Innovative Idea Generating Centre
- AAVPCR, a next-generation AAV manufacturing platform that features in cellulo plasmid DNA replication for superior rAAV production.
- Potential future directions towards economical and robust off-the-shelf AAV manufacturing.
Hao Liu Viral Vector Core Research Associate III Umass
Gene Therapy Center
12:55 Questions & Discussion
13:00 Networking Lunch Break
14:00 Unlocking Scalable Innovation in Cell & Gene Therapy: Strategic Frameworks for Accelerating Market Access and Commercial Viability Across Global Biotech
This conversation centers around how to align innovation with infrastructure, streamline development-to-launch timelines, and ensure broader patient access. Attendees will gain actionable insights into building adaptable, future-ready strategies that support CGT growth across diverse markets worldwide.
14:25 Questions & Discussion
14:30 Reimbursement Challenges and Strategies of Cell and Gene Therapies in Fee-for-Service Medicaid
- Medicaid programs have encountered challenges with cell and gene therapies, particularly in terms of coverage policies and reimbursement.
- These challenges have necessitated creative approaches by Medicaid Pharmacy Directors to ensure patients have access to these novel therapies and hospitals receive appropriate reimbursement.
- Cell and gene therapies are evolving at a rapid pace compared to reimbursement systems, prompting innovative solutions.
- States have been creative to find equitable reimbursement policies to not only ensure sustainability but also capture available rebates Carveouts from Managed Medicaid Plans and traditional reimbursement methodologies have grown as more products come to market
- How can value based agreements help states address the financial hardships posed by the numerous cell and gene therapies?
Chad M. Bissell, PharmD, MBA Vice President, Drug Launch Services Artia Solutions
14:55 Questions & Discussion
15:00 Networking Refreshment Break
PANEL DISCUSSION
Driving Market Access in Cell and Gene Therapies Through Value-Based Pricing and Real-World Evidence Integration
15:30 Unlocking Payer Value: Aligning Cell and Gene Therapy Pricing Strategies with Long-Term Outcomes and Real-World Evidence for Market Access Success
This session explores innovative strategies to align CGT pricing with long-term clinical outcomes and real-world evidence (RWE), addressing payer concerns around value, sustainability, and budget impact. Attendees will gain insights into outcome-based agreements, data-driven value assessments, and collaborative approaches to market access that can unlock payer confidence and ensure timely patient access. Learn how to position therapies for reimbursement success in a value-based healthcare environment.
15:45 Automating Evidence: Can AI Bridge Access Gaps in High-Cost Advanced Therapies?
Artificial intelligence is gaining traction in predicting patient outcomes and optimizing reimbursement data. This talk assesses current use cases, potential, and readiness of AI for real-time data generation and payer engagement in cell and gene therapy markets.
16:00 Strategic Stakeholder Engagement to Navigate Payer Skepticism in Cell and Gene Therapy Reimbursement
This session will explore how early, strategic engagement with key stakeholders, including payers, providers, regulators, and patient advocacy groups can help mitigate uncertainty and support more sustainable reimbursement pathways. Attendees will gain insights into best practices for evidence generation, real-world data integration, and
value communication tailored to payer concerns. The session will also highlight successful models and collaborative approaches that have improved market access and reimbursement success for CGT innovators.
Jodie Wehling Vice President, Market Access Head of Market Access, Trade & Distribution, Contracting Mesoblast Limited
16:15 Indication-Based Pricing: Opportunity, Risk, and
Reality in Cell and Gene Therapy Expansion
Indication-based pricing offers promise, but limited implementation raises questions. Learn how policy, payer adoption, and provider reimbursement models impact its future, and what lessons can be drawn from successful pricing model.
16:30 Designing Outcome-Based Agreements That
Balance Payer Risk and Biotech ROI in Cell and Gene
Therapies
This session explores how outcome-based agreements (OBAs) can offer a solution aligning payment with therapeutic success while balancing the financial risks for payers and ensuring sustainable returns for biotech innovators. Attendees will gain insights into structuring OBAs, real-world implementation challenges, and strategies to measure outcomes effectively in a rapidly evolving regulatory and commercial landscape.
16:45 Interactive Discussion: Redefining Market Access, Evidence, and Reimbursement Strategies in Cell & Gene Therapy
Panelist:
- Chad M. Bissell, PharmD, MBA Vice President, Drug Launch Services Artia Solutions
- Jodie Wehling Vice President, Market Access Head of Market Access, Trade & Distribution, Contracting Mesoblast Limited
17:30 End of conference
08:50 Chairperson Opening Remarks
CELL & GENE THERAPY MANUFACTURING PANEL DISCUSSION Innovative Strategies for Overcoming Cell and Gene Therapy Manufacturing Bottlenecks to Enhance Efficiency, Consistency, and Product Quality
09:00 Addressing Critical Product and Process Challenges in Cell & Gene Therapy Manufacturing
This presentation delves into innovative strategies and technologies that streamline manufacturing workflows, reduce variability, and improve batch consistency, ultimately enabling more reliable and scalable production of life-changing therapies.
Chaozhong Zou Executive Director(Head), Applied Gene and Cell Therapy Center Cincinnati Children's
09:15 Advancing Fully Automated, Closed-System Manufacturing to Improve Scalability, Contamination Control, and Efficiency in Cell and Gene Therapy Production
This talk explores the integration of fully automated, closed-system technologies in CGT manufacturing. Attendees will learn how automation minimizes human error, reduces contamination risks, and supports regulatory compliance. The session will showcase case studies, discuss equipment and digital integration, and highlight how these systems enable scalability from clinical to commercial production.
09:30 Overcoming Process and Scale-Up Challenges in Viral Vector Manufacturing to Enable Commercial-Ready Cell and Gene Therapies
In this session, we examine key strategies for scalable and robust viral vector manufacturing, including upstream and downstream optimization, platform technologies, and quality control. Attendees will gain insights into process intensification, automation, and regulatory expectations, with real-world case studies illustrating successful tech transfers.
09:45 Modular Manufacturing Platforms for Cell Therapies: Designing Agile, Scalable Facilities to Enable Multi-Product Flexibility and Accelerate Clinical-to Commercial Transitions.
The talk investigates how modular facility design and process platforms are transforming cell therapy manufacturing. Attendees will gain insights into implementing flexible, multi-product environments that support rapid product changeover, tech transfer, and scale-up. We’ll highlight engineering strategies, facility layouts, automation integration, and regulatory considerations that reduce time-to-market while ensuring GMP compliance. Case studies will showcase real-world examples of modular cleanroom pods, closed systems, and digital infrastructure that support concurrent manufacturing of autologous and allogeneic therapies.
10:00 Standardizing Potency Assays for Cell and Gene Therapies to Ensure Consistent Clinical Outcomes via Robust Analytical Strategies
In this presentation, we address the critical role of potency assays in cell and gene therapy development, focusing on analytical strategies to ensure consistency, reliability. Topics include assay design principles, qualification and validation, biological relevance, and case studies highlighting challenges in autologous, allogeneic, and gene-modified products.
10:15 Explore how engineering allogeneic cell therapies enables scalable, off-the-shelf manufacturing strategies that enhance access, lower costs, and accelerate commercial readiness for global impact.
This session explores the evolving landscape of allogeneic cell therapy manufacturing, focusing on scalable bioprocesses, universal donor strategies, and gene editing technologies that enable off-the-shelf therapeutic platforms. Key topics include closed-system automation, potency and safety challenges, and how robust CMC frameworks can support affordability and global commercialization. The talk will highlight technical solutions to overcome immunogenicity, ensure consistent product quality, and meet regulatory expectations for allogeneic therapies.
10:30 Redefining Manufacturing Excellence in Cell & Gene Therapy: Operational Innovations for Consistency and Scalability.
This talk will explore how the industry is redefining manufacturing excellence through operational innovation. Key topics include advanced automation strategies, data driven process control, and quality-by-design (QbD) approaches that ensure product consistency across batches. Attendees will gain insights into best practices, real-world case studies, and the strategic integration of technology to overcome common production bottlenecks in CGT.
10:45 Interactive Discussion: Redefining Manufacturing Excellence in Scalable, Automated, and Consistent Cell & Gene Therapy Production
Panelist:
- Chaozhong Zou Executive Director(Head), Applied Gene and Cell Therapy Center Cincinnati Children's
- Hao Liu Viral Vector Core Research Associate III Umass Gene Therapy Center
- Kok-Seong Lim Expert Analytical Sciences & Quality Control
11:30 Networking Refreshment Break
12:00 Evaluating Scalable Approaches to Cell and Gene Therapy Manufacturing in the Context of Speed, Safety, and Sustainability
In this session, we will navigate scalable manufacturing strategies that optimize speed to market, ensure product safety and quality, and uphold principles of sustainability. We will examine current bottlenecks, emerging technologies, and innovative process designs that enable efficient, compliant, and environmentally conscious production.
12:25 Questions & Discussion
12:30 Integrating cutting-edge technologies in cell and gene therapy manufacturing to optimize speed, safety, and environmental sustainability in biotech.
- Current challenges in gene therapy viral vector manufacturing.
- Recent technical innovations that significantly improve AAV titer, purity and vector potency with dramatically reduced manufacturing cost and turnaround time.