Kara Renai King
VP, Platform Leader Americas and China and Head, Global Manufacturing Learning and Development
Zoetis
April 14, 2026
* JOIN US FOR THE PRE-EVENT HAPPY HOUR ON APRIL 13, 2026 FROM 6:00 PM – 7:00 PM
7:00 am – 8:00 am PST
Registration and Networking Breakfast
8:00 am – 8:10 am PST
Chair's Welcome and Opening Remarks
Manufacturing and Technology
Quality and Compliance
Paul Houri
SVP and Chief Quality Officer
Bristol Myers Squibb
Supply Chain and Logistics
Laura Alquist
SVP and Global Head, Technical Operations
Kite Pharma
Cell and Gene Therapy
Blair McNeill, Ph.D.
SVP and Head, Cell Therapy
Sumitomo Pharma
8:10 am – 8:40 am PST
Keynote
Rao Mantri
Chief Manufacturing Officer
Astellas Pharma
Synchronizing Modality-Agnostic Development and Manufacturing Excellence: An Integrated Lifecycle Approach
- Integrated Process Architecture: Harmonizing early-stage product development with commercial manufacturing to ensure seamless lifecycle scalability.
- Multi-Modality Operational Frameworks: Engineering flexible manufacturing infrastructures to manage diverse biological modalities and complex portfolios.
- Digitally-Enabled Talent Ecosystems: Developing cross-functional, tech-fluent teams to drive next-generation biomanufacturing operating models.
- Agile Tech Transfer: Leveraging integrated capabilities to accelerate clinical-to-commercial transitions while maintaining rigorous quality.
8:40 am – 9:10 am PST
Plenary
Paul Houri
SVP and Chief Quality Officer
Bristol Myers Squibb
From Compliance to Competitive Advantage: Evolving Quality Culture in a Global Organization
- Building and strengthening a culture of quality and continuous improvement
- Ensuring accountability and ownership of quality practices at all levels
- Partnering with the business to deliver quality as a strategic value driver
- Enhancing agility by leveraging innovation and risk-based quality management approaches, while maintaining global regulatory compliance
9:10 am – 9:40 am PST
Plenary
Speaker TBA
Project Farma
Optimizing Facility Strategy in a Volatile Market: A Practical Approach
- Building agility into facility design and planning to meet evolving capacity needs
- Making informed decisions on internal vs. external manufacturing for complex modalities
- Best practices for de-risking capital investments in a fast-changing regulatory and commercial environment
- Leveraging modular and single-use technologies to accelerate timelines and reduce cost
9:45 am – 11:25 am PST
Refreshments, Networking, and Pre-Arranged 1-2-1 Meetings
11:30 am – 12:00 pm PST
Sessions
Manufacturing and Technology
Judy Chou, Ph.D.
President and CEO
AltruBio, Inc.
Managing Development Strategy and Scale as a Clinical-Stage Biotech
- Designing a development strategy for Phase 2 and beyond
- Strengthening the link between clinical progress and CMC readiness
- Leveraging partnerships and CDMOs for clinical-stage manufacturing
- Anticipating regulatory needs while remaining agile
- Building a scalable platform without overextending resources
Quality and Compliance
Stelios Tsinontides
VP, QMS, Transformation and External Advocacy
Merck & Co., Inc
Bridging the Gap: Aligning Quality Management Systems with Evolving FDA Manufacturing Assessments for Successful PAIs/PLIs, Approvals & Commercialization
- Translating regulatory expectations into actionable QMS strategies to de-risk commercial manufacturing assessments
- Transforming legacy quality systems to enable advanced biotechnologies and accelerate product lifecycle management
- Leveraging external advocacy and industry collaborations to influence and adapt to emerging Regulatory tools and compliance standards
- Selecting facilities and implementing control and oversight strategies with regulatory assessment criteria to ensure rapid approval
Supply Chain and Logistics
Thomas Spitznagel
SVP, Technical Operatons
MacroGenics Inc.
Building a Reliable Supply Chain for ADCs: Strategies for a Complex Modality
- Partnering for success: Selecting and managing CDMOs with ADC capabilities
- Mitigating risk in sourcing high-potency payloads and linker chemistries
- Coordinating upstream biologics and small molecule manufacturing timelines
- Ensuring compliance and safety in handling and transport of cytotoxic components
- Aligning supply strategy with clinical and commercial goals for ADC programs
Cell and Gene Therapy
Harish Santhanam
VP, Cell Therapy Technical Operations
Bristol Myers Squibb
Digitizing Autologous Manufacturing: Lessons from Cell Therapy at Scale
- Automation frameworks BMS is deploying in cell therapy
- How they're using predictive analytics for batch optimization or QC
- Data pipelines and process control strategies
- Case study: Reducing variability in autologous workflows using real-time monitoring
12:05 pm – 12:40 pm PST
Workshops
Room 1
Speaker TBA
Alula
Leading Through the Chaos: Driving Performance and Engagement
- Overcoming the daily challenges of manufacturing leadership to drive real impact
- Breaking the cycle of failed performance initiatives and creating lasting momentum
- Applying behavioral science-backed strategies to boost engagement and results
- Practical leadership approaches that work in high-pressure manufacturing environments
ROOM 2
Speaker TBA
Jacobs
Streamlining Commissioning and Qualification to Accelerate Time-to-Market
- Modular facility design that scales with emerging pipelines
- Integrating sustainable engineering throughout project life cycles
- Embedding digital twins and smart tech for operational readiness
- Streamlining C&Q paths to accelerate time-to-market
- Ensuring regulatory alignment through iterative engineering and compliance
- Proving through documented testing (IQ/OQ/PQ) that those systems meet predefined standards for Good Manufacturing Practice (GMP) compliance
ROOM 3
Speaker TBA
Bluecrux
AI-Driven Planning and Scheduling in Biomanufacturing
- Enhancing network scalability and resilience through data-driven capacity planning
- Using digital twins to enable predictive modeling and scenario analysis
- Optimizing production with AI-powered scheduling and real-time adjustments
- Improving resource allocation to boost efficiency and reduce delays
Room 4
Speaker TBA
Asimov
Model-driven Genetic Design and Bioprocess Optimization Across Modalities
- Addressing the limitations of traditional biopharmaceutical production
- Presenting a vision for biopharmaceutical development using AI-driven, mechanistic, and hybrid models for genetic systems, cell lines, and bioprocesses
- Case Studies: Demonstrating the power of our approach across multiple modalities, including monoclonal antibodies and viral vectors
12:45 pm – 1:45 pm PST
Lunch & Learn Roundtables and Open Seating Lunch
Benefit from additional learning by joining a moderated roundtable discussion on pressing issues in the industry. Registration is required, and attendance for moderated roundtables on Day 1 is limited to attendees and speakers. Choose from:
Speaker TBA
Rentschler BioPharma Inc.
Navigating the Tech Transfer Process: Finding and Sourcing a Reliable CDMO
Speaker TBA
Afton Scientific
Flexible Small‑Batch Aseptic Fill‑Finish for Biologics & Small Molecules
Speaker TBA
Cytiva
Building a robust compliance infrastructure to meet pre-use post sterilization filter integrity testing (PUPSIT) requirements in a revised Annex 1 world
Speaker TBA
Resilience
Accelerating Cell Therapies to the Clinic While Assuring Commercial Success – Is There a Solution?
Speaker TBA
PBS Biotech Inc
Managing Shear Stress for High-Yield and High-Quality Bioprocessing
Speaker TBA
Bionova Scientific
Accelerating Biologics Development and Manufacturing: From Cell Line to Commercial Success
Speaker TBA
Singota Solutions
Accelerating Drug Development: Optimizing Aseptic Manufacturing and Cold Chain Solutions
Speaker TBA
AbbVie
Transforming Biomanufacturing: Driving Efficiency and Quality from Discovery to Commercialization
Speaker TBA
Avid Bioservices
Bridging Process Development and cGMP Manufacturing to Accelerate Biologic Commercialization
Speaker TBA
OXB
Next-Generation Viral Vector Process Design for Scalable Cell & Gene CDMO Services
Speaker TBA
Novartis
Integrating Biologics, Small Molecule, and Cell & Gene CDMO Capabilities in a Unified Platform
Speaker TBA
Honeywell
Implementing Smart Automation & MES for cGMP Biomanufacturing Control and Compliance
Speaker TBA
A-Life
From Cells to Products: Leveraging AI for Efficient Biomanufacturing
SPEAKER TBA
Mareana
Leveraging AI-Powered Review by Exception to Accelerate Batch Release and Ensure Continuous GxP Compliance
Speaker TBA
ZS Associates
Exploring the shift toward AI-enabled commercial models to drive precision and efficiency across diverse therapeutic portfolios
1:50 pm – 2:20 pm PST
sessions
Manufacturing and Technology
Tina Self, Ph.D.
SVP, Global Biologics Manufacturing and Berkeley Site Head
Bayer
Building a Performance Culture to Accelerate Innovation and Operational Scale
- Embedding performance culture principles to strengthen collaboration and drive team accountability
- Leveraging Bayer’s Dynamic Shared Ownership model to empower high-performing operations
- Aligning organizational vision with operational execution to sustain innovation at scale
- Driving agility by connecting manufacturing, people, and performance across the value chain
- Case study: Lessons learned from Bayer and BlueRock’s partnership to accelerate next-gen therapy readiness
- Creating a scalable foundation for future growth while navigating complexity and change
Quality and Compliance
Farah Fawaz
SVP, Quality and Compliance
Allogene Therapeutics
Ensuring End-to-End Product Excellence: Integrating Quality Attributes Across the Cell Therapy Lifecycle
- Designing and implementing quality strategies spanning early development through commercial launch
- Defining and monitoring critical quality attributes at each stage of the cell therapy lifecycle
- Streamlining processes ensuring regulatory compliance while maintaining product integrity and consistency
- Leveraging cross-functional collaboration to embed quality and compliance into development and manufacturing
Supply Chain and Logistics
Sheena Behn
VP, Vaccine and Immune Therapy and Oncology Global Supply
AstraZeneca
Scaling Supply Chains for Advanced Therapies to Meet Global Patient Needs
- Reimagining supply chains to prepare for the delivery of new modalities to patients
- Integrating clinical and commercial supply strategies for seamless product scale-up and delivery
- Enhancing intelligent supply chain resilience with AI-enabled forecasting while maintaining compliance and quality outcomes
- Building a future-ready, digitally empowered workforce through AI upskilling
Cell and Gene Therapy
Andy Lin
VP and Global Head, Individualized and Cell Therapy Development, Pharma Technical
Genentech
Bridging Chemistry, Manufacturing, and Controls (CMC) Management and Commercial Strategy in Cell and Gene Therapy
- Integrating CMC, clinical, and regulatory strategies to accelerate early-to-mid stage development
- Building frameworks to enable scalability across diverse cell and gene therapy modalities
- Overcoming end-to-end value chain complexities in patient-specific material acquisition and processing
- Case study: Operationalizing personalized therapy at Genentech’s Hillsboro Individualized Therapies (HIT) facility
- Preparing technical operations for the next 5 years of CGT innovation and commercialization
2:25 pm – 2:55 pm PST
Workshops
ROOM 1
Speaker TBA
Yokogawa
Digital Twin–Driven Process Optimization in Biologics Production
- Implementing digital twins from development through full-scale manufacturing
- Leveraging hybrid mechanistic/AI models for predictive control
- Validating twin models within regulatory frameworks
- Automating feed-forward controls to correct deviations in real time
ROOM 2
Speaker TBA
Rapid Micro Biosystems
Accelerating Contamination Control with Real-Time Monitoring
- Automating microbial QC to streamline workflows
- Real-time environmental monitoring for rapid contamination detection
- Ensuring GMP compliance with automated data integrity and audit trails
- Shortening time-to-release by reducing manual testing
- Defining a proactive QC strategy with digital monitoring tools
ROOM 3
Speaker TBA
Fujifilm
LEANING INTO KOJOX™ VISION BY BUILDING A FLEXIBLE SUPPLY CHAIN FUELED BY INNOVATION
- Investing billions in global cell culture capacity expansion to drive industry transformation
- Enabling seamless clinical-to-commercial scale-up and scale-out with the KojoX™ strategy
- Standardizing, modularizing, and optimizing facilities for speed, flexibility, and efficiency
- Implementing a uniform operating philosophy to enhance supply chain agility across all sites
ROOM 4
Speaker TBA
USDM Life Sciences
How Agentic AI amplifies productivity by leveraging autonomous agents
- How autonomous agents are transforming productivity in life sciences operations
- Real-world applications of autonomous agents in GxP environments, including quality, compliance, and validation
- Enabling faster decision-making and workflow execution through intelligent task delegation
- Integrating agentic AI into existing digital ecosystems: challenges and opportunities
- Ensuring trust, transparency, and regulatory alignment when deploying AI-driven agents
3:00 pm – 4:20 pm PST
Happy Hour, Networking and Pre-Arranged 1-2-1 Meetings
4:25 pm – 5:10 pm PST
plenary
Speaker TBA
Rentschler BioPharma Inc.
Driving Excellence Through Innovative Solutions in Process Optimization and Facility Management
- Aligning early-stage innovation with long-term scalability through AI and digital-driven frameworks
- Balancing flexibility and standardization as biomanufacturing infrastructure rapidly evolves
- Integrating AI, digital twins, and MES to accelerate tech transfer and process optimization
- Leveraging CDMO partnerships to ensure agility, scalability, and operational execution
- Building digitally fluent, AI-aware teams to support next-generation biomanufacturing initiatives
- Mitigating risks and driving success when scaling from clinical to commercial production
5:10 pm – 5:55 pm PST
Panel Discussion
Wolfram Carius, Ph.D.
EVP, Pharmaceuticals
BayerLaura Alquist
SVP and Global Head, Technical Operations
Kite PharmaMaria Brown
VP, Manufacturing Science and Technology
Bristol Myers SquibbBen Beneski
Chief Technology Officer
Allogene TherapeuticsAndy Ramelmeier, Ph.D.
Chief Technology Officer
Adverum Biotechnologies
From Innovation to Execution: Enabling Scalable Agile and Tech Forward Biomanufacturing
- How are organizations aligning early stage innovation with long term manufacturing scalability
- Balancing flexibility and standardization as the next generation of biomanufacturing infrastructure evolves
- Integrating digital tools such as AI, digital twins, and MES for accelerated tech transfer and process optimization
- The role of CDMO partnerships in ensuring agility and execution at scale
- Addressing talent gaps by building digitally fluent cross functional teams to support modern biomanufacturing
- Key risks and success factors when moving from clinical to commercial scale production in emerging modalities
5:55 pm – 6:05 pm PST
Chair's closing remarks
Manufacturing and Technology
Kara Renai King
VP, Platform Leader Americas and China and Head, Global Manufacturing Learning and Development
Zoetis
Quality and Compliance
Paul Houri
SVP and Chief Quality Officer
Bristol Myers Squibb
Supply Chain and Logistics
Laura Alquist
SVP and Global Head, Technical Operations
Kite Pharma
Cell and Gene Therapy
Blair McNeill, Ph.D.
SVP and Head, Cell Therapy
Sumitomo Pharma
6:10 pm – 7:10 pm PST
Networking drinks reception
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