COVID-19: Navigating the Pandemic: COVID-19’s potential impact on the global pharmaceutical market?

 

COVID-19 has spread to more than 60 countries, causing tens of thousands of illnesses and thousands of deaths. Pharma companies, biotechs, governments, academic institutions, nonprofits and others are all racing to develop a treatment, a cure and a vaccine.

In this Sanguine Speaker Series (3) virtual fireside chat, we will discuss:

  • Response efforts to the current COVID-19 pandemic
  • How does the race for the cure affect the hundreds of other drugs in development
  • COVID-19’s potential impact on the global pharmaceutical market?
  • How COVID-19 is delaying research, and what are the long-term implications?

Moderator:

Kevin Davies, EVP/Executive Editor, The CRISPR Journal

Panelist:

Brian Neman, CEO & Co-Founder, Sanguine

Joe Panetta, President & CEO of Biocom

Ronald Dorenbos, Former Head Innovation Management & Scouting at Takeda

TRANSCRIPT

John:

We would like to welcome you to the Sanguine Speaker Series webinar COVID-19: Navigating the pandemic. Our moderator is Kevin Davies. Kevin is the Executive Vice President and Executive Editor of the CRISPR journal. Our panelists are Brian Neman, the CEO and co founder of Sanguine. Joe Panetta, President and CEO of Biocom, and Ronald Dorenbos, former head of innovation management and scouting at Takeda Pharmaceuticals. Now I’m going to turn it over to Kevin.

Kevin Davies:

Thank you very much, John. And Hi, everybody. Welcome to this latest Sanguine Speaker Series, virtual fireside chat. I think that’s how they’re calling it. A great pleasure for me to be with you. So we’ll go to our three guests and have them introduce themselves in just a minute. I’ll be the host for the next hour, Kevin Davis. I’m with the Mary Ann Liebert Publishing Company. We published not only the CRISPR journal, which is a peer reviewed journal devoted to genome editing, but also genetic engineering and biotechnology news. The publication that’s really been the bellwether publication of the biotech industry for 14 years now, and doing a bang up job in covering all aspects of the COVID-19 crisis.

Kevin Davies:

I’ll give some introductory remarks in a minute. But first of all, I think I’ll go around to each of our three special guests so that they can introduce themselves and tell you in particular, why they’re interested in this subject and why they’re pleased to be with me. So we’ll start with Ron, Ron Dorenbos from Takeda, or formerly from Takeda. Ron. Hi, welcome.

Ron Dorenbos:

Hi. Nice to be here. And thank you so much for the organizers to be part of this panel, much appreciate it. Yeah, like you said, until recently, I was part of Takeda, head of innovation management and scouting. And throughout the last two and a half, three years, I brought in a lot of different technologies platform. Everything from your formulation technologies, to delivery technologies, to digital, to things that could help clinical trials, management, diagnostics and such.

Ron Dorenbos:

So we’re really a wide portfolio of technologies. I have a background in microbiology and neuroscience, for an academic track for quite a long time. Worked at Harvard Medical School for six, seven years where I studied mostly Parkinson’s. But then about 10 years ago, I went into an industry and since then, I’ve worked with a variety of different companies, many of the Big Pharma, but also lots of small companies, academic partners. Really helping them with business development, commercialization, change management, and a whole variety of other things.

Ron Dorenbos:

And I’m often invited also to talk about things like artificial intelligence, digital machine learning, and how those new technologies are going to impact the pharmaceutical industry. It’s very interesting, to be honest, panel because obviously we live in very interesting tumultuous times and nobody really knows where it goes. But obviously, you see already some of the shifts in the market, focus of pharmaceutical industry is changing from secondary market to primary markets, supply chains are being affected, potentially many other things that are going to happen, and it’s great to talk about some of those effects here in this panel.

Kevin Davies:

Great. And thanks, Ron. And where are you calling in from?

Ron Dorenbos:

I’m calling in from Boston. So Boston is my hometown for the last 15, 16 years or so. And yeah, really loving it. But obviously, you see me from my living room. And yeah, it’s a strange experience to be home basically, since March 9th, I think it was that we took our six year old out of school and kept him home. So a little bit challenging also with holding all the balls in the air. But so far, so good. And luckily we have been able to keep the virus out of the door.

Kevin Davies:

That’s good. Well, if your six year old would like to join us, that’s totally fine. We’re [crosstalk 00:04:09].

Ron Dorenbos:

He might join in later.

Kevin Davies:

We’re going to swing over to the west coast. And let me introduce and welcome Joe Panetta, the President and CEO of Biocom, who I’m sure is a familiar figure to many of the people on the call. Hi, Joe.

Joe Panetta:

Hi, Kevin. I’m probably not so familiar talking from my home office here where I’ve been hold up since a little bit longer than Ron. We actually sent everyone home to work at Biocom on March 12. And so I’ve almost lost track of the time, but I think I’m about into the middle of our seventh week. But I think it would be fair to say that we’ve been busier than ever at Biocom. And I know some of the folks on the webinar are not familiar with our organization. But we are the life science industry organization for the state of California, privately funded by 1300 members throughout the state.

Joe Panetta:

We have offices here in my town, San Diego, where we were founded, and also in Los Angeles and in South San Francisco, as well as in Sacramento. So this has been an interesting time for us for many reasons. Probably the most significant being that our greatest focus is in working in policy. My background is actually in policy I did by training and public health and environmental science. And so, this pandemic has been Of particular interest to me in terms of actually having a little bit of the background to understand some of the truths behind how we look at epidemics and epidemiology, and trying to help folks to better understand what we’re really facing.

Joe Panetta:

At Biocom, I think our greatest challenge for our members has been that many of our companies are engaged in very essential services. And in they’re located in different parts of the state in different cities, in different counties. And you can just imagine the patchwork quilt of ordinances that our members are having to deal with between the federal government, the state government, county governments and city governments throughout all of our locations.

Kevin Davies:

Well, your expertise is going to be invaluable as we talk about this over the next 50 minutes or so. And last but not least, our host and sponsor and chief organizer, I guess, for today’s chat is Brian Neman, the CEO and co founder of Sanguine. Hi, Brian?

Brian Nieman:

Hi. Thank you everyone for coming today.

Kevin Davies:

I was going to say Sanguine was a new concept to me and being invited to join you. So for the few people who may not be familiar with the company, please tell us what you do and also why you’re building these communities to talk about these topics.

Brian Neman:

Absolutely. So the best way to describe Sanguine in simplest form is that, by making as easy and as convenient, transparent as possible for patients throughout the research process, therefore increases the amount and depth of data collection, as well as the speed of data aggregation for the purposes of translational research, clinical and outcomes research. Started the company 10 years ago, and start started from scratch in Los Angeles. And the initial idea was that by working with patients directly through the comfort of their own homes by doing home visits, and by engaging them online via Facebook, collecting their medical records for them on their behalf, that we would be able to match them up with different research opportunities, and we would be able to do so expeditiously.

Brian Neman:

And so, today we’re working with 20 of the 40 top pharmaceutical companies. We specialize in autoimmune conditions lupus, rheumatoid arthritis, as well as rare conditions. We’re in pediatrics of Duchenne muscular dystrophy, sickle cell and what have you. We do hundreds of home visits per month where we make it easier for patients to participate, anything from a simple blood draw all the way to essentially in-home centrifugation and topical treatment of medication.

Brian Neman:

So in today’s world, that sounds exciting and innovative, or I hope it does, in the world before COVID BC, and AC after COVID. I think a lot of companies are coming to us because they know that patients are not willing to go just for a simple blood draw all the way to a health system. It just doesn’t make sense. And so we’re getting two requests at this time to help accelerate the research process. One is samples from convalescent COVID subjects, as well as the ability to perform services to increase the continuity of ongoing clinical trials to make sure that they’re not delayed.

Brian Neman:

So happy to provide a perspective on how existing researchers or clinical operations folks or translational researchers can keep the pace and make sure that [inaudible 00:09:36] data during this time.

Kevin Davies:

Fantastic. Thank you very much. So we’re going to talk about navigating the pandemic. That’s the overarching theme. I probably don’t need to tell anybody on this call about what we’ve lived through over the last two or three months. The numbers are still really bad. That they are the pandemic has spread Probably to about 200 countries, more than 200,000 deaths worldwide, and 3 million cases in the United States alone, a million cases or more, and over 60,000 fatalities now.

Kevin Davies:

The latest estimates you’ve heard just in the course of this week, suggests that we may be looking at 75,000. But these models seem to be varying dramatically from day to day. So I wouldn’t put too much stock into that. We’re going to talk about the current progress of vaccine and drug research, in terms of trying to find effective treatments and vaccines and protection against COVID-19.

Kevin Davies:

Before I lost my first set of questions, just I want to give a quick plug to the phenomenal reporting that my colleagues at Genetic Engineering and Biotechnology News have been doing in particular, my colleague, Alex Filipinas, who has produced, I would argue, the definitive Guide to COVID-19 drugs and vaccines. You can find it on the website, genengnews.com. The last report that he published, which was some 27,000 words, it was like a PhD thesis, it was so complete and definitive. Had more than 160 drugs and vaccine candidates. And the new version that he’s working on, that number has now, I believe, climbed to above 200.

Kevin Davies:

So it’s fascinating and gratifying to see so much international interest and work and, of course, you just turn on the television and open your phone and you are seeing new news and you alerts to progress in these early clinical trials, including new results or preliminary results just been published this morning from Gilead on a Remdesivir. And I’m sure we’ll be hearing more about that in the course of the next few hours and days. So we want to talk about the progress in terms of finding drugs and vaccines for COVID-19. And I will start actually in perhaps a broader lens and ask and get your view or take on how this is going to impact the rest of the drug discovery and drug development industry, before we then perhaps drill down and focus a little bit more in a few minutes on COVID-19.

Kevin Davies:

And we can maneuver this conversation in any direction that the audience would like to go. So I’ll start with Ron, and then we’ll go around the round the dial and do this for a few minutes. So let’s start with our first question, just a big picture question. How would you assess the overall response efforts to the current COVID-19 pandemic? And Ron, I will start with you.

Ron Dorenbos:

Well, I think a lot of companies, including companies like J&J, Pfizer, Eli Lilly, Gilead, of course, as you already mentioned, and many others are, of course, now jumping on the bandwagon. Many companies already working on antiviral compounds, for example, before the crisis. The effect of this of course, is that you see a lot of resources being taken away from other programs. And that’s really a shift. And it also of course has to do with the demand. You see the demand in the market that really is increased demand for antiviral products and products that were earlier in high demand, for example, the chronic diseases and such, you see that there the demand is decreasing because people are not willing to go to the doctor or not go into the hospital for these conditions also, because of being afraid for COVID-19 and trying to avoid being exposed to that.

Ron Dorenbos:

So the whole kind of demand supply picture is starting to change. And yeah, that has a huge effect on the whole landscape. I think also, we should keep in mind that although many companies are working on new products, we saw the first results leaked out about Remdesivir for example. Did you see that it’s not as easy as some people might maybe think. And I think all of us on the phone know that and probably all the people that are in the audience that are working in the life sciences industry are also aware that it’s not something that you just do in one or two years.

Ron Dorenbos:

If you think of the clinical trials involved and everything, then this will be a long process. So I think also further down the road, this whole COVID-19 crisis will have a major effect, which will be felt for the next decade or so, because it will be a changing landscape. I was already earlier also referring to the supply chain and pharma companies changing the focus from the secondary markets more on the primary markets, also to make sure that they can provide the products to those primary customers.

Kevin Davies:

Thanks, Joe. Same question to you.

Joe Panetta:

Thanks, Kevin. Well, I am going to try to supplement what Ron just said. Of course, we’re seeing some of the same impacts on our members. I saw this morning that Merck is estimating about a $1.7 billion loss in revenue this year due to the fact that, as Ron said, people are not going to the doctor. We’re not seeing other types of drugs being prescribed beyond the focus on COVID-19. So significant impact across the board there.

Joe Panetta:

I spent a lot of time on the phone over the last few weeks with our CEOs and many of our site heads. Actually it’s very nice to be able to get people on the phone and spend time talking with them, because they don’t have to catch an airplane or run into a meeting. So it’s been a great opportunity to get some time on the phone. And in some perspective, I think one of the greatest impacts that to supplement what Ron was saying is that, this COVID-19 pandemic has virtually brought the clinical trials process to a halt. Many companies continue to do their basic research or their manufacturing are unable to do the people to people contact in clinical trials. And so on a lot of these clinical trials, you can’t just stop them and pick back up again. They’re going to have to begin all over again.

Joe Panetta:

Think of the number of drugs that are in development across the spectrum of biopharma companies. That’s going to be a tremendous slow down in terms of the progress that we make toward introducing other types of drugs onto the market beyond the incredible work that’s being done on COVID-19. Our memberships throughout California is focused on every aspect of development of testing various types of diagnostics, vaccines, therapeutics as well. You mentioned Gilead, the great progress that Gilead has made.

Joe Panetta:

Sorrento Therapeutics down here in San Diego is in the process of developing a therapeutic. And Inovio here in San Diego is in the process of developing a vaccine, and Hologic here in San Diego, has developed diagnostic testing as well. And we see that through throughout California, that that’s really the focus right now.

Kevin Davies:

Thanks, Joe. We will, I’m sure, dig into some of those very interesting points over the course of the next few minutes. Brian, your initial thoughts on the state of the industry as we deal with this?

Brian Neman:

I, in addition to what Ron and Joe said, which I think is a fantastic overview. The only perspective that I can provide here is, from what I see, how we searches being done. And I think that, from what we’ve seen, basically all non COVID research has been put on hold. And the only research that is being done is focusing around COVID. I think that this new… So there were technologies that existed before, so I’ll just say, BC, before COVID. But the those technologies owing that uptake, we didn’t see that curve growing until now, for example, one is Zoom, which is quite obvious.

Brian Neman:

We were on a couple other calls and webinars and what I’m hearing now is that, no longer are people going to be using non electronic informed consent, or just all the digital tools that were in vogue or in some way exciting or innovative, have now come from the perspective of this is a risk. In order to mitigate risk, we need this. So the home visit… This is speaking for ourselves, we’re seeing home visits are now much more in vogue because of the interaction I described just a few minutes ago.

Brian Neman:

But above and beyond that, I think it also increases the likelihood of per patient participation. So I think that there are two things. One is the phenomenon of, this is our only solution at this time, so like a backup. But then also looking at home visits or any other digital tool, patient recruitment or patient engagement or patient reported outcomes. Looking at those as a primary and not necessarily a secondary or a backup, because of how successful they’ve been.

Brian Neman:

We’re hearing plenty of companies, technology companies that have been successful during this time AiCare, few electronic informed consent companies. So the best way I can say it is that those organizations that have been the laggards or have been slower… Not slow, but slower to adopt the technologies to accelerate their research are now I think going to make it a part of their standard process moving forward. That’s what I think.

Kevin Davies:

Thanks, Brian. I’d love to go round and get people’s thoughts. So let’s keep that in mind. What segments of the industry or what in persons or even individual companies could potentially stand to benefit and help their partners in this terrible situation that we’re in. But that first round was pretty dire in the prognosis, clinical trials. Research on new drugs is really falling away because of the understandable need to focus on COVID-19. So Ron, let’s go back to you. How do you see the search for treatment for COVID-19? Can we quantify what that what impact that’s going to have on the hundreds if not thousands of other drugs that are currently in development?

Ron Dorenbos:

That’s very, very hard to say. Because obviously, like Joe and Brian were also indicating, there’s a lot going on. But at the same time a lot of the programs that were running before COVID are basically completely halted. It’s very dependent on… Something come out of all these efforts that are now ongoing, to find something that could potentially be a cure. If any of the companies will find something that can help with that, then obviously, it will free up much more space to do those other things again.

Ron Dorenbos:

If that doesn’t happen, and I think the chance that it doesn’t happen soon is quite likely. If you look at the efforts to, for example, develop something for HIV or develop something for influenza, then you see that it takes a huge effort to come up with something. And even after many, many years of research, these are still very hard nuts to crack. So hopefully with all the efforts that are ongoing now, because the efforts that are ongoing are really tremendous. And among the funding that has been put into it are also tremendous. So if these two factors, we might be able to come up with something in the next, say, one and a half year or so.

Ron Dorenbos:

Then take all the clinical trials that are needed to also make sure that this can be given as a safe treatment to people [inaudible 00:22:31] probably and earliest. I would say thinking about three years from now or so that sounds maybe dire, but I think that’s that’s the reality and I think even an optimistic reality. So the question how it will impact all those other things? I think that’s dependent on how the whole effort for COVID-19 will pan out, and also how long we will be buried in our houses and on the restrictions.

Ron Dorenbos:

The current situation, if this lasts very long, then yeah, I would say 90% of everything that was going on will be impacted in a major way. If you can restrict it to say, two years or so. And we come up with something, where hopefully the pharmaceutical industry will quickly be able to pick up many of the things that were for a moment on the shelf and try to swing forward again. Yeah, I will stop there.

Kevin Davies:

Let’s see what the others think of that, Joe?

Joe Panetta:

Again, I’m going to build on what Ron just said. I don’t want to in any way in what I’m saying here to underplay the importance of developing the diagnostics and the treatments for getting the vaccine for COVID-19. But in some of my conversations with folks in the industry, I’ve heard that this presents a very challenging dilemma. If we think about the history over the last few years of drug development, the areas that have not been very lucrative have been vaccines and treatments for infection.

Joe Panetta:

In fact, back when we had SARS, there were companies working in this arena and we had the federal government here in the US talking about building a stockpile of anti infective that never panned out, the promises for reimbursement of those products never panned out. So here we have this incredibly large effort across the board. Large pharma companies like Pfizer and Merck, biotech companies like Gilead, smaller companies, all focused on developing therapeutics, vaccines and testing for something that we of course want to wipe out.

Joe Panetta:

And so I think one of the big challenges going forward for these companies is that, now they’ve stopped their drug development in other areas. We’re seeing that there are fewer visits to the doctor, fewer drugs being prescribed in other areas. The entire focus is on COVID-19. And I think one of the big questions is going to be, in addition to the most important payback, which is that we need to wipe out this pandemic and get people in the economy back up and running again. What’s the payback going to be for all this effort that’s going to sustain our biotech and pharmaceutical industries moving forward?

Kevin Davies:

Thanks, Joe. Bryan, same point for you. You touched on it since as the lack of patient recruitment for clinical trials. This sounds pretty like there’s going to be some serious ramifications for the pharma and clinical trial industry.

Brian Neman:

Yes. But as I’m thinking about it, I think that all you have to look at… Well, depends on the constituents. But if you’re looking at shareholders and companies, lets say, companies and employees, I mean, you have to look at the companies that are in early biotech, just went public, not yet profitable. One group and then you have the ones that are flush with cash in another group. I, for one, believe that large pharmaceutical companies… Joe just mentioned that Mercer announced a billion and a half dollar loss this year or at least an abatement, I’m not exactly sure, in revenue.

Brian Nieman:

My perspective is that, for companies like this that are brand name, I don’t know if that much money in order to make that much of an impact. I think if some people are worried about those large companies doing layoffs, I think that we’re going to experience a similar wave of acquisitions as we did in 2009, 2010. I think what’s going to happen is that if these organizations need more cash, and I’m talking about Pfizer, Abby’s, NFV, and all those top organization, if they need more cash, I think that they can issue debt very cheaply.

Brian Neman:

I mean, who wouldn’t want to lend Pfizer money for 2% right now, anybody would want to do one and a half percent even. And so those organizations will do that, if necessary. And then they will acquire other companies. We’ve seen in the past and speaking with business development, folks, and Joe and Biocom sponsor this fantastic annual event. So their life science partnering event, which is just a few weeks after JP Morgan. The sentiment that I’ve heard over the past few years that prices are really expensive for the stocks.

Brian Neman:

And of course, there are companies that have taken hits and some companies that have remained stable. But I do think that there will be acquisitions coming up in the next six months, especially with those publicly traded companies, takeovers is my sense. Like we saw Pfizer [inaudible 00:28:23] years ago. I think we’ll see it again.

Kevin Davies:

Okay.

Ron Dorenbos:

Yeah, I agree with Brian. It was very much also, after the last crisis.

Kevin Davies:

Excellent. We will watch for that. So we’re starting to get questions from the audience. Thank you keep them coming. The first is about AI. But perhaps we can just slightly broaden the question. The question is, how can AI assist in the development of a treatment or vaccine? But perhaps I could broaden that. Ron, I’ll start with you. Maybe you think AI is the holy grail or the key technology, but maybe you see hope in some other area of drug or vaccine development. So whether it’s AI or something else, what do you think is going to be the key towards getting us to successful treatment or vaccine or both?

Ron Dorenbos:

Well, I think there’s definitely a lot of effort, of course, in that sector. You have companies like Accenture, Silicon, medicine, Cloud pharmaceuticals that are working in this business. And there’s, I would say, about a dozen of companies that are really leading the field. And if you take a look at the results closely of these companies, what they have really put on the table. A lot of research and a lot of progress, but at the same time there’s not really a key candidate or anything like that.

Ron Dorenbos:

So I’m not entirely sure how much we should put our eggs in that basket. But at the same time, I think it’s an incredible technology. They make some incredible strides. So I think it should not be long before We really see some of the benefits. And you see already another company called Plex, for example, also involved in helping medicinal chemists to do their work much more efficiently. Instead of really making the drug, they provide tools where you can really help medicinal chemists to very quickly come to the right conclusions and be on the right track, so to say, which I think there is a big benefit of AI.

Ron Dorenbos:

And that can be of course, the same for COVID-19, really looking at very difficult to drug targets. And AI can really be the tool there to make that process a little faster and easier. But I do not think it’s the ultimate answer for everything. So we should be cautious there. But it’s definitely a very powerful technology. And actually, most companies understand it and are now embracing that. And what earlier, I think, Joe was saying also that, and Brian as well, conservatism within companies for embracing these new technologies is now also disappearing.

Ron Dorenbos:

And people that were reluctant before COVID are now also on board and also want to bring in these technologies are sometimes a little too late because of course, these technologies can also help with enrollment for clinical trials, personalization, diagnostics, predicting what the spread of COVID-19 will be like, how patients are going to respond. So there’s a lot more to these technologies than only drug development. And I think they can be really applied in certain ways and parts of the pharmaceutical industry that make work much more efficient and much better. So yeah, I’m a proponent on one hand, but I think also we should be a little bit cautious about where we’re going to put our money.

Kevin Davies:

Joe, is that where you are as well?

Joe Panetta:

Yeah. Ron alluded to the development of better tools. I think we have to look at this from two sides. We’re studying the virus, but as one who has been trained more in epidemiology, I think the tools of AI can be very effectively put to work in better understanding the population incidence, prevalence, susceptibility as the virus. We know viral infections are subject to mutation by the virus. So over time, there are companies that I’ve talked to that are… I guess the best way to get I would describe them is the 23andMe of infection that are out there, studying population genetics, even taking a look at susceptibility. For example, I know that I’ve never gotten a flu shot until just coincidentally this year. Not that when I got it I do anything about what was going to be happening in the month following when I got the flu shot.

Joe Panetta:

But why do I not catch the flu even though I travel 125,000 miles a year? It’s not because I’ve done a great job of washing my hands and not touching my face. I can guarantee you that. So I think AI is going to help us to better understand population genetics when it comes to infectious diseases in the future.

Kevin Davies:

Thanks. Brian, what are your thoughts on AI?

Brian Neman:

I think AI has different forms. So I don’t think I’m as familiar as the leading experts. But AI has different forms and how it can help accelerate what we’re doing. There are plenty of companies like Deep 6 analytics here in LA, which is helping with a clinical trial data and helping with enrollment, so it can help with that. There are companies that are looking at Existing molecular entities and seeing if they can expand the labels of those molecular entities for COVID. As I believe the company’s name is Silica, it’s a start-up Health company, which we’re partnered with. So we’re seeing AI taking different shapes and forms to help combat, I think one is clinical trial approvement. Two is positioning of molecular entities.

Kevin Davies:

Okay, that’s great. We’ve got a lot of questions coming in. So don’t worry, let’s move on. And they’re coming in no particular order. So we may jump around in terms of subjects, but that will just keep the panel on their toes. So next question is if the need is immediate for a vaccine or treatment, no one would dispute that, are we jeopardizing patient safety in rushing towards a vaccine or treatment? Ron, do you have any concerns in that regard?

Ron Dorenbos:

Very nice to always be the first to answer these questions. [inaudible 00:34:57]. I think that the AI, of course, and other regulatory agencies around the world are still doing incredible job, especially with everything going on now. Also, obviously, they’re working from home as well. A lot of their people are on their toes because there’s such an enormous demand for clinical trials in this space for approving certain new therapeutics. And so will there be a danger? I think maybe a little bit, but I think… You see that FDA is relaxing some of their regulations to move things ahead faster.

Ron Dorenbos:

I still think they do an incredible job making sure that what they move ahead is indeed verified to a certain extent so that the big accidents are not going to happen. So obviously the gates keepers are there, and that they’ll still keep a good eye on developments. But obviously everybody knows the need. And so everybody does what they can to move things forward as fast as they can.

Kevin Davies:

Yeah. Brian or Joe, do either of you want to comment on that?

Joe Panetta:

Well, the only thing that I would add is, first of all, of course, FDA is not going to jeopardize patient safety. But there are ways to shorten the clinical trials process, the testing process. One of the biggest challenges in developing any drug is enrollment in a clinical trial, the time it takes to get patients enrolled. We with the increase in our ability to do testing and identify patients who could enter into vaccine trials. I think that’s going to shorten… It is shortening things quite a bit.

Kevin Davies:

Okay, great. Let’s move on to the next question. And I will start with Brian. I’m interested in particular to you. Do you think that more studies will rely more on telehealth, and do you think patient recruitment will be harder in the AC, after COVID?

Brian Neman:

I think that unequivocally yes. Telemedicine will be used. I think what’s going to drive that though is too far… So, we’ve been forcing telemedicine on… Well, companies have been evangelizing telemedicine for clinical trials. And then on the other end, telemedicine has been evangelized for just regular clinical care. Now, there are certain health systems that are now seeing that due to reimbursement rates at the general practitioner level. I think that the uptake of it… Ultimately, hospitals and health systems make most of their income or generate less income from specialty care and specialized visits, rheumatology, neurology and so on.

Brian Neman:

So the more incoming leads or patients that they can generate, and the more patients that a GP can see on a daily basis or minute basis, is going to be beneficial to them. So I think telemedicine is going to be used as an efficiency tool and then also as a continuity tool. And as more health systems start implementing it on their own, the providence and essential health of the world, we’re going to see that that is also going to implicate more uptake on the clinical trial, clinical research level.

Brian Neman:

I do think that clinical research and recruitment, I’m not sure how it’s going to be affected. But I do think that the more telemedicine we use, that’s going to increase the addressable market, so to speak, or addressable pool of patients for example. If providence or whatever clinic or health system is using telemedicine to enroll or engage patients directly, then the likelihood of a patient participating from, let’s say, a different part of the state or a less populous part of the US is going to be higher.

Brian Neman:

So you’re going to be able to get those nooks and crannies or individuals that live in those less populous areas that normally would not travel 200, 300, 400 miles for the [inaudible 00:39:27].

Ron Dorenbos:

Yeah, absolutely. I fully agree with what Brian says. I think the geographic reach, of course, will increase incredibly. And at the same time, the workload for healthcare providers that was already always very, very high, will decrease to a certain extent because of doing telemedicine obviously is more efficient. And if can be done for certain diseases then obviously they will use those tools. And you see really a huge uptake now of telemedicine, and companies in that field also really trying to conquer the market. And COVID-19, obviously is helping to drive that whole process.

Kevin Davies:

Thanks, Ron. Joe, anything to add to that?

Joe Panetta:

Yeah. I mean, if you think about it, the variety of different types of technologies and devices that are being developed today that can increase the use of telemedicine as everyone said, it’s going to create an ability to monitor patients so much more efficiently. When you think about the time that it takes for doctors to see patients in the office whether they’re going into the hospital or into the office, the monitoring devices, for example, glucose monitoring, the personal devices for ECG measurement and others that have been around for blood pressure, and other and other measurements. Our ability to do clinical trials and to monitor patients through telemedicine I think is going to really create a much more efficient world in the future.

Kevin Davies:

Okay, great. Next question again from the audience. Thank you, Megan for this question. Do you think that with the halt in or the reduction in clinical trials and research in general, there’ll be an increase in drug pricing and a decrease in availability of other necessary medications. Brian, I’m going to start with you, because Ron’s getting fed up batting lead off. Brian?

Brian Neman:

[crosstalk 00:41:43] research in general.

Kevin Davies:

Would there be an increase in pricing and potentially a decrease in the availability of other drugs, other necessary medications?

Brian Neman:

I’m not sure. Well, I’ll tell you intuitively how I think about it. Drug pricing I think is a function of the quality of life, just using health economics outcomes. So if you’re discussing drug… Let’s say you’re at a pharmaceutical company, you have a drug candidate or an already approved drug, you’re looking to expand the label. You’re going to want to use data that is effective to essentially negotiate your price with your payers and with your HMOs. So payers, providers, health systems, and also CNS.

Brian Neman:

I don’t know if there’s a connection necessarily regarding the clinical trial costs or clinical trial research pausing and the drug pricing. I think it’s still just a quality question of quality of life and the outcomes, at least in the NHS and other countries that have the National Institutes for clinical excellence or have those entities that measure outcomes [inaudible 00:43:05] price. I don’t think those groups will move to the US, I’m not sure. But I would say that the same rationale applies. Decrease in availability of other necessarily medication.

Brian Neman:

I’m not sure. One of my early jobs was working at Baxter and they were creating, just for the IVs, all of those bags for the IVs. And I think those businesses are like machines. I think that they may be decreasing the supply that’s manufactured. But I think that all of the infrastructure is already there. I think that’s going to be… My instance is telling that that’s going to be the closest thing to switch on a light as we’re seeing out there, because they already have the infrastructure in place. I think if they have for load employees and bringing them back, maybe a retraining, but I don’t think so.

Kevin Davies:

Joe, you take that question.

Joe Panetta:

Thanks a lot. It’s the guy who constantly answers to members of Congress and our governor about drug pricing. I guess the first thing I’ll say is that it’s not a good time to be talking about increasing drug prices, that’s for sure. And of course, drug pricing is a very complex, integrated formula that before it finds its way down to patients, goes through a number of different, different steps. So, I mean, I think the most important thing is, we’re going to be in a situation for awhile here where people are going to be challenged economically. The need to continue to provide affordable medical insurance to the population is going to continue to be important.

Joe Panetta:

I think the most important part of this whole equation is going to be that whatever happens with supply and demand… And I think Brian was right. And hopefully the impact on these pharmaceutical companies isn’t going to be that great in the reduction in revenue. But what it all comes down to, is people have to be able to afford their drugs. So reimbursement has to be at an adequate level so that we don’t see pricing overall going up.

Kevin Davies:

Thank you. Ron, anything to add?

Ron Dorenbos:

Yeah, so a little different than Brian and Joe, and I agree with them. But at the same time you see some problems with the supply chain right now that are not really apparent yet, because most companies, especially the big ones have stockpiles off active pharmaceutical ingredients, medications, especially the brand names, they are available. And the brand names usually also have good supply chains that are obviously because they are the arteries of the pharmaceutical organization. So they need to be very robust. However, when you look at the generic supply chains, then it’s a different story.

Ron Dorenbos:

A lot of these are very lean and if anything happens, then you immediately see the effects. And I believe there is already some of the medications that are feeling this effect. On top of that, you also have now restrictions on the import and export of medication, especially export. India has decided to help the export of I believe 26 APIs, Active Pharmaceutical Ingredients, and that of course has felt through the world. I think these 26 are responsible for about 20% of the drugs in the world. And for the moment we don’t see those effects.

Ron Dorenbos:

But I think five, six months from now, or maybe a year from now, depending on the stockpiles that have being present in the industries, we will start to feel that. And it might drive up the price. And you see already that something very simple as paracetamol in India has gone up in price at 14, 50, 60%, I believe. Also keep in mind that most of the medications… Not most, but I think the number… I don’t know exact number, but about 15% of all the drugs being produced are being produced in China.

Ron Dorenbos:

Another 25 to 30%, I believe of the medications are produced in India, either the medications themselves or their APIs. And so, we have the restriction. And if some of those manufacturing ponds being closed for sometime, that’s something we need to see how that will play out. But that might have an effect on the prices.

Kevin Davies:

Okay. We’ve still got time for maybe one or two questions from the audience and we just got one more in. And I would like to squeeze in one of my own about vaccine production. But this question, Brian, we’ll start with you. Can you talk a little bit more about using in-home collection? What are the benefits of in-home collection versus a draw site?

Brian Neman:

I think first and foremost, it’s safety. So likelihood of contracting something by walking into a hospital, or health system, or clinic is much higher. So home visits, I think one is safety. I think two is convenience for the subjects. Three I think is speed, because the likelihood of cancellation is probably high. We all cancel on our doctors and our are dentists. So I think the speed is also important. I think that communities for patient… And then also the convenience for the patient I think has a different aspect, which is increasing the pool of available subjects.

Brian Neman:

So what we’ve seen is that when the option for home visits is made available to a potential research participants, the likelihood of participation or enrolling increases because they know that it will be less burdensome. So if you think of clinical trials as a product that you’re offering to a group of folks, diagnose certain condition, you’re offering a product or solution. If that product is pay for this treatment, you’re going to have to come in 50 times over the next six months, versus, “Hey, for this product you’ll have to come in only 15 or 20 times, and then the rest from home,” it changes the product or the image of the solution they’re being provided. So I think that the consumers, the research participants will increase in that. So I think enrollment.

Kevin Davies:

Okay. Let me step in this question about vaccine production. And Joe, I’m going to start with you. We’re seeing a lot of news. It’s encouraging news about early vaccine candidates from Oxford University and J&J and Pfizer and there’s several clinical trials that are just getting underway. If as we hope one or more of these is successful in the next six to 12 months, do you have any concerns about the ability to then manufacture the vaccine on the scale that might be necessary? And then I think the other part of that question is, how important is it that the vaccine is manufactured here in the US or does that not matter at all?

Joe Panetta:

Great questions. Well, I think that the answer is going to be multiple vaccine technologies. This isn’t going to be like Jonas Salk developed the polio vaccine until the Sabin vaccine came along. That was it. So I think the answer is going to be that they’re going to be multiple technologies. And I think the benefit we’re going to receive of those multiple technologies is that manufacturing can be done on a broader scale with all these technologies. I don’t know that it’s important that it’d be manufactured in the US.

Joe Panetta:

I certainly don’t want to see it manufactured in China. I don’t think I want to see much more manufactured in China. But just going back to your previous question too, we had a lot of incentives here in the US, in Puerto Rico, for example, for production of drugs that went away. And I think we need to bring those incentives back.

Kevin Davies:

Okay. Ron, do you want to say anything about vaccine production and where you see that going?

Ron Dorenbos:

Well, not too much because I’m definitely not an expert, but I think if we get a vaccine, something that work… Actually very much like Joe says, it’s probably going to be multiple technologies. I think that the Bill and Melinda Gates foundation is sponsoring also now platform technologies to very quickly be able to also generate new vaccines, so not only for COVID-19. But if you would have another endemic maybe a couple of years down the road, that’d be not be in this situation. But we would have a platform that could much faster generate new vaccines.

Ron Dorenbos:

So that’s probably where we are going. And companies [inaudible 00:52:24] now, for example, working on that. And yeah, I think that may take a little bit longer to get it up and running. But once we get it up and running… Yeah, sorry. Go ahead.

Kevin Davies:

Well, I was going to say, I’m just going to segue into another question. I’m going to start with you though, from Tara, who asked. I don’t know if anybody was exactly saying this, but this is the way the question is framed. It seems so irresponsible to just stop important clinical trials in other therapeutic modalities. Is there any organization or somebody in DC advocating for this not to happen? Is that a fact question, first of all?

Ron Dorenbos:

It’s a fair question. And I think, also obviously the pharmaceutical industry is also not… They have put things on hold, but are not forgetting all these programs because then it’s also their bread and butter. So they are not going to abandon these. It’s just for the time being. They need to focus because everybody sees that this COVID-19 crisis is really affecting the whole world. And if you don’t do something about it, then we will be in this situation for a very long time. The sooner we solve it, the better it is for everything. Also for all those other clinical trials that are ongoing. So no, it’s not fair that some of these other things are on hold. But yeah, that’s also human nature that you focused on those things that are most important.

Ron Dorenbos:

And I think, in the current situation it’s needed that there’s a very focused effort from the pharmaceutical industry to solve and tackle this problem. Back to the vaccines, also where should it be produced? I don’t think the US alone can produce vaccines for the whole world. So I think definitely we will be relying on other countries. Some things have happened maybe in China that gave it a bad name in India or in other countries. America in that respect is not without any blame. I mean, things have happened here as well. And I think we should not regard all the companies in China or in India as not good enough to do the work they do. Because there’s also a lot of companies that can do an incredible job and that have worked very hard to build a reputation and to deliver really, really very good work.

Ron Dorenbos:

So I think it will be a global effort. And many countries throughout the world, the US but also China, India and many other countries in Europe will be involved in this effort to provide ultimately everybody with the therapeutic [inaudible 00:55:00] that can help us to beat COVID-19.

Kevin Davies:

Okay. Thanks, Ron. Thanks. We’re almost out of time. And I apologize, I’m going to get to the last couple of questions that were just coming in. But I just want to quickly go around the group for one last time for any final thoughts, reflections, what should we be looking out for? What are the next six months, 12 months going to look like? And Joe, I’ll start with you.

Joe Panetta:

Thanks, Kevin. Well, and I just want to clarify one thing I said about China. It’s not that I don’t believe the quality is there. It’s more that when you look at our relationships with the Chinese government, I get concerned about anything that they might do to stop the supply chain that would be out of our control. But I think I would just sum it up with testing, testing, testing. I think that’s really going to be the focus, both viral screening on a large scale and antibody testing. And I’m hopeful that we begin to see, not only at home collection kits, but in the antibody testing arena that we actually begin to see more.

Joe Panetta:

And I saw a report today that there’s potentially a home antibody test, where the general population is able to determine if they’ve had the virus and are producing antibodies. And I think that’s going to be really important in addition to herd immunity over the next few months.

Kevin Davies:

Thanks, Ron.

Ron Dorenbos:

Yeah, I think same what Joe says, and testing, testing, testing. Absolutely very essential. Also essential that we developed tests that are sensitive and accurate, and I think that’s a very big question at the moment. A lot of tests have been brought to the market, but are they good enough to really give us the answers that we need to get a good idea of the spread of covert 19 in the population. You asked also what are we looking forward to? What do we see ahead? So I’m really looking forward to a cup of coffee with my colleagues and just go to the Starbucks or something like that.

Ron Dorenbos:

But I think together we can beat this and we will get ahead of this and we will get to a new world and may be a new normal, but it will be some normal again, I’m sure.

Kevin Davies:

Okay. And finally, Brian.

Brian Neman:

I think that there’s going to be a significant acceptance of new technologies that are going to accelerate research. I think clinical research professionals and clinical trials are going to be put under a much more pressure to finish things faster. And I think executives or CEOs are going to want to see… CEOs or executive financial managers are going to want to see a faster ROI in terms of getting maybe smaller trials that are faster. And I think the FDA may change it’s opinion on certain things. I think Joe was the expert on the regulatory and policy [inaudible 00:58:00], it is at first.

Kevin Davies:

Well, this has been a very fun and informative discussion. Thanks to Ron, Joe and Brian. And Brian, thanks to you and Sanguine for hosting the Fireside Less Chat, shall we say. Thanks everyone for watching. I’m going to throw it back to John for some closing remarks.

John:

Thank you to our panelists and thank you for joining Sanguine for our COVID-19: Navigating the pandemic webinar. Keep up to date on our other upcoming webinars@researcherdotsanguinebio.com. If you have a need for patient samples for your research, please visit sanguinebio.com thank you again and enjoy the rest of your day.