Well, good morning, everyone, and I'd like to welcome you to the CPA, the Association for Contract Packagers and Manufacturers in the CPC, Cold Pressure Council's webinar on Cold Pressure Technology, Taking Food into the Future. I am Ron Puvak, the Managing Director of the CPA. Allow me just a quick minute to give you an overview of the CPA, and Joyce Longfield, who will be our presenter later today, will give you a review of the CPC later on. The CPA has a voice since 1992 for contract packaging and manufacturing. Our mission is to help the industry grow, expand, and share the knowledge that other contract packages and manufacturers have gained, and also make people aware of the industry itself. We have several opportunities to interact with members, non-members, and CPGs, various trade shows. We have an annual meeting for networking. We have educational events, such as this webinar that you are attending today. And we have an interesting tool called the Request for Quotation tool, which we get over a thousand of those annually, and as well as 4,000 hits to our website a month, people looking for contract packaging services.  If you have any questions, please use the question box and we will respond to as many as we can in the timeframe allotted. The webinar is being recorded and will be posted on the CPA website at contractpackaging.org. At the end of the webinar, as you log off, you will see a link for a very brief seminar. We really welcome your feedback, so please take just about a minute to give us your feedback. Let me introduce today's presenter. Joyce Longfeld is the VP of Product Innovation, Good Foods Group, and is also the chairperson of the Cold Pressure Council. Since 2010, Joyce has been guiding companies on the applications and validation of using HPP to treat food and beverages. Currently, she is the chairperson for the Cold Pressure Council, where she continues to expand her knowledge of food safety validation and meeting regulatory requirements when using HPP. Along with CPC, Joyce is co-chairing the Juice Task Force, which is a collaboration of academia, government, and industry experts to approve upon the validation requirements for juices. It's now my pleasure to hand the presentation over to Joyce. And again, if you have questions, please put them in the question block and we will respond to them as soon as we can. Joyce, take it away. Hi. Thank you very much. Good morning to everyone. Can everyone hear me okay, or should I speak louder? Sounds good, Joyce. Yeah, okay, okay, great. So in terms of moving the slides, just so I know, am I clicking on the next ones, or do you click on the next one? Joyce, you have control. Just go ahead and click through. Okay, perfect. So I'm going to take you through a little bit of background on HPP first, and then kind of move into the applications of it, and then I'll talk a little bit about the Cold Pressure Council. And so maybe we, I'm fine if anybody has questions in between, but if you want to wait to the end as well, we can do that too. Okay, I'm clicking on the slide. Oh, wait, okay, there we go, there we go. Okay, so for those of you who are new to the technology, if you haven't heard of it, or if you've never seen what a piece of equipment looks like, you know, a slide doesn't really do this equipment justice. I mean, this particular unit that's on this slide right now weighs about 90 tons. So they are quite massive pieces of equipment, so they can get up to very large pieces of equipment. But in the picture, you can kind of see in the bottom right hand corner a person.  And so she were to kind of walk over to, you know, where those other blue carriers are that are kind of coming out of the machine. You can see that the mezzanine that's above is well above the height of her, right? So just to kind of give you a little bit of perspective. And I might just kind of put back and forth between the two machines, or between the machine in the next slide, just to kind of help you sort of understand and visualize what's happening. You know, I've heard and had questions from everyone in terms of what's going on inside of that machine.  And unfortunately, that is not as miraculous as the technology works. I mean, that would be amazing. But what it does do is pretty phenomenal in itself in terms of, you know, killing bacteria. So I'm going to just go to the next slide. Just using kind of understand sort of what's going on inside of that machine. So over on the left hand side, where number one is, you'll see a picture of what looks like bottles kind of stacked in something. And essentially that is supposed to represent those blue carriers that were in the previous slide.  So it could be those bottles and it could be other things as long as it's some kind of in packaged food. So in that package has to be flexible. So typically it's often plastic of some sort. But this could be deli meats in like a skin pack or a vacuum pack. It could be matte packaging. You know, it could be a whole leg of like prosciutto ham could be an entire like, you know, bar ball, like the whole sort of chub of slices of pre-sliced turkey meat. So really kind of what fits into that carrier is what can go into the machine, essentially. And so the carrier sizes are going to vary based on the machine size. And this is one of the largest carriers that you would see. I can do or I should say they could hold probably anywhere between like three to 5,000 pounds of product depending on like what that shape and size of that package is, right? Because you can just imagine you've got this cylinder and so depending on what your package is, not everything is going to fit so great into a cylinder. Whereas other things like, you know, if it's in a pouch or if it's in that skin pack would fit really, really nicely into that carrier compared to like a tub or some kind of awkwardly shaped container. But really at the end of the day, the machine doesn't necessarily have a preference as to, you know, the size, how big or small, as long as everything kind of fits into that carrier and the packaging is flexible is what is the most important piece to what goes in there. So then once you've loaded your carrier with your product, it's going to move inside of a vessel. And so then what's going to happen is once that vessel is filled with all of the necessary carriers, it's going to be plugged on both ends. And so then once it's plugged on both ends, it's going to start to fill up with water. So if I go back to this one, when we look at that mezzanine and we see those things on top that kind of look like barbecue lids, right up there, those are pumps. And so those pumps, they're pumping in water. And essentially what's going to happen is inside of that vessel, it's going to fill with water at atmospheric pressure. Well, once it's filled with water, then the pumps are actually going to force more water into the vessel.  So when the pumps force in 15% more water into the vessel, it forces water to compress, which builds pressure. And that pressure builds, the highest commercial pressure is 87,000 PSI. There's some non-commercial technologies that can probably reach up to 100,000 PSI. But typically within the industry, it's capped at 87,000 PSI. Now that doesn't necessarily mean you always have to go up that high. And I'll get into some examples later in the presentation for products that don't necessarily have to use such an extreme level of pressure. But how you determine the level of pressure is really based off of your needs. And so a majority of the industry is using it for inactivating microbial activity. And so different types of, you know, microbes, so bacteria versus yeast and molds, parasites, they're going to all inactivate at various levels of pressure. And so you're going to do the necessary studies in order to determine what pressure and how long am I holding that pressure will kill the targeted bacteria that I'm going after in my product. And so then once you've determined that through a validation study and you start to use a technology to whatever desired time and pressure has been determined, the machine will program the machine to hold the pressure for that length of time. And then after that, decompression, the pressure will be released within 15 seconds. So it'll come back up to atmospheric pressure within 15 seconds. And so it's essentially just, you know, cold water that's being applied to the exterior of these finished package products. And there's really nothing else that's going on. But, you know, I'll get into a little bit more detail of what's actually happening to the bacteria to kind of help you understand why the pressure is so lethal. So if any of you are, you know, scuba divers or just familiar with, you know, the depth of the ocean, if we look at where the deepest part of the ocean is, that would be Marianna's trench. And so when you achieve 87,000 pounds of pressure, that's six times the depth of Marianna's trench. And so, you know, if you're familiar with scuba diving or just how pressure works, that when you are at such extreme pressures in order to then come back up to atmospheric pressure, you typically have to come back slowly in order to make sure that everything equilibrates correctly. So you can imagine that if you are at 87,000 psi and you come back up to atmospheric pressure within 15 seconds, it's quite lethal. And so I'll explain in a couple more slides just what it's doing to the cell so you can have a better picture. But what's going on inside of the chamber is a uniform pressure. So this picture beside with the styrofoam cup gives you a really good example because oftentimes when we think of pressure, we think of one directional pressure, but inside that vessel, it's uniform. So every single part of the package in there is experiencing the same amount of pressure on all sides. So in this styrofoam cup, what you just see is that it kind of shrinks down. It shrinks down because as we know, styrofoam is mainly air and the pressure is going to push out any type of air. So if I were to put a whole strawberry in there, a strawberry typically has a little pocket inside of it. And so that strawberry will collapse. And then if I put a grape in there, the grape will just come out still looking like the grape, but be a little bit softer and more malleable. But because there's no air pocket inside of the grape, it holds its structure. So with the cup that you see to the right there, essentially it doesn't crush the cup. It just pushes all the air and in a way kind of just shrinks it down. And the nice thing about that is because it's all uniform 100 percent of the time, you don't have any gradients, right? So there's like, you know, it's not like that one part of it is experiencing a different type of pressure at another part. So as the pressure is building, everything is experiencing the same level of pressure at the same time. So for microorganisms, what that means is a lot of times people envision the microorganisms sort of exploding at such severe pressures. But that's not really what happens. In fact, they more kind of implode. And you can see like in this microscopic picture, or if you can kind of just visualize, if you remember your days of biology, when you think of a membrane in a cell, it's kind of, you know, sort of held together like a cheesecloth, right? Sort of got this membrane that kind of woven together. And essentially what the lethality of the pressure is doing is almost poking holes in that membrane. And it's really challenging the integrity of the membrane. And so then when you go through the decompression, it's quite harsh and severe to the integrity of the membrane to keep it intact. And so essentially you start to see these cells that just kind of are imploding there because their membrane is now leaking and allowing in exterior fluid. So they can't really keep it together for lack of better way of describing it. And this gets to be a really important piece in determining that whole pressure and time combination that I was mentioning early on in the beginning. So if we look at this other visual here, there's a, you know, this is a great slide to kind of give you a nice, easy depiction of what's happening. But there's actually a lot going on here in terms of determining what is the right pressure and hold time for you. So first of all, you know, we have this single celled organism, got its membrane helping to keep this organism alive. And then as it's exposed to various levels of pressure, different types of organisms can withstand pressure better than other organisms. So remember Harry's just mentioning that that membrane kind of starts to have holes poked into it. So if you look at the little bubble that says sublethal injury.  So the question always becomes, well, is there enough damage that's been done to get to the point of irreversible damage, which then the cell will actually die? Or is there not enough damage done? And then the cell actually after the process could repair itself and recover and start to grow again and actually even potentially be a little bit more robust now because it's been through this sort of environmental conditioning. And so, you know, to the left side of the picture there, you've got an example of different organisms and their tolerances to different levels of pressure. And it's reading in bar, but essentially 6,000 bars, 87,000 PSI. So 3,000 bars, about half of that. And it's accurate and it's correct. The interesting thing is that, you know, when we get down to, like, lyceria and lactic acid, they're a part of the gram-positive family. And things like salmonella and E. coli, they're a part of the gram-negative family. So if you remember, you used to do that purple staining back in high school and that would tell you if the bacteria is gram-positive or gram-negative. And the gram-positive bacteria, they have a much more stronger membrane. They have more peptidoglycan, essentially kind of like a gel or a glue to keep it together. So they have a better, you know, possibility to recover even at really high levels of pressure. And all that is going to be determined based on kind of the chemistry of the food that's going on. You know, just how long now do I have to expose those bacteria to the pressure in order to make sure that we get irreversible damage and they start to die? And in majority of the cases, we know that it's very unlikely we're ever going to have 100% lethal kill for lactic acid-producing bacteria. So this is why we typically do not refer to HVP as a method of sterilization.  And it's mainly, it just comes down to the fact that typically with lactic acid bacteria, there's such an abundance of it in the environment going into HVP. And then it just has such a high tolerance for pressure. So it's very rare that you would ever find a sterile product using HVP on its own and therefore all products need to be refrigerated after the fact. But going back to the Listeria piece versus the other pathogens, we all know that Listeria is one of the most concerning pathogens within the food industry, in particular for meat and even also for ready-to-eat food. And so oftentimes when we're doing validation, validation studies can get quite expensive and a lot of times we try and use something like Listeria monocytogenase is almost like a marker or a target pathogen that we know we can achieve the kill that we're looking for in that particular pathogen. If there's a very high probability that we're going to also achieve the same kill for salmonella and E. coli with the same pressure that's being applied. But we can talk about that more at the end if anybody has any questions on how you validate the process. In terms of yeast and mold, they typically are much more susceptible. However, the one thing about mold sometimes is that there can be spore-forming molds. Now, as I mentioned that HPP is not a method of sterility. It does not address spore-forming organisms. So it does not address Listeria and botulinum in a spore state or the Phyllis Sirius in a spore state. If they were in a vegetative state, then it would be addressed. But any type of spore-forming state, the technology does not address that unless you're up at the 100,000 PSI, which commercially those machines aren't available, or if you're doing a combination of pressure and heat, that's how you achieve spore destruction. And so with something like mold spores, most of them are pretty well addressed by HPP, but it can just be a little bit more challenging. I've seen some products like apple juices that have asco spores in them that would need a little bit more longer whole time than, say, what a normal apple juice might need, just because you have the acidity combination with the pressure, which tends to be very lethal for vegetative cells. So just to kind of give you a little comparison between HPP and other traditional thermal types of shelf-life extensions. So we do refer to HPP as a non-thermal technology, and that's typically with the understanding that that piece of machinery is going to be in a cold environment. It's going to be using cold water. It's going to have that temperature monitored. That's not to say that it couldn't be in a cold environment. And that's kind of why there is an area of research for high pressure thermal sterilization, is to have that combination of pressure and heat to address things like spores. But in most commercial cases, you will find that it is referred to as a non-thermal because people are using it under cold conditions. At the end of the day, though, it is a hunk of metal and it will absorb heat. So you do have to ensure that you have the right temperature monitoring programs within your production facility. We often think of the technology as innovative and that, you know, like it's barely new for a lot of people and a lot of people have heard of it. The technology itself is over 100 years old. However, commercially, it's only been used for about 25 years. It is calm. Eric sort of came about 25 years ago because of the avocado industry. You know, you have this very delicate, high premium product that was at that point in time really just being frozen. And yet then that would change, you know, the texture and the flavor and the consistency of the product. And it also, as we know, freeing does not deliver on lethality. So HPP really sort of changed the dynamic in the platform for shelf life extension of avocado based products. And then in 2004, you know, with the zero listeria tolerance policy that came in from the USDA, HPP really was and kind of is today the only technology that allows ready to each meet manufacturers to clean up their labels, have lower sodium levels, get the preservatives out and deliver on the full lethal kill for listeria while maintaining all the taste in the organoleptic.  As I mentioned before, you know, the transmission is immediate. It's continuous. You know, there's no gradient. Everything is completely homogeneous all of the time. Oftentimes with passuration, there can be fluctuations or gradients or a slow rise. So, you know, there's there's definitely a difference between that. So if anybody has some questions about other non-thermal technologies after, we could, you know, talk a little bit about UV or PEF and just see if you have any questions around that.  So that's, you know, kind of a new area that I keep getting a lot of questions about. And if that is kind of confusing to you, do you think of, you know, there's oftentimes compounds like purine and acrylamide that are created through heat, you know, that caramelization, you know, those those types of compounds are not created with HPP. So again, you know, it's just kind of leading into that cleaner product that is created with or sort of maintained with this technology. So I'm just going to go over a little bit of an industry overview. So as I mentioned, you know, the technology is relatively new in terms of our commercial application. And we it's kind of been a bit of a sleeper technology because it has been growing quite rapidly behind the scenes, primarily, you know, for the interest of food safety and shelf life extension. And so you have, you know, avocado and ready to eat meat really making up like 60 percent of the market that was using the technology for a long time. Well, those applications, you know, they don't really need to talk about it and explain to the consumer that they're using it. But in 2012, we had a lot of growth in the juice category using the technology. And, you know, with that, it started to actually grow the demand for like more outsourcing because not everybody can afford this technology, right? It's very expensive.  So we really started to see a growth in outsourcing. So in third party tolling facilities, so companies that were, you know, offering the service like without having to actually buy your own machine. So I think the combination of, you know, products using the technology that are bringing more consumer awareness and starting to demand the desire for their products to go through HPP, along with then this increased growth in accessibility and availability of the technology that we started to see quite an exponential growth going on in the industry over the last five, six years. And as I mentioned before, these are just some of the major reasons why companies look at using HPP over other technologies.  You know, it's one of the only technologies that, you know, if you have a validated five-long reduction and if you have any present or positive in your environment, you don't have to do a recall of that product because you've got this validated five-long reduction for in-package process depth, where you can't, you know, that's not the case with preservatives, right? Because preservatives aren't a lethality treatment, right? So, yes, they may prevent bacteria from growing, but they're not going to kill it right there in that instant. And so therefore, you know, you still have a chance to have a recall, even if you are using preservatives. But with HPP, your chances of recalls go down significantly, if at all. And so then the Better For You Clean label, as I mentioned with the meat industry, this technology has allowed meat companies to reduce sodium levels tremendously. In some cases, even make products for very specialized, you know, hospitals or geriatric homes, you know, compromised immune systems to have meat products available that don't even have any added sodium whatsoever. And they couldn't do that before without this type of technology. So it's really allowing, you know, to create some products that weren't even possible to create before, you know, in the whole movement of, you know, clean labels, no artificial dis, you know, that's one of the beauties of HPP is that if you are using fresh ingredients, it really sustains and maintains those flavor profiles. So, you know, you kind of essentially get to experience the benefits or the bounty of mother nature in your packaged product. Shelf life extension. So this definitely there is, you know, a huge increase in shelf life. Just how huge that can get is variable to the specificity of the product. You know, if we're looking at something that has 100 percent raw ingredients like a juice, that's not going to have quite as long of a shelf life as, say, a ready to eat deli meat. You know, when you think of how a deli meat is prepared, it's already cooked and then, you know, sliced and packaged. And so using HPP for a shelf life extension can last quite a long time. And depending on, you know, still you might have some particularly high salt levels or maybe even a combination of some clean natural preservatives. You know, something that in some cases, you know, products could be still good for a year. Now, not that you would ever see one of those products on the shelf for that long, but that's the reality of what you could potentially achieve. When you look at a raw product, that's highly unlikely. Most likely with something like a completely raw juice, you're going to have maybe about a 60 day shelf life refrigerated. So it really just varies. But, you know, that raw juice originally only had a three to five day shelf life. So going to 60 days, that is a really big significance for that type of product. So it just kind of depends, you know, on what the product is and what's the recipe and the chemistry that's going on in there. Anything with more acid is definitely going to help get you a longer shelf life.  With that, with the advent of shelf life extension and, you know, that example that I was just giving for juice, your product traditionally only has a three to five day shelf life, or even if it's a ready to prepared food that only has, you know, say like a two week shelf life, then you potentially have quite a bit of shrink that's going on and a lot of waste. And so there's been a lot of discussion in the industry around, well, how is HPP actually benefiting, you know, companies in terms of reducing waste, you know, the supply chain aspect of it and where are some new areas that we can start to talk to other companies about how the technology will benefit to the through shelf life extension to actually reduce their food waste. So this is just kind of a summary of the key advantage points. And as I mentioned, you know, the food safety is typically the number one, but you can see that all of these are relatively kind of close to each other within interest to the people that are buying the technology or looking into the technology.  So they're all relatively, you know, close to each other. It's not like one far exceeds the other. And I think it just kind of demonstrates that all the main things that food manufacturers are looking for, HPP really delivers on all of them. And then this is just a graph to kind of help you like give you an example of how the categories are broken down. So as I mentioned, you know, avocado and deli meats, they tend to make up a large portion of the users for the technology. Other fruits and vegetables, you know, that could also be like purees or some kind of prepared food that is much more sensitive to heat, similar to avocado. You could also include any types of like, you know, dairy or I'm sorry, dips like salsas and dressings, hummuses, that kind of thing. Beverages, definitely over the last eight years we've seen beverages have quite a bit of growth for use of the technology. And because of that, we then saw the growth in the tolling facilities as well. And the tolling facilities, you know, one of the newer ones that a lot of people are reaching out to them for is pet food. You know, pet food is also kind of falls into that or it can fall into that premium category the amount of money that people are willing to spend on their pet food. Seafood is interesting. Seafood is probably one of the sort of sleeper areas that people don't really talk about with HPP and I'll explain why in a couple of slides going forward.  I think that this is one of the categories that's going to jump leaps and bounds because we are seeing an increase in ready-to-eat foods, you know, growth of this category on the go, on the demand. And that also comes with high risk, you know, and that's something that preservatives can't necessarily address. So I think there will be quite an increase in that category for HPP. So it's especially with FISMA coming into place kind of the way that in 2004 when the USDA put in their zero-lusterity tolerance policies and it made everybody really take a look at this technology. I think that with things like genome sequencing and the technology is getting better at identifying and connecting the sources of where the bacteria is coming from and what food it's in. I think that the ready-to-eat food category is going to take a really close look at HPP. Dairy is definitely an area of potential. It's just that there typically is a lot of really strict dairy laws and regulations and, you know, HPP is not, hasn't been approved by the dairy industry for like the AAA certification I think is what it is. But there's other parts of the world that are looking to use the technology to treat raw milk. So there's a product that's in Mexico. There's a product in Australia. So it definitely thinks that there's a lot of potential. Again, if that type of product continues to grow in demand. And other R&D areas, there's even non-food applications for HPP. So looking at other areas where you might want to take out preservatives, whether that be vaccines or cosmetics, beauty products, you know, just other areas, there are some applications for it too. So going over just to some examples, I've kind of talked about a bit of these products along the way, you know, and as I mentioned before, in this picture kind of shows you different types of containers, you know, that can go through the machine. So you have tubs, you have little pods, you have cups, like anything that's plastic and flexible can go through the machine. Now I talked a little bit about kind of the chemistry and the matrix of the criteria that's going on inside of that cup, right? So the food chemistry and matrix. So since the pressure is moving through water, that's its conducive medium. Therefore that means that the food itself that's inside of the package also has to have a certain level of water activity. It can't be too dry. So, you know, people have tried to put things like peanut butter in there. Well, that doesn't work because peanut butter typically has a water activity below 0.5. And in most of the cases, you need to have a water activity above 0.8. So the best kind of example that I could give you is when you kind of look at the meat category. You know, something like most jelly meats are gonna have fairly high level of water activity, probably well into 0.9, close to one. But if you look at a perjudo, that can get pretty dry, right? That goes through the whole dry curing process. It can be in the 0.8 and very, in the low 0.8. So that gets to start to really challenge the efficacy of the technology. However, that product tends to have really high salt levels. So instead what you get is you kind of get a combination of the pressure and the salt working effectively to kill the bacteria. Whereas if I was looking at the juice category, the beverage category, where the water activity is almost that of water, it's virtually one, here you kind of have the combination of acid and pressure working together in order to deliver the efficacy that you're looking for. So when we look at on the right side there, when we talk about milk and we talk about these other innovative applications, colostrum, those tend to be things that don't necessarily have an acidic pH. They tend to be more alkaline. So in that case, while HPP could still work for those products, they're not gonna have as long of a shelf life as the juice. So those type of alkaline beverages could have maybe a 30 day shelf life, whereas a juice could have like a 60 day shelf life, if that makes sense. As I mentioned before, about seafood, so seafood is a little bit unique. It's kind of the one that doesn't have to go into a package prior being loaded into the carrier, as you can see in the second picture where you have oysters going right in the carrier. So the seafood industry uses the technology a little differently. They typically use it for shucking. So the membrane, the protein that holds the membrane of the muscle to the shell in seafood, is very thick and it's very sensitive to pressure. So even something that like half of 87,000 PSI, so like 3,000 bar, is effective enough to denature that protein that's clinging to the side of the shell and release the meat from the shell. So you get 100% meat retention. So you can just imagine how this has benefited the seafood industry in terms of shucking. No injury prevention, the speeding up the rate of it, like so many benefits, 100% of the meat retention coming out, that you can kind of see in that lobster picture there, it shows just how it's like identical to the shell itself. It's not cut up or choppy or it hasn't been handled really roughly. They don't show it in that picture, but there's even like a gel in the antenna that can be pulled out of the lobster after HPP. So it really does get 100% of it.  So now you also have the industry looking at using the technology for food safety as well as shucking. So it's one of the more innovative ways to use the technology. And probably one of the new areas that we're seeing the technology get some attention is for baby food. Similar to the cold press juices. In 2012, there was a really big sort of trend, diet trend happening. Everybody was kind of doing juice cleanses and this is where the technology really got some attention from the industry because it was changing the shelf life from three days to 30 days. And it was also essentially providing the same benefit as that raw food. It was delivering on the nutrients, it was delivering on the taste. It doesn't necessarily denature the enzymes the same way that thermal pasteurization does. So with the same thought process, baby food has really looked to HPP to help deliver a superior product than what's on the shelf. And so we're seeing quite a rise and increase in this category. And I think that this will only continue to increase as well. But the thing here that I try and give a lot of advice to people is that this is a different audience. It's a very sensitive audience. And so I think we're always taking extreme cautions when it comes to food safety. And this is one area that definitely needs to be vetted out and needs a lot of testing and support. And so the council wants to be involved in helping these companies and guide them and make sure that they're considering all aspects. As I mentioned before, the technology is not a method of sterilization. So considering the audience of this product, we really want to be involved and help these companies make the best food safety decisions possible. So with that said, I'm going to just talk a little bit about how the council came together and what we're doing. So as this title implies, unifying the industry. So a couple of years ago, we'd been talking for a while, the manufacturers of the machine, the towing facilities. And just to clarify, when I say towing facility, that's the third-party facility that is offering the technology as a service. So companies don't have to buy the equipment themselves. They can take their finished product to one of those facilities. The facility will run it through the machine, and then the people either take it back with them or sometimes, depending on the dynamics of the facility, they might offer storage and distribution through their facility as well. So that's what I mean by a towing. It's a third-party service provider for the technology. So with those companies that were leading the category and the manufacturers and just other users, we realized there wasn't really one place, one resource that you could go to to kind of ask HPV questions that were non-bias, that weren't trying to sell a service or trying to sell a machine or something like that. So we really needed to have a body for people to go to, to ask the questions, learn about the technology, make educated decisions, and also be there as a conduit to the regulatory bodies, to how we start to build the relationships in order to have the right guidance and understanding on the regulatory piece of the technology. Up to this point, there's been directives on HPV from the USDA, not as much from the FDA. The FDA mentions it in certain asset plans, like in the juice assets, but not the specific directives that the USDA has delivered. So currently, myself, I'm also coach herring a position on the juice task force, which is an affiliation between the Institute of Food Safety and Health, IFISH, out of Illinois, and working with regulatory bodies to kind of help better decision-making models for inspectors when they are going into HPV juice facilities. So we just kind of really realized as an industry, we need something. We need a resource for everyone to go to, and that's kind of how the Council all came about, was bringing together our founding members, manufacturers, equipment, third-party facilities, and some key users of the technology in the industry, including good foods. And so with that, we realized that we also wanted to have a high pressure-certified mark in order to identify products that were using the technology. And the thought behind this was kind of twofold. So internally, when we thought of it for the industry, it really is kind of the first mark of its kind that focuses on the food safety aspect of it. So the criteria in order to get the mark really evaluates the company's food safety protocol that they have in place for validating the use of the technology. So on our high pressure-certified website, you can go there and you can see the guidelines for different categories that would qualify to use the mark. So what it basically comes down to is, if you write in your HACCP plan that you are achieving the technology to, let's say, deliver a five-log reduction of final juice companies, if I need it as a least-valid treatment, do I have the validation studies that support that? And so essentially, then, we are working with NSF Labs to take the criteria that these companies would provide, evaluate them, and let us know if they meet the criteria or not. This way, at the council, we never see anybody's proprietary documents or information. And there's never access to it from our end. And then from the industry, or I'm sorry, from the consumer side of it, if I pick up this package and it's got this mark on it, I want to know what that means because, obviously, you put it on here for a reason. So I, as a consumer, now go to the website. The website is separate from the Coal Pressure Council website because this is the website for the consumer. It's consumer education. It's not about selling an HPP machine. It's a non-competitive website. It's easy to digest language. It's not too scientific. So really just explaining the benefit of the technology for different product categories. And our hope is that it will actually drive consumers to want to look for products that have the mark on it and that they understand that company is investing millions of dollars in order to use this technology to make a product that's better for me. And so this is just kind of a summary of what I was just mentioning. What the High Pressure Certified really represents to the company. So brand protection, food safety, non-thermal, clean label, preservative free potentially, just the quality of their product, the organoleptics, really maintaining the best possible flavor profile as if you made it that day with any type of changing of the product as you might get with some other technologies like with traditional thermal pasteurization. And so with that, kind of left it out open to Q&A, and I've seen some questions come up. Yeah, Joyce, this is Ron and back on. Yeah, there's some interesting questions. Looks like one of them is pretty interesting. Is this only useful for rigid packaging like bottles, cartons, and less useful for flexible film packaging? Well, so when you say flexible film, just so we understand, because again, flexible packaging is what you want with this. But it kind of depends on what you're talking about. So there's anything from those deli meat packages, which is incredibly flexible, pouches, very flexible. When you look at a container like, say, salsa, that has a rigid component, and then it has a film seal on top. But still both pieces to that are quite flexible. So I think it just depends on what they mean by what type of flexible packaging. Because flexible packaging is desirable for this technology. Is there a follow-up question on that? It might be, what packaging is not acceptable? They said rigid. So what is not acceptable? So glass traditionally does not work. There was a company in Japan that was successful with doing a glass bowl. But that's because they had a flexible film top. And so when the 15% compression was occurring, that flexible film top was absorbing all of that 15%. And I can't say firsthand if every single bowl went through and never broke. I'm sure there was. But they are the only one that I'm aware of that was ever successful with glass. But typically we try and encourage people to avoid glass. Sure. Well, here's a simple one. Why doesn't the meat cell break also during the pressure? Right. Right. So it's not that they're not experiencing the same type of, I guess, changes or damage that would occur. A couple of things are happening here. In a meat cell, it already is fully cooked. We kind of have this product that has already gone through a denatured process in itself. And then essentially it's been reformed and compacted and put back together. And it has multi-layers. And so similar to that grape example that I was giving, that the grape itself doesn't completely dissolve or break down or anything like that. It's multi-cellular, right? So you've got layers upon layers upon layers. So yes, all of the cells are experiencing some damage to create weakness. And so that grape will come out and it will reap, right? As if you had put it in the freezer and taken it out. And it'll be kind of very soft and malleable. But it's not disintegrated. With bacteria, they're single-celled organisms, right? So they're not multi-cellular. So they're essentially their own house. And they just can't survive on their own. Sorry, that is how they survive, is on their own. So once they're membrane is compromised, that's it. They're just kind of their debt. OK. I guess on the follow-up, are the cells and meats and vegetables affected? Do they burst thereby affecting flavor and taste? I think that's the key question right there. Yes, so that's a really interesting question. And it kind of goes back to what is similar with the discussion. When you're looking at ingredients that are 100% raw versus something that's already cooked. So in most cases with your cooked product, how it tastes at that point in time is how it will continue to taste for the remainder of the shelf life. Now with a raw product, that's a little bit different because if you are thinking of the way that that cell could be containing certain compounds that actually do have flavor profiles to them and stuff. And then if you put holes into those cells and some of those flavor profiles release, then it could change the taste of the product post-HPP, if that makes sense. And so with everybody, I always try and educate them, you have to do a sensory shelf life on your product. So making up samples, run it through the technology and store over X amount of weeks of shelf life and taste it every single week and see if you notice a change in the flavor profile of that product. Because nine times out of 10, you're going to say that an HPP product has, or you're going to base the shelf life off of the sensory and not really the microbial, because the microbial oftentimes just keeps on going. You usually determine your shelf life of your product based on the taste of it. Got it. This is interesting. What is the impact of pressure technology on the micelles or the emotions? Yes. And that's another key benefit to the innovation side of the technology. As we know with something like thermal, you de-mature things, right? So you kind of break them down to their primary structure. The thing that gets really interesting with pressure, let's take proteins, for example. Proteins are held together by a strong bond and a weak bond. Now we know the strong bonds are incredibly stable under pressure. We know it's the weak bonds that are always questionable, kind of like what you saw with the shellfish, right? And how they're questionable really depends on the overall chemistry in the matrix. If I'm a cucumber juice, I could do one thing going through HPP. If I am in acidified cucumber juice, I could give you a completely different result in how my enzymes behave post-HPP, right? And so that combination of acid and pressure can really impact the behavior of those weak bonded proteins. So in terms of food development, what gets really interesting with proteins is that they can start to coagulate. And they can start to thicken, essentially, due to pressure. And again, it all kind of depends on the chemistry that's going on for the product that you're creating. The best example I could give you, if anyone has ever had a nut milk, like an almond milk, right? So if I were to make an almond milk at home, if I strain it and then run it through HPP, essentially, it's really just kind of water with almond flavor, has very little protein in it or any type of pulp or fat left over. And that probably will still come out like a watery almond milk. However, if I want to make a more almost kind of similar to like a smoothie and I leave a lot of the almond pulp in my bottle that goes through HPP, I have seen products that come out like cream and mushroom soup. So they just completely thicken and congeal just because of the changes that are happening between the proteins and the fats, because the fats are also emulsifying at the same time. And so you're going to have a potential to make innovative products that you wouldn't necessarily be able to make with pasteurization. And same thing with starches, carbohydrates, they are going to, essentially, you're going to start to have thickening and gelling of those products, right? So oatmeal tend to get really, really sticky. You're making an overnight oats type of product and putting it through HPP. So all of that has some really interesting potential for innovation, in particular, if you're looking for different binders, if you want to get away from typical xanthum gum and guar gum and other things, and you want to use more natural starches, maybe you want to use citrus fiber, maybe you want to use chia or something like that, but it's a little bit more label friendly to have some potential new opportunities with HPP. OK, here's one that goes to the consumer. Do you have any research data on consumer attitudes towards HPP? Yeah, well, I have seen one paper. And not that I'm surprised at this. We kind of are a culture of consumers that doesn't necessarily want to know how our food is made. We just kind of want to sometimes turn a blind eye and, if anything, we just look at the nutritional panel on the back, and that's kind of enough for us. Now, things are changing, and we are definitely having younger generations now that are much more interested in understanding the manufacturing side of things. Ever since consumers started to become aware of food industries using things like processing aids and what really goes on to make their food, we are having a new area of interest. And that's why I think our timing is right. We're launching the high pressure certified mark because the millennials are starting to become the household shoppers. They're growing up. And these are the generation of tech kids that are fascinated by technology. They understand that these kind of processes. So historically, with Baby Boomers or Generation X, we stayed away from that word process. We don't want to think of our previous process. And probably even younger generations don't either. But they're more open-minded to understanding that this technology isn't necessarily a bad process. Like there's actually a benefit to it and stuff. So historically, I would say people are really interested and open to wanting to know about the technology. But I strongly believe that things are changing. Sure. Here's an interesting.  I think it's more of the capabilities of the technology, the physics of it. So the machines all have to be approved by ASME. And I think at this point in time, I think the manufacturers just have not demonstrated the use of those levels of pressure, I guess, for a commercial application. So right now, the approved limitation has been 87,000 PSI. OK. Here's an interesting. Can you be used for raw meat, example, a whole bird in shrink bag, chopped meat tray? So it could. You just have to be open-minded to the fact that because of some protein changes, what ends up happening with raw meat, if they take on the appearance as if they were cooked, so a chicken would turn kind of a white color on the exterior. A shrimp would go kind of pink. Some kind of beef patty would go gray. But that isn't a cooked product. The food manufacturer still has to cook it. So there have been companies that have used HPP to make food service like hamburgers. And when they sell it to the restaurant, they have to educate the cook. This isn't cooked. You still have to cook it, but you don't have to cook it for as long of a cook time. So there is an education piece around that type of product. Excellent. Here's an interesting one. Would the high-pressure certified badge be available for just the packaging if proven to be HPP compliant? So it is kind of for that now. I made him just not understanding the question correctly. I think he's asking the packaging by itself. If someone was selling packaging, could they use the certified logo on the packaging itself? Oh, I see. That's not the way that it's currently set up, because right now, since we are basing the criteria off of understanding the company's safety side of how they're using the technology. So we just want to make sure that how they're writing, they're using it in their HACCP plan, that they have validated that appropriately. So we haven't really considered it for that. And even the HPCP, or I'm sorry, the CPC logo, our council logo, right now, we don't promote that to go on packaging either. That's just used for other material, like either on your website or marketing materials. But it's not a logo that's meant to go on packaged products. OK, excellent. Well, we've reached our time limit. I do appreciate there was a question about, will a copy of the presentation be available? The entire presentation has been recorded. It will be available in a couple of days on the CPA website at contractpackaging.org. I'd like to take a moment to thank Joyce so much for presenting today. Thank you, Joyce. It was a fantastic presentation. Thank you, all of you, for who participated. Joyce, any closing thoughts? No. I mean, I leave my email box open for people who have any follow-up questions that didn't get answered or they didn't feel comfortable asking. I'm more than happy to answer any question, because I know that this technology can seem really confusing, and I don't want anybody to feel intimidated by it. Excellent, excellent. Well, thank you for that, Joyce. Thank you all for attending the CPA and the CPC webinar today on cold pressure technology. We hope you enjoyed it. Thank you.


All right, welcome to the Cloud Founders of a Diversity Luncheon. Thank you all for being here. My name is Keelah Huddle. I am a content for the foundation. I also oversee our diversity initiatives. Every time we approach one of our conferences, I kind of briefly ask myself, if we still need to have a diversity-specific event, and then a board member for a company being investigated for sexism, makes a sexist joke during the meeting in which they are discussing possible solutions, and I start planning on a state-of-the-art recipe panel. Being here, thank you for showing up. We have to continue to show up to make change. This is doing the work. I want to begin by introducing two special guests today. The foundation is proud to have on-site for the first time junior ambassadors. In a report we issued last year, we found that the shortage of skilled cloud developers will grow exponentially in the coming decade, meaning companies need more developers and more developers must be trained on cloud. We as a foundation also made a commitment to invest in the diversity of the open-source community by being actively inclusive, outspoken, and dedicated to seeking out underrepresented parties. The most effective way to perpetuate diversity is to show rather than tell. And in practicing, we had over a 100% increase in women-identified speakers since last year. We've seen over 11% of attendees are women-identified. That number may sound small, but in the tech and industry, it's pretty sizable. So how do we leave together the need for more skilled cloud developers and increase diversity in our open-source developer community? We look ahead to the next generation of developers. And that's what the junior ambassador program is for. Please join me in welcoming Sandra Nitham and Sydney Hull. She graduated from high school and will be attending her cluster in the fall. And Sydney just finished her freshman year at high school. Good to know them. Join us in the community realm. We're in today at 5.15 to 8.10. Make yourself available to them because one day you will likely be working alongside of them. So welcome, Sydney and Sandra. I also want to thank Cornelia and Elriza at Pivotal for all of the work they've done with the Girls Who Code program. And I want to give a big thank you to IBM for sponsoring this luncheon. So thank you. And now I'd like to introduce today's featured speaker, Karen Holtzblatt, who will be giving a presentation and then leading our panel. Karen is a thought leader, industry speaker, and author in computer-human interaction. She received the first Lifetime Award for practice from the Computer-Human Interaction Association for her impact on the industry. Karen has recently turned her energy to the challenges of women and technology and founded the Women in Tech Retention Project to understand women's experience at work and create interventions that help. Please join me in welcoming Karen. You having fun? I hear we're at the tail end of the conference. I like to see a nicely filled room and I like to see men showing up for a women in tech thing. So any man at your table, turn around and say thank you and you are my ally. Okay? So I've been leading teams for the last 30 years to help understand requirements and design. And as you can tell, I'm a little bit older than lots of you in the room, which means I was one of the first, or what we call the second wave women's movement and we broke down lots of doors because the rooms we were in, there were no women. There was all guys. Okay? So much to my chagrin eight years ago, because I do a lot of coaching of young people, they started coming up to me and crying. And recently I heard about senior leadership women, senior leadership in a group of women crying because what it's like to be in our industry. And that's when I started to think that it was time for us to really take responsibility for this ourselves, yeah? Okay? So I am known in my world for my hats, but we're having an intimate conversation here, so I'm going to take that on. Now, what was also going on, you have to understand that, you know, all of us who were in human-computer interaction started out as psychologists. So I started teaching gender relationships 40-something years ago. So the other thing that's kind of sad and scary is that the research is in no way advanced in the last 45 years. Now, the Anita Board Institute and all of our pipeline programs started way back in the late 70s and in the 80s. And it was also true that whereas the Suffragettes, that was first wave women's movement, okay, they were trying to get something pretty tangible, which was what? The vogue, you know? Okay, my generation, we were trying to get something pretty tangible, too, and that was we wanted to work, okay? We wanted to be paid because power and equality comes also with dollars, okay? Inside the family we're talking about, and we worked. Now, the sad news is that in all the other hero industries, so what's a hero industry? Anyone who works too much and is sort of compulsively obsessed with working, do you know, recognize the eye bankers, doctors, lawyers, right? Business, all those guys. From the late 70s and 80s until today, all of us have had a massive increase in women and they continue to go higher. And we, and only we, and only in our industry are women walking out. You got to turn it on if you think it's going on. All right, so we've had massive efforts for pipeline, getting young women in like the young women we have today. And we can talk all we want about leaning in leadership, except for one problem. When we get them in the door, 50% of them leave midway through their career, excuse me, 50% more than men. So if you have a hole in your corporate bucket, what happens? They're just gone, yes? We don't have to talk about how we get more women leaders if you're losing half of the potential candidates mid-career. So it turns out, as far as I can tell, virtually no one is trying to understand what's happening. So when I looked at this and all the young people that were still upset 30 years later, I thought, well, I'm a pretty good spokesperson people sort of thing. Maybe I better do something. So I started the women in tech retention project and we started with trying to understand, this is too loud, trying to understand why women stay. Now, if you want to understand why women leave, you don't start by asking why women leave. It's not any different than if you want to get the right requirements, you don't ask the customer what do you want because the customer knows everything about their world and their practice, but they don't pay any attention to it. And so if you ask them what they want, they always say things like, make it faster, right? Do it like this other thing I'm used to. And so what we learned in requirements and design is you go out into the field and you talk with people about what they're doing while they do it and that's what I'm known for. So if I want to understand why women leave, I have to first understand why they don't. And then when we look at women who leave, we have to ask if it's because they don't have that stuff, yes? Do you understand what's going on? So we went out into the field and we talked with women using our user-centered design processes to understand why they stay. And the result of that is the at-work framework, which I'm going to breeze through here today and use as the context for our conversation. And we wanted to be sure we knew what we were talking about and so from that we made a survey. And so hundreds of interviews later, the Women Retention Project, which like open source, started and has started as a grassroots, 100% unfunded effort, has a way of understanding what's going on, a measurement tool, and we're now working on intervention techniques and also even games because if we're talking about early career, we are talking about people in their 20s up till about 40 because those of us who kind of made it, we figured it out. You know, we know what we're doing, you know? Otherwise you would have marched with your feet long ago. So in our survey, the sad news is that 49% of the women are still saying they're thinking of leaving and that should scare you. And when I go and talk to very large, very well-known corporations, they say to me, of course it couldn't be happening here. And I say, you want to check those numbers? And then they come back and go, well, I'm sure it's different here, but yes, they are leaving. So don't pretend. And we are living in the middle of a media storm, as you all know, which means we better take it seriously as an industry. And I think we better understand. Yes? With me? OK. So let's do it. The first, and the most important reason women stay, is because they feel in a tight, cohesive group up to something that matters. They feel like they can lead and they can follow. They are heard and they're asked for their opinion. They participate in a group in which they have a sense of belonging and they are connected. And if they're not in a product team, then instead they talk about partnering, dynamic individual partnership. In other words, the psychological sense of connection is critical. And why would that be surprising? Because who would want to go to work every day feeling alienated existentially? I mean, think about it. And if you think the guys don't come to work for the same exact reason, well, we are, the next survey is going to have men in it, so I'll know better than anecdotally. But you all know this, right? You know that guy who works with those other guys and he takes a job, you know that guy? And what happens when that guy goes to that other company? All his buddies come with him. Work is a social endeavor even for coders, okay? And when women feel that they're up to something that matters and that they can belong, then they stay. And almost every woman I talk to who leaves what's underneath it is the lack of that. It might sound like I'm invisible. It might sound like everyone interrupts me. But in the end, it's about that. Right now we're developing intervention techniques which include putting in more structure because women do better when they know the rules of engagement. One of the saddest pieces in our survey also is that 50% of the women don't know what they have to do to be successful. In other words, what does a successful deliverable look like? What does a successful good piece of code look like? What does it look like to do a job well done? How do you advance? What does that look like? 50% don't know. You think we could fix that, yes? All right, so there's other techniques that we can use that make the team process work better. And we're working on those but I got 20 minutes so I gotta fly, okay? All right, so now I have to do something here because this is less a factor than a sub-element because the up to something big part really counts. Now I don't know what's going on here because you guys a little more technical, you know, down in that cloud coding stuff. All the time people want to say stuff like, well, women need more socially relevant topics. If there were more socially relevant topics, women would come to hardcore tech. That is not what we heard. You see this one? I love my work because this one is social issues. You see that one? Is that the big one? No. What makes women crazy is being bored. They want to be on the bleeding edge of technology. They want to do the challenging work. They want a new hard problem and they hate being bored. They want to impact the industry. They want to make impact for their company and they want to invent the next thing. So stop it. They're motivated by the same stuff as men. Ready? But women may need different things than men. We may not like it. And many of the women that I like, for example, I'm about to tell you this principle. I asked one woman if she'd be on a panel so she reviewed a webinar and I said, so what did you think? And she said, I didn't like that push and support thing, Karen. I said, well, was it true for you? And she said, yes. There's a lot of things we don't like. But if we aren't honest about what's going on, we can't do anything. All right. So what does this look like? When there's a new job, unfortunately a lot of women will look at the 10 things you have to do and they'll go, oh, I don't have all 10 things. I can't apply. I need a whole other degree before I can apply for that job. And they'll say, angrily, the men don't think that. They'll apply if they just have three things. Well, women are mad because the men will take a stretch. The women don't like to. Story after story after story is women who are pushed by their teachers, by their husbands, by their coworkers, and by their managers. Did you see hidden figures? OK. You know the chalk scene? That's the push. Did you see it? That chalk scene where the man who has power, men, you have a job, says, you can do this. Go to the board. That's the push. And that story was shocking when I saw it because that happened to me. But pushing alone doesn't work. In fact, women leave under those circumstances because if you're pushed, like one woman who was a graduate of MIT, not a dummy, and she had a deal with a whole big fat, it was in fact open source. And they said, you're so smart, you can do it. And then they were done talking to her. And now she was alone in it. And she did this and that, but it wasn't sure how to start or how to think about it. So she'd go back to the manager and say, how is this?  You're so smart. Just keep going. Well, she just felt abandoned because women don't just need the push, but they need the support. What does support look like? It looks like someone to talk it over with, the leeway to fail, the idea that you can try things out and iterate a little bit. But mostly they don't want to be doing it alone. There's someone in your world you could push right now. There's someone in your world you could support right now. I want you to go home and do it. The push and support, it's not a management only problem. The team can do it too. Yes. Ready? Local role models. You know who this is, right? I know you know who this is. This is our Supreme Court justice.  And if you didn't know that, you need to go know that. Ruth Bader Ginsburg. To me, I'm like, whoa, that's Ruth Bader Ginsburg. Right? The guys grow up and they go, yeah, I'm going to be a steep job. I'm going to be Bill Gates. You know, you go, I work a lot with young people.  I hate to tell you, you're not going to be, no, it's not happening. So Ruth Bader Ginsburg is scary because you forget that she had an amazingly supportive husband and you forget that she did law Monday, Tuesday, Wednesday, Thursday, Friday, Saturday, Sunday. She wasn't saying, I think I'll change the world. She was just doing her thing. Two years ago I had an opportunity to meet Ruth Bader Ginsburg, but she was still Ruth Bader Ginsburg. It did not help make her real to me.  Who does a five-year-old play with? The seven-year-old. And when they're nine, they want to talk to the 12-year-old, not the 17-year-old. When we want to think about where we're going in life, we want someone who's just a little bit more experienced. We look at the next level up to find out what might life be like there. What we found in talking to women is that they thrived when they had local role models. We tend to have a bad habit of, you know, I was at Grace Hopper last year.  And one of them was a top-level VP who had twins, worked, and also wrote a children's book at the same time. This is a real story. Good for her. She does not help anyone think they can do it because she's like Ruth Bader Ginsburg, yes? What women need and when they thrive is when they look for local role models, people with a little bit more experience than they have. And they look at them and they want to say, let's talk it over. And they look at their life and they say, is that a life I could live? And if the answer is no, I can't live that life, then they don't want to be a manager. And even a director-level woman I talked to when she looked at the VP, EVP up above her, she's like, oh no, I couldn't do that. And she'd already made it because she didn't like that life he lived. If you have one-year experience, what are you?  How's your life? Are you a good role model? You all know who you've been chickened to go ask to talk to who's a little bit more than you, yeah? All right, I want you to talk to them next week. And what about family issues? Everyone wants to make that the problem, but HP and the industry in the 80s gave the best benefits ever, and so did Sweden and every other country. And if you look, the issues of benefits and women and children are no different across any of the hero industries, no different. What does it mean? It means that's not why people are leaving. It is not a homework balance problem. No matter what women tell you, and I've interviewed a lot of them who said they were leaving and they said because of their kids, and at the end, as one of them said to me, she looked at me and she said, I didn't leave because of my kids, did I? I said, no, you didn't. She said, I left because I was bored. I said, yes, you did. But women appreciate when the team and the manager have non-judgmental flexibility. So when they have to take care of that kid, they don't sneak out of the office and make sure no one sees. They don't have to worry about it. They're accommodated to. It's a team thing again, yeah? Everything I'm talking to you about is a product development and engineering problem. We're not going to fix it with a workshop. We're not going to fix it with networking. And we're not going to fix it by expecting every woman who's only 11%, did you say, of the people here to take on every other woman as their mentor?  I got where I was with a bunch of men. We can't be looking to HR to fix this. We have to and can do it by changing factors on the graph. And that's what we're working on. But we can't stop here if we do not acknowledge that women come in with tons of baggage. This has been documented for years and we certainly found it again. Is they live with a negative voice in their ear and it keeps going like this? No, I don't think you can do that. That's too hard. What are they thinking about me? Maybe they're not thinking I'm good enough. I don't think they think I'm good enough. Did you see that guy? They moved their head in a funny way. I'm sure that means they didn't like me. They come home and they hyper-judge themselves. And they think that the men don't do that. I don't know how courageous you guys are. Are you courageous? Can I ask you a question? All right, are you ready? How many men ever feel like they're not good enough and come home with low self-esteem? Okay, women, would you please look around? You know if you live with them, you know what they're like. But what do we do? They come home. They whine and moan. Wining and moaning is part of a relationship. It's very important. They think they're not good enough. Someone's going to do this. I don't know if I'm going to advance.  You're so terrific. I know you can do it. We kiss them on two cheeks. We dress them up the next day. We kick them out the door and back they go into the war. Everybody has those voices, but women are pretty plagued. And so if we do not deal with techniques to help them think through how to hold their personal power, how to always be professional, what professional behavior looks like, how to stand their ground, how to handle straight talk, and how to look at that guy.  It's a dybbuk in Jewish. And this is what you do. You got one of those guys? You got one? Okay, here's how you do it.  Part of what we're doing with my students is we're creating board games to look at cases to help people think through this and do a bunch of reframing. So the fixes problem, we believe you need to have intervention techniques in the industry and work, and we need intervention techniques for women themselves. And if we do that, then we're going to be able to retain more women. And if we also do what maybe is being done this week, fire people who need to be fired in our company. Yeah? All right, so if you want to join us, be part of it. Go out to incontextdesign.com, women in tech. And from that, I'm going to turn it over to Kamie.


Hi. Welcome to ByteScout. In this tutorial, I'll be showing you how to generate a vCard QR code with ByteScout barcode SDK using C sharp programming language. Let's start. First, you need to add a reference. Right click references and click add reference. Search and select ByteScout barcode SDK. Then, browse and select thought vCards DLL. To download the though vCards DLL, you may go to the website shown on the video. I'll put the link in the descriptions below. Once you're done with the references, you may now insert your code and run the program. Once the program runs successfully, the generated QR code will automatically open and will be saved in the bin folder. That's all for this tutorial. Check out our other tutorials on our YouTube channel. Just search for ByteScout and don't forget to subscribe.


Stephen, do you want to join the panel? Thanks. Thanks, both of you, Stephen, for describing your process and Paula for kind of walking us through the FDA regulations and thought process. If anyone has any questions, if they can come to the aisle, you'll have to turn on the mic. But I wanted to, I had a quick question that I wanted to kind of start with. So apparently 2014 is way outdated from Stephen's presentation. And I was wondering, have you had to update your application as your device changed, or how did that work? That's a good question. So one of the benefits of perspective study is that we did lock down the device while we were enrolling. However, that enrollment in that study is now finished. And we've moved to a new institute, a new lab, and the technologies have advanced amazingly. And so our previous methods are considerably outdated versus the specifications today. So we, in all likelihood, will be contacting you pretty soon to update our device description. The intended use is pretty much the same, but maybe slight differences. Also, the other regulatory environment in terms of specialized bodies, such as the ACMG, are increasingly expecting us to return additional types of findings besides diagnostic results. And that's an area that we also will need to think carefully about. That's a new area for us. And what is the requirement for confirmatory assays for those? In general, this is a troublesome area. I can very much understand the need to make sure that a diagnostic test result is accurate. But as we get into the myriad other things that we can see in a genome, at some point it becomes impossible to confirm these other findings. And so will this be a substantive limitation of the types of additional information that patients may want to get from a genome, such as their pharmacogenomics status? And then I had one for Paula. So you said that even if the device subsequently is being learned about, if that's not the primary purpose of your study, if you're still learning about the device, then it is a device. And that just kind of brought up the question. How do you balance safety and innovation? As Steven pointed out, 2014 the methods are already so outdated. And how do you keep up with having to file these device exemptions and move just this balance of moving research forward but still allowing for safety? We are committed to being very interactive in this process and doing the most that we can to be timely. And it is our regulatory authority. It's our responsibility to ensure the safety of subjects. And we have developed processes like the pre-submissions that we try to give informal information as quickly as possible. And also our IDE turnaround times are the fastest that we have. We have 30 days.  And we can do that through the IDE. NSR being not significant risk. I think we had a question in the back first, and then, yeah. I have a question for David and Paula, mainly. My name is Yelena Berglund. I'm director of regulatory affairs at Duke University. So one of the things that our group does is review all PI-initiated studies before going to RB and making sure that all regulatory or some regulatory questions are addressed. Starting from simple one, is there a device? Are there drugs? Do you need to do submission to the FDA or not? So the question that we, especially in the last few years, have quite often is use of IVD as a companion diagnostic. So in a situations like in which you are using IVD to randomize the patients, so you're using as a companion diagnostic to non FDA approved drugs, obviously the study will have an IND because drugs are not FDA approved. If study is run under an IND and there is a companion diagnostic development, can we safely assume that CDR rage been reviewing those protocols as well and some issues regarding device being addressed? Or does every investigator need to do also separate ID submission? Because often those studies, I mean those devices itself simply have inherited the risk associated with the drug. So therefore device itself will be significant trace device because you're randomizing patients to non FDA approved drugs. So what are your thoughts on that? You've been getting some mixed messages. So we will work both ways. So if the device comes in with the IND, CDR reaches out to us and we review the device under the IND as a consult. Or it can come directly to us as an IDE, as a separate IDE. But I think we've seen both. And David, if I don't work too much on the companion diagnostics, but if you have anything to add? Yeah, so just to address that a little more, because this is an area of change. We do see many, and you'll hear more about this later on today, but we do see many IVDs because they come in through an IND and CDR notices it and sends a consult. And we will look at it through there. We are changing our policy. So we have accepted in the past device information and sort of the formal review through that mechanism. But it turns out nobody really, the regulations are difficult enough that we're going to now require a separate IDE if it's a significant risk device. And that is because CEDR does not have experience with the device regulations. CDRH doesn't have experience with the drug regulations. So it sort of works out better for everybody in the end to keep those separate. So we plan on releasing guidance sometime in the next few months that we'll describe this more thoroughly. But now what will happen, though, is through the console process, we'll send language back to the sponsor saying, we need a separate x, y, or z. So you'll get that specific type of guidance. Thank you very much. So I'm Jonathan Berg from UNC Chapel Hall. I'll be speaking later today. I had a question about devices because I think we got some conflicting information about what constitutes a device when we went through our own process. And without getting too much into the details, it wasn't just limited to the sequencing device. It was inclusive of all the possible results that might be returned and the parental decision-making process. So it was really a very broad definition of device in our particular case. And I just want to note that something that's evolved to a changing and thinking much more about this specific device that generates the data, or was there just some kind of blurring of the lines in our particular case? I mean, we do work on a very case by case. We look at everything independently. I mean, sometimes we ask questions because we want to understand the risk of the study. The device is whatever gets you from sample to whatever goes on the test result, on the report. So that is including the molecular geneticists clinical assessment of pathogenicity. That is a gray area. We may need to understand what the process is to understand the risk. So sometimes it gets blurred more because we want to understand what you're doing. So we can figure out if you have a study that is significant risk or not significant risk. As you know, we do not have the authority to regulate medical practice. And that part of it is very complicated. So no, that shouldn't be part of the device. But sometimes it's a part of our review process, for example, including submitting, allowing the FDA to review the decision aid that we were preparing for parents. That was part of the device. Anyway, I think maybe the communication was that it's part of the study. So we need to review that. It's part of the study. Whereas the device was really just the. So it may be some clearer language for investigation where the device ends and the study begins. Right. And maybe we're not so clear with that as to why we're asking for something not because we're trying to figure out the device, but the downstream parts of it do impact our risk determination. And a lot of the times we are trying to get to an NSR determination if we can. Because it reduces our burden, our workload, as well as yours. So sometimes we ask questions that we're to get a better understanding of the study. But from our perspective, the device is whatever is going from sample to the test result that is given to the patient. I'm Jarvis Kern from the NCI Intramural Program, CCR. I'm going to go back to the first question that was asked. So we at the CCR have also developed a clinical sequencing platform, Ex-Home for patients with cancer. And the advice that the FDA gave us is that there should be a central umbrella protocol where the device, we produce a device master file. And essentially all the other principal investigators who are then going to use that for clinical trials are then going to actually submit an IDE exemption. And the question to you is I think we actually thought that's quite a good way of doing it, actually. Because you spend a lot of time evaluating the device. And then it should speed up the process for all the other PIs when they submit the clinical trial. So can you make a comment on that? And then secondly, who actually determines for those principal investigators who then submit the risk? Can the IRB do that? Or do they have to always submit to the FDA for a decision? I will take the second. And I will defer to maybe David, who may have more experience with this specific topic on the master file. So the investigator makes the risk determination and the IRB. FDA helps if you want. If you're looking for help, if you submit an ID, then we will make the determination. So that's how that is done. So sometimes we get questions from the IRBs. They come to us and they say, we're not sure if this is a non-significant risk. But the initial responsibility is with the investigator and the IRB. And we can help. And then David, if you can talk to the other or Sharon. So I have a question for Dr. Kingsmore. I just wanted to ask about the modifications part of what you talked about about changing the test during the course of the study. I was wondering if you could illuminate, you could describe a little more what the thought process is. Like what triggers the decision to actually change the test and what do you do then as you're changing the test to make sure it's still working the way, giving similar results or adequately results? Sure. Thank you. So new technologies will come along, David. Either a new algorithm, a software algorithm, let's say for alignment or variant calling, or a new tool for waiting variants with regard to pathogenicity, or a new sequencing chemistry, like going from version 3 to version 4, where it's believed the quality is improved or the yield, or indeed an entirely new sequencing instrument, such as the HighSeq 4000. And so as those become available, generally there's some evidence in the literature that supports their performance, analytic performance, generally relative to their predecessors, some kind of benchmarking studies. Some groups are faster than others in terms of adoption of these. We have always been keen to adopt new technologies quickly. And so we will often contact companies who have technologies at the beta test stage when they are still developing their analytic validation information and work with them to define that analytic validation in a particular medical application. Because often it's very much application-specific. And the analytic validation absent its linkage to a specific application area doesn't always make a lot of sense. So we'll often work with them to find the application for the technology. Pacific Bioscience is long-read sequencing. On the SQL instrument is a brand new technology this year that potentially is transformative in terms of our ability to pick up structural variation in a clinical sense. We can see 20,000 structural variations routinely in a human genome with that technology. Our best current approved technology, the chromosomal microwave picks up tens. And so clearly this is going to very rapidly need to be examined in terms of what are the analytic metrics those studies have started to come out. But so far there have been no clinical applications of that technology. And so really we have to think long and hard about how to do that. And it's really a matter that's somewhat guided by our CLIA CAP type regulations where anything that we're going to introduce as part of an LDT needs to have a formal change order associated with it that's documented. It says exactly what has changed from what to what, when, those types of things. And then it has some information related to performance testing in the old method versus the new method. And typically that will speak to sensitivity and specificity and precision. But it depends somewhat on the actual thing. And again, that needs to be part of the document file that we would keep for subsequent CLIA CAP inspections. We have had a lot of discussion and I would love to get feedback because it's not been clear to me when those changes become material enough that we need to go back to FDA and say, we really think this is a fresh investigational device that that was not an incremental change. That was a material change. That's not been quite clear to us. As I say, once you've locked down a study to a specific protocol, you're good for a while. But nevertheless, the pace of technology change is such that even within protocols, we just can't do testing that we now know is, let's say, 2% less sensitive. That doesn't make sense. So this is a difficult question for us to understand is how frequently might you want us to come back to you in this era? Thank you. Cappuccino. I mean, I think there are going to be two types of situations to answer your question. There are labs who are developing methods and deploying them in clear cap regulated environments and who are used to thinking of, I would say, 90% of the things that FDA are concerned about and appropriately so. And in that environment, it's not a huge amount of extra work. It definitely is a learning curve to understand, for example, risk. That's not a clear cap type thing at all. There are some aspects of the device, as Jonathan has pointed out, that also fall beyond the remit of what we think is an LDT. So that matching doesn't necessarily fit that well. So there may be additional things there that we need to think carefully about, and are they in or out? I think if you're doing this type of genomic research outside of a clear cap approved laboratory, you may be in a very, very, very tough spot and may find it extremely difficult to continue. So that's a big change for genomic research, I think, is that really, you need to saddle up with a clear cap lab, get a board certified lab director, make sure that that individual is empowered, and putting in place all of the aspects of training and documentation related to the testing that's done. I definitely think second time round, we have a much clearer sense of what the FDA is looking for. That will help us to focus in on providing that information in an accurate and succinct manner and likely in our first application. We didn't quite get that. We weren't sure why we were providing information, or even whether it was relevant or not, and we have a much clearer sense of that. I would say my personal experience with the FDA was positive, but we did find that what Paula's been saying was true, that this was a team of people who were working alongside us. It was something which actually I benefited from and I think the project did. And I think also for IRBs who are somewhat new to this area, it can lead the IRB to have an additional level of comfort to know that a federal agency has specifically looked at a protocol. You know, I do have to say that I've been at FDA now for about seven years. And I do see that we've gotten better with IDEs, because we've gotten more familiar with them. And yeah, I think that we're learning as well. And our goal is to be, if you have questions, call the lead reviewer. And we benefit a lot from having the information that we need. So if we have a pre-sub and we can understand what you're doing, it's much better than if we have something where we're sending you back a lot of questions, because we can't figure out at all what you're trying to get done. With the IDEs, we do just have the 30 days. We are interactive. A few years back, we wouldn't do that, because we didn't have felt that we had enough time. So now we will ask questions and try to get to a decision in the 30 days without having a disapproval and any subsequent IDEs. I don't know about David is better versed in the resources that we have coming out to maybe help people. The pre-sub guidance document does have some good information. And we do have resources to try to help you put together the best submission you can put together for us to be able to start quickly with the file. I have one more question. Maybe it's a little bit random. So when you are assessing risk analysis for IVD, you're going through these potential exemption criteria. And one of them is if the same sampling is invasive and presents significant risk. So what we often see is that investigators are using samples that already been biobanked. However, at the point when that biobank was created, sampling was invasive, let's say it was a liver biopsy, that if done in present time would constitute four significant risk based on your guidance and the study could not be exempt. It would go into abbreviated ID. How do you reconcile these things? That's again another question that we were getting a little bit different answers from when we submitted different protocols. So I was wondering what is your opinion on that? Obviously when biobank is created, there is no device. So 812 does not even apply. But then once when you're taking samples for biobank, there is no risk to the patient at that particular moment. Then again, we don't want to create a loop in which investigator biobanks it for two days and then use it. So how do you see that process? I think we try to understand what happened and how much of that was a decision based on the study. So we try to understand how much of, so if you have patients that get biopsies as a standard of care, that may not raise something to a significant risk. But if the investigation is requiring that you get this procedure, that may be different.  So those might be, you know, those biobanks are because people got these biopsies. So just to clarify, sometimes we do have a clinical research protocol. So it's not part of clinical care or leftover samples. So there is a clinical protocol going through the RB in which it's clear objective is to take samples for research that will be used for some future unspecified research. And that goes into Biobank. So it's for research. But then again, like two months later, there is another protocol which gonna use those samples that been classified before. So it was not leftovers and it's not part of standard of care because I see what you mean there. It wouldn't be considered invasive in that case. So I haven't dealt with that. I'm not, do you guys have any thoughts on it? Yeah, it's, we may address this. I mean, I don't think it would occur to me that people would Biobank them for two days to avoid something, but. We have this question and then after you, we have a question from online. Rajeev Agrawal from ORWH and IHOD. So my question is if I'm using Dr. King's more technology, he already has ID exception. Do I need to again get an exception because I'm using his platform, which is already cleared or do I have to cross file to FDA to get exemption on how exactly I'm going to proceed? So you would come in independently because. So there is no exception to that because he already has approval from FDA and I'm going to use his technology in my lab that I can just use his exception or approval and move forward. You might be able to leverage some of that information to say that this is being, this is part of an investigation the same, but this is not an approved technology. You know, your study is NSR, I'm not familiar with it. So you would be able to leverage some of that, but this applies to each study. So every study is viewed separately. Sure, but like as far as IND is concerned, if a company has an IND and you want to use the same drug, you don't have to do the whole process. You can just do a cross filing against the original IND and get very quick review. So it's not the same here or similar. Okay. Well, we will address that later, yeah, for the use, yeah. And then I think we'll do our online question and move to break. Okay, this is a question from online. If a study searching for genetic variants that increases risk for disease does not return results to participants or their physicians, does it need this approval process? It seems to be something that would be NSR, but I think we'll get into that when we talk about risk determination a little bit more. That scenario is consistent with an NSR, but without really understanding the specifics of it, you know, we'd have to figure it out a little bit more. Thank you to both of our presenters and for answering questions, and we will take a break and get caffeine and get some energy in this room and meet back at 10 o'clock for analytical validation. Thank you.