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

2:30 pm

Registration

3:00 pm - 3:50 pm WELCOME DAY SPECIAL CONTENT

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

Moderator

Alec Nielsen

Co-founder and CEO

ASIMOV

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
3:55 pm - 4:30 pm WELCOME DAY SPECIAL CONTENT

Workshop: Connecting Manufacturing, Quality, and Data to Improve Operational Performance

Session Details Arrow Icon
  • Breaking down silos between manufacturing, quality, and operations to create more connected, informed, and agile decision-making across biomanufacturing
  • Building trusted digital foundations that improve process visibility, execution consistency, and collaboration across sites and functions
  • Turning manufacturing and quality data into actionable operational insights that support continuous improvement, faster issue resolution, and stronger performance
  • Practical lessons from connecting people, processes, and technologies to improve reliability, operational excellence, and long-term manufacturing readiness
4:45 pm - 5:35 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

Aura Biosciences

Craig Beasley

Chief Technology Officer

BlueRock Therapeutics

Mayo Pujols

Chief Technical Officer

Kyverna 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
5:40 pm - 6:30 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?
6:30 pm

Welcome Drinks Reception

7:00 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 - 8:25 am

Opening Remarks & Important Announcements

Aine Hanly

Vice President, Quality

Amgen

8:25 am - 8:35 am

Welcome Address

Yatin Gokarn

SVP, Head of Product Development & Clinical Supply

Alexion Pharmaceuticals

8:35 am - 9:10 am KEYNOTE

From Molecule to Medicine: Driving AI-powered Pharmaceutical Manufacturing for a More Productive and Sustainable Future

Pam Cheng

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

AstraZeneca

Session Details Arrow Icon
  • Discussing why sustainability is no longer a constraint on pharmaceutical manufacturing, but a driver of innovation, resilience, and long-term competitiveness
  • Exploring how AI, digital technologies, and data are helping manufacturers deliver greater value while reducing environmental impact
  • Examining the role of green chemistry, advanced manufacturing technologies, and new approaches to scaling increasingly complex therapies
  • Addressing how to build a more resilient, efficient, and patient-focused future for the development, production, and delivery of medicines
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

Scaling Smarter: Intelligent Planning for Biomanufacturing Growth

Scott Barnard

Managing Director USA

BlueCrux

James Ward

Lab Digital Transformation Lead

BlueCrux

Session Details Arrow Icon

As biotech companies grow, planning complexity increases across labs, manufacturing, external partners, and commercial operations, with systems and processes quickly becoming outdated. Organizations that scale successfully are rethinking how planning connects people, processes, and data across the value chain, creating the foundation for smarter decisions and more agile operations.

What you’ll learn:

  • What scalable planning looks like in modern biotech organizations
  • The role of lab, manufacturing, and partner planning in supporting growth
  • Lessons from advanced therapies and patient-centric supply chains
  • Priorities for building a more connected and resilient operating model
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

Sebastian Stening

VP, Global Head Device, Packaging & Distribution MSAT

Roche

Stream Two - Quality

Panel: Redefining Quality & Compliance: Adapting to a Changing Regulatory Landscape

Session Details Arrow Icon
  • How evolving regulatory expectations are changing the role and priorities of Quality organizations
  • Balancing compliance, quality performance, and operational agility across complex manufacturing environments
  • Strengthening collaboration between Quality, Regulatory, CMC, and Manufacturing as expectations evolve
  • Using risk, data, and technology to become more proactive in identifying and managing quality risks
  • Preparing quality organizations for the regulatory and operational challenges ahead
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.

Two Functions, One Radar: Building Trust, Transparency, and Shared Risk Ownership Between CMC and Quality

Ella Hwang

Vice President, Technical Operations and Supply Chain

Abcuro

Yuyi Shen

Vice President, Technical Operations and Supply Chain

Abcuro

Content to be Announced

Krista Kerr

Executive Director, Gcp, Glp, Gvp Quality

Ardelyx

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

Raghavan Venkat

SVP, Biopharmaceutical Development

AstraZeneca

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

Miranda Neville

Chief Technology Officer

Autolus

Technical Integration Following Company Acquisition:  A Conjugate Drug Perspective

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

Bristol Myers Squibb

Content to be Announced

Executive to be Announced

Katalyze AI

Content to be Announced

Hans Nowak

Senior Vice President, Manufacturing Operations

Ossium Health

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

Aparna Deora

Vice President BTx Portfolio and Strategy

Pfizer

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

From AI Hype to AI Impact: Deploying AI in Small to Mid-size Biotech

Opeyemi Tayo Balogun

Executive Director

Disc Medicine

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

Beyond Compliance: How AI is Transforming Quality into a Strategic Business Partner

Rodrigo Muradas

Vice President, Global Head of R&D GMP Quality

Takeda

Session Details Arrow Icon
  • How quality organizations are evolving from reactive compliance to predictive, AI-driven risk management
  • Using AI and advanced analytics for real-time decision support, deviation detection, and quality event prediction
  • Human-AI collaboration in GxP environments – where automation adds value and where human judgment remains essential
  • What quality leaders need to prioritize over the next 24 months to stay ahead of the curve
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

Automation That Works. Digital That Delivers. Lights-Out Next

Edgardo Hernandez

President, Global Manufacturing

Eli Lilly and Company

Session Details Arrow Icon
  • Cutting-edge science is a manufacturing advantage, not just an R&D one. How applying advanced process science on the floor improved robustness and set the foundation for everything else that followed.
  • Standardized platforms let you scale fast. Replicating proven designs across sites is an unlock that most networks underuse.
  • Automation earns the right to digital. End-to-end automation that genuinely works at the site level is the precondition for meaningful digital and AI.
  • Lights-out is a direction, and we’re charging at it deliberately. What the bold ambition for parenteral looks like, why it’s credible given the track record, and what it demands of leadership to get there.
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

Panel: The Changing Biomanufacturing Landscape: Balancing Innovation, Regulation, AI, and Operational Reality

Session Details Arrow Icon
  • How advances in AI, automation, and emerging technologies are changing the way biomanufacturing organizations operate
  • Where new technologies are creating meaningful opportunities across development, manufacturing, and supply
  • Balancing the pace of innovation with the realities of implementing new technologies in complex manufacturing environments
  • How shifting market dynamics, product portfolios, and manufacturing models are influencing investment and strategic priorities
  • What biomanufacturing leaders see as the biggest opportunities and challenges shaping the industry over the next several years
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: Leveraging digital and A.I. into global risk based QMS frameworks

Anthony Morandi

Senior Vice President, Quality

AstraZeneca

Session Details Arrow Icon
  • Scalable QMS structure integration into manufacturing operations to improve consistency, speed, and risk based decision-making across diverse global sites
  • Leveraging digital tools and data to strengthen visibility, oversight, and quality system alignment across business units
  • Compliant and effective implementation of A.I. in GxP processes and environments, principles and case studies
STREAM 3 CASE STUDY

Science, Manufacturing and Commercialization

Stephen Hill

Chief Operating Officer

Lyell Immunopharma

Session Details Arrow Icon
  • The cell therapy scientific and manufacturing journey at Lyell
  • CMC translation: science and manufacturing platforms
  • Manufacturing paradox – manufacturing with early positive clinical data
  • Managing change and commercialization
  • The need for leader resilience
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.

Andrea Goddard

Chief Technical Officer

CatalYm GmbH

Kara Calhoun

SVP, Head of CMC & Technical Operations

Enlaza Therapeutics

Kevin Kerls

Vice President, General Manager

Lonza

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

Your AI Strategy Has an Accountability Problem

Krystyna Riley

Chief Executive Officer

Havior

Session Details Arrow Icon
  • Why AI implementation doesn’t guarantee AI adoption
  • Identifying accountability gaps before they derail results
  • Recognizing the environments that accelerate or suppress adoption
  • Turning AI investments into measurable business impact
STREAM 3 WORKSHOP

Building Connected Manufacturing Networks: Driving Performance Through Digital Operations

Executive to be Announced

Modicus Prime

Session Details Arrow Icon
  • Building greater visibility and coordination across global manufacturing networks through connected digital platforms and standardized operational processes
  • Improving agility across sites by enabling faster tech transfer, consistent execution, and real-time operational decision-making
  • Using manufacturing data and performance insights to identify bottlenecks, reduce variability, and strengthen network-wide execution
  • Establishing common operational metrics and digital governance that drive consistency, continuous improvement, and resilient manufacturing performance
12:05 pm - 12:40 am KEYNOTE

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

12:45 pm - 2:00 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

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

Bristol Myers Squibb

Aligning Multi-Region Compliance for Advanced Therapies

Scott Afman

Vice President, Central Quality

Gilead

Bridging Commercial and Tech Ops: Lessons from First Cell Therapy Launches

Amy Gamber

Executive Director, Lifecycle Lead SPS Program

Kyverna Therapeutics

Content to be Announced

Sona Son

Vice President of Operations

Microbial Discovery Group

Before the Agent Acts: Why Business AI Needs a Governed Intelligence Layer

Eris Crosswhite

Global Operations Pfizer Supply Head of Supply Chain

Pfizer Global Supply

Content to be Announced

Michele Lastro

VP, CMC Regulatory Sciences

Regeneron

Driving Performance and Agility with Single Use System Platforms: Real-World Implementation Insights

Joseph Panella

Head of Biologics Manufacturing, Mass BioCampus

Sanofi