In the first episode of Diamond Insights TV CAR-T mini-series, Eradigm’s Gala Farooq speaks to Dr. Álvaro Urbano-Ispizua, current Director for the Department of Haematology and Oncology at the Hospital Clinical Barcelona and a Professor of Medicine at University of Barcelona. In this insightful conversation, Dr. Álvaro Urbano-Ispizua shares his view on the future of CAR-T cell therapies in Europe, discussing outpatient administration, evolving treatment paradigms and his take on emerging scientific disruptors. He also sheds light on the current challenges in administering CAR-Ts, along with the immediate and perceived long-term impact of Covid-19 on the high-touch CAR-T model.
Alongside his work as a medical director and consultant haematologist, Dr. Urbano-Ispizua also leads research into stem cell transplant and CAR-T cell therapies in haematology at Hospital Clinical Barcelona, which has been recognised as one of the pioneering institutes for cell therapies in Europe. Dr. Urbano-Ispizua has extensive experience with both commercial and academic CAR-T therapies, and has authored over 180 articles in peer reviewed journals, with over 2400 citations. Beyond the clinic, Dr. Urbano-Ispizua has been the General Secretary of the European Bone Marrow Transplant Group (EBMT) between 1998-2004 and the President of the Joint Accreditation Committee of EBMT and ISHAGE until October 2006. He has also been a private consultant of the European Commission, and has formed part of the Official panel of experts of the European Medicine Agency.View full faculty here
Starring: Dr Álvaro Urbano-Ispizua i
Hosted by: Gala Farooq
From a physician’s perspective, while CAR-T therapies hold unprecedented clinical promise for multiple refractory patients, the high-touch treatment model and need for consistent monitoring for side effects places considerable strain on hospital resources and limits CAR-T to centres of excellence (CoE). Along with the restrictive pricing, this CoE model further reduces patient access to CAR-Ts. One potential resolution is moving to outpatient settings, as improved toxicity management protocols and predictable side-effect onset timelines for newer CAR-Ts could enable CAR-T to be administered as an outpatient infusion, followed by readmission as and when necessary for side effect management. However, as CAR-T therapies aim to move into broader patient segments and earlier lines of treatment, the pressure on hospital resources will only intensify, even in outpatient settings. The question as to the risk: benefit ratio and the value proposition for CAR-T therapies has therefore never been more relevant. In the first of our three-part series on CAR-T therapies, Dr Alvaro Urbano shares his opinions on the current challenges in administering CAR-Ts, where he sees the greatest value for CAR-Ts in comparison to other more traditional modalities, and how concepts such as outpatient therapy or off-the-shelf CAR-T manufacture would impact clinical practice in Europe.
In the second episode of Diamond Insights TV CAR-T mini-series, Eradigm’s Ilaria Coppola (virtually) meets and speaks to Joseph Mikhael. Dr Mikhael is a Professor at the Applied Cancer Research and Drug Discovery Division at the Translational Genomics Research Institute (TGen), an affiliate of City of Hope National Medical Center located in Phoenix, Arizona; he is also Director of Myeloma Research at Honour Health and Chief Medical Officer at the International Myeloma Foundation, the largest myeloma-specific charity in the world, and serves as a Councilor on the Executive of the American Society of Hematology (ASH).
As a leading multiple myeloma expert, Professor Michael is currently the principal investigator of several clinical trials focussing on the incorporation of immunotherapies into the current treatment algorithm. He personally contributed towards the development of Isatuximab (a CD38 monoclononal antibody, FDA-approved in May 2020 and now sold under the brand name Sarclisa by Sanofi) from its infancy. His other clinical research interests also include pharmaco-economics, communication skills and media relations, with over 100 peer reviewed articles in these fields.
Because of his deep clinical and commercial expertise, Dr Mikhael is the perfect interlocutor to discuss the current challenges of CAR-T access and the new challenges that arise once this therapy breaks into the wider multiple myeloma patient population. Don’t miss out!View full faculty here
Starring: Professor Joseph Mikhael i
Hosted by: Ilaria Coppola
Until recently, CAR-T has been limited to niche haematological indications, and it is just about to break into the multiple myeloma space with its disproportionately wider patient population. As mentioned above, this strains hospital infrastructures and complicates supply chains, while also posing a new challenge for manufacturers in terms of commercial access. How can pharma convince community physicians to break away from the standard of care and experiment with such innovative treatments? How can physicians ensure that patients are correctly referred to CoE centres and their experience seamlessly managed? What is the role of patient and physician education in ensuring high quality follow ups? In the second of our three-part series on CAR-T therapies, we speak to Professor Joseph Mikhael, Chief Medical Officer of the International Myeloma Foundation, about the current challenges of CAR-T access trying to capture both oncologists and patients’ perspectives.
In the third episode of Diamond Insights TV CAR-T mini-series, Eradigm’s Victoria Blackbeard chats with Dr. Rohin Iyer, Global Program Manager for Cell & Gene Therapy Market Support at Cytiva (formerly GE Healthcare Life Sciences), one of the leading providers of technologies and services that advance and accelerate the development and manufacture of innovative therapeutics. After achieving his Doctorate in Cardiac Tissue Engineering at the Institute of Biomaterials and Biomedical Engineering (IBBME) of the University of Toronto, Dr Iyer joined Tissue Regeneration Therapeutics and then moved onto GE Healthcare to specialise in process development for cell and gene therapy. Over his career in academia and industry, Dr Iyer has contributed to more than 24 scholarly articles and book chapters, as well as a number of white papers, application notes, and patents.
As current Global Program Manager for Market Support at Cytiva, his activities involve novel application development and range extension on numerous products, product care and support, R&D leadership, application note development, driving the company’s external scientific publication, conference and documentation strategy, validation guide development, knowledge database development, competitive benchmarking and cross-functional oversight of programs at several Cytiva divisions.
As a leading expert in the space, Dr Iyer will help us shed light on the commercial and competitive angles around CAR-T manufacturing and delivery, one of today’s hottest topic in the industry – don’t forget to tune in!View full faculty here
Starring: Dr Rohin Iyer i
Hosted by: Victoria Blackbeard
Finally, in the world of CAR-T, and, more generally, in that of cell therapy, it is notorious that “the product is the process”. There are multiple examples of manufacturing impacting both regulatory approvals (e.g. FDA’s refusal to file Ide-cel’s BLA in May 2020 and the more recent Liso-cel approval delay) and product performance (e.g. Kite touting 2-week turnaround time among their key differentiators). As manufacturers are subject to scrutiny like ever before, it is crucial to understand why, in the first place, manufacturing autologous cell therapies is so much more complicated than producing small molecules or biologics, why such processes are considered the industry’s most guarded secrets, and how difficult it is to incorporate new tech into existing operations. In the third of our three-part series on CAR-T therapies, Rohin Iyer, Global Program Manager for Cell & Gene Therapy at Cytiva (formerly GE Healthcare) gives us his take on the commercial and competitive angles around CAR T manufacturing and delivery.
From last-line to frontline: Clinical trials and a growing chorus of expert opinion suggest CAR-T’s true value lies in an early-line treatment
Venturing Out: How advances in remote monitoring solutions and tools may be the key to widening CAR-T treatment into the community
Cell and gene therapy represents one of the most exciting medical revolutions, and most complex commercial challenges, of our time.
In a world where the process is the product, and developers must provide not only a product but a service, we’ve found that solutions requires inter-disciplinary collaboration, broad thinking and an open mind.
What we do?
At Eradigm, we’ve partnered with big and small pioneering companies to help understand and address diverse commercial challenges in cell and gene therapy. Our experience stretches across leading on-market therapies like CAR-T, early stage breakthroughs like allogeneic and iPSC-based cell therapies, and enabling technologies like gene editing and manufacture.
How we can help?
We work with stakeholders across the value chain, including market intelligence, market access, commercial teams and senior leadership, to inform and enable strategic decisions.
Our work mostly falls into three distinct yet complementary core areas: competitive intelligence, market access and commercial strategy, including…
Market access – pricing and reimbursement assessment, competitor benchmarking, product launch planning, value dossiers, lifecycle management
Commercial strategy – asset strategy, portfolio strategy, corporate strategy, opportunity assessments, technology assessments, strategic workshops
To build the full picture, we combine comprehensive secondary research with primary insights from our global expert network, giving us access to over 300 vetted cell and gene therapy sources including leading physicians, payers and KOLs across the US, EU and APAC, and counting.