Panel discussion - Point-of-care cell therapy innovations: barriers and solutions
January 17, 2024 | 4:30 - 7:00 PM | Miami Beach Convention Center, Florida, USA
This 90-minute panel discussion, followed by a networking reception, will be held at Advanced Therapies Week 2024 (USA). Registration to the event itself will be required to attend the panel discussion. An invite to the panel discussion will not enable access to the venue.
Attendance to the panel is by invitation only. Places are limited.
Imec will be hosting an exclusive 90-minute panel discussion followed by a reception, at Advanced Therapies Week (USA) on the drivers and challenges to making point-of-care cell therapy a reality. The panel discussion will feature and be attended by key industry opinion leaders, and followed by a small reception.
Centralized cell therapy manufacturing is the dominant model today. While this model has led to clinical success, there are several drivers toward closed-system point-of-care manufacturing of cell therapies. Some of the main drivers are manufacturing scalability, cost, accessibility, and the ability to foster therapeutic innovations. At the same time, there are significant scientific, technical, logistical, quality and regulatory challenges that need to be addressed to make point-of-care cell therapy a reality. In this panel, we will address some of these key challenges in a discussion with industry key opinion leaders. It will be a unique opportunity to connect across disciplines from deep technology stacks like semiconductors, AI and compute (for example, cell sorting & sensor solutions) to the application, business, clinical aspects, and regulatory concerns.
The panel will focus on the following questions:
- What are the required measurement end points that are needed to allow for quality assurance at the point of care?
- Which innovations in process analytical technologies, measurements of critical quality attributes, and product release measurements (sterility, potency, etc.) need to be enabled at the point of care?
- How do we incentivize the industry to adopt new technologies and the regulators to approve their use?
- Can data sharing (potentially in a privacy preserving way) be leveraged to gain better insights into optimal quality assurance to the benefit of the patient?
Following the panel discussion, imec will facilitate a detailed white paper co-authored by the participants, which will be disseminated and may serve as the basis of more in-depth workshops.
Panelists
Rich Stoner - CEO, Exthymic
Dr. Stoner, a serial entrepreneur in the intersection of engineering and biology, is currently building a biotechnology startup focused on democratizing access to autologous cell therapies through point-of-care manufacturing. He previously served as the founding Chief Scientific Officer at Resilience, a venture-backed biomanufacturing startup, and as the CSO of Synthego, a CRISPR genome engineering startup. Dr. Stoner holds a Ph.D. in bioengineering from the University of Pittsburgh and completed a postdoctoral fellowship at UC San Diego.
Lee Buckler - Managing Director, Cell Therapy Group
Lee Buckler is a cell therapy executive whose experience spans across business development and senior management of CDMOs, non-profits, service and tools companies, and therapeutic developers. He is currently Senior Vice President of Advanced Therapies at the Blood Centers of America, working on leveraging expertise, facilities, and experience for decentralized processing and supply of biomaterials to U.S. hospitals; as well as Managing Director of Cell Therapy Group, where he consults businesses in the cell therapy & regenerative medicine industry.
Dorothea Ledergerber - CTO, Tigen Pharma
Dr. Ledergerber is a pharmacist and experienced biotech leader currently serving as Chief Technical Officer at Tigen Pharma, a biotech company dedicated to pioneering a distributed manufacturing model for autologous cell therapies, aiming to cut costs, and accelerate access to cancer treatments. She is an Independent Board Director at Cellaïon, contributing to the advanced-stage clinical development of HepaStem®, a highly advanced cell therapy platform to stop the progression of chronic liver disease. And has formerly held a key leadership role at Novartis, where she led the launch of the first commercial cell & gene manufacturing facility for the company in Europe. Dr. Ledergerber holds a Ph.D. in pharmaceutical chemistry from Saarland University.
Robert Hughes - SVP & Global Head of Tech Ops, Galapagos
Robert Hughes is currently SVP and Global Head of Tech Operations at Galapagos. Prior to this role, he was SVP & Head of Bioindustry at Miltenyi Biotec. He has held executive roles across a number of pharmaceutical and medtech companies, and contract research organizations. Furthermore, he has experience in manufacturing and quality control. Robert Hughes is a biology graduate from the University of San Diego and holds an MBA from Kaplan University.
Anthony Davies - CEO, Dark Horse Consulting Group
Dr. Davies, founder and CEO of Dark Horse Consulting, leverages his extensive leadership background in product, process, and manufacturing development to assist CGT companies. With past senior roles in the biotech industry, he played a key role in advancing cardiovascular therapeutics, pioneering oncology drugs, and achieving FDA clearance for the first hESC-derived product. Dr. Davies holds a Ph.D. in biochemical engineering from the University of Birmingham and an M.A. (Hons) in biochemistry from the University of Cambridge.
Boro Dropulić - Co-founder & Executive Director, Caring Cross
Dr. Dropulić currently serves as the Executive Director at Caring Cross, a company he co-founded to address the need for accessible gene therapies. Before this role, he orchestrated the acquisition of Lentigen by Miltenyi Biotec in 2014, establishing a global clinical network for CAR-T cell manufacturing. His earlier contributions include founding ViRxSys, where he demonstrated Lentiviral vector safety in humans. Additionally, during his tenure at Lentigen, he played a crucial role in developing key gene therapy technologies. Dr. Dropulić holds a Ph.D. in microbiology and pathology from the University of Western Australia, and an MBA from Johns Hopkins University.
Peter Peumans - CTO Health, imec
Dr. Peumans currently serves as the Chief Technology Officer of Health at imec, where he plays a pivotal role in driving advancements in life sciences through nanotechnology. He has previously held the position of CTO at miDiagnostics, a spin-off from imec and Johns Hopkins University. And served as a Professor at Stanford University, focusing on large-area electronics and biomedical applications, earning the National Science Foundation CAREER Award in 2005. Dr. Peumans holds a Ph.D. in electrical engineering from Princeton University.
Target audience
This discussion is designed for individuals engaged in cell and gene therapy related technology innovation, investments, clinical research, regulatory affairs, business, or non for profit activities.
Register interest
This panel discussion is organized by imec within Advanced Therapies Week (16-19 January 2024, Miami Beach Convention Center, USA).
Registration to the Advanced Therapies Week event itself will be required to attend the panel discussion. An invite to the panel discussion will not enable access to the venue.
Please register below if you are interested in attending the panel discussion. Due to limited capacity, invitations will be sent out to selected delegates at a later date.