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Hi, I'm Doctor Tara Graph, and I'm going to be taking you through module 2, which is from Evidence to implementation. We'll be discussing more about bringing bi-specific antibodies into the community. So, bi-specific antibodies in community practice, you know, there are some challenges, right? So, introducing bi-specifics into a community practice formulary can create implementation challenges that may be less common in specialized centers. The most important thing is to identify practice leaders to champion protocol development without having somebody at the helm, a physician champion if you will. This doesn't work. You've got to have somebody who has that passion and that drive and that dedication to really bring a team together in order to do this. Next step is really educating clinic and hospital staff involved in the care of patients who will be receiving bi-specific antibodies. Forming a team, which we'll talk about shortly, is number one, then providing that education, deciding who really needs to be involved, you know, who's gonna have their hands on the patients in each step of the care, and that's who you really need to make sure is being educated. You have to have established and coordinated approaches to managing by specific associated toxicities. We know there are some, you know, unique side effects with bi-specific antibodies like cytokine release syndrome and neurotoxicity that you need to be aware of. Staff need to be aware of, and you need to be able to recognize these. You need to have collaborative partnerships across the care network, and you need to assess and address patient and support the patient and the caregiver needs. So building readiness for community by specific antibody delivery is very, very important. You want to expand by specific antibody administration across practice settings, and this is key to really improving treatment access and patient outcomes. These patients, so many of them live in the community, and we want them to have better access to these novel therapies. Many community providers seek outpatient by specific antibody delivery but lack the training or infrastructure to support it. I've worked with a number of physicians that are really very, you know, well trained and apt and wanna do these therapies, but you need to have a support staff. You need to have nurses and APPs who can help you supporting delivery. Um, of these therapies to patients. By specific antibody-specific guidance for administration is currently limited in some settings, not everywhere. This is not a blanket statement, right? Some sites are really, really able to carry out these therapies, you know, um, quite regularly in their clinic, in their community practice. And consensus recommendations outline key considerations for safe and effective by specific antibody delivery in outpatient and community settings, as a bible, as a guide if you will, to help, to help patients safely be treated in the community. Outpatient treatment decisions should be individualized based on potential compounding factors and the overall clinical judgment of the healthcare provider. So let's get to our first polling question. Following further treatment, Sue now meets criteria for bi-specific antibody therapy, and treatment has been selected. Before the first dose is scheduled, what is the most important question for the community team to answer? A, which bi-specific antibody demonstrated the highest response rate in its pivotal trial? B, can our practice safely deliver the required initiation, monitoring and escalation pathway? C, whether Sue would prefer IV or sub Q treatment, or D, whether treatment can begin at her next routine clinical appointment. Cast your votes. So these are all really good questions, but the correct answer in this is, can our practice safely deliver the required initiation, monitoring and escalation pathway? This is something we must ask from a, from a safety standpoint, right? Are we, are we ready? Are we able? Have we dotted all of our I's and crossed our T's? Do we know what to do if a patient calls at 2 o'clock in the morning and reports a fever, right? So very, very important that you, you, the practice, the practice lead can answer this question before they opt to treat Sue at their location. So let's prepare for bi-specific antibody delivery in community practice. Key implementation considerations for outpatient bi-specific antibody delivery in community practice are listed below. What do you do before dosing? I mentioned, designate a project champion, a physician champion. I would say you need to have that lead. You need to have somebody who people can go to, to ask their questions, to lead that team. Training staff on toxicities and protocols at our site, you know, for over 4 years now, I have been that lead and I am the one along with my trained staff, a very specific group of people who've been with me for the last 4 years doing this. We provide in-services and ongoing education. It's not one and done, right? Therapies evolved, toxicities evolved, nuances evolved, and it's very important to regularly educate on these drugs because it's not one size fits all. Coordination with hospital and ED and, you know, who has a tosallizumab. A lot of community sites stock it in their office. You should if you're going to bring that patient in for intervention if necessary. But the hospital that you are partnered with or that you rely on if you need to admit a patient also needs to have it, and everybody needs to know where it's at. You don't wanna be scrambling at one o'clock in the morning. And establishing communication and triage workflows. Communication is so important. If everybody knows what they're supposed to be doing and has the plan, you know, plan for the worst, right? And then expect the best. And that's this, I cannot, cannot stress enough how important communication is, as well as having really, really great SOPs and escalation pathways to be able to, you know, people know what to do when they need to do it. And then after dosing, right? So educate patients and caregivers. We have an entire treatment. Teach that they have to go through the patient and the caregiver before a patient even receives therapy to make sure they understand their role, they understand what to watch for, how to use medical equipment, how to know if they have a fever. You wanna support self-monitoring at home. We ask patients to have their own medical equipment and we, you know, provide them equipment, um, when we can as well. You want to define who to call and when to escalate. You don't want them sitting on hold with an answering service for 30 minutes if they've got a fever and they need to be evaluated. And you have to know that you know the timing during step-up dosing of these drugs over the highest risk onset for cytokine release syndrome, so that you know when and how close to monitor these patients. This is so, so important. If you can kind of make sure that you check off each one of these things, then I think you're off to a really good start on getting these therapies into your, into your site to treat these patients. So a lot of this is, you know, we've been talking about it and we'll kind of build on each other, but internal planning and infrastructure set up. So, obviously, you have to have authorization to be able to give the bi-specific antibody, right? Insurance approval, as well as, as a supportive meds, right? And for some of the drugs we use in myeloma, we'll even use prophylactic tosallizumab. But you need to make sure that those drugs are covered before you administer them to the patient. You need to also build standardized electronic medical record pathways for CRS management or acute care. These documents, these escalation pathways need to be readily available in a moment's notice, so everybody knows where they're at, right? It's kind of like as a kid when you have a fire drill, you know, you have to know where do you go in the middle of the night if there's a real fire at your house, right? It's the tree, is it across the street? Like you have to have that plan in place so that you know what to do. You also want to ensure staff readiness to locate and administer Ptosi or anything else that's needed for intervention should a patient need to be evaluated and a, um, you know, a therapy given. And then you need to designate an outpatient treatment area for patients with concerns for grade 1 to 2 CRS. A lot of patients with grade 1 CRS, they don't really even have to come in, you know, you, as you get more comfortable with administration of these drugs, you can manage them at home. But, you know, if, if there's some concerning symptoms, if you're worried grade 1 might be turning into grade 2, if it's just a patient you're not sure because of other comorbidities, you bring them in, right? You always wanna go with your gut. Especially, you know, a grade, kind of a grade 1 that's sort of kind of going into a grade 2 based on vital sign changes. But you need to know the patient and the caregiver need to know where that address is, where that site is, what the designated area is for that evaluation. And you also again wanna make sure that you have the tosallizumab at the site you're bringing the patient to with at least 2 doses accessible for immediate use. Just again, you wanna have the plan in place in case you need to use it. So what does this multidisciplinary setup and training look like? I don't think of this as 1, then 2, then 3. I think a lot of these things are happening simultaneously, except number 1, you have to have the team first. Without the team, without this dedicated staff that could be made up of