Clinical Implementation Director

ImmunityBio shares rose 9.94% to $9.29 following a meeting between founder Dr Patrick Soon-Shiong and Turkish President Recep Tayyip Erdoğan. The meeting fuelled optimism about the company's expansion plans in Turkey. ImmunityBio has sought approval in various countries for Anktiva, an FDA-approved immunotherapy for non-muscle invasive bladder cancer. The drug has been accepted in 34 countries, including the US, UK, and Saudi Arabia. The company recently raised $100 million, with $75 million from Oberland Capital and $25 million from a debt-to-share conversion by Nant Capital LLC. Second-quarter revenues nearly doubled to $51.24 million from $26.4 million year-on-year, though net losses widened to $230.39 million. Institutional investors increased their holdings by 62.6% to $314.9 million in the second quarter.

Designing patient centric clinical trials: who is in the room when a protocol is written. On Public Day of the World Bladder Cancer Patient Forum 2026 in Hong Kong, Lauren Pretorius, CEO of Campaigning for Cancer, moderated Designing patient-centric clinical trials, joined by Alessandro Boni, Vice President of Associazione PaLiNUro in Italy, Dr Kenneth Chen, Senior Consultant in Uro-oncology at Singapore General Hospital, and Anjali Malhotra, Senior Vice President of Clinical Operations at ImmunityBio. Lauren set the terms of the discussion in her opening. "At the end of the day, a clinical trial is a person" she said. Every protocol is a set of decisions about what someone will be asked to do while they are frightened and on a road they have never travelled: how many hospital visits, how many biopsies, and whether anyone will ask them how they actually feel. Those decisions, she noted, are usually made in a room with no patient in it. Her challenge to the room was that everybody should leave with one thing they could do to make that journey easier. The patient view: a schedule nobody designed around daily life Alessandro brought three years of BCG treatment to the panel. If he had a time machine, he said, he would go back and ask the original researchers one question: where exactly did the treatment schedule come from? BCG was first used for bladder cancer 50 years ago, and the original six instillations were essentially accidental, followed by maintenance stretching to 36 months. That schedule still varies today, and it shapes patients' lives through travel costs, time off work, and the side effects they manage alone: burning, urgency, blood in the urine and flu-like fatigue. He was equally direct about what trials choose to measure. Researchers rightly focus on recurrence and progression. But when PaLiNUro asks its members what affects them most, they talk about quality of life, sexual and urinary function, and the burden of repeated biopsies. "If patient-reported outcomes are only secondary measures, we are telling patients that what matters most to them is of secondary importance." His practical case for involving patient organisations early was about trials working better, not just feeling kinder. Bladder cancer trials struggle with recruitment and dropout, often because trust is missing and people do not understand what they are agreeing to. Patient groups can co-create consent documents in language people actually understand, surface fears that otherwise go unspoken, and flag when a design is simply undoable. A trial requiring weekly cystoscopies (camera checks inside the bladder) may be rich in data and impossible to complete. As he put it, when patients are heard and respected they are more likely to enrol and stay, which means faster recruitment and better data for researchers. Inside the room: what a sponsor is juggling Anjali took the audience into the protocol meeting itself. Before anything is written, a sponsor maps the unmet need and the patient population, then runs feasibility work. Then the room fills up: * Scientists and clinicians, asking whether the drug will work in this population. * Pharmacovigilance, focused on the safety profile. * Statisticians, checking the data will actually answer the question. * Regulatory colleagues and medical writers, making sure the trial will satisfy the FDA or other regulators. * Nurses, added by ImmunityBio to its review process precisely because they are the ones beside patients in clinic and can say plainly when something will be too burdensome. International guidance is pushing in the same direction. The latest revision of the ICH good clinical practice guideline introduces "quality by design", which in plain terms means making trials simpler and less burdensome, and encourages patient advocacy input as part of a multidisciplinary approach. Her honest summary was that it is a balancing act rather than a single decision: less burden for patients, enough scientific validity, and enough evidence for regulators. But she made a clear case for bringing advocates in early. Feedback built into a protocol upfront means fewer amendments later, and where an extra visit is not required for safety or data integrity, there is real room to remove it. ImmunityBio also collects data the protocol does not require. Bladder preservation is not a primary or secondary endpoint in its trials, but patients kept saying it was what mattered most, so the company tracks it anyway at its own expense. A UK study of 86 patients who had received BCG, carried out with Fight Bladder Cancer, produced a finding that complicated the whole burden conversation: those patients said they would accept extra visits and extra tests if it meant keeping their bladder. In the clinic: the red flags Dr Chen looks for Dr Chen described the moment a trial is offered. The patient is either newly diagnosed or has just been told their treatment has failed, and is still absorbing the shock. The last thing they need is a doctor listing the frequency of cystoscopies, biopsies, imaging and blood tests. He tries instead to frame a trial as a partnership and to package the research question around something the patient actually cares about. His own recently completed study tested a urine test to detect bladder cancer, which answers one of the most common questions he hears: is there a better way to check on my cancer without all the procedures? When he reads a new protocol, two things make him uneasy: * Demands beyond standard care. Frequent visits, biopsies and invasive tests that go well past what a patient would otherwise have. If he doubts a patient can complete it, compliance and the trial itself are at risk. * An arm that disadvantages patients. No arm of a trial should fall below the standard of care. That principle, equipoise, is non-negotiable. His test for any design was memorable: it must be scientifically sound, honest about what it cannot answer, and built to protect patients' time, energy and dignity. On whether trials measure what patients care about, he was optimistic. Much of the field is now working on de-escalating surveillance, using urine biomarkers and urinary tumour DNA to reduce or supplement repeated cystoscopies. "What is convenient for the patient is really the crux of the matter, because that can be practice changing." The question from the floor: what about mental health? An advocate and general practitioner from Melbourne asked what is being done about the psychological burden across the whole pathway, including the anxiety of not knowing which treatment arm you have been allocated to. Dr Chen's answer drew a distinction worth keeping. Trials are now good at collecting quality of life measures, but there is a real gap around patient satisfaction and decisional regret, meaning whether people wish they had chosen differently. If a patient reports good quality of life while satisfaction is low, something important is being missed. Anjali added two things patients are not always told: informed consent is a process rather than a signature, and it should be written so anyone can understand it. Patients can withdraw from a trial at any point, though many fear that leaving means being left with no treatment at all. Both panellists pointed to advocacy groups as the support that fills this space, because the most useful information often comes from someone who has already walked the same road. One thing you can do The session ended where Lauren began. Nobody has to redesign the clinical trials system to make it more patient centric. A sponsor can invite an advocate to the protocol meeting instead of the results presentation. A clinician can ask what the trial costs a patient in time and dignity, not just in visits. A patient organisation can offer to rewrite a consent form before it reaches a single patient. And anyone writing a protocol can remember that at the other end of it is a person. Get involved. If your organisation is approached about a trial, ask to be involved at the design stage rather than at recruitment. Explore its resources and its global network to connect with members already doing this work. 31 May 2020 EVENT. Building Community, EVENTS Today the World Bladder Cancer Patient Coalition (WBCPC) has launched a newly developed start-up guide that will provide information and support to bladder cancer... 6 August 2020 EVENT. Engaging in Advocacy, EVENTS This year World Bladder Cancer is meeting virtually and hope to bring its event to an even wider global audience. The WBCPC 2020 Annual Meeting theme is... 2 February 2021 . Engaging in Advocacy, EVENTS Join World Bladder Cancer for the first Coalition Connection event, an interactive session that will examine the effects of COVID-19 and the innovative strategies patient advocacy... World Bladder Cancer Patient Coalition aisbl. Square de Meeus 38-40 1000 Brussels - Belgium Tel: +32 (0) 2 300 33 45 Registration Number: 0720.618.047 VAT: BE0720618047 Member of. For general information, information about membership or policy information, please contact the WBCPC Secretariat at [email protected]