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

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 in the Industry

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

November 11th

Stream 1 Chair

Stream 2 Co-Chair

Executive to be Announced

Project Farma

Stream 3 Co-Chair

Executive to be Announced

Körber Pharma Software

7:45 am - 8:30 am

registration & breakfast

8:30 am - 8:35 am

Opening Remarks and Important Announcements

8:35 am - 8:40 am

Chair’s Welcome Address

8:40 am - 9:15 am KEYNOTE

The Road to Operational Excellence: Building Reliability, Efficiency, and Agility

Kimberly Lounds-Foster

Global Head of Innovative Medicines, Advanced Therapies Supply Chain

Johnson & Johnson

Session Details

Building organizational agility to effectively adapt to market demands and regulatory changes
Mitigating risk with responsive and resilient supply chains
Strategies for optimizing processes and reducing CoGs

9:15 am - 9:40 am KEYNOTE

Leading Through Transformations and Integrations – Keeping the Wheels Turning

Karin Shanahan

EVP, Global Product Development & Supply

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

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

Executive to be Announced

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

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

Quality Leadership: Integrating Quality into the Core of your Organization

Session Details

Recognizing Quality as a competitive and financial advantage
Making risk-informed decisions and aligning businesses with patient needs
Engaging employees at all levels to foster quality accountability and continuous improvement

Stream Three - Innovation

Advances in CAR-T Cell Therapy Manufacturing: Scaling New Modalities

Chris Crowell

SVP, Global Head of Manufacturing

Kite Pharma

Session Details

Addressing technical challenges in T-cell extraction, genetic modification, and expansion for CAR-T therapies
Scaling production of autologous CAR-T therapies from clinical to commercial stages with improved cost-efficiency
Ensuring compliance with rigorous regulatory requirements and maintaining robust quality control

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.

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

Umang Trivedi

Global Head of Tech Management, Drug Substance

Daiichi Sankyo

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

Lyndsey Young

Senior Director of Quality

Tr1X

Issues and Trends Discovered in Cell & Gene Therapy Commercialization

Advancing Peptide Therapies: Manufacturing Challenges and Solutions

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

The Evolving Operational Quality Landscape for Advanced Therapies

David Geoghegan

SVP, Head of Quality Assurance & Validation

Spark Therapeutics

Session Details

Looking at technology through a process and analytical lens
Discussing the move from Adherent to Suspension technology
Quality considerations for meeting health authority expectations
Workforce development needs and approaches – internal and external considerations

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

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

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

5:00 pm - 5:05 pm

Chair’s Closing Remarks

5:10 pm

Drinks Reception

6:00 pm

executive dinner

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

8:35 am - 9:10 am KEYNOTE

Building Resilience and Optimization through Strategic Decision Making

Matt Winterman

SVP, Global Supply Chain & Strategy

AstraZeneca

Session Details

Adapting supply chains for resilience through digital transformation
Strategically driving cost optimization and business growth with timed investments for long-term, positive outcomes
Exploring how AI and machine learning can improve demand forecasting, and logistics management

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

A Culture of Continuous Improvement: Integrating digital solutions for improved QMS

Session Details

Enhancing collaboration and transparency in quality control across different teams and sites
Leveraging cloud-based QMS for data tracking and reporting
Strategies for monitoring consistency and quality at scale

Stream Three - Innovation

Advancing Gene Editing: Exploring Next-Wave Technologies

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

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

Implementing Automated Quality Assurance Systems in Biomanufacturing

Session Details

How CDMOs are integrating automated quality assurance systems to enhance reliability
The use of AI and machine learning to predict quality issues and improve decision-making
Improving efficiency and accuracy in testing and monitoring
Real-world examples of automated systems that have enhanced product quality and consistency

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

Key Trends Shaping the Future of Manufacturing

Session Details

Improvements in process efficiency to meet growing demand for biologics
Leveraging technology to optimize global supply chains, reduce lead times, and mitigate disruptions
Rising challenges in technical development

Stream Two - Quality

Ensuring Quality and Compliance in Monoclonal Antibody Manufacturing

Session Details

Investigating best practices for maintaining compliance in MAb manufacturing, particularly within a global context
Strategies for robust testing and process controls for ensuring product quality
Real examples of successful quality control systems in MAb production

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

Leading with a People and Patient Centered Approach

Session Details

Emphasizing diversity to create stronger teams and foster improved outcomes
Effectively navigating through periods of change and preparing your organization to remain adaptable
Discussing the importance of championing talent and leadership development to create a more resilient organization

2:10 pm - 2:45 pm KEYNOTE

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

Session Details

Discussing the impacts of the IRA & Biosecure Act
Developing innovative strategies to support development of medications for rare and ultra-rare diseases
Leveraging technology to mitigate risks related to regulatory changes

2:45 pm - 2:50 pm