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

Siddhartha Shrivastava, Ph.D.

SVP and Head, CMC and Global Technical Operations
Cue Biopharma

Smart CMC and Quality-Driven Acceleration

  • Embedding quality and compliance into accelerated CMC strategies across the product lifecycle
  • Leveraging calculated risk and non-traditional approaches while maintaining compliance
  • Driving rapid IND readiness through innovative yet well-controlled practices
  • Collaborating across functions and with external partners to align speed with regulatory expectations
  • Case study: accelerating clinic entry through strategic lifecycle planning and CMC agility

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


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 3

Speaker TBA


Jacobs

Engineering Flexibility into Future Capabilities

  • 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

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

Ensuring Data Integrity and Digital Maturity in Quality Systems

  • Leveraging digital QMS tools to improve traceability, audit readiness, and cross-site consistency
  • Mitigating risk through real-time monitoring, predictive quality analytics, and deviation management
  • Aligning digital transformation with quality culture to reduce manual interventions and human error

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

Advancing Industrialization in Cell Therapy Manufacturing

  • Evolving from manual, small-batch operations to automated, industrial-scale platforms
  • Addressing raw material variability and its impact on cell therapy outcomes
  • Leveraging digital tools and closed systems to reduce variability and accelerate QC release
  • Lessons learned from scale-up and tech transfer across global facilities

 

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


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

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


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
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 Iacovelli

    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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