April 14, 2026

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

Supply Chain and Logistics

Cell and Gene Therapy

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 and Head, 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

1:50 pm – 2:20 pm PST

sessions

Manufacturing and Technology

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

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

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

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

plenary

  • Daniele Lacovelli

    SVP and Global Head, Digital, Analytics and Operational Excellence
    Roche

Scaling Digital Maturity for Sustainable Impact

  • Defining digital maturity in the context of modern biomanufacturing
  • Moving beyond pilots: governance, change enablement, and talent development
  • Aligning digital innovation with operational excellence and regulatory standards
  • Lessons learned from Roche’s global digital scale-up and future readiness strategy
5:45 pm – 6:15 pm PST

plenary

  • Speaker TBA


    Rentschler BioPharma Inc.

Driving Excellence Through Innovative Solutions in Process Optimization and Facility Management

  • Streamlining biopharmaceutical processes with tailored solutions for maximum efficiency
  • Implementing scalable solutions for flexible and future-proof facility design
  • Enhancing collaboration to drive innovation and improve manufacturing outcomes
5:45 pm – 6:30 pm PST

Panel Discussion

  • Joydeep Ganguly

    SVP, Corporate Operations
    Gilead

  • Wolfram Carius, Ph.D.

    EVP, Pharmaceuticals
    Bayer

  • Tom Cheslock

    VP, Global Supply Chain, Specialty and Oncology Supply
    Pfizer

  • Laura Alquist

    SVP and Global Head, Technical Operations
    Kite Pharma

  • Maria Brown

    VP, Manufacturing Science and Technology
    Bristol Myers Squibb

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

Quality and Compliance

Supply Chain and Logistics

Cell and Gene Therapy

6:45 pm – 7:45 pm PST

Networking drinks reception

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