SCIENCE & INNOVATION: Concurrent Sessions
Beyond Boundaries: The Future of Regenerative Medicine, 3D Bioengineering, and CGT in Space
CHAIR: Uma Lakshmipathy, PhD, Thermo Fisher Scientific, United States
SPEAKERS:
- Doris A. Taylor, PhD, Organamet Bio Inc., United States
- Pinar Mesci, PhD, Axiom Space, United States
- Dhruv Sareen, PhD, Cedars-Sinai Biomanufacturing Center, United States
Imagine a future where science unlocks the power to heal, create, and explore in ways we’ve only dreamed of! Today, groundbreaking stem cell treatments are restoring vision for those with eye diseases, while next-gen technologies are crafting 3D tissues and even building hearts. And that's just the beginning. Soon, we’ll harness the unique environment of space to revolutionize cell manufacturing—paving the way for deeper understanding, faster advancements, and a future where seeing, feeling, and even traveling beyond Earth take on a whole new meaning. The boundaries of what's possible are expanding—get ready to see the impossible come to life!
SESSION OBJECTIVES:
- Discuss the most recent developments in enabling methods and technologies for CGT.
- Address the current challenges and bottlenecks toward reaching effective scale.
- Understand the effect of microgravity and the future potential for these unique approaches to accelerate biomanufacturing.
Moving Beyond the Vanilla: Employing Intelligent Therapeutic Design and Manufacturing Automation to Develop Multiple Cell and Gene Therapy Flavors
CHAIR: Matthew Hewitt, PhD, Charles River Laboratories, United States
SPEAKERS:
- Dan Getts, PhD, MBA, Myeloid Therapeutics, United States
- Ian Gaudet, PhD, Galapagos, VP, Head of US Technical Operations
- Aaron Foster, PhD, Outpace Bio, United States
Attendees will learn about several high interest topics within the space of automation and CGT. The first, intelligent cell therapy therapeutic design enables cells to adapt and thrive in challenging environments such as the solid tumor microenvironment. Next, the session will address the shift from ex vivo cell therapeutics to in vivo using LNPs and RNA. One key consideration is how to achieve the desired level of tropism and access to impart significant clinical benefit. Lastly, as demand continues to outpace supply in the commercial cell therapy market, decentralized manufacturing will be discussed as a potential solution. Critical to this is understanding what is needed to establish a decentralized manufacturing network from an automation and digital perspective.
SESSION OBJECTIVES:
- Discuss how therapeutic developers are employing synthetic biology to improve cell therapy functionality in oncology.
- Understand the potential shift as well as benefits from ex vivo cell therapies to in vivo and how this may affect therapeutic access.
- Understand how therapeutic developers can leverage automation in manufacturing to launch a decentralized manufacturing network to increase therapeutic access for patients.
Advanced Analytics: Harnessing AI and Cutting-Edge Technologies to Accelerate Cell Therapy Development
CHAIR: Marinna Madrid, PhD, Cellino, United States
SPEAKER:
- Dalip Sethi, PhD, MBA, Terumo Blood and Cell Technologies, United States
- Geoffrey Stephens, PhD, AiCella, United States
This session brings together pioneers in advanced analytics to address the most pressing challenges in cell and gene therapy development. Attendees will gain insights into state-of-the-art imaging techniques, AI-driven data analysis, and genomic profiling methods that are reshaping the CGT landscape. The session will showcase how these technologies can be leveraged to enhance product characterization, streamline manufacturing processes, and develop more robust potency assays.
SESSION OBJECTIVES:
- Explore cutting-edge analytical technologies to enhance characterization and quality control of cell and gene therapies, addressing critical bottlenecks in product development and manufacturing.
- Discuss how AI and machine learning can revolutionize analytics, leading to faster and more cost-effective product development.
- Provide practical insights on implementing novel assays to improve product consistency, efficacy assessment, and regulatory compliance across all phases of CGT development.
New Approach Methodologies (NAMs) and Non-Animal Models: How does CGT move forward along with FDA Modernization Act 2.0 and 3.0?
CHAIR: Shannon Eaker, PhD, Xcell Biosciences, United States
SPEAKERS:
- Ludovico Buti, PhD, Charles River Laboratories, Netherlands
- Ankur Singh, PhD, Georgia Institute of Technology, United States
Most researchers want to minimize the use of animals in scientific experiments. Whether from the vantage point of a research, medical or federal funding organization, the reasons to discover alternatives are numerous. Over the last two years, the US has reached a tipping-point where all are accountable to reduce animal use within life science research. The focus of this session is on 3D culture models (Spheroids/Organoids/Organ-on-a-chip/Tumoroids) as Non-Animal Models or New Approach Methodologies (NAMs). This is a sustainability initiative to reduce the need for animals and vivarium’s in life science research (FDA Modernization Act 2.0 and 3.0).
SESSION OBJECTIVES:
- Perspectives from Industry, Academia and Government on the current situation and strategies for using new approach methodologies and non-animal models.
- Provide real-world examples of the new approach methodologies and non-animal models.
- Highlight the inclusion and applications of AI and machine learning in new approach methodologies and non-animal models.
Building the Future: Multidimensional Strategies in Organ Regeneration
CHAIR: Julie Allickson, PhD, Mayo Clinic
SPEAKERS:
- Harald Ott, MD, MBA, United Therapeutics, United States
- Laura Niklason, PhD, MD, Humacyte, United States
- Toshiharu Shinoka, MD, PhD, Nationwide Children's Hospital, United States
Attendees will gain insights into the transformative potential of organ regeneration through a multidisciplinary lens, featuring presentations from leading experts who are at the forefront of this exciting field. The session will address critical issues such as the challenges of scaling tissue engineering solutions, the regulatory landscape for new regenerative products, and the integration of novel technologies into clinical practice. By examining successful studies and emerging research, participants will leave with a deeper understanding of the current state of organ regeneration and the future possibilities it holds.
SESSION OBJECTIVES:
- Highlight Innovative Approaches: To explore and discuss groundbreaking strategies and technologies that are advancing the field of organ regeneration.
- Showcase Successful Studies: To present case studies and research findings that illustrate the efficacy of current and emerging therapies in regenerative medicine.
- Foster Collaboration: To create networking opportunities among attendees, encouraging partnerships and collaborations that can drive further innovation in organ regeneration.