Hello everyone. Welcome to our webinar “Finding the right dose”, “Using patient data”, “Data reported in early phase clinical trials ". Welcome everyone to this extremely exciting session. In order to enable the interpretation service on Zoom, I invite you to follow the instructions on the transparency. You select the globe interpretation, you select your language. The webinar will originally be in English. You can click on your mother tongue if you wish. You just have to click. You also have a number of guidelines for using messaging and we will also share terms and glossaries that may be available after this event. We would like to thank our sponsors, our partners for supporting the IASLC program This year. The goal of our program is to help patients suffering from lung cancer. The objective of the program is to create a network to fight against lung cancer with a certain amount of research and also identify research advocacy opportunities. Some very important questions. We invite you to ask questions to our presenters using the question and answer session. Panelists will respond during the session questions and answers at the end of the session. I invite you to take a look at the guidelines in terms of linguistic interpretation. Messaging is not available for participants to exchange with each other. It's more for asking questions about the webinar and recording and will be available a little later in all languages that have been proposed. We have four presenters and a moderator who will share their expertise and their skills. First up, we have Dr. Belinda King-Kalimanis, Director of Patient Auguste Research at Longevity. Belinda worked within the FDA in the department of oncology. We also have a pre-recorded presentation from Anne Loeser, who was diagnosed with lung cancer at age 39, and 18 years later, chest cancer, breast cancer, within the PCDI. She established the PCDI, the institution that works within the framework of oncology advocacy to strengthen discussions between patients and doctors to select the right doses for patients. Our third speaker will be Lee Jones, who is a cancer survivor of the colon and who works on advocacy work in terms of cancer research. He works within several works councils. He has co-published a number of medical literatures as well. We also have Janice Cowden, who will be participating in the question-and-answer session. Janice works within the Dosage Initiative. She has been an active member of PCDI, the patient dosing initiative since 2021. We have also Janet Freeman-Dailey, who will moderate the Q&A. She is a freelance engineer, independent worker in a field of advocacy within teams Management. Our speakers will allow us to have a certain number of perspectives about the work we are going to concentrate on and focus on. Our first expert now has the floor. Just a second, please. Thank you, Sarah, for this introduction to the IASLC. Thank you for giving me the opportunity. You have the overview of our working hour. We are going to talk about drug manufacturing and therapies that are available. Next, I'll talk about the potential impact that patient experience data could have on dose optimization. Next, we'll explore the role patient research advocates can play in the areas of discussion. We will also talk about the initiative with a certain number of projects, with Anne Perdante, then Lee Jones. She will speak in terms of advocacy on cancer policies. Next, we will participate in a question-and-answer session. First, we will open our webinar with a discovery on drugs of medications, how they traditionally determine the dose. A number of very important terms are on screen that will help us follow debates in a much more flexible way. This is very important in trials, especially when doses need to be increased. All this is defined before the trial periods. There are maximum doses, that is to say the largest dose, without having to suffer from side effects. We will work on questions of maximum tolerated dose, patient experience data and also results concerning patient studies. We will also talk about patient preferences regarding treatments. The most important data are patient outcomes. These are studies of patient conditions and their treatments. Before moving on to dosing, I would like to provide an overview of the data regarding drug developments when they are being treated, when they are being tested. on humans. So you have the paradigm in terms of traditional development, drug implementation development in a linear, one-to-one sequential framework. weak process for drugs and also diagnostics development. It is therefore a pharmaceutical research and development process with a certain number of important points. We have medicinal propositions, target validation, lead identification, lead optimization. Today we are going to focus more on phase 1, but we will also talk about phase 2 a little later, phase 2 being Early Clinical Safety. The traditional dosing paradigm for anti-cancer drugs. We have the three points which represent three people who are taken in a trial and therefore you have the dose and the time. So you have the highest doses weak, without any toxicity, especially if you follow my little red laser. If we increase the dose, three new people, these are the three points that are accepted during the trial. We take into account the fact that side effects are not felt, always in terms of toxicity. Then we move on to the other three points. 50 mg, 50 mg, three people, one of these people in red has a problem with toxicity and that is not enough to go back. So three new people are involved in these 50 mg doses, no one has a problem in terms of of toxicity and we move on to the next step with three new people, 60 mg. But now we see that two people have a problem of toxicity, of limits in terms toxicity. So we go back down into the protocol, which is the recommended dose for the next study, for the next trial. You also have on the transparency three patients who are involved with 0 DLT, 1 DLT, 2 and 3 DLT. Why do we want to change dosing paradigms? Current dose selection is based on identification of the maximum tolerated dose, developed with cytotoxic chemotherapies in mind. Many trials now focus on molecular targeted therapies. Traditional assays can lead to doses that are insufficiently characterized before starting the registration trial. When we begin phase number 3, patients may receive targeted therapies for longer periods than typically seen with cytotoxic chemotherapies. Therefore, poorly characterized dose, schedule could result in additional toxicity without an increase in efficacy. The FDA is concerned that use of the current dosing paradigm may lead to serious toxicities that require a high rate of dose reduction, intolerable toxicities that lead to premature discontinuation and missed opportunity for continued benefit from the drug and potentially persistent toxicities or irreversible which limit the possibilities of benefiting from subsequent therapies, in particular with side effects which would be irreversible. To conclude, I would like to offer you an overview in terms of dosage in the 90s, when HIV was affecting populations. A British medical journal spoke slightly higher doses of 600 and 1500 mg. This was achieved by the New England Journal with lower doses of zivonudine. In 2002, the FDA, North American drug authorities and a number of co-authors have published a paper on changing drug dosages after these drugs have been approved. Researchers have been working on these questions. So, we We published a guide that brought together a number of guidelines for dosing in Japanese populations. In 2019, the patient dosing initiative was established. Then, Canadian authorities published a guide on changing drug dosages and on the timing in terms of immunotherapy on cancer treatments. The FDA presented a project, Project Optimus, to reform dose optimization and dose selection. In 2022, the IMA established a number of medical forums anti-cancer to optimize anti-cancer treatments in clinical practice. Now, if we want to focus on oncology issues, the Oncology Center for excellence, the US Food and Administration Oncology Center of Excellence, in 2021, established an FDA Oncology Center of Excellence and launched the project Optimus. The Optimus Project aims to educate, innovate and collaborate with businesses, universities, professional societies, international regulatory authorities and patients to move forward with a dose research and optimization paradigm in oncology studies that emphasize selection of a or multiple doses that maximize not only the effectiveness of a drug, but also its safety and tolerability. The objective being that the FDA can communicate its achieved in research and dose optimization through guidelines and other public meetings, provide opportunities, encourage developers of drugs and develop dose research and optimization strategies. In terms of draft guidelines to help drug developers to identify optimal doses, a certain number of important points in the guide work on the maximum tolerated doses, the dosage administered in one or more registration trials, that is, the trial or sub-study designed to evaluate the safety and effectiveness and support a marketing application, for these targeted therapies, and often the MTD or the highest dose administered in the dose escalation trial if the MTD is not defined. This paradigm can result in a recommended dosage that is poorly tolerated. Regarding patient-reported outcomes, PROs can provide a systematic and quantitative assessment of expected symptomatic adverse events and their impact on function. On patient engagement, engagement with patients and other key stakeholders, such as advocacy groups in a given disease area, will provide valuable input on important Safety and tolerability considerations when determining the optimal dosage(s). Now, regarding the patient reported concepts that the FDA has identified as important, symptomatic side effects using item libraries e.g. PRO, CTCA, CE, selection may be based on other medications of class or similar mode of action, on the use of the NCI core set or on the possibility of using a free text element. Furthermore, a Additional single global element could be included to assess the overall impact of side effects in the context of specific side effects. Now, physical functions using well-defined subscales, for example IoR-TCI, QLQ-C30, PROMIS, with a primary outcome for the FDA, early collection which can provide data to define thresholds for recording tests. During these early trials, other concepts, if any, could be captured, for example symptoms of illness. Decisions will depend in this context on illness or treatment. We can talk about colorectal cancers, for example. Is it a first treatment or an advanced treatment, a treatment that has already been tested by another patient? Now, what are the benefits of using early phase PRO data? The literature shows that symptomatic side effects tend to be underestimated by clinicians, as shown in the graph. The curves, in terms of fatigue, are moderate. Grades 2, severe. Ranks 3. Patients are experts in how they experience vital functions. The noses, too, are taken into account. PRO measures provide a systematic way to collect symptomatic side effects. Instead of asking someone to give their impressions in terms of their feelings about the treatments, we can work on this in a much more continuous way. So, the side effects less serious which can have a cumulative impact. Thus, these less serious side effects which may have a cumulative impact can be better managed in later phases clinical trials if there is early awareness, for example with the early use of anti-diarrheal drugs. This can be very important in the phase anti-diarrheal medications during the fourth month so that diarrhea does not become a major side effect. The differences now regarding the patients' symptoms. We have a certain number of criteria, terminologies concerning the questions diarrhea. Sometimes the side effects can lead to death. You see for example that there is the “never” option, the “never” option. Why should we see these differences in terms of reporting between doctors and patients? Concerning the terms of the CTSAE, in the event of diarrhea, in grade 1, an increase 4 bowel movements per day. In grade 2, an increase from 4 to 6. In grade 3, an increase from 7 bowel movements per day. In grade 4, a dangerous situation for the lives of patients. As part of the CTSAE, what role can you play in these discussions? It is very important that stakeholders, regulators, financial, the people who work on these trials, are trained on the values and on the approaches within the framework of inclusion of patient experiences and data on the study of dosages, ensure that they are involved in terms of pharmaceutical advice and that they can also participate in working groups with several stakeholders which could be organized under professional associations, government groups, patient advocacy groups. I have a link that is available also within the framework of the IRB, the institutional review office. Now I will hand over the floor to the next presentation. Thank you very much for your attention. Hello and welcome, my name is Anne Lausier and on behalf of the Patient-Centered Posing Initiative PCDI, I would like to thank ISLC for inviting me to present this overview of our work as well as our key learnings that we can share. For your information, PCDI was started by people with metastatic breast cancer, or MBC, four years ago. We aimed to mitigate the prevalence and severity of treatment-related side effects in patients with MBC. We quickly formed an advisory board of medical oncologists to ensure that everything we did was medically and ethically sound. We researched the leading cause of treatment-related toxicity and determined that it was mainly due to the use of the maximum tolerated dose, also called MTD, as the recommended starting dose, or RSD in oncology drugs. We also found studies in which lower doses of certain drugs were as effective as DMT and precipitated less toxicity. Our conclusion was twofold. So, if possible, change the MTD as part of a larger paradigm, but also encourage physician-patient discussions at the start of treatment and afterward regarding the best dose for the patient based on the patient's unique characteristics. We conducted two surveys. In 2020, we launched a survey of MBC patients and the year Next, we distributed a survey to medical oncologists who treated patients with MBC. The objectives of the two surveys were identical. We wanted to understand the prevalence and severity of MBC treatment-related side effects in patients. We wanted to know the level of doctor-patient communication about side effects. We also needed to discover the impact of lower doses on patient outcomes in terms of quality of life and effectiveness. Finally, determine the willingness of patients and physicians to discuss flexible medication dosing options together based on unique personal attributes of the patient. Essentially, we wanted to know if we were on the right track. We received 1,221 responses from patients and 119 responses from oncologists. Oncologist survey responses are in gold font and patient survey results are in white font. The vast majority of patients, 86%, reported experiencing at least one side effect related to the poor treatment. The majority of oncologists underestimated this by less than 60%. One in five patients experiencing side effects had to go to the emergency room, emergency room or hospital as a result. The oncologist's estimate was less than 15%. More than two in five patients had to miss one or more treatments and the oncologist's estimate was 37%. Almost all patients, 98%, told their doctor about their side effects and among patients who received a dose reduction, 83% felt better on a lower dose. weaker. 71% of doctors reported that patients felt better with a lower dose and that the effectiveness was similar to that of RSV. We also asked patients and doctors whether they think a higher dose is always more effective than a lower dose and more than half of patients, 85% of oncologists responded in the affirmative “not subscribing to MTD is a better paradigm”. Finally, we asked them if they would be ready to discuss flexible dosing options based on patient attributes and more 90% of both groups responded affirmatively that they were willing to take this path. These results therefore justified our mission. It was determined that yes, there is considerable prevalence and severity of side effects. Most patients who experience side effects tell their doctor. Patients felt better with a lower dose and the vast majority of patients and physicians would be willing to discuss flexible dosing options based on the patient's unique characteristics. Well, it's one thing to conduct surveys and another to do something with the results. So, in 2021, we had the chance to orally present the results of this patient survey at the American Society of Clinical Global Meeting Oncology. Since then, we have presented posters of our results and published a peer-reviewed journal article. Five months after our oral presentation of LASCO, the FDA announced it, it is clear from our patients that the drugs are too toxic. Patients deserve a more tolerable dose. This was the feeling of the patients. I would like to draw your attention to the fact that there is a migration away from the paradigm that more is better. Regarding experimental drugs, especially in phase 1, the optimistic project FDA encourages industry to evaluate at least two doses based on effectiveness and their tolerability, instead of automatically selecting the maximum tolerated dose. Regarding drugs approved on the market, the renewal of the project of the FDA is reviewing the dosages of some approved cancer drugs and the oral chemotherapy drug Zolota is the first drug to receive a updated dosage label for this program. And in the clinic, the PCDI continues to encourage physician-patient discussions about flexible dosing options. These will remain important because the drugs currently approved on the market will mainly continue to be prescribed using the old method based on the MTD. It will take time for drug development to actualize the new optimistic project paradigm. Real-world patient reactions may differ from those of clinical trial participants. And last but not least, we are all unique individuals. When it comes to key learnings about instigating change, we have learned along the way that you can engage patients and professionals, integrate them to your team whenever possible, conduct research, identify the root cause(s) of the problem, and evaluate the concepts to be resolved. Make sure everyone on the team recognizes that the only bad idea is what isn't said, collaboratively develop a mission and plan with strategies for testing and updating them. The data really speaks. Or you can conduct studies. I know there are confounding factors like AI, but you can conduct your studies. Evaluate the results against your mission and present them, publish them in wherever possible. If necessary, reassess and rework. The map to success is seemingly simple, but there is a lot of work to be done. It involves motivation, ability and perseverance. And finally, I want to share some key learnings about studying. The first is to avoid open-ended questions where the recipient has to fill in blanks. This involves considerable data cleaning and quantification problems. After developing your survey questions, test the survey for feedback from a diverse group of potential recipients. Plan how and where your study will be. What language and by whom will it be analyzed? We develop flyers in Spanish and English. Engage an IRB or institutional review board before launching your study. Run a no-response velocity graph throughout the study to find out if you need to do additional advertising or attract more participants. Our velocity graph is in white and at a lower point, we created this infographic on the right to encourage greater participation. And lastly, get it, get it out, present and publish your results wherever you can, informally and professionally. Last but not least, I would like to thank you for your attention. A big thank you to you! Thank you very much Sarah, thank you LLC, thank you for giving me this opportunity to speak during this webinar. These are important parts of my career, I am always happy to talk about my experiences and encourage other lawyers or other supporters to be particularly in research. As we all know, as a patient we need as much assistance as possible. There are two conflicts of interest I would like to mention regarding compensation by making part of the patient engagement board for Baird and Jen Baird and this is an example where you are compensated for the work of advocating and helping patients, which is extraordinary. Today I would like to talk about this webinar by actually highlighting how I became involved in this topic and give you context on how you can increase your support in the same way by finding opportunities here and there. First of all, it is important to participate in STAR, it is a great beginning. I had the chance to participate in training on cancer, it’s a program which went back ten years ago. We spent two and a half days meeting oncologists, radiologists, surgeons and we learned as much as we could about lung cancer and in those days we didn't have as much information as we do now, but we had to start somewhere. But what's even more important is that a cancer space, things in this cancer space, things move very quickly. So it was a very interesting and enriching experience. But something that came out of this training was that we didn't have a plan on how we should move forward, because it was difficult for some people, but it was good because we were able to actually demonstrate our interest in asking questions as caregivers and there I was able to actually speak in my cancer institution where I received my cancer treatment and I involved them in this network, in this oncology RIB and as stupid as that, I was also involved in two others, three other RIBs. This was mentioned by two previous speakers, but this was an extraordinary opportunity. This allows you to be part of these networks, allows you to have a lot of protocols and also to have patient consent. So I think it's very important from now on, in this world of cancer research, to have this consent, but also to be part of these RIB allows you to have the skills, to know what is a good protocol, what is a bad protocol and in particular, what is a good consent form. So the majority of these forms, they're just 20 page documents and everything has to, you really have to, you have to have a doctor to understand them, but we have an opportunity to correct this error by reviewing these consent forms and making changes and suggestions that can be incorporated in our feedback to sponsors. So I think it's something important to do. In 2018, I was invited by ASCO and the American Association of Oncology to be a member of a panel that is working on guidelines, after guidelines, for stage 3 cancer patients and this has demonstrated, in fact, for stage 3 cancers, in fact, three months of chemo is as effective as six months of the same drug which had less toxicity. I was really, it was of significant interest, because I had used this medication when I was going through this treatment, I was a stage 4 patient and we couldn't reduce doses. But what is very important and what crossed my mind, how many people have poisoned it over time, there I had my cancer in 2004, that means that I have been there for 20 years, how many patients were poisoned in a non- necessary because they were three months old and they had to suffer and this is the most important side effect and which has nothing to do, in fact, it is effects side effects that are not clinical and many people have not asked me about these side effects. That same year, in 2018, I was invited by the Cancer Research Center and I would like that you remember this research center because this research center is involved in a lot of experiments and a lot of treatments and there, we talked about tolerance, of tolerability of cancer and the definition of tolerability clinically, it is a, in fact, if the doctor tells you that you tolerate, that means that you will tolerate this medicine. Everything is actually based on the functions of the lung, the amount of medication, but we don't ask patients the question, how do you feel, does this suit you? So, as a patient representative in this group, I drew attention to this concept, why we cannot include the patient perspective in defining tolerability, because patients have a life and we all have the right to say I don't want to do it anymore, I don't want to do it anymore and of course, that's the final definition that is became like this, but it was a fairly significant change, the tolerability of a drug or chemical or asymptomatic or symptomatic effects following administration affect a patient's ability or desire to take that dose or to continue therapy. So an understanding of the patient means understanding the patient's measurement and how patients function and feel during treatment. When you can expect it, these direct measurements are based on the patient outcome. So here, interallability and patient outcomes were taken into consideration during the study. This is why it is very important for others and for other lawyers to be present and in this cancer.org research center, you will find this document and these studies, you have videos, you also have several of the sessions that we had and we have also started and this allows us to have opportunities to be a member of this panel group and to also be part of this group which includes the FDA, pharmaceutical companies, research centers and of course, lots of research. This might be intimidating because every day, but when you have heard several Sometimes disease experts, in fact, as a patient, we know things that they, that the experts do not have. In reference to intolerability, someone told me “I have a lot of learned a lot about intolerability and how we need to organize and take into consideration the patient perspective.” I spoke at the same meeting about understanding cancer tolerability and I had a colleague who spoke about the tolerability perspective and together we provided the lawyers' approach. In 2022, a friend brought together a group of stakeholders called PROs to talk about tolerability. On the first floor we talked about intolerability and intolerability, take into consideration patient intolerance in relation to the dose and we have also had excellent results for trials or experiments in the first phase or second phase which have not been done before. We were able to introduce the patient perspective in the third phase and we realized that the management of taking into consideration the patient's visions is to be able to be taken. This will allow me to move on to group number 4 where we started in April 2023 and this fits a little into the context of my presentation today. We look at first-phase trials or experiments in relation to doses for patients. Glenda had mentioned it and other colleagues had mentioned it. Clinical trials are based on chemotherapy where it's based that more doses than you give, the more you kill cancer, but the side effects will be even greater. Another study had demonstrated even in the world of chemotherapy, it was said that more doses did not mean better treatment. Chemotherapy is more about reaching a threshold and if you get to a threshold, at Within this threshold, toxicity becomes greater, but the drug begins to have its effect. You don't have to go higher and more toxic and everything becomes complicated. And there we use terms from pharmacokinetics and pharmacovigilance when talking about medications. And it becomes more difficult, especially in this world of chemotherapy. So my goal is to find what Anna and I are looking for is to have a effective dose that could have an effect. You know, we've been working on these doses for a long time, we're making progress, which is quite interesting. And actually, I thought it was important to start the clinical trials of Doreen. For what? Because I think the old clinical trials are different in the era we live in. It is important that we can adapt these clinical trials to the existing process and technology. Chemotherapy, radiotherapy, pharmacokinetics and so on should also be taken into consideration in these clinical trials. So I'll stop there. I think we have 15 minutes left for questions and answers. So I thank you once again for the time allocated to me. Thank you for your presentation. We'll move on to questions and answers. And we have one that was just put up. So are we going to give the links for what were the presentations that were discussed? Yes Yes Yes. Sarah will do it. So I'm going to put the link on... I had to do it actually, I had to put it on the chat. But I can assure you that Sarah will provide you with the links for the presentations on the chat and you can download them. Janice, do you want to talk very quickly about your experience on this topic? Janice? Janice, are you with us? I am with you. Sorry, I couldn't activate my microphone a bit. Can you just ask the question again? Can you tell us how you got involved in this so the assistant can know how you got involved? As for my involvement with the PCDI, I have been a lawyer with a passion for research since my diagnosis at seven years ago and I have known Anne for a while. I have been very interested in the research that PCDI has been doing since the beginning, but I was also interested in offering and sharing the surveys within the group of breast cancer patients on Facebook to get a little more participation. It was my first role at the very beginning, was simply to help the survey be disseminated and distributed a little and to have the patients register. And in 2021, I played the PCDR again as a member. Thank you very much for this sharing. We have several questions that came up in the question-and-answer session, but we also have other squash patients. We will not be able to answer all the questions, but we'll do our best. So Belinda and others, as for Melinda, I would like to know, what are the common misunderstandings people have about the use of patient reported data? So for the first clinical trials, we cannot talk about these, we cannot share, we cannot talk about the first clinical data either. We have seen several PR information, but we have to also say that this data can be subjective. And we have an element of subjectivity which are involved in these reports and which do not allow us to have results perfect. So, in fact, these subjective opinions prevent us from having good results in relation to patients and patient outcomes. What you need to know is that we let's collect this data with one hand, therefore with only one type of dose. And in what we do, in fact, we randomize all this information and we take the same considerations. And I think this is the biggest misunderstanding or prejudice that exists and that I hear. During the first phases. And that's what the majority of lawyers do. What I would like to say previously, it is that if patients have some ideas regarding their expectations in terms side effects, then it would be easier for them to tolerate. These are unexpected things. That means, when I was doing philanthropy, at a certain point, my hand was shaking and burning when I touched the refrigerator. She was burning me. But if someone had told me before, I had been told, then I would have understood. I had to go to my oncologist and I said there you go, my hands are on fire. But if we understood, these things were explained to us from the start, so maybe it would have been easy. It is not only a question, it must be explained to patients that they may vomit, that they may have diarrhea and so on. But their explain any side effects that may exist. Another element also is the delayed side effects. From time to time, we start treatment and three months later, you start to have a side effect. Maybe you have changed your treatment. It's about thinking. Is this the first treatment that has this effect on me or is this the second treatment? Patients often don't know. Are these side effects the first one? With immunotherapy, it's the same thing. You know, with immunotherapy, you may have side effects several years later. And doctors can't tell you. They do not know. Doctors cannot say. They can't tell you it's a drug and they send it to the oncologist. It is important that you talk to your doctor. Often, patients find themselves alone. They don't know who to contact. Another question. When you're in clinical trials, maybe it's important to take multiple doses. Maybe that we can start giving doses while waiting for the drug to be approved. Very good question. I don't think we have enough information. You know, at the FDA, we have this dose optimization strategy. This means that we have a bit of a scope or a range or a range of doses. This means that typically, in phase 2, in the past we have this dose of intolerability, but during this phase 2, we randomize the patients. And although maybe sometimes we don't have enough information, we don't have safety and security data, but I think it It is important that we can study this situation. But if you finish at phase 3 with an optimal dose, then you may not have the right dose when the drug comes onto the market or is marketed. So, from time to time, patients are not going to get the right dose. I think if you look at the Glendale for what it's been for the duration, phase 1 is so short for this multi-annual duration that this phase 1 will not have not much effect and will not affect the approval and marketing of the drug. On another drug, you talked in particular about doing this dose strategy in phase 1. When you try to find effective doses, are the strategies different dosages are different in phase 2? Sorry. It really depends. There are variations in this direction and things evolve over time. We have tests that do several, but the basis would be to understand what is done in a common and usual way for phase 2 at FX. There is an opportunity for doctors to change doses in phase 1 and 3. This is not not specified in the protocol. You certainly have this table where you can reduce the doses in the different therapies and phase 3, you will see the protocols. But these things, we don't have a lot of discussions along these lines and we don't really know how it we must move forward. But what has to happen is that I don't know if Jeanette will be able to answer this question because I don't know where to go with this question. So one question, we don't know. As soon as its dose strategy and the different levels dose have been determined and the drug is approved, how does this information regarding the dosage is communicated to oncologists? Can an oncologist make variations that are different from what was done in the trials? We have a discussion. In fact, it's quite complicated, but in fact, what you need understand is that the FDA mentions that the FDA regulates medical practice. When the medicine reaches clinics or hospitals, a lot is happening. You sometimes have the phase 4 where the company has made a commitment, has written a commitment to the FDA which relates to the dosage. Maybe the company is taking action to make a change or is making a change in dosage. The company could change the dosage rating to give a bit of a rest to people. This may be discussed and by the FDA to view or review or include Changes. But of course, there are always developments, but not always. But in the testing protocol, there are questions, there is information to include. Things can be complicate. We have the cooperative group that is still doing trials to understand these issues with a given drug. Jessica spoke about HIV and it's a study which was funded by the NIH. There is another medicine where the dose was changed after the approval of, yes, it was AsapKiné which was used. And regarding this medicine, it is that a PCI oncologist who shared with our group that several oncologists and even before that the drug was upgraded, were not informed of the new dose. What happened past is that a lot of these, so we were delighted that the oncology center of excellence has changed the label and dose. We have a few minutes, so I'd like to give each of you a minute to express one final perspective. Janice, you had plenty of time to express yourself. You have one minute, Janice. Thank you very much, Janet. I think truly that such workshops are critically important because not only are we educating other patients and patient advocates, but we are educating clinicians and we emphasize the importance of personalized medicine and optimal dosages for patients. Because as a blood cancer patient, the treatment is a marathon and we we talked about side effects where cumulative side effects can have an impact on the quality of life of patients. So if we can get it right from the start, then maybe that patients will stay on the medications longer and in return, patients can have a better quality of life and therefore a long life. Which is also quite true for patients with lung cancer. Anne, the floor is yours. Yes, finally, one of the things that What we need to keep in mind is that each of us is a unique individual in our own right. We are unique in race, DNA, including our own purpose and wishes personal. So, even with all these extra initiatives from the FDA and other partners, we believe that it is very important for patients and doctors to take into consideration the physical attributes of patients, including DNA and so on, DMI, but also objectives of each patient and even define the best medications for patients. And another reason in this sense, and everyone is familiar with this, is that in the tests clinics, patients are chosen based on inclusion and access criteria, while the reality is different. So access to these medications may vary in the real world. And this is the same for clinical trials and likewise, it is for this reason that this discussion between the patient and the doctor must be taken into consideration. I remember that in our experts, in our medicines, they can work, but we could also add that to the different treatments. By working patients and doctors and oncologists together we can better serve patients and medicines, improve outcomes, our outcomes, but also improve the outcomes of people who deal with our disease. Belinda? I don't know if I could add, you know, the panel said a lot of nice things. I completely agree as a researcher. You know, working with, with, you know, I met Janice and I wish I had the opportunity to work, I worked at Vanally during, and with Jeanette as well, and it was really a great pleasure to to work with them and to have, to develop this capacity of medicines and researcher, and add patient experience. And I'm always happy to have this conversation with people, because these exchanges are fruitful and very important. Thank you to all participants for explaining how dosage is so important and having, and the importance of having the patient perspective and the role of patient advocates or advocate caregivers, which is very valuable. Thank you for being present in this webinar and I wish you an excellent evening.

Finding the Right Dose

Patient Data

Early Phase Clinical Trials

Dosage Optimization

Patient Perspectives

Patient Advocacy Research

Patient-Centered Dosing Initiative

FDA Project Optimus

Personalized Medicine

Dosing Decisions