This agenda is still in development. All sessions and timings are subject to regular change at this time.
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Investment Summit
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Indigo Ballroom, Hilton Bayfront HotelOpening remarks
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Indigo Ballroom, Hilton Bayfront HotelGain a data-driven outlook on the current state of cell and gene therapy (CGT) investment. This keynote explores emerging trends, evolving investor priorities, and why early-stage innovation remains essential to sustaining industry growth
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Indigo Ballroom, Hilton Bayfront HotelPanel: This discussion brings together leading VCs to dissect how decision criteria have evolved, what defines a “fundable” company in 2026, and how scientific, regulatory, and commercial factors intersect to shape valuation and deal momentum.
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Indigo Ballroom, Hilton Bayfront HotelSpotlight:
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Refreshment & networking breakIndigo Ballroom, Hilton Bayfront Hotel
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Indigo Ballroom, Hilton Bayfront HotelPanel: As market dynamics continue to shift, biotech should reconsider how they access capital. Traditional venture financing may not be suitable for every stage or strategic need. This session will explore the landscape of non-traditional financing models including secondary transactions, liquidity solutions for existing shareholders, royalty financing, and the increasing role of family offices and angel investors.
Chairperson
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Indigo Ballroom, Hilton Bayfront HotelFireside Chat: Explore how investors are identifying value in the infrastructure behind advanced therapies, and why tools and tech providers may be an opportunity for long-term growth.
Chairperson
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Indigo Ballroom, Hilton Bayfront HotelNetworking
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Indigo Ballroom, Hilton Bayfront HotelFireside chat: Unpack why strong commercial acumen is just as important as scientific excellence in securing funding and scaling successfully.
Chairperson
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LunchIndigo Ballroom, Hilton Bayfront HotelLunch: Investment Summit, Founders Forum and WIAT
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Indigo Ballroom, Hilton Bayfront HotelPanel: Evaluate cross-border opportunities, and what factors differentiate regions in building sustainable biotech ecosystems.
Chairperson
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Indigo Ballroom, Hilton Bayfront HotelRoundtable: Investor only roundtable
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Indigo Ballroom, Hilton Bayfront HotelRoundtable
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Indigo Ballroom, Hilton Bayfront HotelInvestor roundtable
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Indigo Ballroom, Hilton Bayfront HotelClosing wrap up – covering the landscape of what’s next and where biotech investment will grow in the next 5 years
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Founders Forum
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LunchIndigo Ballroom, Hilton Bayfront HotelLunch: Investment Summit, Founders Forum and WIAT
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Room AScaling Workshop: Build under pressure, not despite it. Secure capital, fortify your team, and make crisp decisions that keep growth compounding when resources are thin.
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Room AWorkshop: Many scientific companies have the expertise and loyal customers but still struggle to be seen. They outperform competitors yet remain overlooked by potential clients and partners—resulting in slower growth and missed opportunities.
And in the age of AI and new tech, filling the marketing function isn’t as simple as it used to be.
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Women in Advanced Therapies Congress
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LunchIndigo Ballroom, Hilton Bayfront HotelLunch: Investment Summit, Founders Forum and WIAT
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Room D
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Room D
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Room D
- How representation in leadership impacts innovation, culture, and organisational performance
- The role of male allies in accelerating gender equity and creating systemic, long-term change
- Practical pathways for companies to improve representation across scientific, technical, and executive roles
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Room DSpotlight: Discover strategies to address disparities in women’s health research, clinical trials, and access to care. Learn how policy, advocacy, and industry engagement can advance equity in health outcomes.
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Room D
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Room DRoundtable: Explore how to build, maintain and leverage networks and mentorships to advance careers and influence your industry.
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Room DRoundtable: Share approaches to recognise and overcome self-doubt while thriving in male-dominated spaces.
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Room DRoundtable: Discuss how empathy, intuition and people skills can be leveraged as leadership strengths.
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Room DRoubdtable: Learn how to intentionally assemble a trusted group of mentors, sponsors and peers who can provide strategic guidance, advocacy and perspective at different stages of your career.
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Room DRoundtable: Explore strategies for securing funding, support and recognition for women-led initiatives.
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Room DRoundtable: Explore strategies to close gaps in research, clinical trials and healthcare access for women
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Room DRoundtable: Looking at your interactions through the lens of an observer
Chairperson
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Room DRoundtable: Explore how to lead with confidence and clarity in uncertain, fast-moving environments by making informed decisions, aligning teams, and embracing experimentation.
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Room DRoundtable: Examine how organisations can adopt AI responsibly while balancing regulatory compliance, ethical considerations and inclusive, human-centred decision-making.
Chairperson
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Room DRoundtable: Discuss practical approaches to communicating effectively across cultures, geographies and perspectives to build trust, avoid misalignment and lead more inclusive teams
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Room DRoundtabe: TBC
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Welcome Drinks and Patient Spotlight
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Indigo Ballroom, Hilton Bayfront Hotel
The welcome drinks will kick off Advanced Therapies Week in style at the Hilton Bayside terrace. Join us for a few drinks, connect with friends/make new connections whilst enjoying the California sunshine. The welcome drinks will be followed by a patient spotlight talk from Luke Keller and his daughter. Luke is the founder of Mighty Oaks Foundation which is focused on CAR-T cell patient advocation, education, and financial support for families impacted by childhood cancer. Luke will be sharing his personal story, reminding us why we do what we do as an industry.
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Networking
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San Diego, Wine & Culinary CenterKick off Advanced Therapies Week in style at Sip & Connect, the official welcome party that blends great food, fine wine, and meaningful conversation.
Advanced Therapies Live
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Theatre 5ATW HARDTalk cuts through the noise with candid, one-to-one conversations that tackle the toughest questions in advanced therapies. No scripts, no softball questions - just real leaders, real stories, and real insight.
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Theatre 5True leadership in biotech and pharma is built not just on expertise, but on sponsorship, visibility, and the power dynamics that shape who advances and who doesn’t. In this unfiltered conversation, i ...
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Theatre 5Biotech is a field where progress is nonlinear, the stakes are immense, and “failure” is often just another word for iteration. In this interview, a leading biotech builder reflects on what it really ...
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Theatre 5Hosted by Sharron Cox, Founder & Host, She Leads Podcast
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Innovation Zone
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Innovation Zone
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Innovation ZoneBausch+Stroebel
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Innovation ZoneABEC
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Innovation ZoneBracco
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Innovation Zone
Cell therapy is rapidly transforming modern medicine, offering new hope for patients with cancer, autoimmune conditions, and genetic disorders. However, the development and manufacturing of these therapies demand reagents of uncompromising quality, consistency, and safety. Qkine’s new Cell Therapy Grade proteins address this critical need by delivering:
- Defined manufacturing standards – Produced under controlled conditions with full traceability and regulatory support documentation
- Enhanced quality attributes – High purity, animal origin-free, low endotoxin levels, and reduced host cell protein/DNA contamination
- Scalability for clinical workflows – Consistent performance from research-grade to therapy-grade materials, enabling seamless transition to GMP production
- Regulatory readiness – Comprehensive Certificates of Analysis (CoA), Safety Data Sheets (SDS), and technical dossiers to support IND and clinical submissions
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Innovation ZoneVIVEbiotech
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Innovation ZoneLentitek
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Innovation ZoneKoerber
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Innovation ZonePluristyx
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Innovation ZoneHouston Gene Therapeutics
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Innovation ZoneProBio
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Innovation ZoneKiraGen Bio
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Innovation ZoneXintela
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Innovation ZoneNKILT Therapeutics
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Innovation ZoneCREATe Therapeutics
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Innovation ZoneCraftonBio
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Innovation ZoneCrafton Bio
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Innovation ZoneEx-Amplify Therapeutics
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Plenary
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Theatre 1
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Theatre 1
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As the advanced therapies field moves from recovery into recalibration, Phacilitate convened its Advisory Board—leaders spanning industry, academia, clinical delivery, investment, and regulation—to take a candid look at 2025 and what it truly set in motion for 2026.
This plenary reflects the unfiltered perspectives of some of the most experienced minds in cell and gene therapy. Rather than focusing on hype, predictions, or isolated breakthroughs, the Advisory Board focused on 3 simple but difficult questions: What actually worked in 2025? What didn’t? And what are we now working on as we move into 2026?
What emerged was not a single narrative, but a shared recognition that the field has entered a new phase. Scientific feasibility is no longer the central question. Instead, access, delivery, manufacturability, regulation, and economic viability are now the defining constraints—and opportunities.
In this opening plenary, we will surface where the Advisory Board strongly aligns, where views diverge, and what those tensions reveal about the next phase of advanced therapies. The discussion will highlight practical lessons from 2025, emerging shifts already underway, and the realities shaping how therapies are being developed, delivered, and funded today.
This is not a forecast. It is a grounded assessment of where the field stands—and what it will take to move forward.
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Theatre 1Victoria Grey and Tom Whitehead share their experiences as patients and advocates navigating the complexities of advanced therapies. The conversation explores the real-world challenges of access, treatment logistics, and the decisions patients face, providing a candid look at the human impact of emerging CGT.
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Theatre 1
The CGT field has achieved what once seemed impossible: the scientific capability to engineer sophisticated therapies with unprecedented precision. Yet as the pipeline grows, new challenges are emerging. FDA rejections are on the rise, quality lapses are more visible, and hard-won manufacturing advances don’t always translate into real-world access.
What does the next chapter of this rapidly evolving field look like? How do we continue to translate scientific breakthroughs into safe, accessible, and scalable therapies? Join our panel of leading experts as they explore these questions, highlighting strategies in regulatory navigation, quality assurance, manufacturing optimization, and collaborative approaches to ensure that the next generation of therapies reaches the patients who need them most.
Chairperson
Speakers (4)
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Kristin Hege
Former: Senior Vice President, Early Clinical Development, Hematology/Oncology & Cell Therapy - Bristol Myers Squibb -
Eric Shiozaki
Partner - Revelation Partners -
Miguel Forte
Chief Executive Officer & President, ISCT - Kiji Therapeutics -
Susan Nichols
Chief Executive Officer - Propel Biosciences
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Technology and Innovation
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Theatre 1Fireside Chat: Make automation your force multiplier for CGT manufacturing. Faster, more consistent batches with real-time oversight and smarter integration.
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Theatre 1Spotlight: Explore how automation is transforming cell therapy production. Learn strategies to optimize processes, improve reproducibility, and enable scalable manufacturing for external and internal operations.
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Theatre 1Spotlight: Discover how automated systems can scale Advanced Therapy Medicinal Product (ATMP) production. Learn strategies for flexible, decentralized and centralized manufacturing that support diverse cell products and time-sensitive personalized medicine workflows.
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Theatre 1Spotlight: Explore strategies for implementing automation in early development of advanced therapies. Learn how robotics and process automation can improve reproducibility, streamline workflows, and accelerate product development.
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Theatre 1
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Theatre 1Fireside Chat: Learn how to design and operate a smart cell and gene therapy manufacturing facility. Explore strategies for integrating automation, optimizing processes, and preparing a workforce for advanced manufacturing demands.
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Theatre 1Fireside Chat: Unlock the next wave of CGT with platforms that cut cycle time, scale cleanly, and lift your hit rate from model to patient.
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Theatre 1Spotlight: Discover how enabling technologies and next-generation tooling can accelerate process development and manufacturing in cell and gene therapies. Learn to adopt tools that enhance efficiency, reproducibility, and product quality.
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From days to hours: The closest you can get to real-time sterility testing for cell & gene therapiesTheatre 1
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Theatre 1
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Theatre 1Panel: Discover how artificial intelligence can enhance research and development in cell and gene therapies. Learn strategies to leverage AI for predictive modelling, translational insights, and streamlined R&D workflows.
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Development and Scale-up
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Theatre 2Panel: Efficient technology transfer and scalable manufacturing are critical for moving advanced therapy programs from development to clinical and commercial stages.
Chairperson
Speakers (5)
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Poh Yeh-Chuin
Head of Technical Ops - Tolerance Bio -
Justin Skoble
Vice President of Technical Operations - Caribou Biosciences -
Kumar Karyampudi
Senior Director & Site Head, Cell Therapy and Gene Engineering Facility - Moffitt Cancer Center -
Nikki Bishop
VP Marketing and Experience - Emerson -
Gregg Nyberg
Chief Technology Officer
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Theatre 2Spotlight: Explore adaptable bioseparation strategies that streamline purification for viral and non-viral modalities while improving scalability, yield and cost efficiency in advanced therapies manufacturing.
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Theatre 2Spotlight: Discover how novel cell, gene and nucleic acid modalities are scaled for commercial manufacturing with flexible, efficient platforms at this advanced therapies conference session.
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Theatre 2Panel: With proof of concept established, gene therapy is entering a new phase of technical refinement and operational maturity. This panel will explore how innovations in capsid design, manufacturing scalability, and U.S. regulatory clarity are advancing the field toward a sustainable modality capable of fulfilling its therapeutic promise while strengthening confidence in gene therapy’s long-term impact for patients.
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Theatre 2
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Theatre 2Spotlight: Explore new models that relieve CGT manufacturing bottlenecks, boosting throughput, efficiency and scalable high-quality cell and gene therapy production.
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Theatre 2Fireside chat: Explore how to build GMP ready manufacturing frameworks that align quality systems, tech transfer and scalable processes for advanced therapies production.
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Clinical and translational excellence
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Theatre 3Fireside chat: Examine how emerging biotech organizations can design translational infrastructure that supports the progression from discovery research to first-in-human studies.
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Theatre 3Spotlight: Explore practical ways to structure first-in-human and early phase CGT trials, balancing dose escalation, biomarker and PK PD readouts with manufacturing, regulatory and program readiness milestones.
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Theatre 3
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Theatre 3Fireside chat: Experts unpack how smarter model selection, dose and safety frameworks, and mechanistic insights can close the gap between animal data and human outcomes in advanced therapy programs.
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Theatre 3Through the example of hematopoietic stem cell gene therapy for cystinosis, this presentation will highlight the major steps involved in translating a gene therapy product from preclinical research to clinical application
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Theatre 3Spotlight: Discover collaborative models that unite academia, industry and translational partners to speed cell and gene therapy translation at this advanced therapies conference session.
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Theatre 3Panel: Explore what truly trial-ready looks like in 2026, from aligning preclinical and translational data with dose, biomarker and safety requirements to building workflows that de-risk first-in-human studies and speed early clinical decisions.
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Theatre 3Fireside chat: Experts share practical ways to structure early cell and gene therapy trials that balance safety, dose and biomarker strategy with regulatory expectations and translational predictivity.
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Theatre 3Spotlight: Speakers compare solid tumor focused modalities through mechanism of action, tumor biology, dosing, biomarker strategy, manufacturing and delivery constraints so teams can make structured, early clinical modality choices with stronger predictive validity.
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Commercial models & partnerships
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Theatre 4Fireside chat: Discover how academic industry partnerships accelerate advanced therapies translation with effective models for governance, funding and IP at this conference session.
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Theatre 4Panel: Dive into how to build viable cell and gene therapy commercial models, balancing pricing, access, manufacturing costs and investor expectations in this conference session.
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Theatre 4Fireside chat: Discover cross-sector partnerships that align academic, industry and investor goals to accelerate advanced therapies from research to commercialization.
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Theatre 4
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Theatre 4Spotlight: Compare CDMO partnerships and in house manufacturing for cost, control and scalability in advanced therapies at this cell and gene therapy conference session.
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Theatre 4Fireside chat: Explore how strategic CDMO partnerships accelerate cell and gene therapy development, improving scalability, tech transfer and regulatory readiness in this session.
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Theatre 4A tough economic and geopolitical landscape put pressure on innovator funding in 2023-24, the impact of which continues to reverberate through the industry. A hoped-for investor rebound has not yet materialized, instead venture capital investment into biotech continued to fall in early 2025, with public markets remaining selective and risk-averse. However, over a series of expert panel discussions with subject matter experts from CDMOs, innovators and investor organizations, it became clear that innovation cannot – and will not – wait for improved macro conditions.
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Theatre 4
Fireside chat: Turn GMP sourcing into a strength, not a risk. Secure critical inputs, squeeze out bottlenecks, and build a supply chain that scales on schedule.
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Theatre 4
Can decentralised and point of care models deliver speed without sacrificing quality or cost control? See how digital tools, modular sites, and closed systems make local manufacturing scale.
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Phacilitate.TV
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ElevateBio: Coming soonPhacilitate.TV Studio
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Bio-techne: Coming soonPhacilitate.TV Studio
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Phacilitate.TV StudioLive Interview: An expert discussion on how supplier partnerships can stabilise quality, streamline GMP changeovers, and protect timelines as cell therapy manufacturing scales.Bio-techne
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Phacilitate.TV StudioLive Interview: DMSO toxicity and variability can compromise both cells and patients. Learn how Pentahibe® DMSO-free and low-DMSO formulations support high recovery with cGMP consistency.
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Assurea LLC: Coming soonPhacilitate.TV StudioAssurea LLC
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Marken: Coming soonPhacilitate.TV Studio
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Workshop
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Theatre 2
Quality control (QC) remains one of the biggest constraints in scaling cell and gene therapy manufacturing — not only at release, but across the many in-process checkpoints that keep batches moving. These measurements are essential, yet today they’re slow, manual, and highly variable, creating delays long before a product ever reaches final testing. As developers work to increase batch throughput and move toward commercial readiness, the gap between what QC can handle and what manufacturing requires is widening.
Chairperson
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Theatre 1Workshop: Join industry leaders for an engaging panel discussion exploring the future of end-to-end cell therapy manufacturing.Thermofisher
Speakers (5)
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Shirley Bartido
CGT Consultant - CELLiCONsultant, LLC -
Uma Lakshmipathy
Senior Director, Research & Development, Pharma Services Group - Thermo Fisher Scientific Inc. -
Namritha Ravinder
Director, Cell Biology - Thermo Fisher Scientific -
Shannon Eaker
Chief Technical Officer - Xcell Biosciences -
Holly Young
CMC and Cell Therapy Manufacturing Leader, Director University of California San Diego Advanced Cell Therapy Laboratory GMP Facility (UCSD ACTL) - University of California San Diego
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Theatre 2
Workshop: Advancing CAR-T Cell Therapy Workflow with Novel Cell Selection and Non-Viral Delivery Methods
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Theatre 1
Workshop: Key Considerations in Preparing for Commercial Approval and Launch
Speakers (6)
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Barry Oliver
Senior Principal - Dark Horse Consulting -
Kimberly Benton
Master Principal, Head of Regulatory - Dark Horse Consulting -
Robert Cantow
Practice Director, Supply Chain - Converge Consulting -
Eileen Choi
VP of Manufacturing Science and Technology - Dark Horse Consulting -
Heath Coats
Senior Principal, Head of Quality and Compliance - Dark Horse Consulting -
Joe Balleydier
Senior Practice Expert - Dark Horse Consulting
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Theatre 2Cell and gene therapies have delivered transformative treatment opportunities for patients suffering from circulating tumors and rare diseases. Rapid in-process testing improves manufacturing efficien ...
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Theatre 2
Discover how leading CDMOs and innovators reduce contamination risk, overcome manual bottlenecks, and scale efficiently using closed, automated solutions—and the evidence that drives adoption decisions.
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Theatre 1
Autologous CAR T manufacturing remains operationally complex, highly manual, and difficult to scale, often extending regulatory and commercialization timelines. As more programs move into earlier-line settings, larger indications, and global expansion, the ability to translate processes reproducibly and support a robust comparability strategy becomes a critical success factor.
Cellares
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Networking
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Petco Park StadiumFor one night only, Phacilitate takes over San Diego’s iconic Petco Park. This is networking on a grand scale, with food, drinks, and panoramic views of the city skyline. With drinks, canapés & entertainment, it will be the biggest night of the week, where biotech leaders, investors, and solution providers come together.
Advanced Therapies Live
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Theatre 5
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Theatre 5
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Theatre 5Four leaders each share one bold prediction for the future of cell and gene therapy. Short, fast, and unfiltered, with live audience polling to vote on the most disruptive or exciting idea. A must-att ...
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Theatre 5Advanced therapies are being reshaped by geopolitics, funding shifts, and emerging regional capabilities. U.S. momentum behind mRNA research is softening, creating downstream challenges for innovation ...
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Theatre 5California hosts one of the world’s most vibrant and fast-growing advanced therapies ecosystems. This session will explore how local institution, from CIRM’s strategic funding and UCSD’s translational research to the pivotal role of regional CDMOs and innovation hubs, are propelling the next generation of cell and gene therapies from breakthrough discovery to patient delivery.
Chairperson
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Theatre 5Saudi Arabia is fast transforming into a major hub for advanced therapies—driven by the strategic imperatives of Vision 2030 and its National Biotechnology Strategy. With the recent launch of the firs ...
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Theatre 5Advanced therapies can’t scale without one thing: the right places to put them. Labs, cleanrooms, GMP suites, manufacturing space these are the foundations of every breakthrough, yet they remain the industry’s biggest bottleneck. It’s the chicken-and-egg problem no one wants to talk about: biotechs can’t grow without facilities, and developers won’t build without tenants.
This talk dives into why infrastructure shapes community, investment, and commercial success, and what it will take to build the flexible, future-ready facilities the ATMP sector desperately needs. We’ll also spotlight a new cross-sector initiative created to bring science, developers, investors, and policymakers together to finally break the cycle. -
Theatre 5From translational research to commercial manufacturing, APAC’s ecosystem is increasingly integrated with global stakeholders. Learn how collaborations with international CDMOs, pharma, and research n ...
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Innovation Zone
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Innovation ZoneCharter Medical’s Felipe Rivas, PhD, R&D Engineer II, will discuss how engaging early with a single-use solutions partner can help cell & gene therapy manufacturers mitigate risks associated with the cryopreservation steps in their processes. He will address the origins of specific cryopreservation risks and how advanced therapy manufacturers can customize single-use solutions and leverage freezing studies to design scalable, repeatable cryopreservation steps to avoid downstream delays and product loss
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Innovation ZoneAlpha Teknova
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Innovation ZoneVitrafy
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Innovation ZoneAlphalyse
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Innovation ZoneTrenchant Biosystems
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Innovation ZoneTBC
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Innovation ZoneTBC
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Innovation ZoneTBC
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Innovation ZoneMatricelf
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Innovation Zone
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Innovation ZoneTQ Therapeutics
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Innovation ZoneKomodo
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Innovation ZoneGlafabra Therapeutics
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Innovation ZonePythera Therapeutics
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Innovation ZoneZelig Therapeutics
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Innovation ZoneTBC
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Innovation ZoneErnexa Therapeutics
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Innovation ZoneAlder Therapeutics / Xintela
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Innovation ZoneD&P BioInnovations
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Innovation ZoneTBC
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Technology and Innovation
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Theatre 1Spotlight
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Theatre 1Spotlight: Explore strategies for reprogramming multiple immune cell types in vivo using a redosable CAR platform. Learn how this approach can enhance therapeutic precision, efficacy, and flexibility in targeting solid tumors.
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Theatre 1Spotlight: Skip the ex vivo bottlenecks with in vivo engineering. Balance potency, safety, and trial design to bring cell therapy to more patients.
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Theatre 1
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Theatre 1Spotlight: Learn how tools and technologies support process robustness and comparability from discovery through chemistry, manufacturing, and controls (CMC). Discover strategies to streamline development, ensure reproducibility, and de-risk scale-up.
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Theatre 1
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Theatre 1Spotlight: Discover how automated, closed, and simplified technology transfer systems support scalable cell therapy manufacturing. Learn strategies to improve process reproducibility, reduce errors, and accelerate scale-up.
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Theatre 1Spotlight: Discover how Process Control 4.0 can integrate digital tools across the manufacturing lifecycle. Learn strategies to enhance data-driven decision-making, improve efficiency, and ensure consistent product quality.
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Theatre 1Panel: This panel explores strategies for designing robust analytical and quality control frameworks in cell and gene therapy manufacturing.
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Development and Scale-up
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Theatre 2Fireside chat: Delve into scalable viral vector manufacturing models that enhance throughput, quality and regulatory readiness at this advanced therapies conference session.
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Theatre 2Spotlight: TBC
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Theatre 2Fireside chat: Discover how to maintain product comparability across sites and phases with robust analytics, process control and risk management in CGT manufacturing.
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Theatre 2Spotlight: Explore how allogeneic cell therapies can deliver long-term scalability through robust process design, donor strategy and quality systems in this session.
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Theatre 2Spotlight: Dive into practical strategies to scale allogeneic cell therapy manufacturing, increasing throughput while maintaining product quality, consistency and compliance.
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Theatre 2Fireside chat: Compare autologous and allogeneic cell therapy manufacturing models for scalable, high-speed production while maintaining quality, consistency and compliance.
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Theatre 2Spotlight: Explore how to overcome persistence challenges in allogeneic therapies using dosing, biomarkers and process design to deliver durable, scalable clinical impact.
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Clinical and translational excellence
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Theatre 3Panel: Gain practical ways to embed patient perspectives into study design, endpoints, biomarkers and access frameworks so advanced therapies deliver clinically meaningful benefits for diverse real-world populations.
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Theatre 3
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Theatre 3Fireside chat: Explore how structured collaboration with patient advocacy groups can bring real world priorities into early trial design, endpoint and biomarker choices so CGT programs deliver more relevant and impactful early clinical outcomes.
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Theatre 3Panel: Early stage developers explore practical ways to engage regulators proactively in cell and gene therapy, aligning preclinical and translational data, safety, dose and biomarker plans with evolving first-in-human and early trial expectations.
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Theatre 3Spotlight: Explora holistic framework for integrating commercial viability, quality assurance, and regulatory strategy into therapeutic design from the outset.
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Theatre 3Panel: Explore how to fund and run global CGT clinical programs by aligning multinational trial design, translational data and regulatory strategies with the resources and operational models needed to move from discovery toward approval.
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Commercial models & partnerships
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Theatre 4Panel: Learn how payers evaluate cell and gene therapies, from evidence and long-term outcomes to pricing, value demonstration and innovative payment models in this CGT conference session.
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Theatre 4
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Theatre 4Fireside chat: Delve into global market access strategies for advanced therapies, from regulatory and payer requirements to launch sequencing and patient delivery in this conference session.
Chairperson
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Theatre 4Fireside chat: Explore funding models, investor expectations and market trends shaping capital-intensive CGT development in this cell and gene therapy conference session.
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Theatre 4Fireside chat: Learn how to fund advanced therapy programs from FIH to launch by aligning capital with milestones, risk and scalability at this advanced therapies conference session.
Chairperson
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Theatre 4
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Phacilitate.TV
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Phacilitate.TV Studio
Showcase your announcements on Phacilitate.TV
Roundtable
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Theatre 1
Roundtable: Decentralized Apheresis: The Next Generation Ecosystem for Advanced Therapies
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Theatre 1Roundtable: Coming soon
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Maximizing value of intellectual property portfolios in cell and gene therapies to attract investorsTheatre 1
- Advantages and strategies for extending Loss of Exclusivity (LOE) beyond regulatory exclusivity
- Preparing for investor IP diligence scrutiny
- Knowing the patent landscape to proactively address freedom-to-operate inquiries
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Theatre 1
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Building strategic patent value for cell and gene therapies in a competitive landscapeTheatre 1Roundtable
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Theatre 1Roundtable: Coming soon
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Theatre 1Roundtable: Coming soon
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Theatre 1Roundtable
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Theatre 1Roundtable: Coming soon
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Partnering with patient organisations to influence policy & accelerate accessTheatre 1Roundtable: Coming soon
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Protecting IP in a rapidly evolving ATMP landscapeTheatre 2Roundtable: Coming soon
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Digitalising documentation for scalable, compliant CGT manufacturingTheatre 2Roundtable: Coming soon
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Global access & equity: Expanding CGT availability beyond US/EU marketsTheatre 2Roundtable: Coming soon
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Strategic asset prioritisation: Making the right pipeline bets in a resource-limited environmentTheatre 2Roundtable: Coming soon
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Workshop
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Theatre 1Are you ready to simplify your MSC workflow? Would you like a reliable, scale-up-ready solution to support your MSC therapy development? The road from early discovery to commercial manufacturing is ra ...Fujifilm
Chairperson
Speakers (4)
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Yosuke Kurokawa
Senior Scientist II, R&D Cell Therapy - FUJIFILM Biosciences -
Jeff Shumway
Principle Account Manager, Life Sciences - Entegris -
Dalip Sethi
Commercial Leader, Cell Therapy Technologies - Terumo Blood & Cell Technologies (BCT) NA -
Bill Mirsch
Chief Executive Officer - Mill Creek Life Sciences
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Theatre 2This presentation highlights how early digital integration enables accelerated timelines across the Cell Therapy manufacturing lifecycle, showcasing how a strategically deployed MES helps deliver pati ...Resilience
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Theatre 1
Workshop: Navigating the Road Ahead for In Vivo CAR-T: An Interactive Roundtable
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Networking
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Hilton San Diego BayfrontKickstart your day with a refreshing 5k run alongside fellow attendees.
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San Diego Convention CenterWhen the sessions finish, the networking continues! Open to all ticket holders and free to attend, the Exhibition Party takes place on the show floor with a mix of bars, a DJ, and a few fun surprises. It is the perfect way to carry on conversations, make new connections, and enjoy the evening with the community.
Plenary
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Theatre 1
Chairperson
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Theatre 1
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Technology and Innovation
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Theatre 1Spotlight: Discover how SynCav1 gene therapy is being developed to address central nervous system (CNS) disorders. Learn strategies for targeted delivery, therapeutic design, and translational development in challenging neurological conditions.
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Theatre 1Spotlight session: Route, dose, and monitor with confidence. Practical tactics to reach the right cells, manage adverse events, and execute lean trials in small populations.
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Theatre 1Spotlight session: Explore the current landscape of cell therapies for type 1 diabetes. Learn how recent advances are shaping therapeutic strategies and bringing curative approaches closer to clinical reality.
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Clinical and translational excellence
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Theatre 3Spotlight: Explore practical frameworks for selecting and validating biomarkers and companion diagnostics that connect mechanism, dose, safety and patient stratification with endpoints to make CGT trials more precise and predictable.
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Theatre 3Spotlight: Learn how to design and validate unbiased rcAAV assays with the sensitivity, specificity and reproducibility needed to support safety margins, regulatory expectations and confident clinical vector product release.
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Theatre 3
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Theatre 3Spotlight: Navigate novel cell sources and sourcing strategies that improve scalability, reproducibility and product quality in advanced therapies manufacturing.
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Special Interest Groups
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Theatre 1The Automation SIG unites experts from biopharma, technology, contract manufacturing, and academia to accelerate automation in cell and gene therapy (CGT) manufacturing, focusing on closed-system processing, digital integration, and workforce considerations to improve efficiency, consistency, and scalability.
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Theatre 2
The Decentralized Manufacturing SIG unites stakeholders to explore scalable, resilient, and accessible models for cell therapy production. This group focuses on regulatory, technological, and quality challenges to advance collaborative, practical approaches worldwide.
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Networking
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SIG networking eventTheatre 1Dedicated networking event for the Special Interest Groups - more info to come soon!