A Decade Strong — Celebrating 10 Years of BMWS

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2026 Agenda

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November 9th

3:30 pm

Registration

4:00 pm - 4:55 pm WELCOME DAY SPECIAL CONTENT

Advancing Biomanufacturing: What’s Working, What’s Changing, and What’s Next

Christine Goldschneider

Vice President, Head of Alliances, Manufacturing & Supply Specialty Care

Sanofi

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  • Programs & Culture: How are current programs fostering curiosity, accountability, and continuous improvement in advanced manufacturing? What approaches actually drive measurable results across multiple sites and modalities?
  • Technology & Data: How are AI, digital twins, and predictive analytics transforming manufacturing operations and quality systems? Which tools deliver actionable insights without overloading teams?
  • Supply Chain & Network Resilience: What strategies ensure agility, traceability, and risk mitigation across global biologics networks? How are companies building long-term resilience against disruptions?
  • Regulatory Alignment & Innovation: How can organizations harmonize regulatory compliance across regions while supporting innovation in cell, gene, and next-generation therapies?
  • Leadership & Talent Development: How are senior leaders preparing the next generation of biomanufacturing leaders to navigate complexity, integrate cross-functional teams, and drive enterprise performance?
5:00 pm - 5:55 pm WELCOME DAY SPECIAL CONTENT

Scaling the Future: Innovation, Operations, and Execution in New Modalities & CGT

Craig Beasley

Chief Technology Officer

BlueRock Therapeutics

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  • Operational Readiness & Scale-up: Translating breakthrough modalities into reliable, efficient manufacturing
  • Process & Technology Enablement: Implementing scalable, robust, and flexible manufacturing approaches to support new modality production
  • Talent Retention and Development: Attracting, retaining, and upskilling teams in cell, gene, RNA, and other advanced modality operations
  • Leadership in Emerging Modalities: Preparing teams to manage technical challenges and rapid growth in next-generation therapies
6:00 pm - 7:00 pm

Welcome Drinks Reception

6:30 pm

Executive dinner

November 10th

7:30 am - 8:15 am

registration & breakfast

8:15 am - 8:30 am

Opening Remarks, Important Announcements & Chair’s Welcome Address

Aine Hanly

Vice President, Quality

Amgen

8:30 am - 9:05 am KEYNOTE

Accelerating Innovation Through AI-Driven, Resilient Biomanufacturing Networks

Pam Cheng

Executive Vice President, Global Operations & IT, Chief Sustainability Officer

AstraZeneca

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  • Discussing AI and digital systems for predictive decision-making, quality, and throughput optimization
  • How data-driven supply chain resilience can anticipate disruptions and balance capacity
  • Discussing flexible, agile networks that accelerate scale-up of next-generation biologics and therapies
  • Looking at how the integration of IT, operations, and product development enables innovation across the enterprise
9:10 am - 9:45 am Case Studies
Stream One - Strategic Manufacturing

Product Development to Product Supply: Accelerating Commercial Readiness in Complex Modalities

Manisha Desai

Senior Vice President, Product Development, Global Product & Supply

Bristol Myers Squibb

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  • How product development strategy must evolve to support scalable manufacturing and robust supply chains
  • Integrating development timelines with manufacturing readiness, especially for cell & gene therapies and next-gen biologics
  • Leveraging cross-functional data and real-world learnings to reduce risk and speed time-to-market
Stream Two - Quality

Cross-Functional Quality: Aligning Operations, R&D, and Regulatory

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  • Creating shared accountability for quality across functions
  • Integrating process development, CMC, and manufacturing quality
  • Leveraging collaborative digital platforms for improved data sharing
  • Lessons on balancing speed, innovation, and compliance at enterprise scale
Stream Three - Innovation

Advances and Challenges in Next Generation CAR T Cell Therapy

Ben Beneski

Chief Technical Officer

Allogene

9:50 am - 10:25 am Workshops
STREAM 1 WORKSHOP

Scaling Biologics with Speed and Reliability: Lessons from the Front Lines

Executive to be Announced

Boehringer Ingelheim

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  • Strategies for accelerating complex biologics production while maintaining compliance
  • Best practices for managing global CDMO networks and tech transfer efficiently
  • Approaches to reducing risk and cycle time in multi-site manufacturing
  • Insights into aligning internal and external partners for faster product launch
STREAM 2 WORKSHOP

Automated Cell Therapy Manufacturing: From Concept to Commercial Reality

Executive to be Announced

Cellares

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  • Designing high-throughput automated processes that reduce variability and errors
  • Scaling modular automation for distributed manufacturing networks
  • Ensuring regulatory readiness and validation in automated environments
  • Lessons from real-world deployments: throughput, yield, and operational efficiency metrics
STREAM 3 WORKSHOP

AI-Powered Planning: Turning Data Into Operational Decisions

Executive to be Announced

BlueCrux

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  • Using AI to forecast capacity, optimize scheduling, and balance resources across sites
  • Integrating QC, CGT, and manufacturing operations for actionable insights
  • Driving decision-making through performance dashboards and KPIs
  • Lessons from deployments: how digital planning translates to measurable operational improvements
10:30 am - 12:10 pm Pre-Arranged One-To-One Meetings Arrow Icon

These mutually agreed-upon conversations are arranged and facilitated by Executive Platforms staff to ensure attendees have valuable discussions about their top-of-mind questions, challenges, and opportunities.

  • 10:35 am – 10:55 am: Meeting Slot 1/Networking
  • 11:00 am – 11:20 am: Meeting Slot 2/Networking
  • 11:25 am – 11:45 am: Meeting Slot 3/Networking
  • 11:50 am – 12:10 pm: Meeting Slot 4/Networking
12:15 pm - 12:50 pm Case Studies
Stream One - Strategic Manufacturing

Technical Product Health

Silke Mohl

SVP - Head of Global MSAT, Engineering and Sustainability

Roche

Stream Two - Quality

Quality Systems for Tomorrow's Modalities: Building Frameworks for What Doesn't Exist Yet

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  • Designing flexible quality frameworks for emerging therapies (cell, gene, RNA, bispecifics)
  • Managing uncertainty and variability in novel manufacturing processes
  • Integrating risk-based approaches and predictive analytics before processes are fully defined
  • Practical insights from creating quality systems that support innovation without slowing development
Stream Three - Innovation

Next-Gen Tech Transfer and Commercialization for Novel Modalities

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  • Managing rapid scale-up of gene therapies and other advanced modalities
  • Aligning CMC, manufacturing, and quality systems across multi-site networks
  • Strategies to mitigate regulatory and operational risk in novel modality launches
  • Lessons learned from first-in-class programs achieving commercial readiness
12:50 pm - 1:50 pm THEMED LUNCH DISCUSSIONS

Explore this year’s themed lunch discussions led by industry leaders, where executives engage in focused conversations over a meal, discussing topics they’re passionate about alongside their peers.

The Economics of Innovation: Designing Facilities and Processes for Sustainable Growth

LC Campeau

AVP, Head of Small Molecule Process R&D

Merck

Turning Data into Strategic Decisions: Breaking Silos Between Operations, Quality, and Supply Chain

Sheila Iyer

VP of Supply Chain

Teva

Workforce Transformation in Advanced Modalities: Reskilling, Retaining, and Aligning Team

Embedding Sustainability and ESG into Manufacturing Operations: Linking Operational Goals to Long-Term Impact

1:55 pm - 2:30 pm Case Studies
Stream One - Strategic Manufacturing

Scaling Technical Operations for Commercial Cell Therapy

Laura Alquist

Global Head of Technical Operations

Kite Pharma

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  • Highlighting the non-negotiable standards for Environmental Monitoring Programs (EMP) and incident response, positioning them as a core component of organizational resilience against major outbreaks
Stream Two - Quality

Leading Quality Through Transformation: Navigating Organizational Change and Technology Integration

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  • Embedding quality leadership into organizational change initiatives for smooth adoption
  • Integrating digital tools, automation, and AI into quality systems without disrupting operations
  • Strategies for aligning cross-functional teams (R&D, manufacturing, regulatory) during transformation
  • Lessons from real-world programs on maintaining compliance while driving innovation and efficiency
Stream Three - Innovation

From Clinical to Commercial: De-risking Manufacturing Scale-Up for Advanced Therapies

Executive to be Announced

Gilead

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  • Technical and operational challenges in transitioning cell, gene, and biologics from clinical to commercial
  • Lessons on achieving consistent process outcomes, comparability, and robust tech transfer
  • Balancing productivity with compliance in an era of rapid pipeline growth
2:35 pm - 3:10 pm Workshops
STREAM 1 WORKSHOP

Bringing Advanced Modalities to Commercial Scale: Strategy in Action

Executive to be Announced

Project Farma

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  • Translating technical ops strategy into GMP-ready execution
  • Accelerating capital projects and commissioning in multi-modality facilities
  • Managing cross-functional complexity in advanced therapy manufacturing
  • Practical takeaways for reducing time-to-market while maintaining compliance
STREAM 2 WORKSHOP

Practical Scale-Up in Cell Therapy: Platforms That Work

Executive to be Announced

Scale Ready

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  • Designing scalable workflows for cell and gene therapies
  • Reducing operational complexity with closed-system manufacturing and ready-to-use reagents
  • Optimizing throughput without compromising quality
  • Lessons from commercial implementations: efficiency, compliance, and reproducibility
STREAM 3 WORKSHOP

Full-Spectrum Biologics Manufacturing: Balancing Innovation and Execution

Executive to be Announced

Boston Institute of Biotechnology, LLC

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  • Strategies for scaling from early development to commercial supply
  • Leveraging adaptive scale approaches for upstream and downstream processes
  • Ensuring supply continuity and global network resilience
  • Real-world insights into integrating innovation with operational rigo
3:15 pm - 4:25 pm Pre-Arranged One-To-One Meetings Arrow Icon

These mutually agreed-upon conversations are arranged and facilitated by Executive Platforms staff to ensure attendees have valuable discussions about their top-of-mind questions, challenges, and opportunities.

  • 3:15 pm – 3:35 pm: Meeting Slot 5/Networking
  • 3:40 pm – 4:00 pm: Meeting Slot 6/Networking
  • 4:05 pm – 4:25 pm: Meeting Slot 7/Networking
4:30 pm - 5:05 pm KEYNOTE

Content To Be Announced

Edgardo Hernandez

President, Global Manufacturing

Eli Lilly and Company

5:05 pm - 5:20 pm
5:20 pm - 5:25 pm

Chair’s Closing Remarks

5:25 pm

Drinks Reception

5:55 pm

Executive dinner

November 11th

8:00 am - 8:45 am

registration & breakfast

8:10 am - 8:45 am breakfast workshops
Stream Two

Data-Driven Agility: Optimizing Cell & Gene Therapy Manufacturing Networks

Executive to be Announced

Körber Pharma Software

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  • Leveraging real-time data and MES integration to improve flexibility across multi-site operations
  • Turning process and operational data into actionable insights for faster, more reliable decision-making
  • Enhancing scale-up and commercial readiness through predictive analytics and connected systems
  • Lessons from advanced therapy deployments: balancing robustness, compliance, and speed
8:50 am - 9:00 am

Chair’s Opening Remarks

9:00 am - 9:35 am KEYNOTE

High-Reliability Quality in a Rapidly Evolving Biomanufacturing Landscape

Jackie Elbonne

Senior Vice President, Quality and Chief Quality Officer

Amgen

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  • Quality as a strategic driver across global operations, not just compliance
  • Practical insights into integrating quality into R&D to commercial handoffs, enterprise risk frameworks, and digital quality systems
  • Discussing culture, leadership, and talent for future quality maturity
9:40 am - 10:15 am Case Studies
Stream One - Strategic Manufacturing

Scaling Global API and Advanced Therapy Networks: Innovation at Commercial Speed

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  • Strategies for managing large-scale network expansion across APIs, antibodies, and gene therapies
  • Leading new facility projects and integrating cutting-edge biomanufacturing technologies
  • Achieving record-time project execution while maintaining operational excellence
  • Lessons from innovative antibody and gene therapy manufacturing projects and their impact on commercial readiness
Stream Two - Quality

Quality at the Enterprise Scale: Bridging Compliance, Efficiency, and Operations

Anthony Morandi

Senior Vice President, Quality

AstraZeneca

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  • Embedding quality into operations for faster, more reliable outcomes
  • Using risk-based approaches to prioritize deviations and optimize QC resources
  • Integrating digital tools and analytics for real-time quality insights
  • Case studies demonstrating improved compliance and operational efficiency across sites
STREAM 3 CASE STUDY

Science, Manufacturing and Commercialization

Stephen Hill

Chief Operating Officer

Lyell Immunopharma

Session Details Arrow Icon
10:20 am - 11:15 am Pre-Arranged One-To-One Meetings Arrow Icon

These mutually agreed-upon conversations are arranged and facilitated by Executive Platforms staff to ensure attendees have valuable discussions about their top-of-mind questions, challenges, and opportunities.

  • 10:25 am – 10:45 am: Meeting Slot 8/Networking
  • 10:50 am – 11:10 am: Meeting Slot 9/Networking
10:25 am - 11:00 am FOCUS GROUP

Executive focus groups are informal moderated discussions among peers, held during networking breaks outside the summit agenda. No sign-up is required; delegates and speakers can join any group of interest.

11:20 am - 11:55 am Workshops
STREAM 1 WORKSHOP

Building Resilient and Adaptive Global Manufacturing Networks

Session Details Arrow Icon
  • Strategies for network flexibility across geographies, modalities, and regulatory frameworks
  • Balancing capacity, demand volatility, and dual-sourcing to mitigate risk
  • Lessons from implementing rapid tech transfers and multi-product facility strategies
  • Operational metrics and KPIs that drive performance and inform executive decision-making
STREAM 2 WORKSHOP

Next-Generation Quality: Embedding Compliance and Risk Management into Operations

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  • Implementing real-time quality monitoring and digital oversight across manufacturing networks
  • Leveraging risk-based approaches to streamline QC and deviation management
  • Integrating quality systems early in product development for advanced modalities
  • Lessons from industry leaders on reducing compliance gaps while accelerating time-to-marke
STREAM 3 WORKSHOP

Accelerating Next-Gen Modalities: From Lab Innovation to Commercial Reality

Session Details Arrow Icon
  • Best practices for scaling novel therapies (cell, gene, bispecifics) efficiently
  • Integrating process development, analytics, and tech transfer for faster commercialization
  • Overcoming bottlenecks in CMC and manufacturing readiness for advanced modalities
  • Case studies showing how innovation drives measurable operational and clinical outcome
12:00 pm - 12:35 pm KEYNOTE

Fireside Chat: Orchestrating at Scale: Leadership in the New Era of Biotech Manufacturing

Sanat Chattopadhyay

EVP & President, Merck Manufacturing Division

Merck

Pascal Bécotte

Managing Director

Russell Reynolds

12:45 pm - 1:45 pm THEMED LUNCH DISCUSSIONS

Explore this year’s themed lunch discussions led by industry leaders, where executives engage in focused conversations over a meal, discussing topics they’re passionate about alongside their peers.

Quality Intelligence: Harnessing Data and AI to Drive Better Decisions Faster

Christine Acklin

Vice President Quality Assurance

Xencor Inc.

Managing Risk and Compliance Across Global Networks: Lessons for Multi-Site, Multi-Modality Operations

Talent Strategies for the Future of Biomanufacturing: Retention, Engagement, and Building Capabilities

Aligning Multi-Region Compliance for Advanced Therapies

1:50 pm - 2:25 pm PANEL

Antibody Data Bank - A Call to Action

Pat Yang

Chairman

Taiwan BioManufacturing Corp (TBMC)

Yatin Gokarn

SVP, Head of Product Development & Clinical Supply

Alexion Pharmaceuticals

2:25 pm - 2:30 pm

Chair’s Closing Remarks

Aine Hanly

Vice President, Quality

Amgen