This agenda is still in development. All sessions and timings are subject to regular change at this time.
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Indigo Ballroom, Hilton Bayfront HotelOpening remarks by Christiaan Engstrom, CEO, BLPN
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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.
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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.
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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.
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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.
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Indigo Ballroom, Hilton Bayfront HotelRoundtable
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Indigo Ballroom, Hilton Bayfront HotelRoundtable
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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 HotelRoundtable
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Indigo Ballroom, Hilton Bayfront HotelClosing wrap up
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LunchIndigo Ballroom, Hilton Bayfront HotelLunch: Investment Summit, Founders Forum and WIAT
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Indigo 202 A & BScaling 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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Indigo 202 A & BWorkshop: 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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LunchIndigo Ballroom, Hilton Bayfront HotelLunch: Investment Summit, Founders Forum and WIAT
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Indigo 204 BYour expertise deserves to be seen before you ever speak. Join us for on-site professional headshots designed for women in advanced therapies who are stepping into greater visibility, influence, and l ...Sponsored by Joanna Ghayad Coaching
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Indigo Ballroom A & E
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Indigo Ballroom A & E
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Indigo Ballroom A & E
- 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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Indigo Ballroom A & ESpotlight: 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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Indigo Ballroom A & E
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Indigo Ballroom A & ERoundtable: Explore how to build, maintain and leverage networks and mentorships to advance careers and influence your industry.
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Indigo Ballroom A & ERoundtable: Share approaches to recognise and overcome self-doubt while thriving in male-dominated spaces.
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Indigo Ballroom A & ERoundtable: Discuss how empathy, intuition and people skills can be leveraged as leadership strengths.
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Indigo Ballroom A & E
Roundtable: 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.
CGT CircleChairperson
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Indigo Ballroom A & ERoundtable: Explore strategies for securing funding, support and recognition for women-led initiatives.
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Indigo Ballroom A & ERoundtable: Explore strategies to close gaps in research, clinical trials and healthcare access for women
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Indigo Ballroom A & ERoundtable: Looking at your interactions through the lens of an observer
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Indigo Ballroom A & ERoundtable: 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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Indigo Ballroom A & E
Roundtable: Examine how organisations can adopt AI responsibly while balancing regulatory compliance, ethical considerations and inclusive, human-centred decision-making.
AssureaChairperson
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Indigo Ballroom A & EPluristyx
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Indigo Ballroom A & ERoundtable: Discuss practical approaches to communicating effectively across cultures, geographies and perspectives to build trust, avoid misalignment and lead more inclusive teamsEmerson
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Indigo Ballroom A & ERoundtable: Share experiences of unconventional career trajectories and how they can create leadership opportunities.
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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 from 3.45-4.45pm. 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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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.
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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 5Hosted by Sharron Cox, Founder & Host, She Leads Podcast
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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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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 ZoneAs a CDMO fully specialized in lentiviral vector (LVV) development and manufacturing, VIVEbiotech has spent the last decade building deep scientific, technical, and regulatory expertise—an effort reco ...
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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 Zone
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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.
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Kristen 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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Poster Gallery
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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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Theatre 2Panel: Efficient technology transfer and scalable manufacturing are critical for moving advanced therapy programs from development to clinical and commercial stages.
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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 - Landmark Bio
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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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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 3
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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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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 StudioWe will bring a novel off-the-shelf cell therapy to tackle over half of cancers across hematologic and solid tumors. Our unique technology will allow to scale manufacturing so we can "democratize" cel ...NKILT
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Phacilitate.TV StudioThe storage and transportation of cell therapies are oftentimes an afterthought. CaseBioscience focuses on preservation of cells for storage and transport, so cell therapy developers have a partner f ...CaseBioscience
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Phacilitate.TV StudioCell therapy manufacturing is defined by biological variability, sensitive unit operations, evolving analytical methods, and fragile supply chains-factors that collectively introduce profound risk int ...ElevateBio
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Phacilitate.TV StudioAs a cell therapy advances from early-stage research to commercial-scale manufacturing, the challenges extend far beyond sourcing GMP-grade raw materials. Success depends on strategic partnerships tha ...Bio-techne
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Phacilitate.TV StudioEntegris
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Phacilitate.TV StudioLimula is addressing the challenges of clinical centres and biotech companies looking for a solution enabling fully automated production of cell therapies at the point-of-care. We have reimagined how ...Limula
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Phacilitate.TV StudioThis live interview is designed for cell therapy developers across PD, MSAT, CMC, and Manufacturing who are working to improve critical quality attributes (CQAs) while scaling toward clinical and comm ...
Tolemy Bio
Gemini Bio
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Phacilitate.TV StudioAdeno‑associated virus, or AAV, continues to be the dominant viral vector in gene therapy, and the global clinical trial landscape reflects that leadership. Today, we’re seeing investors increasingly ...Catalent
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Phacilitate.TV StudioAssurea LLC
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Phacilitate.TV StudioThis interview challenges conventional thinking in global logistics and asks a critical question: how do you deliver life-saving advanced therapies when every minute matters? As treatments evolve and ...Marken
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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.
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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
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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 -
James Lim
Chief Scientific 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
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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
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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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Exhibition
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Catering AreaNetworking and Exhibition time
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ExhibitionNetworking and exhibition time
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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.
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Theatre 5Last year, Montana passed Senate Bill 535. Clinics can now offer experimental treatments that have completed Phase I trials but haven't yet received FDA approval. It's the most expansive legislation ...
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Theatre 5
Join The CGT Circle for an unfiltered conversation with women leaders in CGT. We examine the data on barriers to leadership, then hear the real stories behind the statistics: the moments that propelled careers forward and the experiences that nearly derailed them.
Let’s journey from science class to senior leadership.
Introduction:
- Survey insights and what the data reveal about barriers to leadership and the attrition of girls from STEM
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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.
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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.Chairperson
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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 ZoneTozaro
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Innovation ZoneTBC
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Innovation ZoneAnew Cell Therapies
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Innovation ZoneMatricelf
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Innovation Zone
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Innovation ZoneTQ Therapeutics
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Innovation ZoneKommodo
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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 ZoneAxent Bio
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Innovation ZoneD&P Bioinnovations
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Innovation Zone
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Poster Gallery
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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: 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 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: Mygogenesis LLC tm is a Stem Cell Research and Development Company, which has a unique proprietary process, the Mygotic Process , to revert somatic cells to totipotent zygotic clones.
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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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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 2
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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 2Learn how massively parallelized microfluidics can address cell therapy bottlenecks from discovery to commercialization. Key aspects that will be covered in this presentation by Astraveus: Microfluidi ...
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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 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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Amy Christenson
Executive Director, Medical Affairs - Beacon Therapeutics -
Adrienne Mendoza
Chief Operative Office (COO) - BBG Advanced Therapies -
Robert Tressler
CSO & Co-founder - Excellos -
Abigail Jastrab
Director, Patient Engagement and Clinical Innovation - PANTHERx Rare -
Farhatullah Syed
Group Leader/Senior Scientist ,Head of Advance Cell and Gene Therapy Section, Cancer Center of Excellence (CCoE) - King Faisal Specialist Hospital & Research Centre (KFSH&RC),
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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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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 4Microbubbles are the paradigm-changing cell separation platform, the first to: Enable large scale production of therapeutics Increase access with a fast process that can be run anywhere Reduce costs t ...
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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.
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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.
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Theatre 4
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Phacilitate.TV StudioSymcel addresses one of the biggest remaining bottlenecks in cell & gene therapy: QC release, which often takes 7–21 days due to the slowest test—sterility testing. Reducing this timeline is essential ...Symcel
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Phacilitate.TV StudioGenomic medicine promises transformative treatments, but progress has often been slowed by complexity, uncertainty, and risk. What if accelerating innovation and reducing risk were not opposing forces ...Siegfried DiNAMIQS
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Phacilitate.TV StudioNovel therapy development is focused on increasingly individualized and diverse solutions, requiring smaller, more customized batches of reagents and buffers to be used across the clinical pipeline as ...Teknova
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Phacilitate.TV StudioExcellos
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Phacilitate.TV StudioAs the field of advanced therapies matures, one barrier remains constant: access. Whether autologous or allogeneic, developers need reliable access to high-quality starting material, as well as downst ...BBG Advanced Therapies Network (BioBridge Global)
Chairperson
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Phacilitate.TV StudioThis session is designed for cell and gene therapy developers, process development teams, and manufacturing leaders seeking to accelerate timelines while reducing manufacturing costs. Nucleus Biologic ...Nucleus Biologics
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Phacilitate.TV StudioHistorically, cryopreservation has depended on one-size-fits-all freezers, fragmented workflows, and limited digital oversight. Vitrafy takes a systems approach, combining purpose-built hardware with ...Vitrafy Life Sciences
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Theatre 1
Roundtable: Decentralized Apheresis: The Next Generation Ecosystem for Advanced Therapies
BBG Advanced Therapies -
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
Sterne, Kessler, Goldstein & Fox
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Theatre 1BlueSquared
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Theatre 1RoundtableMorrison Foerster
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Theatre 1Roundtable: Coming soon
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Theatre 1Roundtable
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Theatre 1Roundtable
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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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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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Hilton San Diego BayfrontKickstart your day with a refreshing 5k run alongside fellow attendees.
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Catering Area
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Exhibition
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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.
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Theatre 3Join us for an exciting session where innovative biotech start-ups pitch their groundbreaking ideas and solutions. Watch as they present to a panel of expert investors, who will provide real-time feedback, insights, and guidance. This is a unique opportunity to explore cutting-edge advancements in the biotech space and gain valuable perspectives from both entrepreneurs and industry leaders.
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Theatre 1
Chairperson
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Theatre 1
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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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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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Theatre 1
The 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.
This session builds on the three core themes selected by the group in Barcelona last September—modularity, analytics, and infrastructure—which continue to resurface in every serious discussion around automation and scaling manufacturing. Rather than treating them as separate pillars, this session frames them under one unifying lens: standardisation, but focussing that lens on either end of the product development pathway; clinical phase one end, commercialisation the other.
As the industry pushes toward reduced COGs, faster paths to the clinic and commercial/Industrial scale manufacturing, true scale-up/out remains elusive without process standardisation and standardised processes and assays. Standardisation has to be considered at both ends of the product development pathway.
Clinical Phase
While founders, pre-clinical or early clinical manufacturers often believe their process is uniquely superior, in practice most workflows differ only marginally—often by just 2–5%. These small optimizations frequently come at the cost of speed, interoperability, and automation readiness.
Pre-commercial/Commercial
Commercial manufacturers and those planning post-approval production phase up may seek to copy&paste more of their clinical processes to reach scale but failures, variability, errors and contaminations multiply directly with the production output to untenable degrees of incidence.
From a consulting perspective—supporting startups and small biotechs advancing toward clinical stages—the observation is clear: greater ROI often comes from turning around products faster, not from squeezing out incremental process improvements. Embracing standardization could accelerate the field as a whole, enabling automation to shift from bespoke solutions to more off-the-shelf platforms.
From an industrial automation perspective – full automation and robotics need employing to scale operations and production but also to standardise processes with a minimal amount of change under a high level of regulatory scrutiny. Vital as we scale towards 10,000s to 100,000s products produced a year.
Objectives
- Reframe modularity, analytics, and infrastructure as enablers of standardisation, which is in term an enabler of scale
- Explore the trade off between marginal process optimization and speed-to-clinic
- Explore the trade off between process innovation and process standardisation
- Discuss the potential hurdles and best approach to stepping into full automation versus process change and risk
- Does standardisation mean less human input?
- Discuss how standardisation impacts automation design, scalability, and cost
- Examine barriers—technical, cultural, and economic—to adopting standards
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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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