Phacilitate Advanced Therapies Week 2027 Agenda
This agenda is still in development. All sessions and timings are subject to regular change at this time.
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- Workshop
- Women in Advanced Therapies
- Streamlining Early Development to Enable Rapid Clinical Proof of Concept
- Roundtables
- Plenary
- Phacilitate Stage
- Networking
- Manufacturing, CMC and Supply Chain
- Investment Summit
- Innovation Zone
- Innovation in Gene Delivery
- Founders Forum
- Empowering Patients, Delivering Access (in Partnership with the Emily Whitehead Foundation)
- Commercializing Advanced Therapies
- CGT Connect
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- Monday, 18th January
- Tuesday, 19th January
- Wednesday, 20th January
- Thursday, 21st January
9:00 AM
1 Session
12:00 PM
1 Session
1:00 PM
2 Sessions
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How to successfully set up, conduct, and leverage the data from Investigator-Initiated Trials (IITs) in China? Learning lessons from real-world experiences. Strategic insights, case studies and audience Q&A – dissecting real-world experiences and clarifying the risks, benefits and key considerations to inform your assessment of whether a clinical study in China is the right option for your company and product candidate. • What is the reality versus the perception in terms of: Evolving regulatory pathways in China? Relative cost and time to result? Acceptability of Chinese clinical data to other regulatory jurisdictions? Manufacturing trial material? Ethical oversight? Quality systems? Long-term follow-up requirements? Considerations in moving your clinical programme from China to other regions? Pathway to eventual global registration and commercialisation?Speakers
4:00 PM
1 Session
4:15 PM
1 Session
6:30 AM
1 Session
8:00 AM
2 Sessions
9:00 AM
2 Sessions
10:30 AM
1 Session
11:00 AM
4 Sessions
11:15 AM
1 Session
12:00 PM
5 Sessions
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- Innovation in Gene Delivery
Theatre 3 -
- Empowering Patients, Delivering Access (in Partnership with the Emily Whitehead Foundation)
Theatre 5Why community oncologists do not refer, and what it would take to change that. The session opens with the referral economics, the chemotherapy and stem cell transplant revenue community oncologists lose by referring a patient out, and works through the awareness gap among community hematologists who have not yet encountered CAR-T in their own practice -
An informal, interactive session providing delegates with the opportunity to discuss regulatory questions and challenges directly with experienced regulatory professionals. Through short, focused discussions, participants can raise specific issues relating to their development programmes, seek clarification on regulatory requirements and exchange perspectives on navigating the regulatory landscape for advanced therapies. The session will cover a range of topics relevant to cell and gene therapy development, with discussions shaped by the questions and priorities of participating delegates.Speakers
12:15 PM
1 Session
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- Commercializing Advanced Therapies
Phacilitate HubPhacilitate Hub Meet Up: Come and meet like minded individuals that are all facing the same challenge as you in a laid back networking setting at the Phacilitate hub. If you would like to discuss 'how to turn clinical success into commercial success', meet at the hub at 12.15pm
12:55 PM
1 Session
1:00 PM
2 Sessions
1:15 PM
1 Session
2:00 PM
7 Sessions
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- Manufacturing, CMC and Supply Chain
Phacilitate HubPhacilitate Hub Meet Up: Come and meet like minded individuals that are all facing the same challenge as you in a laid back networking setting at the Phacilitate hub. If you would like to discuss 'when is the right time for biotech to pursue a processing technology platform', meet at the hub at 2.15pm -
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- Streamlining Early Development to Enable Rapid Clinical Proof of Concept
Theatre 1 -
- Commercializing Advanced Therapies
Theatre 4 -
An interactive session bringing together contract research organisations (CROs) and advanced therapy developers to discuss the practical considerations involved in planning and delivering cell and gene therapy clinical trials. The session will begin with brief introductions from participating CROs, outlining their areas of expertise, the types of advanced therapy trials they support and some of the common misconceptions developers have when engaging CRO partners. This will be followed by an audience-led discussion covering key aspects of clinical trial planning and execution, including protocol design, site selection, timelines, regulatory expectations, patient recruitment, decentralised and hybrid trial models, budgeting and resource requirements. The session will conclude with an opportunity for developers and CRO representatives to connect and discuss potential areas for collaboration.
3:00 PM
4 Sessions
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- Streamlining Early Development to Enable Rapid Clinical Proof of Concept
Theatre 1 -
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- Empowering Patients, Delivering Access (in Partnership with the Emily Whitehead Foundation)
Theatre 5The second-opinion problem and the prior-authorization wall. Presenting the direct-to-patient referral and navigation model that removes the financial friction at the point of eligibility assessment. CAR-T Vision 2030 frames the system-level gap: What would the payer and authorization workflow have to look like to double the treated population by 2030? -
An interactive workshop exploring the current and emerging applications of artificial intelligence across the cell and gene therapy industry. The session will begin with a panel discussion examining how organisations are using AI today, where companies should start when considering adoption, and the opportunities and limitations of the technology. Panellists will share their perspectives on where AI can deliver practical value, where its capabilities remain limited and what advanced therapy companies should be prioritising now. The discussion will be followed by a series of short presentations showcasing real-world AI applications and use cases, highlighting how the technology is being applied across different areas of advanced therapy research, development and manufacturing.Speakers
3:15 PM
1 Session
4:00 PM
5 Sessions
5:00 PM
3 Sessions
6:30 PM
1 Session
8:00 AM
1 Session
9:00 AM
2 Sessions
10:20 AM
1 Session
10:30 AM
2 Sessions
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- Workshop
SartoriusTheatre 1Are you exploring alternatives to viral vectors for cell engineering? Looking for ways to accelerate CAR-T and CAR-NK development while simplifying manufacturing workflows and reducing process complexity? As the cell therapy field continues to evolve, next-generation non-viral approaches are emerging as powerful tools to address many of the challenges associated with traditional viral vector manufacturing. From plasmid engineering and mRNA optimization to mRNA production, purification, and immune cell engineering, integrated workflows are enabling faster, more flexible development of engineered immune cell therapies. Join our experts as they discuss the latest advances in non-viral cell engineering technologies and explore how end-to-end platforms can streamline the generation of CAR-T and CAR-NK products, from early research through process development. What to expect: Our experts will explore key considerations and innovations in next-generation CAR-T and CAR-NK development, including: How to build a customizable end-to-end non-viral workflow spanning plasmid engineering, mRNA optimization, mRNA production, purification, and immune cell engineering through a single technology partner. How mRNA-based cell engineering can serve as an alternative to lentiviral workflows, reducing process complexity while enabling the rapid generation of engineered immune cells. Strategies for improving transfection outcomes in hard-to-engineer cell types, including both T cells and NK cells, using preformed vesicle-based delivery technology. Analytical and purification approaches that support the production of highly pure mRNA while minimizing process-related impurities.Speakers -
- Workshop
Fresenius KabiTheatre 2Cell and gene therapies continue to demonstrate transformative clinical potential, but manufacturing complexity remains a significant barrier to broader patient access. As more therapies progress toward commercial scale, technology providers are innovating beyond individual unit operations to develop integrated solutions that developers and CDMOs can incorporate into their manufacturing workflows. Through collaboration across the ecosystem, these technologies have the potential to improve operational efficiency, support scalability, reduce manual process steps, and help future-proof manufacturing for growing commercial demand.Speakers
11:00 AM
4 Sessions
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- Streamlining Early Development to Enable Rapid Clinical Proof of Concept
Theatre 1 -
- Innovation in Gene Delivery
Theatre 3 -
- Commercializing Advanced Therapies
Theatre 4 -
An interactive session examining how advanced therapy developers can establish effective CDMO strategies that support their programmes as they progress through development and towards commercialisation. The session will explore the challenges involved in CDMO selection, assessing manufacturing capabilities, planning technology transfers and establishing partnerships that can adapt to changing development and commercial requirements. Following an opening discussion on the realities of working with CDMOs, participants will take part in an interactive discussion exploring how to evaluate potential partners, anticipate challenges and develop long-term manufacturing strategies that balance flexibility, scalability, quality and cost.
11:15 AM
1 Session
12:00 PM
5 Sessions
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- Innovation in Gene Delivery
Phacilitate HubPhacilitate Hub Meet Up: Come and meet like minded individuals that are all facing the same challenge as you in a laid back networking setting at the Phacilitate hub. If you would like to discuss 'navigating the complex IP landscape for delivery platforms', meet at the hub at 12.15pm -
- Manufacturing, CMC and Supply Chain
Theatre 2 -
- Empowering Patients, Delivering Access (in Partnership with the Emily Whitehead Foundation)
Theatre 5The decentralization debate, named for what it is. The room is split along predictable lines: academic GMP facilities favour decentralization; pharma cell therapy Presidents favour centralization. The session is designed to make that split visible and productive rather than paper over it. The substantive question is what manufacturing handoff, long-term follow-up architecture, and FDA regulatory posture would let community hospitals stand up CAR-T clinics at scale? -
- CGT Connect
Theatre 6An interactive session exploring the opportunities and challenges of conducting investigator-initiated trials (IITs) across the APAC and Australasian regions. Bringing together regulatory and industry perspectives, the session will examine the practical considerations involved in planning and executing overseas IITs, including regional regulatory requirements, clinical site engagement, local partnerships and operational considerations. Through a fireside discussion featuring real-world experiences, followed by an audience-led Q&A with experts, participants will have the opportunity to explore the advantages and limitations of different regional approaches, discuss common challenges and raise questions about establishing and managing IITs across these markets.Speakers
1:00 PM
3 Sessions
2:00 PM
6 Sessions
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- Streamlining Early Development to Enable Rapid Clinical Proof of Concept
Phacilitate HubPhacilitate Hub Meet Up: Come and meet like minded individuals that are all facing the same challenge as you in a laid back networking setting at the Phacilitate hub. If you would like to discuss 'how can developers accelerate the path to clinical proof of concept without making early decisions that compromise future scalability, regulatory readiness or commercial viability', meet at the hub at 2.15pm -
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- Manufacturing, CMC and Supply Chain
Theatre 2 -
- Innovation in Gene Delivery
Theatre 3 -
- Commercializing Advanced Therapies
Theatre 4Chairperson
3:00 PM
4 Sessions
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Mezzanine Level
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- Manufacturing, CMC and Supply Chain
Theatre 2 -
- Empowering Patients, Delivering Access (in Partnership with the Emily Whitehead Foundation)
Theatre 5What community delivery actually looks like in practice. A newly up and running community program leads the effort. The patient programs and the patient navigator role are presented as the connective tissue. The session closes on the caregiver gap, the single most cited barrier in The Foundation’s program work and an open call for industry investment. -
- CGT Connect
Theatre 6An interactive discussion examining the vulnerabilities and challenges affecting raw material supply chains for cell and gene therapies. The session will explore the factors contributing to supply chain fragility, including supplier concentration, material availability, quality and consistency, lead times and the challenges of sourcing specialised materials for advanced therapy manufacturing. Bringing together perspectives from developers and raw material specialists, the discussion will consider how companies can better manage supply chain risks, evaluate and qualify suppliers, identify alternative sourcing strategies and build more resilient procurement approaches. Participants will have the opportunity to share experiences and discuss practical steps towards securing reliable raw material supply as manufacturing requirements evolve and programmes scale.Chairperson
3:15 PM
1 Session
4:00 PM
5 Sessions
5:00 PM
2 Sessions
6:00 PM
1 Session
7:00 AM
1 Session
8:00 AM
1 Session
9:00 AM
3 Sessions
10:00 AM
4 Sessions
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- Manufacturing, CMC and Supply Chain
Theatre 2 -
- Innovation in Gene Delivery
Theatre 3 -
- Commercializing Advanced Therapies
Theatre 4 -
- Empowering Patients, Delivering Access (in Partnership with the Emily Whitehead Foundation)
Theatre 5Every initiative represented in the track commits a 30/60/90-day pledge on stage: CAR-T Vision 2030, The Access Coalition at ARM, COA’s Cell Therapy Task Force, The Foundation and its stakeholders, and every other named program in the room. A specific commitment, owned by a named person, scoped to that window. Audience members add their own pledges via Slido or equivalent. The aggregated commitments are published as the Access Scorecard, maintained jointly by The Foundation and Phacilitate, and reviewed at ATW 2028
11:00 AM
1 Session
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