Jeff Davis
VP, Clinical Manufacturing
Gilead Sciences
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
Tom Cheslock
VP, Global Supply Chain, Specialty and Oncology Supply
Pfizer
Cell and Gene Therapy
Blair McNeill, Ph.D.
SVP and Head of Cell Therapy
Sumitomo Pharma
8:10 am – 8:40 am PST
Keynote
Jens Vogel, Ph.D.
SVP and Head, Global Biologics Operating Unit
Merck
Modernizing Biologics Manufacturing for a Multi-Modality Pipeline
- Aligning global manufacturing with evolving therapeutic modalities
- Building facility and network flexibility to accommodate pipeline shifts
- Leveraging digital infrastructure and automation to accelerate tech transfer and scale-up
- Strengthening external partnerships to supplement internal capacity and speed-to-market
- Enabling long-term operational agility while ensuring quality and regulatory alignment
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
Rakesh Kakkar
VP, Manufacturing and Supply Vaccines - US
Sanofi
Driving Operational Excellence and Compliance Across Multi-Site Biomanufacturing
- Optimizing end-to-end processes to strengthen operational performance
- Harmonizing tech transfer and execution across multi-site networks
- Embedding quality and compliance into site-level operations
- Enabling cross-functional collaboration to drive results
- Building a high-performing culture through strong leadership and alignment
Quality and Compliance
Dr. Jessica Shen
SVP, Global Head of Quality, Research and Development
Takeda
Integrating Quality, Clinical, and Regulatory Strategy to Accelerate Lifecycle Success
- Advancing quality and regulatory alignment across the entire research and development lifecycle
- Leading global teams through clinical transformation and product development decision-making
- Building integrated quality systems to support innovation, speed, and compliance simultaneously
- Navigating evolving global regulatory landscapes to streamline approvals and market entry
- Harmonizing clinical, medical, and regulatory operations across drug, device, and combination products
Supply Chain and Logistics
Marisa Bookman
VP, Global Commercial Supply Chain and Strategy
Gilead
Driving Commercial Supply Chain Excellence: From Product Launch to Patient Delivery
- Integrating S&OP processes with commercial and brand strategies for synchronized launches
- Managing manufacturing site readiness and technology transfers in global networks
- Establishing patient-centric distribution models, including direct-to-patient and hospital/wholesaler contracts
- Leveraging contract manufacturing partnerships to scale efficiently
- Navigating regulatory and logistical challenges in global distribution
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
1:50 pm – 2:20 pm PST
sessions
Manufacturing and Technology
Sabine Leclercq
SVP, Global Technical R&D, Vaccines
GSK
Transforming Bioprocess Efficiency with Advanced Analytics and Real-Time Monitoring
- Implementing advanced analytics to identify and optimize process inefficiencies in real-time
- Leveraging real-time monitoring tools to ensure consistent product quality and process stability
- Using predictive analytics to forecast potential bottlenecks and prevent production delays
- Integrating data-driven insights into continuous bioprocessing for faster, more reliable production cycles
- The deployment of AI-based digital solutions within GSK's vaccine manufacturing space translates into tangible value, enabling more reliable scaling and optimization of production operations
Quality and Compliance
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
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
- Implementing flexible and modular manufacturing to respond quickly to growing global demand
- Integrating clinical and commercial supply strategies for seamless product scale-up and delivery
- Leveraging digital tools and AI to increase supply chain visibility and efficiency
- Driving sustainable operations while reducing environmental impact across manufacturing and logistics
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
3:05 pm – 4:25 pm PST
Happy Hour, Networking and Pre-Arranged 1-2-1 Meetings
4:30 pm – 5:15 pm PST
sessions
Manufacturing and Technology
Jim Fox
SVP, Americas Supply Operations
AstraZeneca
Harnessing Innovation and Agility to Transform Biopharmaceutical Manufacturing and Supply
- Accelerating new product introduction by integrating cross-functional teams and scalable manufacturing processes
- Driving operational agility through adoption of AI, novel technologies, and advanced analytics across sites
- Enhancing supply chain resilience with AI-enabled forecasting while maintaining compliance and quality outcomes
- Leading cultural transformation to foster innovation, continuous improvement, and operational excellence
Quality and Compliance
Evelyn Marchany García
SVP and Chief Quality Officer
BioMarin Pharmaceuticals
Evolving Global Quality Leadership to Accelerate Access and Innovation
- Transforming quality systems to meet the speed, scale, and precision required for rare therapies
- Aligning technical operations with patient-first principles across diverse global networks
- Driving sustainable, compliant innovation through data, digital tools, and enterprise-wide agility
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
Don Mather
SVP, BioPharma Manufacturing
Astellas Pharma
Overcoming Challenges in Multi-Modal Manufacturing: Practical Strategies for Success
- Designing flexible facilities and infrastructure to support varied product types
- Meeting regulatory and quality expectations across different manufacturing platforms
- Standardizing digital systems to streamline operations across modalities
- Developing a cross-trained workforce to support agile manufacturing needs
5:45 pm – 6:15 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
5:45 pm – 6:30 pm PST
Panel Discussion
Wolfram Carius, Ph.D.
EVP, Pharmaceuticals
BayerTom Cheslock
VP, Global Supply Chain, Specialty and Oncology Supply
Pfizer
Laura Alquist
SVP and Global Head, Technical Operations
Kite PharmaMaria Brown
VP, Manufacturing Science and Technology
Bristol Myers Squibb
Ben Beneski
CTO
Allogene Therapeutics
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
6:30 pm – 6:40 pm PST
Chair's closing remarks
Manufacturing and Technology
Jeff Davis
VP, Clinical Manufacturing
Gilead Sciences
Quality and Compliance
Paul Houri
SVP and Chief Quality Officer
Bristol Myers Squibb
Supply Chain and Logistics
Tom Cheslock
VP, Global Supply Chain, Specialty and Oncology Supply
Pfizer
Cell and Gene Therapy
Blair McNeill, Ph.D.
SVP and Head of Cell Therapy
Sumitomo Pharma
6:45 pm – 7:45 pm PST
Networking drinks reception
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