2025 Agenda

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November 10th

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

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

Nuno Fontes

SVP, Head of Global CMC

WuXi Biologics

Session Details

How can we manage the demands for new talent and continue to develop our workforce to meet the expanding needs in our industry?
Which technologies are going to make the difference, and are we incorporating those into our processes and operations the right way to get the most ROI for our time and capital?
How can we improve accessibility of medicines in an expensive world?
How do we continue to improve the speed of development and efficient manufacturing in the evolving regulatory landscape, with special reference to IRA and the BIOSECURE Acts?
What lessons can we take from our history and from other industries that have experienced incredible innovation-based growth to best set ourselves up for the future?

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

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

Harish Santhanam

Vice President Cell Therapy Technical Operations

Bristol Myers Squibb

Session Details

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

Drinks Reception

6:30 pm

executive dinner

(By Invite Only)

November 11th

Stream 1 Chair

Alison Moore

Chief Technical Officer

Codexis

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 and Chair’s Welcome Address

Alison Moore

Chief Technical Officer

Codexis

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 – Investing to Grow in a VUCA Environment

Kimberly Lounds Foster

Global Head & VP Advanced Therapies Supply Chain, Innovative Medicines

Johnson & Johnson

Session Details

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

Partnering with CDMOs to Optimize Resource Use and Advance Manufacturing Capabilities

Executive to be Announced

Boehringer Ingelheim Biopharmaceuticals GmbH

Session Details

Discussing how a global manufacturing network brings value to patients and your organization
Looking at how collaborative partnerships with CDMO’s drive innovation and product development, improving capacity and costs
Exploring the importance of regulatory compliance and quality control in CDMO partnerships to ensure safe and efficient production

Stream Two

Leveraging Automated Technologies to Accelerate cGMP Manufacturing

Executive to be Announced

Cellares

Session Details

Scaling production to meet increasing demand for life-saving cell therapies
Addressing bottlenecks with end-to-end automation, improving efficiency and streamlining processes
Reducing process failure rates with enhanced consistency

Stream Three

The Role of CDMOs in Advancing Radiotherapeutic Manufacturing and Innovation

Bluecrux

Session Details

Challenges in radiopharmaceutical manufacturing, including isotopes, stability, and regulatory compliance
The role of CDMOs in supporting scalable, high-quality production of radiotherapeutics
Emerging trends and technologies shaping CDMO partnerships in radiotherapy

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

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 1 CASE STUDY

Elevating Manufacturing: Efficiency, Innovation, Impact

Chris Crowell

SVP, Global Head of Manufacturing

Kite Pharma

Session Details

Discussing the effects of streamlined cell therapy manufacturing on turnaround times and patient access
Exploring how operational refinements can accelerate delivery without compromising quality
Looking at how advanced analytics and digital tools are driving innovation in manufacturing; enabling greater control, scalability, and real-time decision-making in complex therapeutic production
Examining the impact of integrated manufacturing strategies on global expansion efforts
Highlighting how efficiency and innovation support broader access to cutting-edge treatments.

Stream Two - Quality

The Journey to Quality Business Leadership

Anders Vinther

Former Chief Quality Officer, Founder & CEO

Quality Business Administration

Stream Three - Innovation

Driving Innovation Through the Biomanufacturing Ecosystem

Koustuv Chatterjee

Senior Vice President, Head of External Manufacturing and Supply

Sanofi

Session Details

Looking at how harnessing strategic partnerships can accelerate innovation across external manufacturing and supply networks
Discussing the value in leveraging digital technologies and real-time data to accelerate tech transfer and enable flexible production
Using agile and adaptable external manufacturing networks to scale advanced modalities

12:45 pm - 1:45 pm

Excutive Lunch Seating

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.

Advancing Peptide Therapies: Manufacturing Challenges and Solutions

Dawn Spiller

Senior Director and Group Manager

AstraZeneca

Content to be Announced

Eric Pukszyn

Executive Director of Supply Chain Business Performance & Transformation

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

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

Sarah Pope Miksinski

Executive Director/Policy, Advisory and Intelligence

Gilead

Issues and Trends Discovered in Cell & Gene Therapy Commercialization

Robert Larson

Executive Director

Gilead

Rethinking the Limits of Batch Manufacturing: What Does Continuous Improvement Look Like in a Process Manufacturing Environment?

Lyndsey Young

Senior Director of Quality

Tr1X

1:45 pm - 2:20 pm Case Studies

Stream One - Strategic Manufacturing

Shaping Tomorrow: Strategies for Success in Manufacturing and Innovation

Session Details

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

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

Advancing Gene Editing: Exploring Next-Wave Technologies

Heidi Zhang

Executive Vice President, Chief Development Officer

Tune Therapeutics

Session Details

Discussing updates to base editing, prime editing, and RNA-targeting technologies
Addressing challenges in safety and delivery
Looking at future trends including AI integration and other new tools

2:25 pm - 3:00 pm Workshops

Stream One

Agile Manufacturing: Technical Strategies for Operational Flexibility

Executive to be Announced

Project Farma

Session Details

Advantages of flexible, phase-appropriate facility builds
Operational readiness and a successful facility startup
Using effective partnerships to accelerate speed to market for next-generation medicines

Stream Two

Modernizing Manufacturing Practices to Advance Quality Assurance

Executive to be Announced

Honeywell Life Sciences

Session Details

Discussing how Advanced Process Analytical Technologies (PAT) enable real-time monitoring for consistent quality
Using Machine Learning pattern recognition capabilities to fine tune procedures for optimized manufacturing
Automation of workflows to ensure streamlined and robust compliance
Enacting continuous process validation to maintain control and enhance product quality

Stream Three

Achieving Seamless Delivery of Antibody-Drug Conjugate (ADC) Services through Strategic Collaboration

Session Details

Embracing initiatives to collaborate with industry partners for sustainable growth to meet evolving requirements effectively
Efficiently addressing market needs and building capacity
Overcoming supply chain challenges to establish a robust and agile network, ensuring uninterrupted service delivery
Ensuring smooth technology transfer processes to meet the diverse needs of global clients

3:05 pm - 4:15 pm Pre-Arranged One-To-One Meetings

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

4:25 pm - 5:00 pm KEYNOTE

Accelerating the Pace of Progress for Innovative Biologic Products

Executive to be Announced

FDA

Session Details

Looking at the potential of ongoing research and technological advances in transforming biologics development
Discussing efforts towards global regulatory convergence
Summarize internal changes and external initiatives at FDA in support of expeditious product development

5:20 pm

Drinks Reception

6:00 pm

executive dinner

(By Invite Only)

November 12th

7:30 am - 8:20 am

registration & breakfast

7:45 am - 8:20 am breakfast workshops

Stream Two

Optimizing Processes with Integrated, Holistic Solutions

Executive to be Announced

Körber Pharma Software

Session Details

Developing digital solutions to future-proof your organization
Using AI to connect and optimize processes
Ensuring your supply chain remains a strategic advantage, not an obstacle to your success
Streamlining production and ensuring compliance through digitalization and data-driven insights

8:25 am - 8:35 am

Chair’s Opening Remarks

Alison Moore

Chief Technical Officer

Codexis

8:35 am - 9:10 am KEYNOTE

Accelerating Sustainable Biomanufacturing: Leadership, Innovation, and the Future of ADCs

Pam Cheng

Executive Vice President, Global Operations, IT & CSO

AstraZeneca

Session Details

Discussing how next-generation biomanufacturing strategies are enabling the scalable, reliable production of complex modalities like ADCs.
Looking at why modern biomanufacturing leadership must balance innovation, quality, and operational resilience in an increasingly complex global landscape.
Exploring the transformation of manufacturing platforms through digitalization, automation, and integrated data systems to enhance agility and efficiency.
Examining how embedding sustainability into facility design and operations is a core enabler of long-term manufacturing excellence.

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

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

Embracing Digital Transformation: AI and its Evolving Impacts

Paul Foley

SVP, Head of Product and Portfolio Strategy

Gilead

Session Details

Leveraging technology to optimize complex biologic processes
Shifting manufacturing operations from reactive to predictive
Dealing with the challenges of Data Security, Algorithmic Bias, and the Regulatory Landscape

Stream Two - Quality

Quality at Scale: Launching Advanced Modalities with Speed and Precision

Nidia Acevedo

Senior Vice President, Global Quality Compliance

Eli Lilly

Session Details

Discussing applications of QbD to complex modalities during development and scale-up
Exploring strategies for building fit-for-purpose quality systems in newly constructed or rapidly expanded manufacturing sites
Examining how to identify and mitigate quality risks under compressed timelines for high-priority product launches
Highlighting methods for maintaining global quality alignment and knowledge transfer across internal and external networks
Sharing best practices for embedding a strong quality culture early in the lifecycle of advanced biomanufacturing programs

Stream Three - Innovation

Revolutionizing the Approach to Regenerative Medicine: Advancements in Cell-Free Therapies

Session Details

Exploring the latest innovations in cell-free therapies, including secretome-based products, extracellular vesicles, peptides, and recombinant proteins, and their therapeutic potential
Overcoming challenges of scaling up cell-free therapy production, including optimizing protocols for consistency, purity, and reproducibility
What’s next for cell-free therapies? Looking at the potential for combination therapies

10:25 am - 11:15 am Pre-Arranged One-To-One Meetings

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

11:20 am - 11:55 am Workshops

Stream One

Optimizing Supply Chain and Logistics for Global Biomanufacturing

Session Details

Strategies to ensure seamless global production and distribution of biologics and therapies
Leveraging digital tools for better inventory management, tracking, and supply chain visibility
Collaborating with global logistics partners to ensure timely delivery of raw materials and finished products

Stream Two

Driving Digital Transformation in Biomanufacturing: From Data to Action

Executive to be Announced

Yokogawa Electric

Session Details

Discussing how digital twin technology enables real-time simulation and optimization of bioprocesses to improve yield and reduce variability
Exploring how AI-driven analytics support proactive quality management and reduce the risk of deviations in GMP environments
Highlighting how integrated data systems help ensure compliance with regulatory standards while streamlining audits and reporting
Examining how advanced process control solutions enhance operational efficiency across upstream and downstream biomanufacturing workflows

Stream Three

Creating Customized Manufacturing Strategies for Biologics

Session Details

Tailoring manufacturing approaches to the unique needs of biologics, from cell line development to final product
Strategies to improve batch consistency, process yield, and reduce cost
Navigating regulatory requirements and ensuring quality control at every stage
Leveraging advanced technologies to optimize production and scale-up for biologics

12:00 pm - 12:35 am Case Studies

Stream One - Strategic Manufacturing

Pivoting through Supply Change Disruption during Times of Change

Bala Sreenivasan

SVP, Global Supply and Value Chain Management

Merck

Session Details

Navigating through regulatory changes while maintaining a robust global supply chain
Discussing strategies for creating self-healing supply chains
Balancing efficiency with resilience
Maintaining a patient-centred focus in supply chain management

Stream Two - Quality

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

Karin Ann Payne

Vice President Corporate Quality

Bristol Myers Squibb

Session Details

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

Advancements in Allogeneic Cell Therapy: Challenges and Opportunities

Session Details

Exploring techniques for scaling up production of allogeneic cell therapies, ensuring consistency, quality, and cost-effectiveness
Addressing logistical challenges to ensure product integrity
Navigating evolving regulations for allogeneic cell therapies

12:35 pm - 1:35 pm

Excutive Lunch Seating

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.

Navigating the Future of Oligonucleotide Therapies: Manufacturing and Quality Insights

The Challenges of ATMPs Affordability and Finding the Key Paths to Optimization

Attracting and Retaining Talent – Building Stronger and More Resilient Teams

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

1:35 pm - 2:10 pm KEYNOTE

Collaborative Innovation: Scaling Allogeneic Cell Therapies

Tina Self

SVP, Global Biologics Manufacturing and Berkeley Site Head

Bayer

Craig Beasley

Chief Technology Officer

BlueRock Therapeutics

2:10 pm - 2:45 pm PANEL

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

Moderator

Alison Moore

Chief Technical Officer

Codexis

Pat Yang

Chairman

Taiwan BioManufacturing Corp (TBMC)

Michael Thien

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

Takeda

Session Details

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