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In the next portion of our discussion, we're gonna be talking about how to build a bi-specific program or become ready for delivering bi-specific therapy, especially in the community oncology setting. My name is Carolis Hanna. I'm an assistant professor of pharmacy at the Mayo Clinic College of Medicine. I'm also director of pharmacy at Minnesota Oncology, a large community oncology practice within the Twin Cities. Before we delve into our content and discussion, I just very quickly want to run through a couple of polling questions. Our first polling question here is a community oncology practice is preparing to launch by-specific therapy. Clinical protocols are in place, but nursing pharmacy, the oncology team, as well as the local hospital have not yet agreed upon who's responsible at each stage of care. What is the most important next step in starting up this program? Providing additional disease state education for the oncology team, establishing clear multidisciplinary responsibilities as well as communication pathways, or moving all step up dosing to the inpatient setting? And the correct answer here is establishing clear multidisciplinary responsibilities and communication pathways. We're gonna run into some content around why this is important as we operationalize by specifics in the community. When we look at bi-specific therapy and successful implementation of bi-specific therapy, it's very important for us to start off with the 30,000 ft overview. Many bi-specific therapies are considered T cell engagers while others are considered non-T cell engagers. As we look at implementing programs, it's not going to be a one size fits all in terms of the infrastructure and the key personnel that are going to be responsible in supporting and managing our patients, as well as how much resources are needed, uh, to help support a successful implementation and operationalizing by specific program. Really, a lot of the next couple of slides that we're gonna be discussing are going to be focused on the T cell engaging by specifics, as those are oftentimes um surrounded by adverse events like cytokine release syndrome or neurotoxicity syndrome as well as ICANNS as we heard earlier in the presentation. And in some cases, such as with multiple myeloma, we know that some of these T cell engaging by specifics may also be associated with a REMS program. So what do we do to ensure successful implementation and, and operations of these therapies? To start off, uh, many of us that might work in the community setting. We might not always have the infrastructure or hospital partnership uh that is required for successful implementation, especially around the ramp up phase of many of these bi-specific therapies. What I like to tell learners is that anytime we mess with T cells, uh, Strange things can happen, right? Like the CRS neurotoxicity and the ICANNs that I briefly alluded to. So we have to have protocols, policies, and procedures in place of what we do in the event or should uh an SCRS or neurotoxicity event occur in our patients. Now, I do want to emphasize that as we look at these by specifics, majority of the adverse events of interest that we're discussing. are oftentimes going to be grade 1 or grade 2 in nature, and many institutions have also adopted strategies to manage those particular adverse events in the outpatient setting, such as pocket dexamethasone or even utilizing things like acetaminophen to help support patients. But it's really important when we start to hit a grade 2 CRS or neurotoxicity event. Uh, or grade 3 and grade 4, that we have these particular strategies in place, uh, to be able to get to the patient to the right place that can safely manage, uh, the adverse event that might, uh, uh, present. And then also during the patient, uh, maintenance therapy, especially that we have protocols in place around self-monitoring or some type of monitoring for the patient, especially if you're doing this in the outpatient setting. So as you all can see here on the slide, hospitalization requirements, developing a program where you evaluate your particular uh resources and infrastructure and looking at your hospital partnerships is going to be critically important. Are your administrators and leaders comfortable with outpatient ramp-ups or do they prefer ramp-ups to be in the inpatient setting? Certainly, it's not a one size fits all. There may be patient populations where we might have to navigate between the different sites of care. And we also have to evaluate drug reimbursement and revenue, uh, dependent on the site of care administration. But in the event that we elect to do an outpatient ramp up for many of our patients, it's going to be very important for us to have SOPs or policies and procedures in place that clearly highlight. Um, and, and outline the escalation criteria of when you should admit the patient. That means to the ED or to the ICU based on potential complications that they're experiencing in the outpatient setting. Uh, I've already mentioned that there are going to be risk mitigation requirements such as the REMS programs. Um, so as we are implementing or adopting these bi-specific therapies, it's going to be critical for us to understand that. And I'll talk about, um, the role of an operational champion or institutional champion or even an authorized representative, uh, in just a little bit. The coordination of care between all of these sites of care is also going to be important. If the patient is receiving therapy in the outpatient setting and they call you after hours because they had a fever, for example, it's going to be important for us that we have clear communication and coordination, uh, if we're going to admit that patient to the emergency room, that the emergency room is aware that the patient is coming in. They know what type of measures we took in the outpatient setting, such as a steroid administration, for example, and potentially considering uh supportive cares like tosallizumab to help offset the cytokine release syndrome that the patient is experiencing, and then that ED may also have to coordinate and communicate with the ICU etc. depending on how aggressive, um, their adverse event might be presenting. We also want to make sure that we have all the right protocols and procedures in place within our treatment plans, within our protocols, within the electronic medical record to make sure that we are appropriately premedicating patients. Uh, it highlights the step up dosing criteria. Uh, that's going to be implemented or utilized within your organization. You'll find that a lot of these by specifics, while it might recommend you give therapy, for example, on days 14, and 7 or 14 and 8, you'll find that a lot of the prescribing information within these by specifics does allow an extension or a more aggressive approach, a more consolidated approach to the step of dosing. Um, depending on how the patient is doing. Sometimes if institutions are doing this in the hospital, they like to consolidate the step up doses as long as the patient is doing OK. So then you can minimize, um, how much, uh, how many, you know, days in the hospital the patient is gonna have to be admitted. Whereas in the outpatient setting, some institutions might extend that, uh, just to allow the patient enough time to recover and minimize some of the complications. There are other institutions that look at prophylactic strategies like prophylactic tosalizumab. There is certainly some data out there, um, that demonstrates that the role of prophylactic tosalizumab has reduced the incidence of CRS syndrome. As well as toxicity management protocols, when and if an event happens, uh, what do we need to do to help ensure that the patient is managed safely and appropriately and in a timely manner. Timely manner is critical because if CRS is not addressed very quickly, we can see the complications continue to escalate. So as you can see, just from highlighting, Uh, a couple of these key criteria, uh, the multidisciplinary approach in managing these patients on bi-specific therapies, especially the T cell engagers, uh, is crucial, uh, and to, and it's very crucial for us in the community setting to, uh, harbor these collaborative initiatives, especially if we are an out, uh, an outpatient infusion center that might not have, uh, an established hospital relationship. The multidisciplinary team is gonna be comprised of multiple individuals. Of course, the hematologist, oncologist, the physicians, the the the the PA, uh, the, the advanced practice provider, pharmacy teams, nurses, etc. But I do wanna call to your attention on the right-hand side. Additional members that sometimes now get more and more involved with these by specific therapies because of the unique toxicities that we can see with these therapeutics. You see here things like neurology, emergency medicine like I've already alluded to. You see intensive care. You also see infectious disease, social work, administration, of course, as well as quality. I'll spend a little bit of time emphasizing why these particular team members are important. And as you develop your program, why you need to think about these different disciplines. Neurology. Neurotoxicity syndrome or ICANS can lead to seizure disorders. Uh, many patients based on their eye score might be prone to having, uh, seizures, uh, associated with their, uh, bi-specific T cell engager. Thus, we might have to tap into a neurologist or neurology, and there are some recommendations of potentially putting some of these patients on prophylactic levetiracetam or anti-epilepsy medications.