Program

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

Enabling the Next Generation of Therapies Through Modern Biomanufacturing

  • Aligning manufacturing strategy with pipeline innovation across mAbs, ADCs, and next-gen biologics
  • Investing in facility modernization and digital infrastructure to shorten time-to-market
  • Navigating global complexity: balancing agility, cost, and regulatory expectations
  • Developing sustainable and patient-centric manufacturing operations for long-term resilience
8:40 am – 9:10 am PST

Plenary

Evolving the Operating Model for Advanced Modalities

  • Redesigning organizational structures to support speed, flexibility, and modality diversity
  • Integrating advanced analytics, automation, and AI across manufacturing and QC
  • Building digitally fluent teams and embedding continuous learning across functions
  • Aligning global networks with local execution to improve responsiveness and resilience
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

Syed Abbas Yar-Khan

GVP, Manufacturing
Eli Lilly and Company

Advancing Parenteral Manufacturing Excellence Through Technology and Process Innovation

  • Enhancing manufacturing efficiency through the integration of advanced technologies and automation
  • Driving continuous improvement in parenteral product manufacturing processes across global facilities
  • Implementing scalable solutions to streamline aseptic filling, device assembly, and packaging operations
  • Leveraging data-driven insights to optimize manufacturing performance and ensure compliance
  • Cultivating a high-performance manufacturing culture focused on innovation and operational excellence

Quality and Compliance

Advancing Purification Technology: Enhancing Efficiency and Quality in Biomanufacturing Processes

  • Overview of current purification technologies used in biomanufacturing for product quality and safety
  • Innovations in chromatography methods to improve separation and purification efficiency
  • Implementation of membrane and ultrafiltration technologies for effective purification
  • Advantages and strategies for integrating single-use systems to streamline purification operations
  • Leveraging automation and digital tools to optimize and monitor purification workflows

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


USDM Life Sciences

How Agentic AI amplifies productivity by leveraging autonomous agents

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


PBS Biotech Inc

Maximizing Bioprocess Yield and Efficiency

  • Benefits of orbital mixing compared to traditional stirred-tank systems
  • Optimizing cell viability and product titer in upstream bioprocesses
  • Seamless scalability from bench to commercial-scale production
  • Reducing shear stress and improving process consistency

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
    F. Hoffmann-La 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


    Sware

Validation Excellence for CDMOs: From Regulatory Burden to Business Driver

  • Harmonize diverse client validation requirements with structured frameworks that balance compliance, speed, and quality
  • Leverage modern validation approaches including automation and user-friendly documentation to simplify execution while maintaining regulatory standards
  • Implement scalable, technology-driven validation processes that adapt to complexity without added resource strain
  • Learn how leading CDMOs standardize validation across sites and systems to drive efficiency and operational excellence
5:45 pm – 6:30 pm PST

Panel Discussion

  • Joydeep Ganguly

    Chief Sustainability Officer and SVP, Corporate Operations
    Gilead Sciences

  • Wolfram Carius, Ph.D.

    EVP and Head, Pharmaceuticals Product Supply
    Bayer AG

  • Tom Cheslock

    VP, Global Supply Chain, Specialty and Oncology Supply
    Pfizer

  • Laura Alquist

    SVP and Global Head, Technical Operations
    Kite Pharma

Advancing Digital Transformation and Manufacturing Excellence in Biomanufacturing

  • How can machine learning enhance manufacturing processes and operational excellence?
  • Integrating digital biotrackers for real-time monitoring and data-driven decision-making
  • What does digital maturity in biomanufacturing operations look like for improved scalability and consistency?
  • Addressing the intersection of digital tools and traditional manufacturing for seamless integration
  • Leveraging advanced technologies to overcome current industry challenges
  • Future-proofing biomanufacturing operations through strategic digital innovations and risk management
  • What are the key challenges and solutions in adopting digital tools for manufacturing excellence?
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