Agenda
Philadelphia, 18 - 19 November 2025
Schedule
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Nov 188:59
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Welcome
Keynotes
Chris Shanks, Content Director, Terrapinn Holdings Ltd
Nov 189:00
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Chair's Opening Remarks
Keynotes
Rita Johnson-Greene, Chief Operating Officer, Alliance for Regenerative Medicine
Nov 189:05
Conference pass
Keynote Panel Discussion: State of the Industry Address for Cell and Gene Therapies
Keynotes
Moderator: Rita Johnson-Greene, Chief Operating Officer, Alliance for Regenerative Medicine
Cokey Nguyen, President and CEO, Atara Biotherapeutics
Huma Qamar, Chief Medical Officer, Ocugen
Tracy Dowling, Chief Business Officer & General Counsel, AskBio
Catherine Bollard, Senior Vice President & Chief Research Officer, Children's National Hospital
Nov 189:55
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Where are we heading with CAR-T for solid tumours?
Keynotes
Catherine Bollard, Senior Vice President & Chief Research Officer, Children's National Hospital
Nov 1810:15
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Unleashing the promise of T-Cell therapies: Treating patients with cancer and autoimmune conditions
Keynotes
Cokey Nguyen, President and CEO, Atara Biotherapeutics
Nov 1810:34
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Chair: Emma Ritchie, Senior Associate, Prevail Partners LLC
Start-up Pitch (Track 2, Seminar Theatre)
Emma Ritchie, Senior Associate, Prevail Partners LLC
Nov 1810:35
Conference pass
AI-Designed Polymer Nanoparticles: A New Frontier in Gene Delivery
Start-up Pitch (Track 2, Seminar Theatre)
Shira Orr, Founder and Chief Executive Officer, Envoya Inc.
Nov 1811:05
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Chair's Remarks: Dara Missan, Staff Scientist, Process Development, Mayo Clinic
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Dara Missan, Staff Scientist, Process Development, Mayo Clinic
Nov 1811:05
Conference pass
Chair's Remarks: Frederic Bushman, Professor and Chair, Department of Microbiology, Co-Director PennCHOP Microbiome Program, Perelman School of Medicine at the University of Pennsylvania
Gene Therapy (Track 5, 120C)
Nov 1811:05
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Chair's Remarks: Justin Skoble, Vice President of Technical Operations, Caribou Biosciences, Inc.
Supply Chain & Logistics (Track 8, 121 C)
Nov 1811:05
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Chair's Remarks: Yuntao Wu, Professor, George Mason University
Viral Vector Manufacturing (Track 7, 121 B)
Nov 1811:05
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Chair's Remarks: Deepu Madduri, Senior Director, Compound Development Team Lead, CARVYKTI, Johnson & Johnson
Cell Therapy (Track 1, Keynote Theatre)
Deepu Madduri, Senior Director, Compound Development Team Lead, CARVYKTI, Johnson & Johnson
Nov 1811:05
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Chair's Remarks: Petter Björquist, CEO, VERIGRAFT
Innovation Showcase (Track 2, Seminar Theatre)
Petter Bjorquist, CEO, VERIGRAFT AB
Nov 1811:05
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Chair's Remarks: Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs
Evidence, Pricing & Access (Track 3, 120A)
Nov 1811:05
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Chair's Remarks: Marcus Calkins, Director of Scientific Communication, GenomeFrontier Therapeutics, Inc.
Gene Modified Cell Therapy (Track 4, 120B)
Marcus Calkins, Director of Scientific Communication, Genomefrontier Therapeutics Inc
Nov 1811:10
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Adding imaging reporting genes to viral vectors
Viral Vector Manufacturing (Track 7, 121 B)
Michael McMahon, Professor, John Hopkins School Of Medicine
Nov 1811:10
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Clinical trials from start to finish: Achieving a joint approach to manufacturing
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Dara Missan, Staff Scientist, Process Development, Mayo Clinic
Nov 1811:10
Conference pass
Novel Modifier Gene Therapy (Gene Agnostic): Cure to Blindness Diseases
Gene Therapy (Track 5, 120C)
Huma Qamar, Chief Medical Officer, Ocugen
Nov 1811:10
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Supply chain strategies for allogenic cell therapies
Supply Chain & Logistics (Track 8, 121 C)
Nov 1811:10
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CAR-T cells for medullary thyroid cancer
Cell Therapy (Track 1, Keynote Theatre)
Don Siegel, Director, Division of Transfusion Medicine & Therapeutic Pathology, Perelman School of Medicine University of Pennsylvania
Nov 1811:10
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Precision gene therapy for heart failure
Innovation Showcase (Track 2, Seminar Theatre)
Matt Killeen, Founder, Vista Point Bio
Nov 1811:10
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Update on the European and US Ecosystem for cell and gene therapies: What does the future of ATMP policy and access look like
Evidence, Pricing & Access (Track 3, 120A)
Nov 1811:10
Conference pass
Clinical phase I data: Use of gamma delta T-cell therapy in complex adult Leukaemia’s
Gene Modified Cell Therapy (Track 4, 120B)
Lawrence Lamb, Chief Scientific Officer, IN8bio
Nov 1811:30
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Advancing Gene Therapy: Streamlined AAV production via next-gen cell lines
Viral Vector Manufacturing (Track 7, 121 B)
Robert Whitfield, Portfolio Manager, Cytiva
Nov 1811:30
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Next Generation Workflow: Modified TCR T Cells in a Hollow-Fiber Bioreactor
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Nov 1811:30
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Non-viral immune cell therapy for oncology & autoimmune diseases
Gene Therapy (Track 5, 120C)
Nov 1811:30
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Key considerations for success in investment and partnering in Biotech
Innovation Showcase (Track 2, Seminar Theatre)
Faizzan Ahmad, Managing Partner & Co-founder, Cure8bio Ventures
Nov 1811:30
Conference pass
Non-viral delivery of stably integrating DNA for in vivo CAR-T TCR therapy
Cell Therapy (Track 1, Keynote Theatre)
Nov 1811:30
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Patient Engagement and Advocacy in Gene Therapies
Evidence, Pricing & Access (Track 3, 120A)
Virginie Delwart, Director Patient Advocacy - Hematology, Oncology, Gene Therapy (CRISPR)/Rare Disease, Ophthalmology, Regeneron
Nov 1811:30
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Quantum Engine for Unlocking the Full Potential for Multiplex Cell and Gene Therapy
Gene Modified Cell Therapy (Track 4, 120B)
- Quantum pBac, a non-viral piggyBac-based vector to deliver sizable transgenes with improved effectiveness and safe integration profile
- Quantum Nufect for gentle and effective electroporation-based gene delivery
- iCellar for clinical-scale expansion of high-quality engineered cell products
- qCART implementation of Quantum Engine for rapid development and consistent manufacture of multiplexed CAR TSCMcells
Marcus Calkins, Director of Scientific Communication, Genomefrontier Therapeutics Inc
Nov 1811:50
Conference pass
Mechanisms and consequences of DNA integration
Gene Therapy (Track 5, 120C)
Nov 1811:50
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Novel skills and competency-based workforce development: Empowering the GMP manufacturing ready talent pool
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Domhnall McGowan, Regional Manager - GMP Sites and Training, Canadian Advanced Therapies Training Institute
Nov 1811:50
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Operational aspects of manufacturing T cell-derived iPSCs
Supply Chain & Logistics (Track 8, 121 C)
Nov 1811:50
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Working with a CDMO to optimize vector functional titer
Viral Vector Manufacturing (Track 7, 121 B)
James Adams, Chief Technical Officer, Tr1x, Inc
Nov 1811:50
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Precision bio materials for T-cell modulation
Cell Therapy (Track 1, Keynote Theatre)
Xiao Huang, Assistant Professor, Precision Immune Engineering Laboratory, Drexel University
Nov 1811:50
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Transforming Lives: How VERIGRAFT is Advancing Personalized Tissue Therapies for Serious Disease
Innovation Showcase (Track 2, Seminar Theatre)
Petter Bjorquist, CEO, VERIGRAFT AB
Nov 1811:50
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Access and pricing considerations for commercialising advanced therapies
Evidence, Pricing & Access (Track 3, 120A)
Craig Martin, Founder, CEO, Orphan Therapeutics Accelerator
Nov 1811:50
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Gene editing strategies for stem-cell derived therapies
Gene Modified Cell Therapy (Track 4, 120B)
Holger Russ, Associate Professor, University of Florida
Nov 1812:09
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Chair: Emma Ritchie, Senior Associate, Prevail Partners LLC
Start-up Pitch (Track 2, Seminar Theatre)
Emma Ritchie, Senior Associate, Prevail Partners LLC
Nov 1812:10
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Simplified Production and Smarter AAVs: The Power of AAVone® and ATHENA
Start-up Pitch (Track 2, Seminar Theatre)
Daozhan Yu, CEO and President, AAVnerGene Inc
Nov 1813:10
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Chair's Remarks: Elizabeth White, Chief Operating Officer and Co-Founder, Orphan Therapeutics Accelerator
Gene Therapy (Track 5, 120C)
Elizabeth White, Chief Operating Officer and Co-Founder, Orphan Therapeutics Accelerator
Nov 1813:10
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Chair's Remarks: Hemachandran Kannan, Director - AI Research Centre, Woxsen University
Supply Chain & Logistics (Track 8, 121 C)
Hemachandran Kannan, Director, Woxsen University
Nov 1813:10
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Chair's Remarks: Nolan Polson, VP Quality Assurance and Product Quality, Iovance Biotherapeutics, inc.
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Nolan Polson, VP Quality Assurance and Product Quality, Iovance Biotherapeutics
Nov 1813:10
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Chair's Remarks: Thomas Weber, Founder and CEO, Gene Therapy Consulting
Viral Vector Manufacturing (Track 7, 121 B)
Thomas Weber, CEO and Founder, Gene Therapy Consulting
Nov 1813:10
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Chair's Remarks: David Morrow, Scientist, EATRIS
Innovation Showcase (Track 2, Seminar Theatre)
David Morrow, Scientific Lead- Cell and Gene Therapies, EATRIS
Nov 1813:10
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Chair's Remarks: Joanne Kurtzberg, Professor of Pediatrics & Pathology, Duke University School of Medicine
Cell Therapy (Track 1, Keynote Theatre)
Joanne Kurtzberg, Director, Marcus Center For Cellular Cures,, Duke University Medical Center
Nov 1813:10
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Chair's Remarks: Alexander Natz, Secretary General, European Confederation of Pharmaceutical Entrepreneurs
Evidence, Pricing & Access (Track 3, 120A)
Nov 1813:10
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Chair's Remarks: Eric Hacherl, Chief Operating Officer, Kyttaro Therapeutics
Gene Modified Cell Therapy (Track 4, 120B)
Eric Hacherl, Chief Operating Officer, Kyttaro Therapeutics
Nov 1813:15
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Comparative overview of logistical considerations for autologous and allogenic
Supply Chain & Logistics (Track 8, 121 C)
Christopher Ballas, Global Commercial Lead, Custom Cell Products, Cook MyoSite Inc
Nov 1813:15
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Manufacturing Innovation and Operational Excellence to Boost a Cell Therapy Development Engine
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Nelly Viseux, VP, Cell Therapies Development, Manufacturing, Supply & Quality, Regeneron
Nov 1813:15
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Optimizing AAV delivery for gene therapies
Gene Therapy (Track 5, 120C)
Denise Sabatino, Research Associate Professor of Pediatrics, Perelman School of Medicine University of Pennsylvania
Nov 1813:15
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Revolutionizing Cardiac and Metabolic Disease Treatment with Gene Therapy Barriers with High-Yield, Low-Cost Manufacturing in Human and Animal Health
Viral Vector Manufacturing (Track 7, 121 B)
Daniel Oliver, Chief Executive Officer And Founder, Rejuvenate Bio
Nov 1813:15
Conference pass
INTASYL for adoptive cell therapy
Innovation Showcase (Track 2, Seminar Theatre)
Nov 1813:15
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The Mygotic Process™ The Next Advancement in Autologous Totipotent Stem Cells from Somatic Cells
Cell Therapy (Track 1, Keynote Theatre)
Arthur Sagoskin, Chief Scientific Development Officer, Mygogenesis
Nov 1813:15
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Overview of the current US payer landscape: Where are we heading?
Evidence, Pricing & Access (Track 3, 120A)
Nov 1813:15
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In vivo outcome of off-the-shelf engineered CIR™NK cells in multiple hematologic and solid tumors cells expressing HLA-G
Gene Modified Cell Therapy (Track 4, 120B)
Nov 1813:35
Conference pass
From process to patient: Advancing cell therapy commercialization with the Sefia™ cell therapy manufacturing platform
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Nov 1813:35
Conference pass
Gene therapy for X-linked retinitis pigmentosa
Gene Therapy (Track 5, 120C)
Daniel Chung, Chief Medical Officer, Beacon Therapeutics
Nov 1813:35
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Operational strategies for iPSC therapies
Supply Chain & Logistics (Track 8, 121 C)
Poh Yeh-Chuin, VP, Head of Tech Ops, Tolerance Bio
Nov 1813:35
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Plant-based manufacturing for AAV gene therapy ophthalmic indications
Viral Vector Manufacturing (Track 7, 121 B)
George Magrath, CEO, Opus Genetics
Nov 1813:35
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Exploring the opportunities of longevity medicine
Innovation Showcase (Track 2, Seminar Theatre)
Fiona Miller, Managing Partner, quadraScope Ventures
Nov 1813:35
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My patient journey: Access to care, clinical trials & CAR-T
Evidence, Pricing & Access (Track 3, 120A)
Tony Newberne, Patient Advocate, Patient Advocate
Nov 1813:35
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Novel approaches to gene regulation: Realising the value of epigenetic engineering
Gene Modified Cell Therapy (Track 4, 120B)
Amber Salzman, Chief Executive Officer, Epicrispr Biotechnologies
Nov 1813:55
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Gene therapy for cancer and inflammatory diseases
Gene Therapy (Track 5, 120C)
Shahrooz Rabizadeh, CEO & Co-Founder, Sagittarius Bio, Inc
Nov 1813:55
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Latest advances in manufacturing technology
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Houman Dehghani, Vice President, Technical Development, Cabaletta Bio
Nov 1813:55
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Logistical considerations when moving to a global based clinical trial
Supply Chain & Logistics (Track 8, 121 C)
Nov 1813:55
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Workforce development for ATMPs
Viral Vector Manufacturing (Track 7, 121 B)
Nov 1813:55
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Restoring vision with optogenetics
Innovation Showcase (Track 2, Seminar Theatre)
Zhenghong Gao, Chief Strategy Officer, Zhongmou Therapeutics
Nov 1813:55
Conference pass
Treating neurologic conditions in children with cord blood and cord tissue derived therapies
Cell Therapy (Track 1, Keynote Theatre)
Joanne Kurtzberg, Director, Marcus Center For Cellular Cures,, Duke University Medical Center
Nov 1813:55
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Overcoming barriers to patient access for CAR-T therapies
Evidence, Pricing & Access (Track 3, 120A)
Michael Lehmicke, Sr. Vice President, Science & Industry Affairs, Alliance for Regenerative Medicine
Nov 1813:55
Conference pass
Using CRISPR/Cas9® functional genomic screens across cancer models and immune cell types to identify the genome’s top therapeutic targets
Gene Modified Cell Therapy (Track 4, 120B)
Hugh Gannon, Associate Director, KSQ Therapeutics, Inc.
Nov 1814:15
Conference pass
A Practical Framework for Selecting Materials in Cell and Gene Therapy Manufacturing
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
- troduction
- A structured methodology for aligning material characteristics with process and product requirements.
- Evaluation criteria for sterility, extractables/leachables, and mechanical durability.
- Guidance on selecting materials for critical applications such as cryopreservation, fluid transfer, and electroporation.
- Tools to support early-stage decision-making and reduce downstream risk.
Conclusions
This framework addresses a critical gap in CGT manufacturing by enabling developers to make informed, application-specific material choices. By focusing on performance, compatibility, and process alignment, it supports more efficient, scalable, and compliant manufacturing. This work represents a significant step toward harmonizing material selection practices across the CGT ecosystem and accelerating the delivery of advanced therapies to patients.
As cell and gene therapies (CGTs) advance toward commercial readiness, the materials used throughout manufacturing particularly ancillary materials (AMs) and single-use systems (SUS) play a critical role in ensuring product quality, sterility, and process consistency. However, the absence of harmonized selection criteria and inconsistent supplier terminology often leads to inappropriate material choices that can compromise performance and delay development. This presentation introduces a practical, consensus-based framework developed by BioPhorum and industry stakeholders to support CGT manufacturers in selecting materials that are appropriate for their specific applications and process conditions.
Methods
A cross-functional team of CGT developers, suppliers, and regulatory experts reviewed global regulatory guidance (FDA, EMA, USP, ISO) and industry best practices. The team developed a structured process for evaluating material suitability, incorporating tools such as critical material attribute (CMA) identification, risk-based assessment models, and applicationspecific performance criteria. Elements of Quality by Design (QbD) were considered as part of this broader strategy to support robust material selection. The framework was refined through iterative feedback from BioPhorum member organizations and validated against real-world CGT manufacturing scenarios.
Results
The framework provides a practical approach to selecting materials that meet the specific demands of CGT processes. Key outputs include:
Donnie Beers, LS Applications Leader - Cell and Gene Therapy, Entegris Inc
Nov 1814:15
Conference pass
Creating Alternative Viable Funding, Development, and Commercialization Strategies for Rare Disease Gene Therapies
Gene Therapy (Track 5, 120C)
Elizabeth White, Chief Operating Officer and Co-Founder, Orphan Therapeutics Accelerator
Nov 1814:15
Conference pass
Mechanistic AI driven decision-making platform for viral vector production
Viral Vector Manufacturing (Track 7, 121 B)
Nov 1814:15
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Topic TBC
Supply Chain & Logistics (Track 8, 121 C)
Nov 1814:15
Conference pass
A pathway to bring non-viral CAR-T cell therapy to Brazilian patients
Cell Therapy (Track 1, Keynote Theatre)
Nov 1814:15
Conference pass
Controlling ice growth: Mitigating Cryoinjury and Transient Warming Effects to Improve Cellular Therapies
Innovation Showcase (Track 2, Seminar Theatre)
Nov 1814:15
Conference pass
Is the healthcare system ready to reward innovation in gene therapies for rare diseases?
Evidence, Pricing & Access (Track 3, 120A)
Oswald Bentinck, Head of Value & Access, Rocket Pharma
Nov 1814:15
Conference pass
Scalable platform manufacturing with gene edited iPSCs
Gene Modified Cell Therapy (Track 4, 120B)
Benjamin Fryer, CEO, Pluristyx Inc
Nov 1814:35
Conference pass
Analytical development for cell therapy manufacturing
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Jie Wei, Director, Bioanalytical Sciences, Tr1x, Inc
Nov 1814:35
Conference pass
Life in the fast lane – working toward accelerated approval
Gene Therapy (Track 5, 120C)
Nov 1814:35
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Novel platforms and processes for lentiviral vector production
Viral Vector Manufacturing (Track 7, 121 B)
Aziza Manceur, Research Officer, National Research Council Canada
Nov 1814:35
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FDA 2.0: What does this mean for Organoids?
Cell Therapy (Track 1, Keynote Theatre)
Nov 1814:35
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Utilizing EU academic infrastructure for developing cell and gene therapies
Innovation Showcase (Track 2, Seminar Theatre)
David Morrow, Scientific Lead- Cell and Gene Therapies, EATRIS
Nov 1814:35
Conference pass
Improving patient access and survivorship
Evidence, Pricing & Access (Track 3, 120A)
Tony Newberne, Patient Advocate, Patient Advocate
Nov 1814:35
Conference pass
In-vivo generation of therapeutic cells: CAR-T and beyond
Gene Modified Cell Therapy (Track 4, 120B)
David Peritt, Chief Scientific Officer, Lupagen
Nov 1814:55
Conference pass
Manufacturing engineered T cell therapy from whole blood
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
January McKee, Principal Scientist, Cabaletta Bio
Nov 1814:55
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Unpacking FDA’s Platform Technology Designation Program: Key Considerations for Sponsors Partnering with CDMOs
Gene Therapy (Track 5, 120C)
This talk provides a comprehensive overview of FDA’s guidance on the Platform Technology Designation Program and highlights considerations for gene therapy sponsors based on real-world experience and practical applications.
Discussion topics include:
- Key elements of FDA draft guidance for Platform Technology Designation Program launched in May 2024.
- CDMO’s perspective on considerations for sponsors to ensure the success of their gene therapy programs.
- Catalent’s approach to platform processes to accelerate AAV-based gene therapies to the clinic.
Philip Wills, Chief Commercial Officer, Catalent Cell & Gene Therapy
Nov 1814:55
Conference pass
Scaling to one million patients: Cross-industry lessons for cell & gene therapy
Cell Therapy (Track 1, Keynote Theatre)
Gene-modified cell therapies remain trapped in a high-cost, low-throughput paradigm, with ~40,000 patients treated to date versus the million-plus we must reach in the next decade. Solving the challenge demands new thinking. By fusing advanced analytics and agentic AI with proven playbooks from retail/CPG, automotive, agriculture, and fashion industries, we can compress vein-to-vein time, reduce costs, and enable quality at scale.
This session distils those insights into a five-step roadmap—people, process, data, tech, culture—to develop a scalable, adaptive value chain ready for the next million patients.
Nov 1814:55
Conference pass
Using AI to Accelerate CGT Supply Chain Maturity
Innovation Showcase (Track 2, Seminar Theatre)
Atit Patel, Binocs Implementation consultant, Bluecrux Inc.
Nov 1814:55
Conference pass
Patient access for CAR-T in Europe
Evidence, Pricing & Access (Track 3, 120A)
Susan Nichols, Chief Executive Officer, Propel Biosciences
Nov 1814:55
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Novel in vivo T-cell engineering
Gene Modified Cell Therapy (Track 4, 120B)
Nov 1815:15
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Mutation agnostic gene therapy for neurodegenerative diseases
Gene Therapy (Track 5, 120C)
Nov 1815:15
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Optimizing Supply Chain and Logistics in Advanced Therapies Using Predictive Analytics
Supply Chain & Logistics (Track 8, 121 C)
Hemachandran Kannan, Director, Woxsen University
Nov 1815:15
Conference pass
Overview and Progress of CAR-T Cell Therapy Manufacturing Development
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Kaiyuan Jiang, Associate Director, API Cell Therapy, Johnson & Johnson Pharmaceutical R&D
Nov 1815:15
Conference pass
Scalable, Serotype-Agnostic AAV Process Eliminating 2-steps (DNase and TFF)
Viral Vector Manufacturing (Track 7, 121 B)
Rok Žigon, Sara Drmota Prebil, Janja Merkelj Koren, Tomaž Švigelj, Mirjam Krašna, Maja Štokelj, Andrej Mihevc, Ivana Petrovič Koshmak, Petra Dekleva, Sandra Potušek, Melita Semič, Maja Leskovec, Ažbe Žnidaršič, Teja Nusdorfer and Aleš Štrancar. Sartorius BIA Separations (Ajdovščina, Slovenia)
This study proposes a streamlined alternative to traditional AAV downstream processing, focusing on reducing the number of steps while simultaneously improving both recovery and process efficiency. We demonstrate a novel approach comprising just five integrated steps shown to work on various serotypes (AAV8, AAV9, AAV2).
By optimizing the treatment conditions and eliminating redundant steps such as DNase digestion, we achieve higher viral yields and reduce the overall time for processing. This approach not only improves the scalability of AAV production but also offers a more efficient and cost-effective pathway for the production of AAV-based gene therapies, potentially accelerating the clinical application of these therapies.
Nov 1815:15
Conference pass
Delivering innovation in healthcare: Verismo Therapeutics
Innovation Showcase (Track 2, Seminar Theatre)
Pavel Aprelev, Director of Corporate Development, Verismo Therapeutics
Nov 1815:15
Conference pass
Unlocking CAR-T Therapy Potential: Screening of Small Molecule Libraries for Enhanced CAR-T Production
Cell Therapy (Track 1, Keynote Theatre)
Guangai Xue, Senior Scientist, Cell Therapy Development Operations, Global Operations, AstraZeneca
Nov 1815:15
Conference pass
Market access considerations for Myeloma
Evidence, Pricing & Access (Track 3, 120A)
Jordan Schecter, Vice President | Multiple Myeloma DAS Leader, Johnson and Johnson
Mike Spencer, Vice President of Oncology Market Access, Johnson & Johnson
Nov 1815:15
Conference pass
Using platform technology to perform effective in vivo T-cell modification
Gene Modified Cell Therapy (Track 4, 120B)
Cecile Bauche, Chief Scientific Officer, Alaya.bio
Nov 1815:35
Conference pass
Harnessing technological innovation to support allogenic manufacturing
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Lior Raviv, CTO, Pluri
Nov 1815:35
Conference pass
Insight on the Parkinson’s Disease Program: How targeting a genetic population enables entry into a larger market of sporadic PD?
Gene Therapy (Track 5, 120C)
Nov 1815:35
Conference pass
Managing cell supply to ensure consistent development and delivery of cell therapies
Supply Chain & Logistics (Track 8, 121 C)
Nov 1815:35
Conference pass
Process development and validation strategy for gene therapy
Viral Vector Manufacturing (Track 7, 121 B)
Nov 1815:35
Conference pass
Advanced Vigilance for Advanced Therapies
Innovation Showcase (Track 2, Seminar Theatre)
- Define the Vigilance challenges in the ATMP Landscape
- Present Modernised Long-Term Vigilance Frameworks Fit for ATMP Innovation
- Connect Vigilance to Regulatory Success and Patient Safety
- Promote Industry Collaboration for Cost-Effective Vigilance Innovation
Advanced therapies bring exciting possibilities — but also new safety challenges.
In this session, PharSafer will explore how vigilance practices must evolve to keep pace with ATMP innovation. From delayed risks to lifecycle monitoring, the talk outlines modern, long-term safety frameworks that support both regulatory success and patient confidence. With a focus on practical solutions, it also highlights how industry collaboration can drive scalable, cost-effective approaches to safety in this rapidly advancing space.
Nov 1815:35
Conference pass
Unlocking the full potential of hepatocytes to become commercial medicines
Cell Therapy (Track 1, Keynote Theatre)
Tom Lowery, President & CEO, Satellite Bio
Nov 1815:35
Conference pass
Shaping the environment in the US to support the successful commercialization of rare disease gene therapies for paediatric populations
Evidence, Pricing & Access (Track 3, 120A)
Nov 1815:35
Conference pass
Emerging novel technologies to enable in vivo cell engineering as an alternative to traditional cell therapies
Gene Modified Cell Therapy (Track 4, 120B)
Nov 1816:25
Conference pass
Chair's Remarks: Hernando Lopez-Bertoni, Associate Professor, Johns Hopkins School of Medicine
Gene Therapy (Track 5, 120C)
Nov 1816:25
Conference pass
Chair's Remarks: Priya Baraniak, Chief Commercial and Development Officer, Pluristyx
Supply Chain & Logistics (Track 8, 121 C)
Nov 1816:25
Conference pass
Chair's Remarks: Stephanie Maistrellis, CEO + Partner, LEAD Life Sciences
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Stephanie Maistrellis, CEO, Lead Life Sciences
Nov 1816:25
Conference pass
Chair's Remarks: Yuntao Wu, Professor, George Mason University
Viral Vector Manufacturing (Track 7, 121 B)
Nov 1816:25
Conference pass
Chair's Remarks: Lara Ionescu Silverman, Principal Consultant, LIS BioConsulting
Innovation Showcase (Track 2, Seminar Theatre)
Lara Silverman, Principal Consultant, Coeptis and LIS BioConsulting
Nov 1816:25
Conference pass
Chair's Remarks: Prachi Narayan, Independent Expert
Cell Therapy (Track 1, Keynote Theatre)
Prachi Narayan, Global Product Quality and Stability Operations and Clinical Science, Independent Expert
Nov 1816:25
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Chair's Remarks: Nneka Onwudiwe, Former PRO/PE Regulatory Review Officer, FDA
Evidence, Pricing & Access (Track 3, 120A)
Nneka Onwudiwe, Former PRO/PE Regulatory Review Officer, Food and Drug Administration (FDA)
Nov 1816:25
Conference pass
Chair's Remarks: Marcus Calkins, Director of Scientific Communication, GenomeFrontier Therapeutics, Inc.
Gene Modified Cell Therapy (Track 4, 120B)
Marcus Calkins, Director of Scientific Communication, Genomefrontier Therapeutics Inc
Nov 1816:30
Conference pass
Applying established quality systems across the CGT supply chain
Supply Chain & Logistics (Track 8, 121 C)
Jeff Wren, Vice President, Biotherapies, AABB
Nov 1816:30
Conference pass
CMC strategy for late stage development of AAV-based gene therapy products
Viral Vector Manufacturing (Track 7, 121 B)
Arun Upadhyay, Chief Scientific Officer, Ocugen
Nov 1816:30
Conference pass
Leveraging AI to support manufacturing in life science cycle management
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Jared Auclair, Director of Bioinnovation, Northeastern University
Nov 1816:30
Conference pass
Novel riboswitch for gene therapy
Gene Therapy (Track 5, 120C)
Xuecui Guo, Director of Gene Regulation, Meiragtx
Nov 1816:30
Conference pass
ATOMIC: Administration of T-Cell Therapies with out-patient management in the community
Cell Therapy (Track 1, Keynote Theatre)
Nov 1816:30
Conference pass
Constructs of Chemically Ligated Guide RNAs (LgRNA) for Precise Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) Gene Editing
Innovation Showcase (Track 2, Seminar Theatre)
Nov 1816:30
Conference pass
Partnering with patient advocacy groups for the regulatory pathway and protecting access
Evidence, Pricing & Access (Track 3, 120A)
Brett Kopelan. MA, Executive Director, DebRa of America
Nov 1816:30
Conference pass
Inside Out: Reprogramming CAR-Engineered Cell Therapies to Overcome Exhaustion and TME Stress
Gene Modified Cell Therapy (Track 4, 120B)
Hind Rafei, Assistant Professor, MD Anderson Cancer Center
Nov 1816:50
Conference pass
Next generation of gene therapy delivery
Gene Therapy (Track 5, 120C)
Andrew Steinsapir, Director of Gene Therapy Program Lead, Deerfield Management
Nov 1816:50
Conference pass
Precompetitive collaboration to determine parameters predictive of manufacturability via decentralized AI
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Kat Kozyrytska, Founder, Cell Therapy Manufacturability Program
Nov 1816:50
Conference pass
Preparing your early-phase supply chain for late-stage success
Supply Chain & Logistics (Track 8, 121 C)
Raymond Luke, Senior Director, MSAT, Verismo Therapeutics
Nov 1816:50
Conference pass
Developing Next-generation Cell and Gene Therapies with Virus-Free Quantum Engine
Innovation Showcase (Track 2, Seminar Theatre)
- Technology to ensure theclinicalsuccess of next-generation cell and gene therapies
- qCART quantum engine for productionof multiplexed CAR TSCMcell therapies
- GF-CART01, a clinical-stage non-viral multiplex CARTSCMtherapy for B cell malignancy
- GF-CART03, a non-viral multiplex CARTSCMtherapy for a wide range of solid tumors
Sareina Wu, Founder & CSO, Genomefrontier Therapeutics Inc
Nov 1816:50
Conference pass
Latest update on allogenic stem cell therapies
Cell Therapy (Track 1, Keynote Theatre)
Raisa Uchurova, Former Principal Scientist, Century Therapeutics
Nov 1816:50
Conference pass
Patient engagement in biopharma R&D
Evidence, Pricing & Access (Track 3, 120A)
Kimberly Neff, Principal, Big Magic
Nov 1816:50
Conference pass
Gene editing beyond the liver
Gene Modified Cell Therapy (Track 4, 120B)
Devyn Smith, CEO, Arbor Biotechnologies
Nov 1817:10
Conference pass
Panel Discussion: Broader Applications for Gene Therapies
Gene Therapy (Track 5, 120C)
Moderator: Matt Killeen, Founder, Vista Point Bio
Eric Kmiec, Founder & CEO, CorriXR Therapeutics
Amy House, VP Corporate Development and Communications, Beacon Therapeutics
Craig Martin, Founder, CEO, Orphan Therapeutics Accelerator
Sean Armour, VP, Head of Discovery, Roche Innovation Center
Andrew Steinsapir, Director of Gene Therapy Program Lead, Deerfield Management
Nov 1817:10
Conference pass
Panel Discussion: Building your supply chain from scratch
Supply Chain & Logistics (Track 8, 121 C)
Moderator: Jeff Wren, Vice President, Biotherapies, AABB
Christopher Ballas, Global Commercial Lead, Custom Cell Products, Cook MyoSite Inc
Raymond Luke, Senior Director, MSAT, Verismo Therapeutics
Mary Carty, Director, Drexel University College of Medicine
Nov 1817:10
Conference pass
Panel Discussion: Staying agile and embracing technological innovations to optimize cell therapy manufacturing
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Moderator: Nolan Polson, VP Quality Assurance and Product Quality, Iovance Biotherapeutics
Stephanie Maistrellis, CEO, Lead Life Sciences
Mark Dudley, Consultant, Independent Advisors
Kaiyuan Jiang, Associate Director, API Cell Therapy, Johnson & Johnson Pharmaceutical R&D
Michael Lehmicke, Sr. Vice President, Science & Industry Affairs, Alliance for Regenerative Medicine
Hugh Gannon, Associate Director, KSQ Therapeutics, Inc.
Sarah Yuan, Chief Technology Officer, Cabaletta Bio
Domhnall McGowan, Regional Manager - GMP Sites and Training, Canadian Advanced Therapies Training Institute
Nov 1817:10
Conference pass
Panel Discussion: Streamlining process development
Viral Vector Manufacturing (Track 7, 121 B)
Moderator: Lior Raviv, CTO, Pluri
Yan Li, Senior Director, Process Development, Cabaletta Bio
James Adams, Chief Technical Officer, Tr1x, Inc
Arnaud Deladeriere, President and Principal Consultant, Cell&Gene Consulting
John Moscariello, Chief Technical Officer, Neuvogen Therapeutics
Monica Raimo, Director of Product and Process Development, Glycostem Therapeutics
Francesca Vitelli, VP, Global Head, Process and Analytical Development and Innovation, Minaris Advanced Therapies
Nov 1817:10
Conference pass
Panel Discussion: Exploring the latest innovations and disruptions shaping cell therapy
Cell Therapy (Track 1, Keynote Theatre)
Moderator: Arthur Sagoskin, Chief Scientific Development Officer, Mygogenesis
Jose Eduardo Vidal, Chief Executive Officer, CytoImmune Therapeutics
Daniel KIlbank, CSO, Mygogenesis LLC
Prachi Narayan, Global Product Quality and Stability Operations and Clinical Science, Independent Expert
Antoine Sreih, Vice President, Medical Director, Cullinan Therapeutics, Inc.
Deepu Madduri, Senior Director, Compound Development Team Lead, CARVYKTI, Johnson & Johnson
Eric Schuur, Chief Executive Officer, Hepatx Corporation
Xiao Huang, Assistant Professor, Precision Immune Engineering Laboratory, Drexel University
Nov 1817:10
Conference pass
Panel Discussion: Partnering and investment in Biotech
Innovation Showcase (Track 2, Seminar Theatre)
Moderator: Lara Silverman, Principal Consultant, Coeptis and LIS BioConsulting
Caralynn Collens, CEO, Dimension Bio
Fiona Miller, Managing Partner, quadraScope Ventures
Susan Nichols, Chief Executive Officer, Propel Biosciences
Tom Lowery, President & CEO, Satellite Bio
Tay Salimullah, Venture Partner, 4BIO Capital
Victor Stukat Gren, Head of Strategy, AskBio
Nov 1817:10
Conference pass
Panel Discussion: Overcoming market access challenges in delivering cures
Evidence, Pricing & Access (Track 3, 120A)
Kris Thiruvillakkat, Sr Director Global Market Access, CSL Behring
Jordan Schecter, Vice President | Multiple Myeloma DAS Leader, Johnson and Johnson
Stephanie Heathman, Business Development Lead, Opie Jones Foundation
Nneka Onwudiwe, Former PRO/PE Regulatory Review Officer, Food and Drug Administration (FDA)
Virginie Delwart, Director Patient Advocacy - Hematology, Oncology, Gene Therapy (CRISPR)/Rare Disease, Ophthalmology, Regeneron
Nov 1817:10
Conference pass
Panel Discussion: In vivo gene editing of immune cells - opportunities, challenges & alternative approaches
Gene Modified Cell Therapy (Track 4, 120B)
Moderator: David Peritt, Chief Scientific Officer, Lupagen
Cecile Bauche, Chief Scientific Officer, Alaya.bio
Devyn Smith, CEO, Arbor Biotechnologies
Zhenghong Gao, Chief Strategy Officer, Zhongmou Therapeutics
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Nov 199:00
Conference pass
Chair’s Opening Remarks
Keynotes
Nov 199:05
Conference pass
Transforming treatment of autoimmune disease with effector T-cell therapy
Keynotes
Gwendolyn Binder, President of Science and Technology, Cabaletta Bio
Nov 199:25
Conference pass
Advancing genetic technology and AAV gene therapy
Keynotes
Jason Krentz, Chief Operating Officer, AskBio
Nov 199:45
Conference pass
Keynote Panel Discussion: Overview of the current regulatory landscape for cell & gene therapies
Keynotes
Jim Wang, VP, Global Regulatory Strategy, Genetic Medicines, Regeneron
Raj Puri, Chief Regulatory Officer, Iovance Biotherapeutics
Nancy Nair, Executive Director, Global Regulatory Affairs, Oncology, Johnson & Johnson Innovative Medicine
Nov 1911:00
Conference pass
Roundtable 1: Patient identification for precision medicine gene therapy studies
Keynotes
Kirstin Liechty, Consultant, K2 Clinical Consulting
Nov 1911:00
Conference pass
Roundtable 10: Exploring the opportunities of technology transfer
Keynotes
Nidhi Kotecha, Program Director, Regulatory Affairs, Gates Institute
Nov 1911:00
Conference pass
Roundtable 11: Analytical cell therapy bio-bank for cell therapy manufacturability
Keynotes
Kat Kozyrytska, Founder, Cell Therapy Manufacturability Program
Nov 1911:00
Conference pass
Roundtable 12: Superdonors and Specialized Cells: Building a Reliable Pipeline for CGT Starting Materials in Decentralized Models
Keynotes
Audrey Greenberg, Mayo Venture Partner and Chair, Dept. Business Development, Mayo Clinic
Nov 1911:00
Conference pass
Roundtable 2: How do we scale-up cell therapy manufacturing?
Keynotes
Rafal P. Witek, VP, Translational R&D, Head of Liver Program, Dimension Bio
Nov 1911:00
Conference pass
Roundtable 3: Operationalizing commercial cell therapies
Keynotes
Amy Pagliarulo, Senior Director Director of ATC Cell Therapy Operations, Iovance Biotherapeutics
Nov 1911:00
Conference pass
Roundtable 4: Topic TBC
Keynotes
Ezequiel Zylberberg, Vice President, Corporate Development, Akron Bio
Nov 1911:00
Conference pass
Roundtable 5: Future-proofing talent acquisition: Workforce training strategies for Cell & Gene Therapy
Keynotes
Nov 1911:00
Conference pass
Roundtable 6: Creative deal-making and partnerships: Thriving in an evolving landscape
Keynotes
Nov 1911:00
Conference pass
Roundtable 7: Navigating Trump 2.0
Keynotes
Lauren Martz, Executive Director, Biopharma Intelligence, BioCentury Inc
Nov 1911:00
Conference pass
Roundtable 8: End-to-end patient journey: Supply chain perspective
Keynotes
Pedro Rodriguez-Cardona, Associate Director, Clinical Supply Operations, Johnson & Johnson
Nov 1911:00
Conference pass
Roundtable 9: Selecting the best antigens for cell therapy
Keynotes
Christopher Murriel, Vice President, Pre-Clinical Pharmacology, ArsenalBio
Nov 1913:00
Conference pass
Chair's Remarks: Kate Excoffon, VP Research, Spirovant Sciences
Gene Therapy (Track 5, 120C)
Nov 1913:00
Conference pass
Chair's Remarks: Martin Bonamino, Head of Cell & Gene Therapy Program, National Cancer Institute of Brazil
Patient Delivery (Track 8, 121C)
Nov 1913:00
Conference pass
Chair's Remarks: Nirav Shah, Associate Professor of Medicine, Director, BMT & Cellular Therapy Program, Medical College of Wisconsin
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Nirav Shah, Associate Professor of Medicine, Director, BMT & Cellular Therapy Program, Medical College of Wisconsin
Nov 1913:00
Conference pass
Chair's Remarks: Omer Butt, VP, Regulatory Affairs, Cytoimmune
Regulatory Affairs & Policy (Track 3, 120A)
Omer Butt, Vice President, Regulatory Affairs, CytoImmune Therapeutics
Nov 1913:00
Conference pass
Chair's Remarks: Renaud Vaillant, CEO, Alaya.bio
Pre-Clinical & Clinical (Track 4, 120B)
Renaud Vaillant, CEO & co-Founder, Alaya.bio
Nov 1913:00
Conference pass
Chair's Remarks: Shadan Yarandi, Principle Scientist, Johnson & Johnson Innovative Medicine
Viral Vector Manufacturing (Track 7, 121 B)
Shadan Yarandi, Principle Scientist, Johnson & Johnson Innovative Medicine
Nov 1913:00
Conference pass
Chair's Remarks: Dana Silverbush, Assistant Professor of Cancer Biology, University of Pennsylvania
Innovation Showcase (Track 2, Seminar Theatre)
Dana Silverbush, Assistant Professor of Cancer Biology, University of Pennsylvania
Nov 1913:00
Conference pass
Chair's Remarks: Kara Spiller, URBN Professor of Biomedical Innovation, Drexel University
Cell Therapy (Track 1, Keynote Theatre)
Nov 1913:05
Conference pass
AAV capsid engineering to improve delivery technologies for gene therapy applications
Gene Therapy (Track 5, 120C)
Quan Jin, Associate Director, Capsid Engineering, Roche Innovation Center
Nov 1913:05
Conference pass
Accelerated development and approval of gene therapies
Regulatory Affairs & Policy (Track 3, 120A)
Keith Wonnacott, Vice President Regulatory Affairs, Lexeo Therapeutics
Nov 1913:05
Conference pass
Brazilian cell therapy landscape and joint initiatives
Patient Delivery (Track 8, 121C)
Nov 1913:05
Conference pass
Manufacturing under an accelerated development timeline
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Nov 1913:05
Conference pass
Success from a pre-clinical company: Insight from Alaya.bio
Pre-Clinical & Clinical (Track 4, 120B)
Renaud Vaillant, CEO & co-Founder, Alaya.bio
Nov 1913:05
Conference pass
Viral clearance for AAV
Viral Vector Manufacturing (Track 7, 121 B)
Wenjun Di, Senior Scientist, Ultragenyx Pharmaceutical Inc.
Nov 1913:05
Conference pass
Harnessing technology to facilitate success in the manufacturing distribution space
Innovation Showcase (Track 2, Seminar Theatre)
Nov 1913:05
Conference pass
Leveraging the accelerated approval process for phase 1-3 trial development
Cell Therapy (Track 1, Keynote Theatre)
Joseph Stavas, Senior Vice President of Clinical Development, ProKidney
Nov 1913:25
Conference pass
CAR-T Long Term Follow-up
Regulatory Affairs & Policy (Track 3, 120A)
Nov 1913:25
Conference pass
Delivering gene therapies for patients in clinical/hospital settings
Patient Delivery (Track 8, 121C)
Nov 1913:25
Conference pass
Enhancing viral vector infectivity through modulating acting dynamics
Viral Vector Manufacturing (Track 7, 121 B)
Nov 1913:25
Conference pass
Establishing an effective analytical strategy to support manufacturing
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Therese Choquette, Head of Analytical and Translational Sciences, Tigen Pharma
Nov 1913:25
Conference pass
How can industry interface with academia to improve talent development
Gene Therapy (Track 5, 120C)
Mary Carty, Director, Drexel University College of Medicine
Nov 1913:25
Conference pass
Universal cell therapy for solid tumours
Pre-Clinical & Clinical (Track 4, 120B)
Adam Snook, Associate Professor, Thomas Jefferson Unversity
Nov 1913:25
Conference pass
Engineered macrophage cell therapy with streamlined manufacturing
Cell Therapy (Track 1, Keynote Theatre)
Nov 1913:25
Conference pass
Execution at Scale in a Squeezed Market: Leadership Levers for Biotech’s Survival
Innovation Showcase (Track 2, Seminar Theatre)
Angela Justice, Executive Coach & Advisor, Justice Group Advisors
Nov 1913:45
Conference pass
Bench to bedside: Delivering cell and gene therapies in hospitals
Patient Delivery (Track 8, 121C)
Michael Storey, Former Medication Use Strategist, Nationwide Children's Hospital
Nov 1913:45
Conference pass
Engineering and Armoring a Pipeline of Gamma-Delta CAR T Cell Therapies to Address Solid Tumors
Pre-Clinical & Clinical (Track 4, 120B)
Nov 1913:45
Conference pass
Genethon: Developing gene therapy for rare diseases
Gene Therapy (Track 5, 120C)
Angela Columbano, Head Business Development and Partnership, Genethon
Nov 1913:45
Conference pass
Navigating Regulatory Challenges for the Development of Gene Therapy Products
Regulatory Affairs & Policy (Track 3, 120A)
Jim Wang, VP, Global Regulatory Strategy, Genetic Medicines, Regeneron
Nov 1913:45
Conference pass
Optimized process and analytical development plan for ocular gene therapies
Viral Vector Manufacturing (Track 7, 121 B)
Nov 1913:45
Conference pass
The impact of apheresis cryopreservation on CAR-T cell manufacturing
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Yan Li, Senior Director, Process Development, Cabaletta Bio
Nov 1913:45
Conference pass
Innovation in CAR T therapy for solid tumours
Innovation Showcase (Track 2, Seminar Theatre)
Nov 1913:45
Conference pass
Insight from the NIH on its phase I/II cell therapy trials
Cell Therapy (Track 1, Keynote Theatre)
Kathryn Martin, Supervisory Clinical Laboratory Scientist, Center for Cellular Engineering (CCE), NIH
Nov 1914:05
Conference pass
Panel Discussion: Best practice for patient centred clinical trial design
Pre-Clinical & Clinical (Track 4, 120B)
Moderator: Renaud Vaillant, CEO & co-Founder, Alaya.bio
Joseph Stavas, Senior Vice President of Clinical Development, ProKidney
Antoine Sreih, Vice President, Medical Director, Cullinan Therapeutics, Inc.
Kirstin Liechty, Consultant, K2 Clinical Consulting
Pedro Rodriguez-Cardona, Associate Director, Clinical Supply Operations, Johnson & Johnson
Chris Tamburrini, Principal & Founder, RonanVance Search
Nov 1914:05
Conference pass
Panel Discussion: Delivering cell & gene therapies for patients in hospital and community settings
Patient Delivery (Track 8, 121C)
Michael Mehler, Director, Cell Therapy Patient Operations, AstraZeneca
Amy Pagliarulo, Senior Director Director of ATC Cell Therapy Operations, Iovance Biotherapeutics
Michael Storey, Former Medication Use Strategist, Nationwide Children's Hospital
Terry Cothran, Senior Pharmacy Director, Oklahoma Health Care Authority
Madelyn Fell, Director of Operations, Cell Therapy and Transplant, University of Pennsylvania Health System
Moderator: Saad Kenderian, Co Leader, Cancer Immunology and Immunotherapy, Mayo Clinic Comprehensive Cancer Center, Mayo Clinic
Nov 1914:05
Conference pass
Panel Discussion: IND preparedness for cell & gene therapies: Overcoming regulatory challenges
Regulatory Affairs & Policy (Track 3, 120A)
Moderator: Omer Butt, Vice President, Regulatory Affairs, CytoImmune Therapeutics
Keith Wonnacott, Vice President Regulatory Affairs, Lexeo Therapeutics
Steven Highfill, Director of Product Development, Center for Cellular Engineering, Clinical Center, National Institutes of Health
Hugh Gannon, Associate Director, KSQ Therapeutics, Inc.
Nidhi Kotecha, Program Director, Regulatory Affairs, Gates Institute
Nov 1914:05
Conference pass
Panel Discussion: Innovations in Novel Capsids for Gene Therapies
Gene Therapy (Track 5, 120C)
Pedro J Cejas, Senior Director, Delivery Platforms, Roche Innovation Center
Arun Upadhyay, Chief Scientific Officer, Ocugen
Seema Bhatlekar, Principal Scientist, Gene Therapy Process Development, Johnson & Johnson Innovative Medicine
Angela Columbano, Head Business Development and Partnership, Genethon
Quan Jin, Associate Director, Capsid Engineering, Roche Innovation Center
Thomas Weber, CEO and Founder, Gene Therapy Consulting
Zhenghong Gao, Chief Strategy Officer, Zhongmou Therapeutics
Nov 1914:05
Conference pass
Panel Discussion: Point-of-care manufacturing
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Nan Zhang, Chief, Cell Therapy Manufacturing Section, Center for Cellular Engineering, National Institutes of Health
Stephanie Heathman, Business Development Lead, Opie Jones Foundation
Kat Kozyrytska, Founder, Cell Therapy Manufacturability Program
Therese Choquette, Head of Analytical and Translational Sciences, Tigen Pharma
Nov 1914:05
Conference pass
Panel Discussion: Understanding the Evolving Landscape of Viral Vector
Viral Vector Manufacturing (Track 7, 121 B)
Daniel Cohen, Head of Vector Optimization, Roche Innovation Center
Aziza Manceur, Research Officer, National Research Council Canada
Moderator: Michael McMahon, Professor, John Hopkins School Of Medicine
Nov 1914:05
Conference pass
Panel Discussion: Company Creation in ATMPs
Innovation Showcase (Track 2, Seminar Theatre)
Moderator: Angela Justice, Executive Coach & Advisor, Justice Group Advisors
Eric Hacherl, Chief Operating Officer, Kyttaro Therapeutics
Fiona Miller, Managing Partner, quadraScope Ventures
Petter Bjorquist, CEO, VERIGRAFT AB
Lauren Martz, Executive Director, Biopharma Intelligence, BioCentury Inc
Susan Nichols, Chief Executive Officer, Propel Biosciences
Eric Schuur, Chief Executive Officer, Hepatx Corporation
Sareina Wu, Founder & CSO, Genomefrontier Therapeutics Inc
Nov 1914:05
Conference pass
Panel Discussion: Ex vivo vs In vivo cell engineering
Cell Therapy (Track 1, Keynote Theatre)
Moderator: Rafal P. Witek, VP, Translational R&D, Head of Liver Program, Dimension Bio
Holger Russ, Associate Professor, University of Florida
Arnaud Deladeriere, President and Principal Consultant, Cell&Gene Consulting
Christopher Murriel, Vice President, Pre-Clinical Pharmacology, ArsenalBio
Daniel Baker, PhD Candidate, June Lab, University of Pennsylvania School Of Medicine
Parimal Pande, Associate Scientific Director, Johnson & Johnson
Raisa Uchurova, Former Principal Scientist, Century Therapeutics
Nov 1915:15
Conference pass
Chair's Remarks: Daniel Weiss, Professor of Medicine, Pulmonary Medicine Department of Medicine, University of Vermont and, President-Elect, ISCT
Pre-Clinical & Clinical (Track 4, 120B)
Daniel Weiss, Professor of Medicine, Pulmonary Medicine Department of Medicine, University of Vermont
Nov 1915:15
Conference pass
Chair's Remarks: Martin Bonamino, Head of Cell & Gene Therapy Program, National Cancer Institute of Brazil
Patient Delivery (Track 8, 121C)
Nov 1915:15
Conference pass
Chair's Remarks: Matthias Stöcker, Regulatory Capability Lead, Boehringer Ingelheim International
Regulatory Affairs & Policy (Track 3, 120A)
Matthias Stöcker, Regulatory Capability Lead, Boehringer Ingelheim International GmbH
Nov 1915:15
Conference pass
Chair's Remarks: Nirav Shah, Associate Professor of Medicine, Director, BMT & Cellular Therapy Program, Medical College of Wisconsin
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Nirav Shah, Associate Professor of Medicine, Director, BMT & Cellular Therapy Program, Medical College of Wisconsin
Nov 1915:15
Conference pass
Chair's Remarks: Pedro Cejas, Senior Director, Delivery Platforms, Roche Innovation Center
Gene Therapy (Track 5, 120C)
Pedro J Cejas, Senior Director, Delivery Platforms, Roche Innovation Center
Nov 1915:15
Conference pass
Chair's Remarks: Seema Bhatlekar, Senior Scientist, Gene Therapy Process Development, Johnson and Johnson Innovative Medicine
Viral Vector Manufacturing (Track 7, 121 B)
Seema Bhatlekar, Principal Scientist, Gene Therapy Process Development, Johnson & Johnson Innovative Medicine
Nov 1915:15
Conference pass
Chair's Remarks: Angela Justice, Founder, Justice Group Advisors
Innovation Showcase (Track 2, Seminar Theatre)
Angela Justice, Executive Coach & Advisor, Justice Group Advisors
Nov 1915:15
Conference pass
Chair's Remarks: Rafal P. Witek, Senior Director of R&D Engineering, Dimension Bio
Cell Therapy (Track 1, Keynote Theatre)
Rafal P. Witek, VP, Translational R&D, Head of Liver Program, Dimension Bio
Nov 1915:20
Conference pass
Applying Lessons from CLN-978 to Advance TCEs in Autoimmune Trials
Pre-Clinical & Clinical (Track 4, 120B)
- Optimize clinical trial design by identifying where T-cell engagers best fit in the autoimmune treatment landscape.
- Refine patient selection strategies tailored to disease type, target biology, and trial jurisdiction.
- Navigate regulatory challenges in clinical development, leveraging CLN-978’s approach to dosing and safety.
Antoine Sreih, Vice President, Medical Director, Cullinan Therapeutics, Inc.
Nov 1915:20
Conference pass
Impact of ITR quality on AAV manufacturing
Viral Vector Manufacturing (Track 7, 121 B)
Daniel Cohen, Head of Vector Optimization, Roche Innovation Center
Nov 1915:20
Conference pass
In Vivo and Ex vivo cell and gene therapies operational oversight
Patient Delivery (Track 8, 121C)
Mark Duckworth, Sr. Director Cellular and Gene Therapy Operations, Children's Hospital of Philadelphia
Nov 1915:20
Conference pass
pH-dependent DNA degradation pathways for adeno-associated virus gene therapy
Gene Therapy (Track 5, 120C)
Kimberly Malecka, Senior Scientist, Genentech
Nov 1915:20
Conference pass
Tech transfer to an academic cell therapy manufacturing lab
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Nov 1915:20
Conference pass
The Importance of Interacting with Regulators
Regulatory Affairs & Policy (Track 3, 120A)
Nov 1915:20
Conference pass
Allogenic CAR-T therapies
Cell Therapy (Track 1, Keynote Theatre)
Sean O'Brien, Senior Scientist, AstraZeneca
Nov 1915:20
Conference pass
Transposon-Based CAR-T cells
Innovation Showcase (Track 2, Seminar Theatre)
Luiza Abdo, Doctor, Brazilian National Cancer Institute
Nov 1915:40
Conference pass
Bioreactors are not created equal: Choose the right device for your therapy
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Arnaud Deladeriere, President and Principal Consultant, Cell&Gene Consulting
Nov 1915:40
Conference pass
Improving Access to Cell and Gene Therapies
Patient Delivery (Track 8, 121C)
Madelyn Fell, Director of Operations, Cell Therapy and Transplant, University of Pennsylvania Health System
Nov 1915:40
Conference pass
Innovating Process Development for Gene Therapy using High-Throughput Sequencing Technology
Gene Therapy (Track 5, 120C)
Prateek Tripathi, Senior Expert, Novartis Gene Therapies
Nov 1915:40
Conference pass
Regulatory challenges of ATMPs in clinical development
Regulatory Affairs & Policy (Track 3, 120A)
Matthias Stöcker, Regulatory Capability Lead, Boehringer Ingelheim International GmbH
Nov 1915:40
Conference pass
Selecting the best antigens for cell therapy
Pre-Clinical & Clinical (Track 4, 120B)
Christopher Murriel, Vice President, Pre-Clinical Pharmacology, ArsenalBio
Nov 1915:40
Conference pass
Strategic planning for IND enabling activities for AAV gene therapies
Viral Vector Manufacturing (Track 7, 121 B)
Elizabeth Higgins, Chief Technical Operations, NysnoBio
Nov 1915:40
Conference pass
Clinical development of NK cell therapies
Cell Therapy (Track 1, Keynote Theatre)
Monica Raimo, Director of Product and Process Development, Glycostem Therapeutics
Nov 1915:40
Conference pass
NPR on CAR-Ts and autoimmune disease
Innovation Showcase (Track 2, Seminar Theatre)
Daniel Baker, PhD Candidate, June Lab, University of Pennsylvania School Of Medicine
Nov 1916:00
Conference pass
Clinical and translational findings following rese-cel infusion in autoimmune disease
Patient Delivery (Track 8, 121C)
Thomas Furmanak, Associate Director, Translational Medicine, Cabaletta Bio
Nov 1916:00
Conference pass
Clinical Biomarkers of durable response to ciltacaptagene autoleucel in multiple myeloma patients
Pre-Clinical & Clinical (Track 4, 120B)
Vicki Plaks, Senior Scientific Director and Head of Cell Therapy, Oncology Translational Research, Johnson & Johnson
Nov 1916:00
Conference pass
Manufacturing for genetically modified cell products
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Friederike Herbst-Nowrouzi, Director of the Human Genome Editing Laboratory (HGEL), Perelman School of Medicine University of Pennsylvania
Nov 1916:00
Conference pass
Mindset and skillset revolution in hiring to meet the emerging workforce needs
Viral Vector Manufacturing (Track 7, 121 B)
Vishal Shah, Dean, Community College of Philadelphia
Nov 1916:00
Conference pass
Model-based dosing of the conditioning in cell & gene therapy
Gene Therapy (Track 5, 120C)
Nov 1916:00
Conference pass
Regulatory Acceleration Pathways for Gene Therapies
Regulatory Affairs & Policy (Track 3, 120A)
Nov 1916:00
Conference pass
Pan-tissue master regulator inference reveals mechanisms of MHC alterations in cancers
Innovation Showcase (Track 2, Seminar Theatre)
Mahnoor Gondal, PhD Candidate, University of Michigan
Nov 1916:00
Conference pass
Tregulatory cell therapies: Clinical experience and the next generation of engineered Tregs
Cell Therapy (Track 1, Keynote Theatre)
Daniel Shelly, Chief Business Development Officer, PolTREG AG
Nov 1916:20
Conference pass
Academic and industry collaboration to develop novel cell therapies
Cell Therapy Manufacturing Sponsored by Terumo Blood and Cell Technologies (Track 6, 121A)
Nirav Shah, Associate Professor of Medicine, Director, BMT & Cellular Therapy Program, Medical College of Wisconsin
Nov 1916:20
Conference pass
CRISPR directed in vivo gene editing for head & neck cancer
Gene Therapy (Track 5, 120C)
Eric Kmiec, Founder & CEO, CorriXR Therapeutics
Nov 1916:20
Conference pass
Designing a robust commercial control strategy for viral vector manufacturing
Viral Vector Manufacturing (Track 7, 121 B)
Nov 1916:20
Conference pass
Developments in autologous muscle cell therapies for women’s health
Patient Delivery (Track 8, 121C)
Parul Nisha, Senior Director, Clinical Development, Cook MyoSite Inc
Nov 1916:20
Conference pass
Labelling in the Age of Personalized Medicine: Digital and Dynamic Labelling for Advanced Therapies
Regulatory Affairs & Policy (Track 3, 120A)
Nov 1916:20
Conference pass
Latest update for MSC clinical trials
Pre-Clinical & Clinical (Track 4, 120B)
Daniel Weiss, Professor of Medicine, Pulmonary Medicine Department of Medicine, University of Vermont
Nov 1916:20
Conference pass
Best practice in quality control for cell therapies
Cell Therapy (Track 1, Keynote Theatre)
Anthony Garcia, Chief Quality Officer, AstroBio Solutions
Nov 1916:20
Conference pass
Biomimetic Digital Twins and Multiomics: To Identify New Therapeutic Targets and to Reduce the Time and Cost of Drug Development
Innovation Showcase (Track 2, Seminar Theatre)
William Kearns, Chief Executive Officer and CSO, Genzeva
last published: 17/Sep/25 15:25 GMT
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