A Decade Strong — Celebrating 10 Years of BMWS

November 10th

3:30 pm

Registration

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

Panel: Our Five Top-of-Mind Issues as 2025 Ends and We Prepare for the Future of Biomanufacturing

Moderator

Alec Nielsen

Co-founder and CEO

ASIMOV

Carlos Candido

Vice President, External Manufacturing, MSAT & Supply Chain

Be Biopharma

Jeff Davis

VP Clinical Manufacturing

Gilead

Nuno Fontes

SVP, Head of Global CMC

WuXi Biologics

Ashley Hesslein

VP, Biologics & DSO Transformation Coach

Bayer

Rich Stoner

Former Chief Scientific Officer

Resilience

Session Details Arrow Icon
  • Emerging Technologies: How can we turn AI, digital twins, continuous processing, and cell & gene innovations into real operational advantage? Which technologies are going to make the difference?

  • Regulatory & Policy Pressures: How do we stay ahead of shifting regulations, biosecurity rules, and geopolitical policy without slowing innovation?

  • Supply Chain Resilience: How do we secure materials, manage global disruptions, and navigate tariffs to keep production running smoothly?

  • Talent & Workforce: How do we attract, retain, and upskill the skilled workforce we need for increasingly complex manufacturing?

  • Scaling Complex Therapies: How do we reliably bring advanced therapies to patients faster while maintaining quality and cost-effectiveness?

5:00 pm - 5:55 pm WELCOME DAY SPECIAL CONTENT

Panel: The Future of Biomanufacturing: Looking at New Modalities and How We Can Set the Course for Advancing Innovation

Moderator

Alec Nielsen

Co-founder and CEO

ASIMOV

Tim Moore

Former Chief Technical Officer

Allogene Therapeutics

Vishal Khanderia

VP Global Supply Chain

Beam Therapeutics

Harish Santhanam

Vice President Cell Therapy Technical Operations

Bristol Myers Squibb

Mitra Cruz

Vice President, Manufacturing Operations Site Head - El Segundo, California

Kite a Gilead Company

Session Details Arrow Icon
  • What are the most important new modalities and technologies that will unlock new paths forward? 
  • How can industry leaders drive innovation through collaboration, technology adoption, and process optimization? 
  • Discussing how innovations in manufacturing technology, including AI, can help meet scaling needs 
  • Looking at strategies for expanding infrastructure globally to increase efficiency and accessibility 
6:00 pm
6:30 pm

Executive dinner

(By Invite Only)

November 11th

Stream 1 Chair

Aine Hanly

Vice President, Quality

Amgen

Stream 2 Co-Chair

Jacob Greenwood

Vice President

Project Farma

Stream 3 Co-Chair

Judith Koliwer

Senior Industry Advisor & Principal Consultant Advanced Therapies

Körber

7:30 am - 8:15 am

registration & breakfast

8:15 am - 8:30 am

Opening Remarks, Important Announcements and Chair’s Welcome Address

Aine Hanly

Vice President, Quality

Amgen

8:30 am - 9:05 am KEYNOTE

Transforming Biopharma Manufacturing by 2030: Harnessing Agentic AI for Cost-Effective Process Innovation

Sanat Chattopadhyay

Executive Vice President & President, Merck Manufacturing Division

Merck

9:05 am - 9:40 am KEYNOTE

Playing to Win for Patients – Leading to Grow in a VUCA Environment

Kimberly Lounds Foster

Global Head & VP Advanced Therapies Supply Chain, Innovative Medicine

Johnson & Johnson Innovative Medicine

Session Details Arrow Icon
  • Fostering a mindset of excellence in execution
  • Industrializing nascent technologies and accelerating to market
  • Investing to compete while navigating a dynamic landscape
9:45 am - 10:20 am Workshops
Stream One

From Partnership to Performance: Driving Agility and Excellence in Biomanufacturing

Rainer Haemmerle

ED, Manufacturing

Boehringer Ingelheim Biopharmaceuticals GmbH

Session Details Arrow Icon
  • Exploring how strategic partnerships accelerate the adoption of new manufacturing capabilities and technologies

  • Highlighting how collaboration enables agility, from early development through commercial scale

  • Discussing how flexible partnership models can help biopharma companies navigate shifting market and regulatory pressures

Stream Two

Turning Capital Into Clinical Milestones: Extending Runway with the World’s First IDMO

Isabel Tian, PhD

Director, Scientific Affairs

Cellares

Session Details Arrow Icon
  • Announcement of the Biotech Incentive Program, designed for early-stage cell therapy developers to extend your runway
  • Leverage integrated manufacturing / QC automation and regulatory-ready infrastructure to accelerate clinical timelines
  • Recoup costs through lower batch price, commercial scale throughput and operation efficiency
Stream Three

J&J's Innovative Medicine Journey to Synchronize Planning & Operations in a “Never Normal” Environment

Anouk Schoenmakers

Managing Partner Consulting Solutions

Bluecrux

Joseph Bitterman

Vice President, Supply Chain Planning

Johnson & Johnson Innovative Medicine

Session Details Arrow Icon

Pharmaceutical Supply Chains are under pressure from a myriad of angles.  Demand volatility, external capacity constraints, complex modalities with longer lead times, evolving regulatory landscape, geopolitical tension and pricing/tariff pressure are just some of the dynamics which require new ways of working.  Supporting reliable supply to customers and patients while maintaining efficient levels of inventory requires a step-change in the way that the planning function interacts with internal Operations and CMO’s.  J&J will lead a conversation with Bluecrux, sharing lessons learned through several practical examples in the area of Plan-to-Plant synchronization.  Key to J&J’s ascent into Gartner’s Top 5 Supply Chains, these advancements in maturity are buoyed by a holistic approach across People/Process/Technology under the Advance Planning Transformation umbrella.

10:25 am - 12:05 pm Pre-Arranged One-To-One Meetings Arrow Icon

Pre-Arranged One-to-One Meetings

  • 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 
12:10 pm - 12:45 pm Case Studies
Stream One - Strategic Manufacturing

Fireside Chat: The Disease Clearing Potential of CAR T-Cell Therapy for Autoimmune Diseases

Karen Walker

Chief Technology Officer

Kyverna Therapeutics

Stream Two - Quality

Quality Business Leadership. From Cost to Value.

Anders Vinther

Former Chief Quality Officer, Founder & CEO

Quality Business Administration

Session Details Arrow Icon
  • The traditional perception of Quality leaders and the Quality organization is to ensure cGMP compliance of the company. However that is rather reactive and limiting reducing Quality to a cost center and a support function. It is time to evolve the Quality leader and the organization into a business partner that has the objective of ensuring a) sustained product quality, b) consistent product supply and c) robust financial performance of the company
  • The 6 traits of Quality Business leadership is the proven way to get there
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.

Best use of AI in Quality

Brian (B.J.) Brunner

Global Quality Practice Lead

Accenture

Advancing Bioconjugate Therapies: CMC Challenges and Regulatory Considerations

Dawn Spiller

Senior Director and Group Manager

AstraZeneca

Mid-Phase Tech Transfer: Onshoring Strategies, Operational Pitfalls, and Lessons Learned

Richard Richieri

Chief Operations Officer

Avid Bioservices

Bayer’s Transformative New Operating Model: How to Realize Innovation Over Bureaucracy

Ashley Hesslein

VP, Biologics & DSO Transformation Coach

Bayer

Digital Innovation in Supply Chain & Manufacturing: Advancing Connectivity & Integration

Eric Pukszyn

Executive Director of Supply Chain Business Performance & Transformation

Bristol Myers Squibb

Rewiring Procurement: AI’s Strategic Leap

Mikaella Gorelik

VP, Global Procurement, Global Product Supply & Development

Bristol-Myers Squibb

Getting the Most Out of Your Process, QA/QC, and Compliance Data

Umang Trivedi

Global Head of Tech Management, Drug Substance

Daiichi Sankyo

From Insights to Impact: Unlocking Business Value with Smart Instrument Data

Bethany Silva

Industry Marketing Manager - Life Science

Endress+Hauser

Jason Pennington

Director of Digital Solutions

Endress+Hauser

Preparing for the Future: Implementing ICH M4Q(R2) to Elevate Quality Documentation Standards

Sarah Pope Miksinski

Executive Director/Policy, Advisory and Intelligence

Gilead

Sustainability Considerations Internal and External Supply Chain

Carrie Bracco

Head Business Development, US

Novartis Contract Manufacturing

Cracking the Code: Lean Strategies for High-Throughput Cell Therapy Manufacturing

Ignacio Nunez

Chief Operations Officer

Scale Ready

What It Really Means to Be Phase-Appropriate: Building Quality Systems to Evolve with Development

Lyndsey Young

Executive Director, Quality

Tr1X

1:45 pm - 2:20 pm KEYNOTE

From Possibilities to Practice: Unlocking New Ways of Working in the Era of AI-Powered Biomanufacturing

Nitin Rathore

Vice President, Process Development

Amgen

2:25 pm - 3:00 pm Workshops
Stream One

Panel: Building Adaptive Technical Operations to Support the Future of Biomanufacturing

Adam Pfeiffer

Senior Vice President

Project Farma

Angela Goodenough

Executive Director of CMC, Analytical Development and Quality Control and Interim Head of Clinical Supply Chain

AnaptysBio

Jeff Davis

VP Clinical Manufacturing

Gilead

George Skillin

VP, Client Engagement

Project Farma

Session Details Arrow Icon
  • Establishing agile technical operations in an ever-changing environment
  • Building trusted internal and external partnerships
  • Strategies to maximize innovation and manufacturing efficiency
  • Planning for the Future – Balancing quality and speed to market
Stream Two

Using Innovation to Accelerate & Optimize Your Manufacturing Scale-Up Strategy

Joe Goodman

GM Americas, Honeywell Life Science

Honeywell Life Sciences

Session Details Arrow Icon
  • Challenges and trends facing the industry
  • Tackling the ever-growing complexity of the industry
  • Most critical outcomes and value in solving the challenges
  • AI is not the answer for everything, but it sure can help
Stream Three

$10/g Biologics and Beyond-- Uplifting Biologics from Billion-Dollar Drugs to Billion-People Drugs

Peng Jiao, Ph.D.

Founder, President & CEO

Boston Institute of Biotechnology, LLC

Session Details Arrow Icon
  • Monoclonal antibodies (mAb) have demonstrated clinical efficacy, but their high cost restricts widespread patient access
  • The cost of goods (COGs) for manufacturing mAbs sets the lower boundary of price
  • BiBo’s 30kL ultra-large mammalian production platform delivers a scalable solution to significantly reduce mAb manufacturing costs while ensuring adequate and robust supply capacity
3:05 pm - 4:15 pm Pre-Arranged One-To-One Meetings Arrow Icon

Pre-Arranged One-to-One Meetings

  • 3:05 pm – 3:25 pm: Meeting Slot 5/Networking 
  • 3:30 pm – 3:50 pm: Meeting Slot 6/Networking 
  • 3:55 pm – 4:15 pm: Meeting Slot 7/Networking 
4:20 pm - 4:55 pm Case Studies
Stream One - Strategic Manufacturing

Shaping Tomorrow: Strategies for Success in Manufacturing and Innovation

Chris Crowell

VP, Global Head of Manufacturing

Kite a Gilead Company

Session Details Arrow Icon
  • The role of process improvements and modern technologies in driving greater productivity 
  • The importance of flexibility and innovation in future-proofing biomanufacturing capabilities 
  • Real-world examples of successful strategies that have led to improved output and reduced COG
Stream Two - Quality

Leading with Quality: Navigating Change and Driving Innovation

Paul Houri

Chief Quality Officer

Bristol Myers Squibb

Session Details Arrow Icon
  • Navigating the rapid evolution of technologies and the regulatory landscape
  • Balancing innovation with efficiency – staying creative during times of change
  • Leading teams through organizational and technological integrations
  • Establishing a competitive advantage that is built to last
Stream Three - Innovation

Expanding the Reach of Genetic Medicine through Gene Tuning

Alicia Collins

VP of Technical Operations

Tune Therapeutics

Session Details Arrow Icon
  • Exploring approaches to modulating the epigenome and the promise for cell and gene therapies
  • Discussion on navigating CMC timelines and complexity through collaboration
5:00 pm - 5:35 pm KEYNOTE

The Future of Manufacturing & Supply in Biopharma

Daniela Ottini

SVP, Manufacturing and Supply Head of Specialty Care

Sanofi

Session Details Arrow Icon
  • Manufacturing Reimagined: Discover Sanofi’s bold transformation from traditional pharma to a unified, agile network delivering breakthrough treatments at unprecedented speed
  • The Formula 1 of Pharma: Learn how racing-inspired techniques and cutting-edge AI are revolutionizing production, cutting months from development timelines
  • Beyond Production: Experience how manufacturing excellence directly translates to patient impact, sustainability leadership, and greater medicine access worldwide
  • Time is Life: See how every innovation and every second saved translates directly into hope for patients waiting for tomorrow’s cures
5:35 pm - 5:45 pm
5:45 pm - 5:50 pm

Chair’s Closing Remarks

Aine Hanly

Vice President, Quality

Amgen

5:50 pm

Drinks Reception

6:20 pm

Executive dinner

(By Invite Only)

November 12th

Stream 1 Chair

Chris Horan

Chief Technical Operations Officer

Artiva Biotherapeutics

Stream Two Co-Chair

Jim Rice

Vice President, Life Sciences

Project Farma

Stream Three Co-Chair

Judith Koliwer

Senior Industry Advisor & Principal Consultant Advanced Therapies

Körber

7:30 am - 8:20 am

registration & breakfast

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

Data as a Catalyst: Enabling Robust and Flexible Manufacturing in Cell and Gene Therapy

Judith Koliwer

Senior Industry Advisor & Principal Consultant Advanced Therapies

Körber

Session Details Arrow Icon
  • Best practice for a data flow concept in cell and gene therapy
  • How a well-structured data management approach can save time and effort for a long-term digitization strategy
  • Applications of digital twins in cell and gene therapy, lessons learned and new developments
  • Overview of data flow requirements for current or future usage of AI tools
8:25 am - 8:35 am

Chair’s Opening Remarks

Chris Horan

Chief Technical Operations Officer

Artiva Biotherapeutics

8:35 am - 9:10 am KEYNOTE

Fireside Chat: An Update on the FDA - Initiatives, Progress, and Outlook

Hilary Marston

Former Chief Medical Officer

U.S. Food & Drug Administration

9:10 am - 9:45 am KEYNOTE

Creative and Impactful Leadership Through Uncertainty

Pascal Bécotte

Managing Director

Russell Reynolds

Marie-Noëlle Gagnon

Chief Talent Officer

Cirque du Soleil Entertainment Group

Session Details Arrow Icon
  • Drawing on Cirque du Soleil’s creative roots to lead through ambiguity and change
  • Building trust and resilience in high-pressure environments through open communication
  • Empowering teams with purpose and flexibility
9:50 am - 10:25 am Case Studies
Stream One - Strategic Manufacturing

Scaling CAR-T: Lessons from a Commercial Manufacturing Launch

Birk Vanderweeën

Senior Vice President, Global Manufacturing & Supply

Legend Biotech

Session Details Arrow Icon
  • Lessons learned from the operational and manufacturing journey of CARVYKTI™.

  • Challenges encountered and how they shaped decision-making.

  • Key takeaways for advancing CAR-T production and delivery.

Stream Two - Quality

Panel: Leading Quality Forward: Executive Strategies for Next Generation Quality Management

Karin Ann Payne

Vice President Corporate Quality

Bristol Myers Squibb

Sang Yoon

VP of Quality Assurance

ImmunityBio

Session Details Arrow Icon
  • How senior leadership is redefining quality as a strategic differentiator
  • Integrating AI to enhance risk management and predictive quality analytics
  • Rethinking organizational structures to support digital transformation
  • Balancing innovation and compliance in a rapidly evolving regulatory landscape
Stream Three - Innovation

Leading through Transition: Strategic Decommissioning to Accelerate Co-Location

Jemelle Dizon-Maspat

Executive Director, Oceanside Operations, PDM Global Manufacturing

Gilead

10:30 am - 11:15 am Pre-Arranged One-To-One Meetings Arrow Icon

Pre-Arranged One-to-One Meetings & Refreshments

  • 10:30 am – 10:50 am: Meeting Slot 8/Networking 
  • 10:55 am – 11:15 am: Meeting Slot 9/Networking 
10:30 am - 11:05 am FOCUS GROUP

Focus Group

TOPIC one

The Fast Track to Patients: How Reliance and Collaboration Pilots Are Accelerating Global Approvals.

11:20 am - 11:55 am Workshops
Stream One

From Bottleneck to Breakthrough: Digital Tech Transfer for Pipeline Acceleration

Michalle Adkins

Director Life Sciences Strategy

Emerson

Session Details Arrow Icon
  • Learn how digital-first workflows and automation systems together eliminate bottlenecks and accelerate recipe transfer
  • Discover how AI augments tech transfer through recipe translation and scheduling optimization
  • See how pipeline acceleration is unlocked when digital platforms, automation, AI, and human expertise converge in a connected ecosystem
Stream Two

Accelerating Bioprocess Automation with Real-Time Integrated Control

Michiya Kanzaki

Senior Advisor

Yokogawa Electric Corporation

Nick Randall

Bioprocessing Product Manager

Repligen Corporation

Session Details Arrow Icon
  • Importance of realtime PAT and Automation
  • Integration of equipment, utilization of data for automation
  • Opportunities for minimizing manual intervention while maintaining flexibility
  • Key considerations for implementing automation to enable long-term success
Stream Three

Harnessing Contextual Data and AI to Accelerate the Transformation of Biomanufacturing Operations

William (Bill) Hendricks

President Americas

Cognite

Session Details Arrow Icon
  • Applying contextualized data to improve operations efficiency with yield, quality, throughput or OTIF in mind
  • Using AI to connect people, systems, and processes across manufacturing networks
  • Achieving faster data-driven insights through a unified digital foundation in a regulated environment
  • Lessons (data, processes and talent) learnt from digital transformation programs driving measurable business impact
12:00 pm - 12:35 pm KEYNOTE

Fireside Chat: Policy, Innovation, and the Future of Advanced Therapies

Scott Gottlieb, M.D.

Former Commissioner

U.S. Food & Drug Administration

Session Details Arrow Icon
  • Discussing the current landscape and the administration’s direction on pharmaceutical policy.
  • Exploring perspectives on CAR-T, emerging trends, and the evolving cell and gene therapy industry.
  • Live Q&A with audience to unpack policy and industry implications.
12:35 pm - 1:35 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.

Balancing Data Needs/Cost: Delivering value across Partnerships, Quality, Process, and Supply

William Beck

Sr. Director Supply Chain

BlueRock Therapeutics

Parenteral Visual Inspection Programs - Heightened FDA Expectations for Program Capability and Compliance

Christian Phillips

Senior Vice President, CMC

Inozyme

The Importance of Operational Technology Cybersecurity in Life Sciences

Allison Snyder

Senior Director, Operational Technology Cybersecurity

Johnson & Jonhson Innovative Medicine

Remembering the Fundamentals of Quality Culture in an Increasingly Complex Business Environment

Humberto Moran

Vice President, Tech Operations & Maryland Site Head

SenseiBio

1:35 pm - 2:10 pm KEYNOTE

Going from Zero to 100: The Bemdaneprocel Journey to Phase 3 and Beyond!

Tina Self

SVP, Global Biologics Manufacturing and Berkeley Site Head

Bayer

Craig Beasley

Chief Technology Officer

BlueRock Therapeutics

Session Details Arrow Icon
  • RMAT – what it really means for manufacturing when you go from Phase 1 to Phase 3
  • Where we started to where we are today
  • The challenges we’ve overcome to get ready for phase 3…and prepare for launch
  • How the team is demonstrating comparability along the journey to enable seamless transitions
  • It takes a village – how BlueRock Therapeutics & Bayer are working together to bring the product to patients
2:10 pm - 2:45 pm PANEL

Fostering Innovation in the Face of Changes in today's Healthcare Environment

Moderator

Michael Thien

Former, SVP & Head of Pharmaceutical Sciences, R&D

Takeda

Pat Yang

Chairman

Taiwan BioManufacturing Corp (TBMC)

Ran Zheng

Chief Executive Officer

Landmark Bio

Session Details Arrow Icon
  • Developing innovative strategies to support development of medications for rare and ultra-rare diseases 
  • Discussing strategies to integrate digital tools and automation for faster, more resilient biomanufacturing processes
  • Exploring ways to foster cross-functional innovation amid evolving regulatory and supply chain challenges
2:45 pm - 2:50 pm

Closing Remarks

Michael Thien

Former, SVP & Head of Pharmaceutical Sciences, R&D

Takeda

Sessions From Previous Years

Download The Agenda PDF

"*" indicates required fields

Are you a Delegate or Solution Provider/Vendor?*