The Pressing Need For Needle-Free Immunization With Heather Callender-Potters
Immunization is an important subject to talk about, especially in the midst of a pandemic like COVID-19. While traditional immunization methods are popular as ever, more and more companies are seeking out methods for needle-free immunization that mitigate some of the risks presented by needle immunization. Bob Roark is joined by Heather Callender-Potters, the Co-Founder of PharmaJet, to discuss the pressing impetus for investing more resources into needle-free immunization. Let Bob and Heather take you through this vital topic with a spirited conversation.
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The Pressing Need For Needle-Free Immunization With Heather Callender-Potters
My guest is Heather Potters. She's the Vice Chairman, Global Business Development Officer, and Cofounder of PharmaJet. Welcome, Heather.
It's exciting for me. Thank you.
I'm so excited to have this time with you and get your story out there, which it's already out there, but at least through this channel. If you could talk about PharmaJet's vision and your vision is needle-free applications for immunization and the story of why you started there and why that's still your focus.
My mother and me cofounded the business. We wanted to make sure that we made a contribution to healthcare. She had experienced needles, she'd seen reused and there was a call to action by the World Health Organization because they were witnessing needle reuse about whether or not somebody could develop a needle-free immunization tool. We decided to rise to that occasion. When we looked at the market, immunization is global. We all share the healthcare burden. We're in the midst of something around Coronavirus where it's abundantly clear that if people are healthy, they're at work, the economy works. If a group of people is healthy, then the population generally is healthy. We focused on what we could do around taking needles out of the garbage dumps and the risk of reuse and needlestick and then that immunization market that's growing in perpetuity.
More people being born, more need for immunization. If you fast forward to where we are, the exciting thing is that over time we've been able to prove that you might be able to move from the muscle to the skin and functionally reduce the dose of the vaccine by 80% and get the same immune response. It’s nifty. It's around the immunology that our skin has. Our body's barriers are always protecting us from things. The other exciting thing is that we kept seeing this glimmer of making vaccines work better. In particular in nucleic acid vaccines, messenger RNA, and DNA vaccines, we tend to see a multiple of higher immune response versus needle-based delivery. There's a whole slew of things, whether or not it's infectious disease or oncology, things coming to market to address disease concerns that we don't have treatment for. Like on the infectious disease side, it could be Zika and now also COVID. On the oncology side, it could be someone who's manifested HPV, cervical cancer, lung cancer, or leukemia. Lots of things that give us joy around near-term immunization, medium-term, reduce the dose in the longer-term of bringing things to market that don't have vaccine cures.
[caption id="attachment_5238" align="aligncenter" width="600"] Needle-Free Immunization: A significant percentage of people avoid immunization because they don't like needles.[/caption]
Thinking about the mechanics, my memory goes back to when I was a little boy. I got my polio sugar cube with a little red dot on it. We have certainly progressed a long way since then. For you with the jet injection, what role do you think that's going to play going forward in the immunization market?
Polio is a standing example because we have that short-term memory or frankly, the older you are, the more you remember about the polio risk. There were people who are basically going swimming feeling fine and the next day, not able to walk, not able to breathe. Things like iron lungs in the ‘50s. That's a distant memory for most people. The oral drops on the sugar cube essentially were discontinued from use in places like the United States because they have a live virus. However, they're inexpensive. The use of oral drops has been continued in the rest of the world. Thanks to the leadership of the Bill & Melinda Gates Foundation, CDC, there's been a drive towards adopting those as the standard of care to bring the disease incidents down.
In fact, if you're exposed to polio and you're not immunized, you have 1 in 200 risks of getting polio and manifesting some form of paralysis that is irreversible. Given that the disease incidence has come down, it's now time to eradicate the disease. The injectable inactivated vaccine that we use as a standard of care here and in numerous countries has been mostly used in the developing world. Now it's time to adopt that safer vaccine that doesn't have the live riders in order to get rid of the virus from the planet truly. While we're close, by no means has polio been eradicated. The exciting thing for PharmaJet is that we've been part of this journey with the WHO leading the charge and the Bill & Melinda Gates Foundation and CDC around how to eradicate it, but afford eradication.
They were dropped to about $0.18. The injectable polio vaccine is about $3 in the cheapest of UNICEF pricing, twenty times more expensive. How do you bridge that gap? We are a tool where we've been able to prove that you can move from the muscle to the skin. Functionally 60% less vaccine injected into generally using our device is superior in the immune response to a full dose into the muscle. It took a long time to prove that and that's a credential that the World Health Organization, a scientific advisory group of experts opined on, which we enjoy now. If you add further, we get functionally 20% more out of the vials versus needles because we've engineered out all of the waste and then push and click up against the body. Any caregiver can deliver that shot and then there are no needle shots to take away, which is also an extra cost. Lastly, we inspire more people to be immunized. We traditionally find a significant percentage of people avoid immunization because they don't like needles and many of those people will participate. It's around that herd immunity, more people immunized moving to the safer vaccine to truly, fully then eradicate polio from the planet.
In the immunization side, there’s the mechanical feature. Many don't like shots. I don't know of anybody that said, “I love to get them.” Also, aren’t there some cultural barriers in some countries against needle-based immunization?
There are. It's an interesting topic because in the United States we want it to be safe, comfortable, and perfect. It’s whatever the services that we're getting whether or not it's healthcare or going off to McDonald's. In certain parts of the rest of the world, there are people who don't like to see blood, particularly in the Muslim world. Consequently, we have a leg up in terms of this noninvasive method of administration. We formed a fast, fluid injection so it goes into the body in less than a tenth of a second, faster than your nervous system can respond. That fluid is traveling quickly and it's the size of two human hairs.
If we wanted to call it magic, that would be easier. We basically get rid of that needle experience and the angst that goes along with that as well. We can't claim that it's pain-free or that you might not see a drop of blood or fluid because we do a small hole, but it's much less invasive, much more patient-friendly, and certainly caregiver friendly. While there are places that pride themselves on if it hurts, it worked, the chief is that most healthcare workers don't want to hurt their patients. There's a much more comfortable way to receive an immunization.
Circling back around to that, your mom, was she a dentist?
She became a dental hygienist and she worked with my father and ran his practices. My dad has three board certifications. He's also retired and older, but they did volunteer medicine and dentistry together in various countries. That's where she was struck by the fact that we all take for granted the healthcare that we have here. If you live in simple means, you make do with what you have. If you don't have much, you're probably going to reuse some of the things that you have. The whole concept of needlestick and risk of reuse was something that touched her.
[caption id="attachment_5239" align="aligncenter" width="600"] Needle-Free Immunization: With needle-free vaccines, we could effectively immunize people while still maintaining a significantly positive patient experience.[/caption]
I think about the evolution of that. I worked in a hospital early on when I was in college and there wasn't much protocol about disposing of needles. They went where they went. The HIV world showed up and the side of the needle of the house became much more prevalent, apparent, or aware. This issue that we have now with the Coronavirus, I'm wondering if that's not a tipping point. There's been an anti-vaxxer movement that's out around doing what they do. It’s a call to arms. I would seem to think that this will be an amazing call to arms for technology like yours.
I appreciate that and I want to make sure that people know that we'll never get rid of these because they can be important and useful. We happen to be basically the only alternative for vaccine delivery for a needle-free jet injection technology. One, it's around the credentials that we have. The FDA and CE mark. We’re the only WHO pre-qualified technology for a needle-free globally and that covers the WHO countries, which are something like 190 countries. Going back to needles and legislation, part of why we started as well is that there eventually were laws passed which require safety provisions for needles. There's about a 65% risk for the patient and caregiver that as you're finishing your injection and in between that moment and disposal, you may have a needlestick. That needlestick could contribute up to twenty bloodborne pathogens. Most commonly would be things like HIV and hepatitis.
Protecting the healthcare workers, protecting the patients from that exchange was key to why it was important to have safety measures. We're fully safe. We have no needle. We don't require necessarily specialized sharps disposal like needle-based delivery does. The laws that were passed in the United States eventually spread to the EU area and Brazil. Every country is a little bit different. When you go into a scenario, where there is no disposal, it's a field setting or getting rid of hazardous waste ends up in the garbage dump, it's incinerated and it goes into the air, we have a bit of an advantage there. We designed the syringe so that you can't reuse it. There are no sharps, there is no metal to incinerate and then our injector is long life.
As a system, it's efficient and beneficial and all of that economics help flow through to make sure that there are savings for every single injection, but for the user. In a Coronavirus scenario and we're not talking about the United States. There are seven billion people on the planet with a highly variant virus that's spreading. The objective is to have multiple vaccine solutions for this. If you can imagine, there are not even enough needles and glass packaging. There's not enough anything. PharmaJet conserves a hugely important role in attracting needle-phobic patients, make it simple to give care. We’re particularly useful in mass immunization settings with the ability to process lots of patients. We capture 20% more typically out of the vials because of the engineering. We have great efficiencies that capture what waste would normally be in that needle cannula thing. This is a scenario where we all get to participate in finding a solution and we have some special features that make us relevant.
[bctt tweet="This is our second year offering Needle-Free flu shots, and we have had several people coming back requesting it again." username=""]
As you were commenting, 65% chance for the administrator of risk. All the people on the planet and the mechanics and logistics of getting some percentage of those people immunized. You have the administrator and if you've got 100 of them, the incidents of risk to each of those. I don't know that it was as the risk to the caregiver as well understood as it is because you have a lot of the health caregivers that are at risk of the virus now.
Back to that statistic, in the US typically, a healthcare worker would need to report a needlestick, and a lot of times they don't. It would be 1 in 7 healthcare workers in a given year would have a needlestick.
It makes you wonder what the real number is.
Much of the rest of the world, they might not be, but in certain literature in Africa, it's been determined that up to 50% of the healthcare workers would be hepatitis positive. In places like South Africa, the burden of HIV is quite significant and 50% of the patients might be HIV positive. You start to see that this disease burden issue can be a real risk. If we can take out the issues associated with those hazards and then we can add to the efficiencies, we've seen teams of people working together, whether or not it's the US, Pakistan, or Cambodia. When they work in teams, our technology tends to be about 2 to 3 times faster than needle-based delivery, so it’s faster patient processing. If we imagine a scenario where you might have a drive-by, instead of testing, it's drive-by immunization. Roll your sleeve down, get your PharmaJet COVID shot. We've had that experience for influenza here. We don't know yet about the vaccine cures that may come about, but we would very much like to be part of all of that and playing a role in multiple places and geographies.
I think of the mechanical advantage. In the military, I can remember lining up for processing for overseas movement and they would have all these stations and you basically lined all the soldiers up and they would tell you, “Roll your sleeves up, shut up, and get your shot.” They could process you a little faster, but still, it was a mechanically long process to get all that done. I think about that a lot. For you, you're knee-deep in the vaccine landscape and you know the difference that exists in the standards of care. What do you see out there? What are your thoughts on that?
Universally, people go into healthcare because they want to help people and they want to make a difference. There are a few nurses I've observed that are a little bit like the grab and jab, efficiency, and get on with it. In general, people want a gentle experience or maybe the example you gave is military. Line up and shut up. I've observed more people standing in the needle-free line versus needle lines. In part, it's for that reason. They're also sometimes caregivers that positively choose that they want to provide needle-free injections versus needle-based delivery. While there might be multiple options, the venues are a place that probably wants to treat people with dignity, respect, but yet be efficient. The possibility thing for the United States, if you look at 2009 and H1N1, in most states, vaccines were not allowed to be given in the pharmacies.
Now all 50 states have approved for immunizations for pharmacies. That's going to become a natural venue in addition to public health or other significant locations. If you look at some of the impoverished countries that are under-resourced, it will be field settings. Mass immunization could occur, neighborhoods to neighborhoods, door to door. We've had that experience in Pakistan where 500,000 children were immunized in five days by 1,100 caregiving teams. We've proven this efficiency and it's probably safe to say that we're confident that we could go into any environment, sophisticated or unsophisticated, and find that we could effectively immunize people and have a significant positive patient and healthcare experience.
[caption id="attachment_5240" align="aligncenter" width="600"] Needle-Free Immunization: Disabled children tend not to have the opportunity to go to school and therefore tend not to have the opportunity for gainful employment.[/caption]
I think about the concept we're going to immunize 500,000 kids. You have this preconceived notion. You have your team set up and then you get the feedback from going through. Were there any a-ha revelations after doing that many kids with your teams?
What's interesting is if you were to listen to my CEO Chris Cappello talk. By the way, he's a little bit like a cofounder and he's helped design our equipment. He's an extraordinary engineer. He had the opportunity to train 50 master caregivers via Webex. They were in Karachi, Pakistan in the middle of our Colorado night and the connection kept breaking. His caregivers also had materials in front of them, the self-training materials that we've developed every time. Based on that two-hour period, those 50 master caregivers went off and trained 1,100 teams in one week. That following week, those teams immunized 500,000 kids in five days. That learning on the training side was invaluable. We designed it to be easy, ship it anywhere and somebody can take it out of the box, self-train with our little practice ball, 4 or 5 injections, twenty minutes, and then start immunizing.
Some of the other a-has are joyous because the healthcare teams are delighted that “the children didn't cry” or if they knew, it didn't matter. The injection process is that you have to be against the body before the trigger will be released and the energy creates that fluid stream. It's safe. If you're a parent, we've all experienced that when your child is in distress, it's stressful for the parent. Consequently, there were numerous people that walked away saying, “Why didn't we always do it like this?” They want every immunization to be this way. That's a positive trend. You would want to keep bringing your child back for their immunization schedules if you knew that it was going to be a happy experience versus the other times when the kids go kicking and screaming. It's no different than the dog going to the veterinarian. They know.
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