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10 Pharmaceutical Technology ® The Real Message Behind Commercial mRNA Products April eBook 2023 PharmTech.com mRNA TReNds going to take a little while for global supply chains to catch up in terms of the raw materials. You would expect hopefully that as they catch up, maybe the cost of some of those things go down. I don't want to use the word stockpile because sometimes it's not re- ally used correctly. But certain stores in place or cer- tain processes such that we have more to go to in the events of rapid scale up initially. It allows sufficient lead time for everyone else to then scale up appropri- ately as you're combating an ongoing problem. So that's raw materials, components. I think you've been reading about vial and needle syringe shortages. And so yes, that is top of mind for people thinking about. It's not that we're going to have a warehouse with bil- lions of vials and components just sitting there. But is there something that helps us to be better prepared the next time around that we can start immediately versus wait around for things to catch up? That's definitely part of the conversation. PharmTech: Have there been a lot of communica- tions improvement? True (Pfizer): Going forward, we need to make it easier for people to understand what's important and what's not important. Does this translate to getting vaccinated? Will that be the best course for protecting you, your fam- ily, your community, and stopping transmission? And something more effective, overall, for the whole world. I think that's something that we do need to work on going forward. Vaccine hesitancy is a big issue that I think al- ways existed. But to have it in the scale that it happened during this pandemic, to know that people were still so adamant against getting this vaccine that had been ad- ministered to billions of people already. It's something we have to figure out, because at some point in the fu- ture pandemic, if any part of the world is not vaccinated, that puts all the rest of us at risk. What will resonate? What will people get behind? You want people to make the choice, but you want them to make the choice that's going to be the best for their health and everybody else health around them. PharmTech: One of the challenges and opportunities for using mRNA are for other indications. What are your thoughts on that? True (Pfizer): When I look at the potential of mRNA, it really is in some of those other breakthrough oppor- tunities, like oncology, like gene editing. The challenge where it was in a maturity stage before this pandemic is that it was still in the development phase. And we're still trying to prove that mRNA works in other application areas, like gene editing, like antigen expression of tumor for tumor antigens. While there's a lot of promise and potential, I also think that to have a balanced discussion about it. You have to understand what the limitations, drawbacks, or uncertainties are as well. I think when everyone thought, oh, look at this mRNA vaccine, look how great it works, you know, 90 plus percent efficacy. PharmTech: Guilty. I was guilty of that. True (Pfizer): Which is a great overall message as well. But people started to think that it could cure ev- erything, and that's just not the case. We're focused at Pfizer on looking at mRNA where it truly has break- through potential. We're not going to try to use it in everything because it's not better than other ways to cure many diseases or treat disease where something else exists out there. So, where it does have promise is oncology, gene editing, and cell reprogramming. At the end of the day, mRNA essentially tells your body to make some sort of a protein, whether it's an antigen or some other type of protein, which is why it has such potential and promise. The challenge is we still don't have a reliable way to make sure that mRNA gets to the right cells. So, right now we know the lipid nanoparticles go to the liver. We know this. T h is is pret t y much wel l agreed. A lot of compa- nies focus on liver directed targets. Where the true breakthrough potential is if you can direct it to the heart cells, and brain cells, and other types of cells in your body. Not even just focused on certain or- gans, but just other types of cells. And that's where the jury is still out. A lot of research, a lot of invest- ments in this area, but it just hasn't been proven yet in a reliable way that we can deliver it, and then also get the expression that we need of that protein. So, two things that need to be solved for. We will learn these things, probably very soon. Because if anything that's come out of this, there's more investment in mRNA now, more investment in lipid nanoparticles or other types of encapsulation technologies. If you invest in it, it will come. So, we will find this out pretty soon. It'll happen more rapidly than it would have happened without the investment. So, I'm very opti- mistic about what we're going to learn in the next, let's say, four or five years. PharmTech: My sense from the outside is that the pandemic was (no pun intended) a shot in the arm for company morale, and for a 'Yes, we can' attitude. Is this true? "We're focused at Pfizer on looking at mRNA where it truly has breakthrough potential. —Jane True, Pfizer