Kara Renai King
VP, Platform Leader Americas and China and Head, Global Manufacturing Learning and Development
Zoetis
Spring, 2027
7:00 am – 8:00 am PST
DELEGATE REGISTRATION AND NETWORKING BREAKFAST
8:00 am – 8:10 am PST
MAYOR’S WELCOME ADDRESS
8:10 am – 8:20 am PST
Chair's Welcome and Opening Remarks
Manufacturing and Technology
Quality and Compliance
Stelios Tsinontides
VP, QMS, Transformation and External Advocacy
Merck & Co., Inc
Supply Chain and Logistics
Jeff Davis
VP, Foster City Manufacturing
Gilead Sciences
Cell and Gene Therapy
Blair McNeill, Ph.D.
SVP, and Head, Cell Gene Therapy
Sumitomo Corp
8:20 am – 8:50 am PST
Keynote
Daniele Iacovelli
SVP and Global Head, Digital Technology Pharma Medicines
Roche
Driving Scalable Biotech Operations Through AI Enabled Digital Transformation and High Performance Culture
- Leveraging AI and advanced analytics to enhance decision making and operational performance
- Building digitally enabled organizations to support scalable and agile biotech production
- Aligning talent strategies with digital transformation to drive innovation and execution
- Integrating data platforms and technologies to improve end to end operational visibility
- Fostering a high performance culture to sustain continuous improvement and competitive advantage
8:50 am – 9:20 am PST
Plenary
Manisha Desai
SVP, Product Development
Bristol Myers Squibb
Accelerating Scalable Commercial Manufacturing Through AI-Driven End To End Product Development Innovation
- Integrating formulation development and CMC strategies to support seamless clinical product progression.
- Utilizing predictive data insights to enhance technology transfer for reliable commercial manufacturing.
- Implementing advanced modeling to optimize development processes and improve overall operational performance.
- Aligning cross functional development goals with global regulatory standards using digital tools.
- Driving innovation across diverse modalities to deliver impactful therapies to patients globally
9:20 am – 9:50 am PST
Plenary
Speaker TBA
Project Farma
Advancing Drug Substance Manufacturing Through Continuous Processing and Integrated Automation Strategies
- Implementing continuous bioprocessing to increase drug substance manufacturing efficiency and quality
- Utilizing automated process control systems to minimize human error in production
- Integrating advanced purification technologies to enhance drug substance purity and yield
- Scaling production volumes through flexible single-use technologies and modular facility designs
- Leveraging real-time analytical tools to ensure consistent drug substance quality attributes
- Developing robust contamination control strategies for high-volume drug substance manufacturing environments
9:55 am – 11:35 am PST
Refreshments, Networking, and Pre-Arranged 1-2-1 Meetings
11:40 am – 12:10 pm PST
Sessions
Manufacturing and Technology
Oliver Hesse
VP, CMC Digital Transformation and Data Science
Bayer
Scaling AI-Driven CMC and Manufacturing Decision-Making Across Modalities
- Applying digital twins and AI to optimize facility strategy and network design
- Embedding data science into CMC decision-making from development through commercialization
- Balancing agility, cost, and compliance in AI-enabled manufacturing environments
- Building scalable digital ecosystems across global biotech operations
Quality and Compliance
Stelios Tsinontides
VP, Quality Management Systems, Transformation and External Advocacy
Merck & Co., Inc.
Beyond Compliance: Operationalizing Next-Generation QMS for Global Scale and Commercial Excellence
- Embedding risk-based, digital-first QMS frameworks across global manufacturing networks
- Scaling quality systems to support advanced modalities and multi-site commercialization
- Integrating real-time data, analytics, and AI to enhance inspection readiness and decision-making
- Driving continuous improvement through global standardization and cross-functional alignment
- Lessons learned from global registrations, tech transfer, and sustained supply reliability
Supply Chain and Logistics
Marisa Bookman
VP, Global Commercial Supply Chain & Strategy
Gilead Sciences
Architecting Resilient End-to-End E2E Commercial Supply Chains Across Complex Global Networks
- Unifying global Plan-To-Make systems to maximize commercial product lifecycle visibility
- Deploying predictive capacity modeling across internal plants and external manufacturing partners
- Establishing rigorous data governance frameworks to ensure uninterrupted patient supply pipelines
- Harmonizing sales and operations planning with complex international trade compliance rules
- Structuring proactive product transfer protocols to prevent inventory gaps during launches
Cell and Gene Therapy
Blair McNeill, Ph.D.
SVP, and Head, Cell Gene Therapy
Sumitomo Corp
Advancing Cell Therapy Development and Manufacturing Through Integrated CMC and Lifecycle Execution
- Aligning technical and business strategies to accelerate cell and gene therapy development
- Integrating process development analytical and manufacturing to enable seamless scale up
- Strengthening tech transfer and CDMO collaboration to support efficient global execution
- Optimizing end to end CMC strategies to enhance speed quality and regulatory success
- Building high performing teams to translate innovation into scalable therapeutic products
12:15 pm – 12:45 pm PST
Workshops
Room 1
Speaker TBA
USDM LifeSciences
Maximizing Bioprocessing Efficiency Through Single-Use Technologies and Advanced Process Controls
- Integrating single-use bioreactors to increase operational flexibility and reduce cleaning
- Implementing automated buffer preparation systems to streamline downstream bioprocessing workflows
- Utilizing advanced filtration techniques to enhance product purity and recovery
- Developing robust cleaning validation protocols for hybrid manufacturing facility designs
- Leveraging real-time data to optimize yield during complex bioprocessing steps
ROOM 2
Speaker TBA
BlueCrux
Implementing Scalable Quality Management Systems to Support Rapid Global Commercialization
- Leveraging digital tools and AI to enhance operational efficiency
- Automating document control processes to ensure inspection readiness and compliance
- Integrating quality risk management into the early stages of development
- Leveraging digital workflows to accelerate deviation investigations and CAPA resolutions
ROOM 3
Speaker TBA
Katalyze
Leveraging AI Agents To Accelerate Root Cause Analysis And Drive Efficient CAPA Resolution
- Utilizing AI-driven analytics to reduce root cause investigation time by over sixty percent.
- Implementing automated data science models to identify hidden quality trends across manufacturing.
- Accelerating CAPA resolution through the deployment of intelligent agentic quality management tools.
- Enhancing inspection readiness by automating the documentation of complex quality deviation investigations.
- Integrating advanced predictive models to prevent recurring deviations in global biomanufacturing networks
Room 4
Speaker TBA
Lifecore Biomedical
Accelerating AAV Manufacturing Through Scalable Viral Vector Production and Optimization
- Scaling viral vector production through optimized fermentation and purification strategies
- Implementing high-throughput screening to identify optimal viral vector production clones
- Leveraging advanced analytical tools to monitor full-to-empty capsid ratios effectively
- Optimizing transfection protocols to increase overall AAV yield and potency
- Developing standardized tech transfer models for large-scale viral vector manufacturing
12:50 pm – 1:50 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
AbbVie
Plant Acquisition, Turnaround, and Transformational Success in Manufacturing
Speaker TBA
Noxilizer
Overcoming Packaging Challenges While Accelerating Market Launches and Commercial Product Rollouts
Speaker TBA
Dark Horse Consulting
Driving Sustainability in Pharma Supply Chains: Meeting Emissions Reduction Targets and ESG Commitments
Speaker TBA
Cellares
Global Automated Smart Factories
Speaker TBA
Project Farma
Complex Modalities In Volatile Markets
Speaker TBA
Resilience US, Inc.
Commercial Success Through Technical Operations
Speaker TBA
Bionova Scientific
Manufacturing In Seven Months
Speaker TBA
Rentschler BioPharma
Defining The Role Of Quality As A Client Partner For Biomanufacturing Success
Speaker TBA
Avid Bioservices
Navigating Mid-Phase Tech Transfer And Onshoring Strategies For Complex Biologics Manufacturing
Speaker TBA
Resilience US, Inc.
Optimizing Technical Operations Strategies To Assure Commercial Success For Innovative Therapies
Speaker TBA
WuXi Biologics
Future-Proofing Biomanufacturing: Driving Agile Supply Chains Through Global Capacity and Innovation
1:55 pm – 2:25 pm PST
STREAM SESSIONS
Manufacturing and Technology
Kara Renai King
VP, Platform Leader Americas and China and Head, Global Manufacturing Learning and Development
Zoetis
Building High Performing Global Manufacturing Teams Through Leadership Development and Operational Excellence
- Strengthening leadership capabilities to drive performance across multi site global manufacturing networks
- Creating a culture of continuous improvement innovation and accountability across operations
- Aligning talent development strategies with evolving manufacturing and supply chain demands
- Empowering teams to deliver consistent quality and operational excellence at scale
- Fostering engagement and collaboration to support sustained business and patient impact
Quality and Compliance
Farah Fawaz, PH.D
SVP and Head, Quality
Allogene Therapeutics
Advancing Cell Therapy Toward Commercial Readiness Through Validation, Quality and Inspection Preparedness
- Building quality strategies that support the transition from clinical development toward commercialization
- Preparing for process validation and BLA readiness within an evolving cell therapy organization
- Advancing inspection readiness across quality, manufacturing and CMC teams
- Applying lessons from large-scale product launches within a growing biotechnology environment
- Developing scalable quality capabilities that support long-term commercial growth and global delivery
Supply Chain and Logistics
Nelly Viseux
Vice President, Cell Therapies Development, Manufacturing, Supply & Quality
Regeneron
Building Early Manufacturing Knowledge to Advance Cell Therapy Commercialization
- Building manufacturing knowledge earlier to support cell therapies through development and commercialization
- Connecting clinical, translational, development, CMC, and manufacturing teams around continuous product learning
- Advancing product and process characterization to strengthen understanding beyond meeting specifications
- Designing early development strategies around future manufacturing, scalability, and commercialization requirements
- Applying proactive learning to inform manufacturing decisions before reaching later clinical development
- Sharing case studies demonstrating how earlier insights can strengthen manufacturing process development
Cell and Gene Therapy
Stacy Springs, Ph.D.
Executive Director, Center for Biomedical Innovation
Massachusetts Institute of Technology
Scaling Advanced Therapy Manufacturing Through Integrated Analytics And Platform-Based Innovation
- Advancing platform technologies to enable standardized and scalable manufacturing across advanced modalities
- Embedding real-time analytics and digital tools to enhance process control and decision-making
- Strengthening technology transfer frameworks to accelerate transition from lab to GMP manufacturing
- Addressing evolving regulatory expectations for complex therapies through proactive validation strategies
- Enabling cross-industry collaboration to drive innovation and global manufacturing readiness
2:30 pm – 3:00 pm PST
Workshops
ROOM 1
Speaker TBA
Bionova Scientific
Implementing Advanced Bioprocess Systems to Enhance Yield and Operational Manufacturing Efficiency
- Deploying automated feedback control loops to maintain optimal dissolved oxygen levels
- Integrating single-use bioreactor technologies to increase operational flexibility and production throughput
- Utilizing high-throughput screening platforms to accelerate early-stage bioprocess parameter identification
- Implementing predictive maintenance models to reduce equipment downtime in large-scale facilities
- Scaling upstream fermentation processes through precise control of critical metabolic pathways
ROOM 2
Speaker TBA
WuXi Biologics
Building Flexible Global Supply Chains Through Large Scale Cell Culture Capacity Expansion
- Investing billions in global cell culture capacity to drive industry transformation
- Enabling seamless clinical to commercial scale up using the KojoX strategy.
- Standardizing modular facilities to enhance manufacturing speed and overall operational efficiency.
- Implementing a uniform operating philosophy to improve supply chain agility globally.
- Optimizing facilities for rapid clinical to commercial transition across all sites.
ROOM 3
Speaker TBA
Lonza
Accelerating Speed To Market Through Integrated Custom Media Manufacturing And MSAT Strategies
- De-risking scale-up by transitioning custom media from early development to commercial supply.
- Bridging the gap between non-GMP prototyping and GMP-compliant manufacturing to ensure readiness.
- Protecting proprietary formulations while maintaining long-term supply continuity across global manufacturing sites.
- Leveraging integrated manufacturing strategies to improve flexibility and accelerate clinical development timelines.
- Implementing robust MSAT frameworks to ensure consistent product quality across multiple facilities.
ROOM 4
Speaker TBA
Araymond Lifesciences
Mitigating Contamination Risks In Aseptic Filling Through Ready To Use Plastic Capping Solutions
- Enhancing contamination control in vial filling lines to support Annex 1 compliance.
- Optimizing line performance by reducing equipment footprint through simplified press-fit capping processes.
- Streamlining aseptic filling operations using automated nest-to-nest plastic capping solution technologies.
- Reducing labor costs and processing time with ready-to-use plastic press-fit caps.
- Implementing validated capping solutions to maintain container closure integrity during lyophilization cycles.
3:05 pm – 4:25 pm PST
Happy Hour, Networking and Pre-Arranged 1-2-1 Meetings
4:30 pm – 5:00 pm PST
plenary
Manufacturing and Technology
Ben Beneski
SVP, Chief Technical Officer
Allogene Therapeutics
Advancing Manufacturing Platforms for Next Generation CAR T Therapies to Enable Consistency and Scale
- Evolving manufacturing platforms to support new modalities and expanded cell therapy indications
- Enhancing process consistency to improve success rates and enable scalable production
- Leveraging platform approaches to streamline development and accelerate clinical execution
- Aligning manufacturing and operations to support agility within dynamic regulatory environments
- Driving cost efficiencies to expand access and support broader
5:05 pm – 5:35 pm PST
plenary
Speaker TBA
Arcwood Environmental
Enhancing Contract Manufacturing Partnerships Through Digital Integration and Strategic Operational Alignment
- Standardizing data sharing protocols to ensure real-time visibility into production status
- Implementing shared quality agreements to align compliance expectations across global networks
- Leveraging integrated tech transfer frameworks to accelerate product launch timelines significantly
- Optimizing resource allocation through collaborative demand forecasting and production planning strategies
- Ensuring long-term partnership success through proactive risk mitigation and performance metrics
5:35 pm – 6:20 pm PST
Panel Discussion
Craig Beasley
Chief Technology Officer
BlueRock TherapeuticsJeff Davis
VP, Foster City Manufacturing
Gilead Sciences
Goldi Kaul
VP and Head, External Alternative CMC Development
Boehringer Ingelheim
Ketan Gujarathi
VP, General Manager, Cell Therapy (CAR-T) US Manufacturing and Supply
Legend Biotech
Daniel McGrath
VP, Facilities, Engineering, and Technical Services
Sarepta Therapeutics
Rakesh Kakkar
VP, Manufacturing and Supply Vaccines - US
Sanofi
From Innovation to Execution: Enabling Autonomous, Agile, and Scalable Biomanufacturing
- Aligning early-stage multimodal innovation with long-term, autonomous commercial manufacturing scalability.
- Balancing facility flexibility and standardization within next-generation, continuous biomanufacturing infrastructures.
- Integrating agentic AI and mature digital twins for autonomous tech transfer optimization.
- Leveraging digitally integrated CDMO ecosystems to ensure agile commercial execution at scale.
- Upskilling digitally fluent hybrid workforces to operate fully automated, smart biomanufacturing facilities.
- Navigating commercial scale-up risks for complex, emerging modalities in volatile global markets.
6:20 pm – 6:30 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
Stelios Tsinontides
VP, QMS, Transformation and External Advocacy
Merck & Co., Inc
Supply Chain and Logistics
Jeff Davis
VP, Foster City Manufacturing
Gilead Sciences
Cell and Gene Therapy
Blair McNeill, Ph.D.
SVP, and Head, Cell Gene Therapy
Sumitomo Corp
6:35 pm – 7:35 pm PST
Networking drinks reception
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