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

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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: Talent, Teams, and Innovation in Next-Generation Biomanufacturing

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  • Talent Retention and Development: Strategies for attracting, retaining, and upskilling top talent in cell, gene, RNA, and other advanced modality operations
  • Leadership in Complex Modalities: How senior leaders are preparing teams to manage uncertainty, technical complexity, and rapid growth in emerging therapies
  • Bridging Innovation and Execution: Translating breakthrough modalities into commercial-scale manufacturing without losing quality, compliance, or team engagement
  • Cross-Functional Collaboration: Best practices for aligning R&D, manufacturing, quality, and supply chain teams to support new modality scale-up
  • Sustainable Workforce Models: Building organizational resilience, reducing turnover risk, and maintaining institutional knowledge in a rapidly evolving talent landscape
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

From Bench to Batch: Platform Innovations in Advanced Therapy Scale-Up

Ben Beneski

Chief Technical Officer

Allogene

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  • Leveraging platform processes to scale multiple cell and gene therapy modalities efficiently
  • Strategies for reducing variability and increasing reproducibility across autologous and allogeneic workflows
  • Integrating advanced analytics, automation, and PAT to accelerate commercial readiness
  • Lessons from real-world implementations on balancing speed, quality, and cost of goods
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

Operational Excellence and Sustainability in Advanced Manufacturing Networks

Silke Mohl

SVP - Head of Global MSAT, Engineering and Sustainability

Roche

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  • Strategies to optimize multi-site operations while reducing environmental footprint
  • Embedding sustainability into process design, utilities, and facility operations
  • Balancing efficiency, cost, and ESG goals in complex manufacturing networks
  • Lessons from advanced modality programs achieving both operational and sustainability impact
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.

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

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

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

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

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

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
5:05 pm - 5:10 pm

Chair’s Closing Remarks

5:10 pm

Drinks Reception

5:40 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

Industrializing Biologics: Operational Strategies for Commercial Excellence

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  • Strategic approaches to building resilient, flexible biologics manufacturing networks that adapt across portfolios and regions
  • Lessons in process standardization, tech transfer governance, and execution excellence across global operations
  • Integrating innovation with reliable supply continuity for high impact therapies
9:40 am - 10:15 am Case Studies
Stream One - Strategic Manufacturing

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

Eric Hahn

SVP, Global API Network Expansion

Eli Lilly

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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

Session Details Arrow Icon
  • 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

Content TBA

Stephen Hill

Chief Operating Officer

Lyell Immunopharma

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

Building Resilient and Adaptive Global Manufacturing Networks

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  • 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

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  • 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

Panel: Driving the Future of Biomanufacturing through Resilience and Innovation

Sanat Chattopadhyay

EVP & President, Merck Manufacturing Division

Merck

Session Details Arrow Icon
  • Strategies for building resilient, flexible global manufacturing networks in a dynamic industry
  • Lessons from scaling advanced modalities and integrating innovation into commercial operations
  • Leveraging digital tools and AI to optimize operations, quality, and supply chain performance
  • Aligning R&D, product development, operations, and quality to drive enterprise-wide manufacturing excellence
12:35 pm - 12:45 pm

Chair’s Closing Remarks

Aine Hanly

Vice President, Quality

Amgen

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.

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

Aligning Multi-Region Compliance for Advanced Therapies

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

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

Sessions From Previous Years

Promoting Quality Excellence and Cultivating a Culture of Proactive Operations

Promoting Quality Excellence and Cultivating a Culture of Proactive Operations

Dec 12, 2024
Sanofi Manufacturing Modernization – The Best in Class Ambition

Sanofi Manufacturing Modernization – The Best in Class Ambition

Dec 2, 2024
Using Innovation to Accelerate and Optimize Your Drug Manufacturing Scale-Up Strategy

Using Innovation to Accelerate and Optimize Your Drug Manufacturing Scale-Up Strategy

Dec 2, 2024
Enhancing the Timely Introduction of Novel Therapies

Enhancing the Timely Introduction of Novel Therapies

Dec 2, 2024
The Coming Patient Treatment Crisis

The Coming Patient Treatment Crisis

Dec 2, 2024
KojoX™ – Transforming the CDMO Industry with a Patient-Centric Approach Fueled by Innovation

KojoX™ – Transforming the CDMO Industry with a Patient-Centric Approach Fueled by Innovation

Dec 2, 2024
Speed to Market: The Power of Centralized Data and the Promise of AI

Speed to Market: The Power of Centralized Data and the Promise of AI

Nov 27, 2024
Building a Leading Quality Management Framework

Building a Leading Quality Management Framework

Nov 27, 2024
Empowering A Culture of Operational Excellence For Sustainable Growth

Empowering A Culture of Operational Excellence For Sustainable Growth

Nov 27, 2024
Panel: Digital Change for Future-Proof Biomanufacturing: How Biopharmas and CDMOs Redefine Operations

Panel: Digital Change for Future-Proof Biomanufacturing: How Biopharmas and CDMOs Redefine Operations

Nov 27, 2024
Revolutionizing RNAi Therapeutics Manufacturing with Enzymes

Revolutionizing RNAi Therapeutics Manufacturing with Enzymes

Nov 27, 2024
Proactivity – the Future of Quality

Proactivity – the Future of Quality

Nov 27, 2024
Data Doesn’t Lie – Digital Manufacturing ROI

Data Doesn’t Lie – Digital Manufacturing ROI

Nov 27, 2024
Welcome Day Panel: The Evolution of Innovative Modalities —Defining the Future of Manufacturing & Development

Welcome Day Panel: The Evolution of Innovative Modalities —Defining the Future of Manufacturing & Development

Nov 27, 2024
Panel Discussion: Reflecting on the Past, Envisioning the Future: Shaping the New Landscape of Biomanufacturing

Panel Discussion: Reflecting on the Past, Envisioning the Future: Shaping the New Landscape of Biomanufacturing

Nov 27, 2024
How to Reset the Pharma Trajectory: From Profit to Patient-Centric

How to Reset the Pharma Trajectory: From Profit to Patient-Centric

Nov 27, 2024
Addressing Cell Therapy Challenges for Rare Diseases

Addressing Cell Therapy Challenges for Rare Diseases

Nov 27, 2024
Advancing Cell Therapy Industrialization: Key Focus Areas

Advancing Cell Therapy Industrialization: Key Focus Areas

Nov 27, 2024
Peak Performance Leadership

Peak Performance Leadership

Nov 27, 2024
Authentic Leadership

Authentic Leadership

Nov 27, 2024
Accelerating the Pace of Progress for Innovative Biologic Products

Accelerating the Pace of Progress for Innovative Biologic Products

Nov 27, 2024
Innovative CMC Contributions: Advancing the Future of Patient Care, Society & Roche

Innovative CMC Contributions: Advancing the Future of Patient Care, Society & Roche

Nov 26, 2024
Panel: Agile Manufacturing: Technical Strategies for Operational Flexibility

Panel: Agile Manufacturing: Technical Strategies for Operational Flexibility

Nov 26, 2024
Emerging Trends Impacting Technical Development and Manufacturing

Emerging Trends Impacting Technical Development and Manufacturing

Nov 26, 2024
Leading a Technical Organization Through Uncertainty

Leading a Technical Organization Through Uncertainty

Nov 26, 2024
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