Convalescent Plasma: The Century-long Therapies Leading up to COVID-19
Originally Broadcast: Wednesday, September 30th at 2 PM EDT
On August 23, the
FDA authorized the emergency use of convalescent plasma in the treatment of hospitalized COVID-19 patients. Identifying and recruiting donors who have recovered from the COVID-19 virus and who possess the antibodies will be one of the outcomes of this webinar. Convalescent plasma is not a new therapy so to better understand its significance, our presenters will step through its evolution from breakthrough to becoming a treatment used for many viruses over the past 100-plus years. The discussion will delve into the effectiveness of using convalescent plasma as a treatment and focus on the potential risk factors that have raised questions regarding its true benefit. A deep dive into the considerations for blood product collectors will follow, including the recruitment of donors with the COVID-19 antibodies and how software is already assisting the majority of community blood centers and many hospital blood banks. Foundational to this discussion is where our current knowledge and software technologies will take us in terms of addressing future viral outbreaks.
Learning Objectives: After participating in this webinar, attendees will be able to:
Describe the evolution of convalescent plasma as a therapy in treating viruses of many types.
Identify the benefits and risks of convalescent plasma as a treatment.
Summarize the software tools used in on-demand recruitment of donors known to have the COVID-19 antibodies.
Avery W. Krouse Senior Product Specialist InVita Healthcare Technologies
Mike Deming VP, Client Services InVita Healthcare Technologies thank you for joining us for today's webinar on convalescent plasma. Before we begin, I would like to let you know that we will allow time for questions at the end of the program in order to get through all of the materials. First, at any point throughout the presentation, please feel free to submit your questions by clicking the button at the bottom of your screen. Our presenters will address those questions in the order they were received. Our presenters today are Mike Demming and Avery Crafts. Mike Demming is the vice president of Client Services for in Vida. Health Care Technologies has been working in the software industry on behalf of blood and plasma clients for more than a decade. First and Integrated Marketing Solutions, then that he Mattera Technologies, which relaunched as in Vida earlier this year. Avery Kraus is the manager of recruitment products for in Vida. He has worked in the industry for years, specializing in donor recruitment and communications. He's been with the Envied A team since 2015. Avery leads the client services team overseeing training, implementation and support for in Vidas donor recruitment drive, scheduling and staffing sweets. I am pleased now hand things over to Mike Deming to begin our conversation. Mike, take it away. Thank you, Peter. And welcome everyone to today's webinar. On behalf of the in Vida Health Care team, we appreciate you being with us. We know many of you and thank you all for the important work you do to serve our communities. Before we begin, I'd like to give you a brief overview of in Vida Health Care Technologies and also invite you to check out our new website at in vida health dot com. Our blood and plasma solutions have been expanded in our recruitment products. Serve as the basis for today's software technology discussion. As you may know, in Vida health Care is the new brand of two successful companies he material technologies and Champion health care technologies. As in Vida, we deliver health care technologies to complex medical environments. We make processes safer, more compliant and more cost effective. And Vita Healthcare delivers leading edge software that manages the full life cycle of blood plasma tissue implants and more are solutions air used by more than 600 customers across blood and plasma centers, hospitals, blood banks, hospitals and health systems. So Now let's take a look at today's topic. Convalescent plasma, a topic that has been in the spotlight a lot recently. We'll discuss its century long path to the FDA, authorizing the emergency use of convalescent plasma on August 23rd of this year in the treatment of Hospitalized Cove in 19 patients. Today will step through its evolution in broad use, and we'll look at its effectiveness as a treatment and potential risk factors that have raised questions about its true benefit. All of this will bring issues to the surface that blood pratt blood product collectors may want to consider. We'll also dive into the software technology that helps to identify and recruit blood donors who have recovered from the Koven 19 virus and who possess the anybody's. So let's get started While it's been around for a while. Convalescent plasma is a term that many people had not likely heard of until it surfaced because of the cove in 19 pandemic convalescent plasma or convalescent blood product, also known as CBP, is plasma that is collected from people who have recovered from the disease and whose blood is presumed to have anybody's for that disease. The basic idea behind convalescent plasma therapy is that people who have had an illness or recovered or convalesced have anybody's that make them immune from the effects of that disease. In most cases, those anybody's air present in plasma for a certain amount of time, ready to fight that virus if it should come back. Convalescent plasma is then transferred intravenously to people who do not have the anybody's resulting a certain level of immunity to the disease. The goal is that the antibodies present in the plasma of people previously infected and now recovered might help. Patients might help treat patients patients who are not on their own, able to fight a particular disease Outbreak from the 18 eighties to the antibiotic era convalescent plasma convalescent blood product was used to prevent and treat many bacterial and viral infections in humans and in animals. The first valid trial was done in 18 92 by the physiologist von Behring and Kita Sato, with the blood serum for the bacterial infection diptheria. Von Behring ended up winning the first noble prize ever given in physiology and medicine for his life saving work, developing a cure for diptheria, which was particularly fatal in Children at the time. His groundbreaking treatment, known as diptheria anti toxin, worked by injecting sick patients with antibodies taken from animals who had recovered from the disease during the pandemic influence outbreak of 1918 known as the Spanish flu. Fatality rates were cut in half for patients who were treated with blood plasma compared to those who weren't. The methods seem particularly effective when patients received the anybody's in the early days of their infection, before their own immune systems had a chance to overreact and then damage vital organs. 1934 a doctor at a private boys school in Pennsylvania tried using convalescent blood product still a unique method at the time, to fend off a potentially deadly measles outbreak among students at the school, Dr J. Roswell Gallagher extracted blood serum from a student who had recently recovered from a serious measles infection and began injecting the plasma into 62 other boys who were at high risk of catching the disease. Miraculously, only three students ended up contracting measles, and all were just mild cases. The treatment was groundbreaking enoughto warrant publication the following year in the American Journal of Public Health and By the late 19 thirties, convalescent blood products serum therapy was widely used to treat a range of infectious diseases such a scarlet fever and pneumococcal pneumonia. During World War two, biochemist Edwin Cone figured out how to split blood product into its component parts, making it possible for the first time to separate plasma from whole blood. Plasma on its own was much more shelf stable than whole blood, which made it possible to ship plasma overseas to provide lifesaving transfusions to our soldiers. After the war, medical advancements lessened the need for convalescent plasma as a treatment for infection. Infectious diseases and post war production of penicillin and other antibiotics took off, and scientists eventually invented antiviral medications in addition to preventative vaccines to protect against some of the older threats, like measles and influenza. One of the wider known modern uses of convalescent plasma is for the production of antivenom to ST to treat snakebites invented in the late 18 hundreds. Antivenom was and still is made by injecting small amounts of snake venom into horses and allowing the horse's immune system to produce antibodies that neutralize the poison. The equine antibodies are then isolated in a lab purified and distributed to hospitals as anti venom for human use. Today, the United States is the top producer of plasma products in the world, accounting for 2% of the country's exports in 2000 and 17. Convalescent serum therapy is still used as a treatment today for a few illnesses, in addition to creating treatments for bleeding disorders and antibody deficiencies. So how exactly is convalescent plasma obtained and how does it work? Within the human body? A person's blood is composed of approximately 55% plasma, with the other 45% being red blood cells, white blood cells and platelets. Convalescent blood products are obtained by collecting whole blood or plasma from a patient who has survived a previous infection and has developed Hugh moral immunity or adaptive immunity against the pathogen. This immunity is the body's ability to protect itself from infectious disease. When a person is immune to a disease, their immune system can fight off infection from it. The transfusion of convalescent blood products is able to neutralize the pathogen and eventually leads to its eradication from the blood circulation by giving plasma or serum containing anybody's to a patient infected with the disease provides the patient with a boost to their adaptive immune system, resulting in passive immunity with passive immunity. The body doesn't create its own antibodies, but instead borrows them from another person or animal who has successfully fought off the disease. Convalescent plasma therefore interacts differently with the immune system than a vaccine, which provides active immunity. When a person is treated with the vaccine, their immune system actively produces its own anybody's that will kill off any future exposure to the target pathogen. Unlike a vaccine, the passive immunity provided by convalescent plasma protection doesn't last forever. But the borrowed antibodies can help reduce recovery times and potentially be the difference between life and death. And now I'd like to hand the discussion off to Avery, who will continue with collections, donor recruitment and software technologies. Avery take it away. Thanks, Mike. And hello, everyone. Just a quick reminder that if you have questions for us, please input them at any time by clicking the button at the bottom of your screen. Now, let's continue. While I'm sure most of you will be familiar with the process for convalescent plasma collection, I'd like to provide a quick primer on the process. For those who aren't. The plasma donations screening process is similar to blood donation, as donors are asked questions about their health history. Unlike blood, Ah, plasma donation is drawn into a machine with a centrifuge to separate the antibody containing plasma through a process called a fairy sis. Following this process, the rest of the blood is returned to the donor's body. The side effects are similar to a normal blood donation, such as a slight feeling of dizziness or faintness. The body usually replenishes the lost plasma in a day or two. The plasma will then undergo tests to measure potency and identify transmittable diseases. Based on FDA regulations, a single donation can result in 2 to 4 units of plasma, each of which could be transfused after processing into a sick patient. Historically, passive immune therapy has taken many forms involving a variety of blood derived products such as convalescent, whole blood, convalescent plasma, pooled human immunoglobulin for intravenous or intramuscular administration, hi tighter human immunoglobulin and polly clonal or mani monoclonal antibodies. However, plasma collected by a fairy sis is currently two preferred therapy. Convalescent plasma has been the subject of increasing attention, especially in the wake of large scale epidemics like Cove in 19. Just like the diseases previously mentioned. When people get sick with Cove in 19 their immune systems generate antibodies to fight the disease, and those antibody proteins stay in their blood plasma. Prior to issuing its August 23rd emergency use authorization for investigational convalescent plasma in the treatment of Cove in 19 and hospitalized patients, the FDA concluded that based on the scientific evidence available, convalescent blood products may be effective in treating Cove in 19 and that the known and potential benefits of the product outweigh the known and potential risks of the product. The guidance provides recommendations on pathways for use of investigational convalescent plasma, collection of convalescent plasma, record keeping and compliance and enforcement policy regarding investigational new drug requirements for use of convalescent plasma. An emergency use authorization for convalescent plasma effectively licenses doctors across the country to begin treating cove in 19 patients with convalescent plasma. But it's unclear it this time if it will result in meaningful expansion in access to the therapy, in part because the supply is limited by the number of recovered patients who donate plasma we'll dive into donor recruitment in a little bit. According to the FDA, the emergency use authorization sanctioned the distribution of Cove in 19 convalescent plasma in the United States and its administration. Quote by health care providers as appropriate to treat suspected or laboratory confirmed Cove in 19 and hospitalized patients with Cove in 19. In a statement, Dr Steven Hawn, FDA commissioner, said, I am committed to releasing safe and potentially helpful treatments for Cove in 19 as quickly as possible in order to save lives were encouraged by the early promising data that we've seen about convalescent plasma. The data from studies conducted this year shows that pay plasma from patients who've recovered from Cove in 19 has the potential to help treat those who are suffering from the effects of getting this terrible virus. At the same time, we will continue to work with researchers to continue randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus. Theo. FDA made it clear, however, that the emergency use authorization is not intended to replace randomized, clear clinical trials and facilitating the enrollment of patients into any on of the ongoing randomized clinical trials is critically important for the definitive demonstration of safety and efficacy of cove in 19 convalescent plasma. The FDA recommends that ongoing randomized clinical trials of Cove in 19 convalescent plasma and other therapeutic agents remain unaltered as cove in 19. Convalescent plasma does not yet represent a new standard of care based on the current available evidence. The FDA is emergency use. Authorization came on the heels of several promising studies on convalescent blood products that showed its efficacy in treating co vid, as Dr Hahn mentioned during the early days of the epidemic. In March 27th 2020 issue of the Journal of Americal Medical Association, or J. M. A, the researchers from China reported the results of five patients treated for Severe Cove in 19 infections with post convalescent serum taken from recovered patients. All patients were treated, were treated, were on ventilators and we're all males who ranged in age from 36 to 73 years old. Within 12 days of receiving convalescent serum, the virus present dropped dramatically to zero all patients recovered from the virus by June 2020 the Mayo Clinic released data that indicated plasma treatment demonstrated clinical benefits following transfusion in a group of 20,000 patients, which included substantial enrollment from black and Latino patients. The studies was sponsored by the National Institutes of Health with the goal of broadening access to convalescent blood products as part of an expanded access program not designed to definitively test how well the treatment works, but instead to quickly get it to patients. The study showed that patients who received convalescent plasma transfusions within three days of their co vid 19 diagnosis had a seven day mortality rate of 8.7%. While patients who received plasma treatment after four or more days had a mortality rate of 11.9% this difference was statistically significant. However, the study did did not include a usual care group for comparison, so it's still unclear exactly how impactful the plasma treatment might be. MAWR rigorous randomized controlled trials of convalescent plasma are still taking place. However, the success of convalescent plasma therapy relies heavily on the donation of plasma by people who have recovered from Cove in 19 and have high concentrations of anti SARS cove to antibodies. It also depends on the safe preparation of serum to eliminate potential risk factors, such as the transmission of viruses via transfusion. An additional use for anti SARS cove to antibodies isolated from plasma is the development of hyper immune globulin, where the antibodies from many donors air pooled. According to the Lancet. Hyper immune therapies could offer a more consistent and predictable therapeutic option, and companies are already planning to test these therapies in clinical trials for Cove in 19 the potential risks of receiving convalescent plasma remain unknown. However, the FDA finds that the current clinical benefits outweigh the risks for coronaviruses. Several mechanisms of antibody dependent enhancement have been proposed, including the theoretical concern that antibodies to one type of coronavirus could enhance infection to another strain. Another theoretical risk is that antibody therapies may weaken the immune response and make patients more susceptible to re infection. According to the American Society of Hematology, over 72,000 people in the United States have received co vid, convalescent plasma and many more worldwide. Initial safety data has been published for the 1st 5000 patients in the U. S. Receiving convalescent plasma via the expanded access program. Based on those patients, convalescent plasma appears to be a relatively safe intervention. The incidents of severe adverse events was less than 1% most of which were deemed to be unrelated to convalescent plasma. Known general risks of plasma transfusion include allergic reactions, transfusion associated, circulatory overload and transfusion associate ID Acute lung injury, However, following the FDA is emergency use authorization. Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, cited concerns over weak data. Dr. Harlan Krumholz, director of the Center for Outcomes Research and Evaluation at Yale New Haven Hospital, states, quote It raises the question of what strength of evidence is necessary to treat during a pandemic. The problem is that we have yet to resolve what sufficient evidence is in order to change the treatment paradigm. On the other hand, Dr Terry Bigger Shimmer of the University of Washington School of Medicine in Seattle and her colleagues are recruiting recovered coded 19 patients to donate plasma. Dr Gurn Schumer noted in a recent interview. The thought of using convalescent plasma makes sense. It's something that we can try to give people to help them recover. It is not going to be any less safe than any unit of plasma that's on the shelf that comes from our volunteer donors. There are always transfusion reactions that we have to worry about, and there are potentially unknown pathogens that we don't yet know about and are not testing for. It is a risk we see with any unit of plasma. Aside from its use in the treatment of Cove in 19 convalescent plasma has shown toe have risks in treating other diseases. While there's been a long history of convalescent blood product usage, clinical efficacy has not been thoroughly studied and conclusions to date or week. Scientists believe this is likely because convalescent plasma was used in critical situations during massive epidemic or pandemic outbreaks requiring immediate action. One theoretical risk of administration of convalescent blood products is the phenomenon of antibody dependent enhancement of infection or a D. E. A. D has been described in other viral infections, such as dengue fever, and generates an enhancement of disease in the presence of certain antibodies. In the case of the dengue virus, receiving convalescent serum actually makes the patients worse as it causes the virus to replicate other general known complications of convalescent blood products like in the case of covert 19 include transfusion associate ID reactions seen with any blood transfusion. There is also the possibility that other known or unknown pathogens could be introduced to the patients in error. There is a risk for laboratory workers handling the serum, a practical way to measure which individuals have the highest tighter of antibodies needs to be established. And the use of support of therapies in addition to plasma will need to be investigated as well. Another consideration is that there are no large longitudinal trials that have proven the value of using convalescent blood products. Now that we've laid the groundwork for our discussion, let's dive into collecting convalescent plasma and considerations for blood collectors. At the top of that list is finding the right donors. While the FDA has made a push for using convalescent blood products in the treatment of Cove in 19 until a vaccine is made available, we recognize that there are a number of challenges associated with the use of convalescent blood products, ah, few of which we briefly touched on so far. First, the identification, selection and recruitment of potential donors for convalescent blood products can be difficult as con volition subjects must meet donor selection criteria in compliance with national policies and routine procedures for Cove in 19. In particular, potential donors must have had documented SARS Cove to infection and meet standard blood donor eligibility requirements. Fortunately, software is available to make the recruitment of these donors a simple task of targeted campaigns and push notifications. We'll get into that technology in just a minute. Most co vid 19 survivors appear to start increasing the tighter of antibody around 28 days post exposure. Therefore, the right donors will not be selected unless they have had a documented infection that began 28 days before they can donate plasma. The FDA also states that to be eligible for donation, the donor must provide a proven diagnosis of Cove in 19 and be symptom free for at least 14 days. Female donors must also be negative for human leukocyte antigen, or HLA antibodies, and all donors must test negative to Cove in 19 either by nasal pharyngeal swab or by molecular diagnostic tests from the blood. The FDA also advises that donors have defined SARS Cove to neutralizing antibody tigers with a tighter greater than one in 3 20 complicated right, But it doesn't have to be when using software to monitor these such requirements. Patients eligible to receive convalescent blood product donations must have severe or immediately life threatening infections, with laboratory confirmed Cove in 19. The FDA defines life threatening in this case as causing acute respiratory distress with increased respiratory rate and decreased blood oxygenation. One of the ways tow. Avoid complications associated with the transfusion of plasma would be toe Onley use purified antibodies derived from the serum of patients who have recovered from Cove in 19. Currently, individuals who themselves were treated with convalescent blood products for their own cove in 19 illness are not allowed to donate blood products, including convalescent blood products, for three months. Donations can occur as frequently as weekly for several months following clearance of infection before antibody tigers begin decreasing. Allowed donation frequency varies between blood centers. This level of scrutiny means that donation centers and blood banks need to be sure that they're targeting the right patients for plasma donations. In Vidas, specialized donor recruitment software is currently the only donor recruitment CRM that can help blood centers find and connect with specific donors who are candidates for life saving plasma donations. Let's take a moment to pause on this point because it is important for all blood collectors, especially hospital blood banks that are in immediate need to begin treating the patients in their own hospital. Hema Connect was the first software product developed in the Siris of blood management software offered by in Vida. It quickly became the market leading CRM ah position it has held for nearly a decade. Its popularity comes largely from its ability to manage large donor history data, integrate with other systems such as hospital ordering and demand, and then launch a multifaceted communications campaign to get the right product from the right donor at the right time. It offers intuitive work flows and configurations to fit any blood center or hospital blood banks procedures, in addition, toe helpful tools for staff performing donor recruitment, marketing and scheduling. It also provides a donor portal that is branded to your organization, allowing donors to manage their own donation experience. Hema Connect provides the ability to schedule convalescent plasma appointments and control eligibility through staff only booking. It also makes it easy to tag and recruit donors for convalescent plasma programs through a flexible assertions tool. Importantly, it also has the ability to display Cove in 19 antibody testing on the donor portal, including initial and confirmatory tests. Hema Connect empowers donors to schedule appointments, check test results and even chat with blood center staff to get more information about donating from any device. It provides blood centers and hospitals with an immediate connection to the blood products they need, even for convalescent plasma, even from donors who may already be within your hospital. And Vida takes pride in being able to offer a system that helps address the needs of hospitalized patients due to Cove in 19. If any of you would like more detail on him a connect or are other supply chain integrated products are contact information will be displayed at the end of the Webinar will be happy to speak with you now that we've covered donor recruitment. Let's move on to collections Proper Collection of a convalescent plasma had strict criteria. According to recommendations from an SBT working party on global blood safety, collection must be performed in certified blood establishments or hospitals and other health care facilities routinely engaged in performing whole blood collection with plasma separation and or a fairy sis procedures. Under special circumstances, collections must be performed by appropriately trained staff alongside the use of only legally approved blood collection or plasmapheresis equipment under standard operating procedures. The recommended volume of plasma to be collected is at least 200 to 600 ml without anti coagulant, based on the procedure and regulatory limits. Plasma units intended as for use as convalescent plasma, should be clearly labeled. This means that blood centers must be constantly aware of what they have in inventory to ensure that they are properly tracking convalescent plasma that could be used to save a critically ill patient in Vida offers. Inventory management software called him a control, which also integrates with Hema connect. If inventory shows less convalescent plasma than what's needed for demand, recruitment efforts can be put into effect immediately and automatically let us know following this webinar. If you have any questions about him, a control or its integration with him a connect. Like all blood products, proper procedures must be followed with convalescent blood products co vid 19 convalescent plasma, maybe stored frozen at negative 18 degrees Celsius or colder and has expiration date one year from the date of collection once thought it could be refrigerated for up to five days prior to patient transfusion. However, because of the potential importance of convalescent blood products and critically ill patients, the World Health Organization suggests that some donor selection criteria may be relaxed, particularly the plasma may undergo pathogen inactivation AH process designed to eliminate pathogens including viruses and bacteria from the plasma. In this circumstance, pathogen reduction could guarantee additional safety while simultaneously supporting less strict selection criteria for centers interested in or using this technology. The complex requirements for pathogen reduction bands and tracking can be easily managed using Hema Comply Lab. This software is our integrated quality control software, which also helps with regularly scheduled QC platelet qualification and re agent management again reach out to us to learn more, given the lack of information around the natural history of Cove in 19. In particular, pathogen reduction would add a layer of safety to protect recipients of convalescent blood products from residual anti gene variants of virus or other possible co infections in the recovered patient or donor. In addition to the challenges of finding the appropriate convalescent blood product, donors based on the FDA is guidance that we mentioned above. Two other major factors on convalescent plasma collections around Cove in 19 include record keeping and compliance, according to the FDA. Registered or licensed blood establishments collecting authorized cove in 19 convalescent plasma under the emergency use authorization or investigational convalescent plasma under an investigational new drug should refer to the guidance for recommendations on donor eligibility and qualification testing plasma for anti SARS cove to antibodies and labeling. Similarly, AH healthcare provider who is participating in an investigational new drug, including an expanded access or single patient investigational new drug for emergency use must maintain records for the investigational convalescent plasma units administered to the cove in 19 patients. Such records should include a unique identification number, such as the SBT donation identification number of the units. This is why having an automated an integrated software platform that can help track managed track and manage plasma throughout the recruitment collection, inventory testing and storage process is absolutely paramount in optimizing convalescent blood products. In Vida is here to help you get started, so that brings us up to where we are today. But what about the future and the use of convalescent broad products being used in the treatment of emerging viruses. As we've mentioned, convalescent blood products have continued to re emerge throughout history as a possible therapy during outbreaks of novel diseases. On average, around five viruses per year, of which 60 to 70% are transmissible in humans have emerged since 1940 which continued to keep convalescent blood products top of mind as a potential resource for treating some diseases. Additionally, in 2006 concern about a widespread outbreak of H five N one prompted the meta analysis of serum therapy. Around the same time, plasma was used to treat SARS patients with a small study indicating a reduction in hospital stays for patients who received convalescent blood products in the 30th and experimental convalescent blood product treatment for Ebola dramatically improved the condition of two Americans with the illness, according to a 2014 article in Annals of Internal Medicine. Positive results led the W H O to publish guidance on the use of the treatment for the Ebola virus. However, definitive clinical evidence showing the efficacy of convalescent plasma is limited in the midst of a rapidly evolving pandemic like cove in 19 therapeutic and convalescent plasma transfusions could be valuable given the lack of specific preventive and therapeutic options. The global reach of this pandemic and the desperate need for effective treatments for patients with severe and critical Cove in 19 is driving both basic science and clinical research at an unprecedented rate. Time will tell if convalescent blood products can improve outcomes for patients in a meaningful way, as the need for high quality research in this arena is vital. The current Cove in 19 Pandemic may provide a really opportunity to incorporate convalescent plasma therapy into a viable treatment option while the vaccine is being developed. And it is becoming increasingly vital to develop processes and protocols for the collection preparation administration, convalescent blood products in response to the current pandemic. That was a lot of information presented today, so I'd like to summarize with two key points. First, the use of convalescent plasma as a treatment in diseases such as Cove in 19 and many before indicates that it is on a path to continue to be used in the year to come. This will likely continue to increase as more studies analyze its benefits versus its risks for blood collectors. The challenges of compliance, donor recruitment, collections, testing and documentation can be overcome through the software already available from in Vida. Again. We're here to help just reach out, and we'll be happy to walk you through the entire process. Now I'll hand it back off to Peter to open the floor for some of your questions. Thank you and thank you both very much for the great presentation today. We have a lot of questions that have come in, so let's get right to it. The first one Avery is directed towards you on that question is our blood bank already has him a connect. How can we use it for CCP? We've not been and are not aware of this option. Certainly, that's a great question. There are a couple of different ways that our clients are using Huma Connect to manage their interaction with convalescent plasma as well as anybody. Testing the number. One way is simply through scheduling. One of the biggest challenges that blood centers face is the fact that, as we mentioned, you have to keep close track on the convalescent plasma donations and make sure everything is thoroughly labeled that the donors have they bring the proper paperwork with them if they receive their testing that they are properly registered and then that they meet the other selection criteria. So being able to schedule those donors in advance through controlled scheduling is pretty important right now. If they just booked themselves for a whole lot appointment, they might not necessarily know to bring with them all the things that they need or whether or not they even qualify. So our software allows you to control those schedules down to the staff only level to make sure that staff have an opportunity to consult with the donors and make sure they meet all the criteria and then allow them to come in. He also have the option to allow the donors to schedule themselves on the portal and provide additional supplementary information to make sure that they understand what criteria they have to meet before they actually donate. Excellent. Thank you for that comprehensive answer. Our next question. Gentlemen, I'm not sure who to who best to direct this to, so I'll let you all decide. Donors often get confused about their antibody test results. Does your software have the ability to provide educational information alongside the test results. That's a great question, and I'll feel that one as well. We absolutely do one of the benefits to the Hema Connect donor portal. It's really twofold. Number one. Our software for donor facing information, is actually branded to look like it's just another page on your website. So that makes donors who are experiencing some nervousness about the donation process or have a lot of questions feel at home on your on your donor portal, which just feels like it's part of your website. Along with that, we give you built into tools that we call user managed content to allow you to on the fly at any information that you need to even down to the thank you for booking appointments screen. If you want to include a link to, go ahead and fill out your questionnaire. If you offer that online or click here to download our convalescent plasma hint sheet that has all that information, any educational materials you need could be put right up on the portal. Same thing for the test results. Ah, lot of the different tests out there can be confusing. What does positive mean versus a negative. What about a non tested? What about confirmatory tests? And what are the differences between those? So you can also take advantage of user manage content in the test results section of our donor portal to include supplemental information that helps put the donor at ease over what it means when their test results. As this or that, Why am I seeing to test results on two different days? Why am I seeing different results? But between an initial test in a confirmatory test, all of those could be put right into the donor portal to help make sure that your donors understand the process and understand what their results mean. Excellent. Okay, again, the next question here, I'll let you decide who will respond. We use separate schedules for our convalescent donations, and it's hard to keep them separate from source plasma and normal. Avaricious. How do you handle splitting those up? Avery. I think that one's right up your alley again. Eso for that one. It's very much, as I said at the start of the questions, um, it is important to manage these schedules and to be able to manage them separately if you are booking. You know, let's say you only have one or two a freezes machines that your particular center. And while you're also collecting convalescent plasma, you need to also be drawing your platelets, drawing your regular plasma your source plasma. Uh, any of those combo products you will need to be able to manage those separately. So with him to connect, we offer a few different scheduling systems that let you either determine you have an individual schedule that is just for convalescent plasma and what the slots look like for that. Like, look like for that. Or you're providing a combo schedule that allows you to say, you know, if a donor is taking up the two oclock slot with convalescent plasma, I can't book another person at two o'clock for platelets because there's only the one bed and somebody's gonna be in there at the time. So we do offer options to make sure that you can either clearly separate them so that each schedule is independent, or put them together in a fashion that make sure you control overbooking and make sure your donor flow works smooth. Fantastic. All right, Our next question please. We remind you, you have the opportunity to same questions and if you like, and we'll get to as many of them this time will allow. But we encourage you to move quickly. If you do have a question next question up is you mentioned Push notifications? Our push notifications? Is that done through an app the donors download? How does that happen? Yeah, eso push notifications, Actually, fairly new offer that we've brought into the market and were the first organization to do so. The donors have the opportunity to download a white label app from the APP store. So if you go to the Google Play Store or the Apple App Store, you would be searching for the name of your blood center or the name of your hospital blood bank and be able to find the app for that blood center. The you know, whatever your blood center is, it's not a generic Hema connect donor or anything of that nature. It's a it's a totally white label AP. One of the features of that app is the ability to send push notifications to ping the donor right on their phone. So if we're particularly, you are reaching out to donors who have had a a positive antibody test but otherwise meet selection criteria. You could pick them right on their phone to say, Did you know a plasma donation could go to help other patients who are recovering from Kobe 19 and then immediately, with that, right on their phone experience, they can tap right in. Begin scheduling an appointment, and you will know that they meet the criteria that you need them to because you specifically selected those donors for that notification. Wonderful. Okay, Wow, the next. We have a lot of questions. The next question coming in. We don't allow all of our hospital partners toe order, convalescent plasma. It's all done through specific contracts. How does your software keep track of who can and cannot order it? E that one. So, yep, That would all originate in our Hema control software, which allows for hospital ordering of all types of blood products. We actually allow you to configure down to the hospital level within him a control which products they can actually order. So everyone of your hospitals could have could see different order forms, different blood products to be able to order or plasma products, whatever it may be. Eso yeah, we give you full control in that area to allow whichever hospitals can order that, you know, 10 or which which everyone's can't. So full control for the blood center's at that level. Fantastic. Thank you for that very much. Much like the next question we have is we're currently using the Hema connect CRM and offer antibody testing to our donors their way to pull in the antibody test results that are shown in the donor portal into the list. Templates and Hema connect as an include our exclude with a date range. I'm happy to read that again. That's a mouthful. I'm happy to read it again if you need it. Yeah, done that A number of times already so way certainly have. Yeah, it's absolutely possibly that. And in fact, that's one of the mechanisms that allows you to retarget those individuals who have a particular test results for future future communications. What this part for those who are not aware of what this this person is referring, Thio is our enlistment engine, so we in Hema connect give you a few different tools to allow you to find and target donors, whether that's taking a list that the lab gave you and uploading those donor IEDs or if it's building your own list using simple sets of criteria such as blood type, donation date eligibility, all of those kind of factors. So some of the information that we do have a human connect are those wellness test results. And, of course, up until this point are centers have been able to target donors based on, you know, hemoglobin or hematocrit levels based on other you know, cholesterol and things of that nature. Depending on which wellness results that they're using, the same thing can happen using your antibody testing results, because every test comes in with a specific date and because the tests will either have, you know, a value of positive negative not tested, re tested, depending on which tests you're using from which provider and how you're sending that data into Hema connect, you can take that data and use it as one of the selection criteria that you're using to target donors, so you might very well be looking for donors who have the positive result who are also eligible to donate plasma have given interval and then use that as a targeting mechanism for them. If any of you are currently on him a connect and not 100% on how that works, so free to give my team a call. I'm happy to get you in there and and show you where those queries are. And make sure that you're able to use that for for targeting those donors. Thank you very much. Every and the final question that we have right now Unless others come in, do you support the serious intercept system for your pathogen reduction tools? I trust I pronounce that correctly. The serious intercept system? Yep. Definitely. And I can jump in on that one. So, yes, and your desired split ranges and guard bands from the serious PRT system can be configured in human Comply. Hema, comply Lab eso. This allows you to see what products can be made from a mother bag. And if any volume reduction could create, um or opt. Hold on. So, yes, we do support that. Fantastic. Thank you very much. And that is the end of the questions we received for this afternoon. Mike and Avery, I want to thank you both for your time and this wonderful presentation. We'd also like to thank all of you for taking the time to be here. And we also want to thank you for the support. Thank you for joining today's program. And we look forward to seeing you next time. Yeah, yeah.