Amber: Hi, we’re here at Alpha Conference. I’m Amber Ambrose and my guest is Heather Potters of PharmaJet, she’s the co-founder. So, welcome to the show.

Heather: Thanks. Super to be here.

Amber: Tell us about PharmaJet.

Heather: We have developed some needle-free injection technologies, so it’s a very fast, fluid immunization, but essentially, it’s about getting rid of the needle and making sure that we can quickly deliver that shot and, in some cases, make it work better.

Amber: That’s right, and so this is the device right here. How many years in the making is this?

Heather: These would be second generation devices, and in our development activities, going really quickly, it takes a good 2-3 years to go from concept through to the scaling with automatic assembly robotics. And then if you add a little bit of regulatory, sometimes a little bit longer. We have had this device in commercial use for the last couple of years. This one is just reaching commercial use, and both of them have very significant clinical claims, as well as the standard regulatory marketing claims from the FDA.

Amber: Tell us about some of those claims.

Heather: If you look at the standard of the FDA for a device, we are a Class II medical device, and there’s a term called 510(k), so it allows us to functionally prove that this works, and then allows healthcare professionals to use it at their discretion.  The biologics division and the drug division are interested now in having claims, clinical claims, so then you go off and you do your studies to demonstrate did it work. In our case, is it the same as needles and syringes? So, noninferiority. This is a 0.5 mL dosage. This is a 0.1 mL dosage in this device.  Interestingly, over a period of time, vaccines have started to migrate from intramuscular subcutaneous 0.5 mL delivery to an intradermal delivery. So, this device actually has a drug master record around it, because in many cases we can actually hyper stimulate the immune response through this intradermal injection. In some cases, the immunizations that are under development don’t work with needles at all.

Amber: Wow. Can you give us an example?

Heather: We’re really excited about Zika data that’s just come out two weeks ago.

Amber: So, this is super fresh?

Heather: This is super fresh. We were paired with the NIH, Dr. Tony Fouchy and his DNA platform, with the FDA agreeing to fast track that development,

Amber: Because it’s such a health crisis right now.

Heather: Because it’s such a health crisis and it’s sexually transmitted, which is really disturbing because it spread like wildfire in one summer from Puerto Rico all the way through 48 states. Our standard depth in dose device is being used there, but the ability for us to improve immune response in nucleic acid DNA and messenger RNA vaccines seems to be related to the speed of delivery. In a Phase I study that was published, they injected one injection with a needle and then two split dose injections with our device into the arm. Our GMTs were six-fold higher than the needle group. So, the needle group was discontinued and they’re progressing the development of that vaccine with our device only.

Amber: So, it’s the only method of delivery for this particular vaccine?

Heather: Right. And we’re already in Phase II with Phase III in planning. So, from start to finish, from pre-clinical and non-human primate use and protection, through to emergency authorization by the FDA, we’re anticipating by the end of this year we may have a solution.

Amber: Zika is just one example of what you guys are doing with this device. But this has some things that are going to help the global population with vaccines and delivery because you have some statistics on costs and how you can save money.

Heather: Yes, we do. If we jump from the intramuscular subcutaneous volume of 0.5 down to the intradermal 0.1mL, so 80% less, tends to be about the same immune response for about 40% of all vaccine preventable diseases, according to literature.  It turns out that over a period of time, working with Bill and Melinda Gates Foundation, WHO and CDC in clinical studies for polio, from polio eradication, that 60% less vaccine is superior in immune response to a full dose.  Two injections using our intradermal technology, so 60% less is superior to full dose. Then, we’ve also engineered some efficiencies where we capture at least 20% more out of the vaccines vials than needles, we’re two to three times faster, we have no needle stick issues, or waste, or trash, and 50% less in waste,  (Amber: Or health hazards with the needle.) or health hazards, right.

Amber: So many implications. I’m sure there’s a lot more research to do and more vaccines to test with your product.

Heather: In the United States, for instance, where we started, we have use in places like the pharmacies. We’re also working on pandemic preparedness around influenza. I think the average person doesn’t understand that we all share the global disease burden. Getting rid of needles and inspiring compliance, and through flu immunization, is an economic boost to the economy. In the rest of the world, it may mean that you have a productive local village because people are healthy and able to breathe. Every single immunization, regardless of the market opportunity, is important. Some of them are really large and global. So, polio eradications, for instance, would be 500 million annual dose market for the next 10-20 years to eradicate that disease.  In the US, flu environment might be 150 million shots, right? So, different places and different partners that we work with to try and go down their channels to access their markets and their vaccine groups.

Amber: Well, thank you so much, Heather, for joining us today.

Heather: Thank you.

Amber: We really appreciate you and the work that you’re doing.

Heather: I appreciate the opportunity.

Amber: Absolutely. Once again, this is Alpha Conference, and I’m Amber Ambrose here with Heather Potters of PharmaJet.  Thanks for joining us.