A Decade Strong — Celebrating 10 Years of BMWS

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2026 Agenda

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November 9th

Welcome Day Chair

Alec Nielsen

Co-founder and CEO

ASIMOV

3:00 pm

Registration

3:30 pm - 4:20 pm WELCOME DAY SPECIAL CONTENT

Leading Through Complexity: Leadership, Talent, and Delivery in Biomanufacturing

Moderator

Alec Nielsen

Co-founder and CEO

ASIMOV

Kartik Subramanian

Vice President, Biologics Product Development, Science and Technology

AbbVie

Ganesh Vedantham

SVP Global Manufacturing

BioMarin

Nihal Tugcu

Global Head, Mammalian Platform

Sanofi

Session Details Arrow Icon
  • How biomanufacturing leaders are adapting organizational structures, decision-making, and operating models to manage growing complexity across modalities, technologies, and global networks
  • Building the leadership capabilities, technical talent, and cross-functional collaboration needed to support faster execution and more agile operations
  • Balancing speed, innovation, and operational discipline as manufacturing organizations navigate increasing portfolio complexity and external partnerships
  • How leading organizations are strengthening culture, accountability, and execution to improve performance in a rapidly evolving manufacturing environment
4:25 pm - 5:15 pm WELCOME DAY SPECIAL CONTENT

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

Moderator

Alec Nielsen

Co-founder and CEO

ASIMOV

Susan Abu-Absi

Chief Operating Officer

Be Biopharma

Hanne Bak

Senior Vice President, Product, Analytical and Process Development

Regeneron

Craig Beasley

Chief Technology Officer

BlueRock Therapeutics

Senthil Ramaswamy

Head of Global Operations, Cell and Gene

Lonza

Session Details Arrow Icon
  • Operational Readiness & Scale-up: Translating breakthrough modalities into reliable, efficient manufacturing
  • Process & Technology Enablement: Implementing scalable, robust, and flexible manufacturing approaches for CGT, RNA, and other advanced modalities
  • 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
5:25 pm - 6:15 pm WELCOME DAY SPECIAL CONTENT

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

Moderator

Alec Nielsen

Co-founder and CEO

ASIMOV

Jose Torres-Vorshirm

SVP Global Technical Operations

BioNTech

Christine Goldschneider

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

Sanofi

Siegfried Hackl

Senior Vice President - Product Supply

Ultragenyx

Nuno Fontes

SVP, Head of Global CMC

WuXi Biologics

Session Details Arrow Icon
  • 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?
6:15 pm

Welcome Drinks Reception

6:45 pm

Executive dinner

November 10th

Stream 1 Chair

Aine Hanly

Vice President, Quality

Amgen

Stream 2 Co-Chair

Executive to be Announced

Project Farma

Stream 3 Co-Chair

Executive to be Announced

Körber Pharma Software

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

Session Details Arrow Icon
  • 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 KEYNOTE

High-Reliability Quality in a Rapidly Evolving Biomanufacturing Landscape

Jackie Elbonne

Senior Vice President, Quality and Chief Quality Officer

Amgen

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

Session Details Arrow Icon
  • 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

Session Details Arrow Icon
  • 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

Session Details Arrow Icon
  • 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
10:25 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.

  • 10:30 am – 10:50 am: Meeting Slot 1/Networking
  • 10:55 am – 11:15 am: Meeting Slot 2/Networking
  • 11:20 am – 11:40 am: Meeting Slot 3/Networking
  • 11:45 am – 12:05 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

Panel: Quality Systems for Tomorrow's Modalities: Building Frameworks for Emerging Therapies

Session Details Arrow Icon
  • Designing flexible quality frameworks for emerging therapies (cell, gene, RNA, bispecifics)
  • Managing uncertainty and variability in novel manufacturing processes
  • Applying risk-based approaches to support evolving products, processes, and control strategies
  • Practical lessons from building quality systems that enable innovation while maintaining compliance and product quality
Stream Three - Innovation

Advances and Challenges in Next Generation CAR T Cell Therapy

Ben Beneski

Chief Technical Officer

Allogene

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.

Content to be Announced

Krista Kerr

Executive Director, Gcp, Glp, Gvp Quality

Ardelyx

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

Venkat Raghavan

SVP, Biopharmaceutical Development

AstraZeneca

Content to be Announced

Bhagya Murali

Head of Digital Transformation, Global Technical Operations

AstraZeneca

Driving the Next Phase of CAR-T Manufacturing Efficiency: Balancing Cost, Capacity and Patient Access

Miranda Neville

Chief Technology Officer

Autolus

From Pilot to Plant Floor: Where Is AI Actually Delivering Measurable Value?

Gulin Erdogan

Senior Director

Avidity Biosciences

Sebastien Caille

Senior Director Process Development

Avidity Biosciences

Content to be Announced

Praful Sanas

Senior Director, Cell Therapy Supply Chain Planning Capability Owner

Bristol Myers Squibb

Content to be Announced

Lon Geraghty

Sr. Director, Business Excellence

BMS

What Does it Really Take to Go From Early Data into Phase 3 Quickly?

Nick Warne

Vice President Pharmaceutical R&D

Pfizer

Industrializing At-Home Biologics at Scale

Sebastian Stening

VP, Global Head PT Device & Packaging

Roche

Content to be Announced

Rakesh Kakkar

Vice President, Head of Manufacturing & Supply, Vaccines, US

Sanofi

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

Executive to be Announced

SGS Vitrology

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

Sheila Iyer

VP of Supply Chain

Teva

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

Session Details Arrow Icon
  • Strategies for scaling technical operations to support commercial cell therapy manufacturing
  • Ensuring process consistency, product quality, and operational reliability across complex manufacturing networks
  • Lessons learned from transitioning cell therapies from clinical development to commercial execution
  • The role of automation, digital infrastructure, and cross-functional coordination in improving scalability and patient access
Stream Two - Quality

Leading Quality Through Transformation: Navigating Organizational Change and Technology Integration

Session Details Arrow Icon
  • 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

Content to be Announced

Sid Advant

Executive Vice President, Global Technical Operations

Savara

Patricia Lufburrow

Senior Vice President, Quality

Savara

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

Session Details Arrow Icon
  • 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

Session Details Arrow Icon
  • 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

Balancing Speed, Quality, and Capacity in Large-Scale Biologics Manufacturing

Executive to be Announced

Boston Institute of Biotechnology, LLC

Session Details Arrow Icon
  • 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
3:10 pm - 4:30 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
4:35 pm - 5:10 pm KEYNOTE

Content To Be Announced

Edgardo Hernandez

President, Global Manufacturing

Eli Lilly and Company

5:10 pm - 5:25 pm
5:25 pm - 5:30 pm

Chair’s Closing Remarks

5:30 pm

Drinks Reception

6:00 pm

Executive dinner

November 11th

Stream 1 Chair

Aine Hanly

Vice President, Quality

Amgen

Stream 2 Co-Chair

Executive to be Announced

Project Farma

Stream 3 Co-Chair

Executive to be Announced

Körber Pharma Software

7:30 am - 8:20 am

registration & breakfast

7:45 am - 8:20 am breakfast workshops
Stream Two

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

Executive to be Announced

Körber Pharma Software

Session Details Arrow Icon
  • 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
8:25 am - 8:35 am

Chair’s Opening Remarks

Aine Hanly

Vice President, Quality

Amgen

8:35 am - 9:10 am KEYNOTE

Content To Be Announced

Brendan O’Callaghan

Executive Vice President, Head of Manufacturing and Supply

Sanofi

9:10 am - 9:45 am KEYNOTE

Cyber Security Leadership Insights in BioPharma

Pascal Bécotte

Managing Director

Russell Reynolds

Angela Jung

Executive Director, Technology & Cyber Security

Russell Reynolds Associates

9:50 am - 10:25 am Case Studies
Stream One - Strategic Manufacturing

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

Yun Mao

Vice President and Head, Drug Product Development

Bristol Myers Squibb

Session Details Arrow Icon
  • 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

Quality at Scale: Aligning Compliance, Efficiency, and Operational Performance

Anthony Morandi

Senior Vice President, Quality

AstraZeneca

Session Details Arrow Icon
  • Integrating quality into manufacturing operations to improve consistency, speed, and decision-making across global sites
  • Applying risk-based approaches to prioritize deviations, investigations, and compliance activities more effectively
  • Leveraging digital tools and data to strengthen visibility, oversight, and cross-functional alignment across the quality system
STREAM 3 CASE STUDY

Science, Manufacturing and Commercialization

Stephen Hill

Chief Operating Officer

Lyell Immunopharma

Session Details Arrow Icon
10:25 am - 11:20 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.

  • 10:30 am – 10:50 am: Meeting Slot 8/Networking
  • 10:55 am – 11:15 am: Meeting Slot 9/Networking
10:35 am - 11:10 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.

TOPIC one

The Small Biotech Advantage: Agility, Innovation, and the Challenges of Scale

Session Details Arrow Icon
  • CTO perspectives on how small biotechs are structuring teams, decision-making, and execution models
  • How innovative ways of working are enabling speed, flexibility, and focus in lean organizations
  • The evolving role of CDMOs and external partners in enabling development and scale-up

Kawa Chiu

Chief Technical Officer

Abdera Therapeutics Inc.

Kara Calhoun

SVP, Head of CMC & Technical Operations

Enlaza Therapeutics

Andrea Goddard

Chief Technical Officer

CatalYm GmbH

11:25 am - 12:00 pm Workshops
STREAM 1 WORKSHOP

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

Executive to be Announced

ElevateBio Technologies, Inc.

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
STREAM 2 WORKSHOP

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

Krystyna Riley

Chief Executive Officer

Havior

Session Details Arrow Icon
  • 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-market
STREAM 3 WORKSHOP

Building Resilient and Adaptive Global Manufacturing Networks

Executive to be Announced

Modicus Prime

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
12:05 pm - 12:40 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 as Enterprise Value: Insights from the Manufacturing Floor

Yvonne Kwan

Executive Director Manufacturing

Amgen

Content to be Announced

Satarupa Das

Director, Product Champion (Global Technical Operations)

AstraZeneca

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

Callum Chapman

Head of Global Product Quality

AstraZeneca

Content to be Announced

William Beck

Sr. Director, Supply Chain

BlueRock

CMC Challenges of Platform Development in CGT

Elena Peletskya

Sr Director, Portfolio Technical Strategy

Bristol Myers Squibb

Content to be Announced

Nidhi Shah

Senior Director, CAR-T Closed Manufacturing Operations

BMS

Aligning Multi-Region Compliance for Advanced Therapies

Scott Afman

Vice President, Central Quality

Gilead

Content to be Announced

Michele Lastro

VP, CMC Regulatory Sciences

Regeneron

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

Christine Acklin

Vice President Quality Assurance

Xencor Inc.

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