one time, I said, you see this chair next to me, I can patent that.
But if it’s not solving a problem that someone’s having that their chair, they’re not going to buy it. So that’s when I taught, I just, I don’t, I’m not required to teach, but I designed a course around, you know, how to put a. A market focused act component into your research plan. And now that’s evolved into this, you know, teaching a whole cadre of courses now, but the one that I’m teaching in the spring, it’s a practicum and really walking from everything from a product description and early market research to really focusing on that value proposition.
Because if you don’t understand who your customers and stakeholders are, and just because you can do something novel, doesn’t mean it’s solving a problem and you, it can take so long and so many pivots. And I tell, I always tell my, I tell my class two things. When we, when we begin the semester, I say, if you haven’t pivoted in this course, it means you haven’t done the work.
And second of all, call your parents and let them know you’re okay.
Good advice for sure. And again, I’m going to go back to, I think we have to educate people because you know, when you’ve been working on things for years and decades, it sounds really reasonable that to make a big change and move to a totally different way to administer a product, we have to bring people along with us.
And so whether that means educating them as we go, or kind of like, you know, you can’t expect for somebody to hear something on Monday. And feel good about it on Wednesday or even, you know, six months down the road, unless it takes many times for people to really catch on and understand the benefits. And that’s, that’s what you have to do.
It’s like doing a pit as humans. We have a naturally short attention spans. So if we have a problem, we’re going to deal with it. But if that problem becomes less of a problem and I can put it down, the, the, the order of the pecking order I will. And so it sounds like to me, with both Tim and Janet has said, is that when SARS came out the first time, 2004, there was a problem.
We addressed it. We threw firepower at it, and then it wasn’t that big of a deal anymore. So we just moved, moved along. Right. And it’s not until now where it’s like, Oh, we really need to pay attention. Is that, is that more or less what you guys, the difference is that the economics. The economics of solving the, the original SARS Corona virus, you know, didn’t warrant the S the sort of focus and attention, you know, that attracted, you know, enough interest to solve that particular problem.
Like the SARS cov two, you know, I mean and, and that was, that’s a direct result of the virulence. Right. And, you know, it’s the virulence you know, and the, you know, the morbidity and mortality rates that, you know, that really drove, you know, drove that decision. And that’s the, you know, that, that.
Aspect of human nature sort of reflects itself a lot. You know, most people there it’s called time span of discretion. It’s how far out into the future, you know, can you sort of think effectively, you know, is relatively short. You know, I mean you know, and you know, and it’s that the, you know, we set up in 2000 four or five BARDA was formed and, and you know, Bush put $2 billion into HHS to form Barta and Barta was essentially chartered to basically develop the health strategy, to protect the civilian population in the United States against bioterror naturally occurring and manmade, you know, bioterror threats.
And by 2008 or nine, we had, you know, something called the strategic national stockpile set up, right then they’re in, they’re in non-disclosed locations around the country, you know, and they stockpiled and they, they continue to develop countermeasures to put into those. And I think by the time we hit 2014 or 2015, most of that stuff was, you know, Expired data not refreshed.
Some of it had been used in an H one at the H one N one and, you know, never put back in, you know, that’s where the mental Emerson from, you know, curious when this first came up, I’m like, boy, I tell you what as much as we spent in our defenses for the U S we certainly have spotlighted a weak area when it comes to, if this was developed and w we know I’m not going to get into that theory or anything like that, but if it was how ill-prepared we would have been, yeah.
Well has been a wonderful discussion with you both. I’m so glad that you guys came on the show and shared insight with the audience and really have enjoyed having this conversation. Excellent. Yep. Thank you.
Thank you again, Janet and Timothy for taking the time to talk and educate us. Our conversation has made understanding vaccines, much more accessible, keep up the great work, and I’m excited to see what you and your organizations do in the future. If you’d like to learn more about Janet and Timothy, please visit the link in our show notes signs at the mall y’all is created in partnership between founding media and the Austin community college.
Bio-science incubator. To learn more about the ACC bioscience incubator, please visit the link in our show notes. If you like what you hear on this show, be sure to subscribe and share it with a friend or family member. .
