Agenda - Pharma Manufacturing World Summit

5:00pm - 6:00pm

Welcome Day Panel: Planning for Pharmaceutical Manufacturing of the Future: What are the Five Big Things We Need to Talk About?

Charles L. Cooney

Robert T. Haslam Professor of Chemical Engineering, Emeritus, and Faculty Director, Emeritus Deshpande Center for Technological Innovation

MIT

Session Details

What are the key challenges affecting production speed and operational efficiency today?
How is the landscape of talent and workforce development evolving within the industry, and what factors are driving these changes?
Which cutting-edge technologies are making the greatest impact on modern pharmaceutical manufacturing?
What recent regulatory advancements have been made, and what opportunities exist to further streamline the approval process?
How can we enhance access to innovative medicines across global markets?

6:00pm

7:30am - 8:15am

8:15am - 8:20am

Opening Remarks and Important Announcements

8:20am - 8:30am

Chair’s Welcome Address

Charles L. Cooney

Robert T. Haslam Professor of Chemical Engineering, Emeritus, and Faculty Director, Emeritus Deshpande Center for Technological Innovation

MIT

8:30am - 9:05am

Driving Innovation and Operational Excellence: AstraZeneca’s Approach to Digital Transformation

Pam Cheng

Executive Vice President, Global Operations & Information Technology

AstraZeneca

Session Details

How AstraZeneca navigates supply chain complexities and ensures operational continuity across global markets
The role of cutting-edge technology and IT innovations in optimizing manufacturing, improving efficiency, and ensuring quality at scale
Utilizing advanced data analytics to enhance predictive capabilities and streamline operational processes
AstraZeneca’s commitment to reducing its environmental impact through sustainable practices and energy-efficient operations
Enhancing employee performance and engagement by integrating technology into everyday workflows
How AstraZeneca stays ahead of regulatory changes while maintaining the highest quality and safety standards across its global operations

9:05am - 9:40am

Transformation in Quality to Meet the Needs of Our Customers

Melissa Seymour

Executive Vice President, Global Quality

Eli Lilly

Session Details

• Quality as a business driver by “Flipping the Ratio”
• Transforming business growth through Proactive Quality
• Preparing our organization for the future of Quality Assurance

9:45am - 10:20am

Technical Operations Strategies for Transformative Medicines

Executive to be Announced

Project Farma

Session Details

Discuss the shifting landscape of current trends and manufacturing strategies for next-generation medicines and their impact on technical operations
Best in class practices for facility planning, build, operational readiness and startup
New innovative technologies on the horizon

9:45am - 10:20am

Data Doesn’t Lie – Digital Marketing ROI

Executive to be Announced

MasterControl

Session Details

Why digitizing production records and connecting to other systems is needed to remain competitive
The areas where digital systems have significant impact and how that translates to the bottom line
How digital systems can improve the work experience for operators
How to clearly demonstrate the ROI of a digital system

9:45am - 10:20am

From “Impossible” to Commercialization

Executive to be Announced

Boehringer Ingelheim

Session Details

Boehringer Ingelheim BioXcellence™ demonstrates how effective collaboration in contract manufacturing can expedite the delivery of innovative medicines
Leveraging expertise in microbial development and manufacturing
Toolbox approach for a groundbreaking cancer vaccine platform
Showcasing two perspectives from CMO and partner
The session will highlight the power of collaboration and innovation in the pharmaceutical industryex

10:25am - 12:05pm

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

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.

12:10pm - 12:45pm

Accelerating Innovation and Manufacturing Excellence: Leveraging Over 30 Years of Biotech Leadership and Cell Therapy Success

Joanne Beck

Chief Technical Officer

Abata Therapeutics

Session Details

Developing a robust manufacturing process to support clinical studies and pipeline expansion
How continuous improvement methodologies are applied in biotech and large pharmaceutical companies to maintain product quality, increase efficiency, and reduce costs over the product lifecycle
Driving operational efficiency and innovation in clinical and commercial manufacturing
The importance of building robust, scalable manufacturing processes in biotech, especially in partnerships like Abata’s collaboration with ElevateBio, which has transformed clinical readiness

12:10pm - 12:45pm

Proactive Quality Management for the Future

Steve Johnson

Vice President Quality Assurance

Ultragenyx

Session Details

Integrating human and organizational performance principles into the design of quality throughout the entire supply chain and ensuring effective implementation
Embracing risk-based strategies to pinpoint and address potential challenges while prioritizing essential processes and adhering to regulatory standards
Cultivating a culture of ongoing improvement by utilizing digital tools to streamline processes and elevate overall quality management
Adopting a proactive stance on regulatory compliance and operational efficiency through effective problem-solving and regular self-assessments

12:10pm - 12:45pm

Supply Chain Revolution: Prioritizing Patients in Pharmaceutical Logistics

Erica Olson

Senior Vice President, Global Supply Chain

Gilead Sciences

Session Details

Overview of the importance of prioritizing patient needs in pharmaceutical logistics and its impact on overall healthcare outcomes
Identification of key challenges in pharmaceutical logistics, such as delays, temperature control, and compliance with regulations
Exploration of advanced technologies enhancing supply chain efficiency, including IoT, blockchain, and real-time tracking systems
Discussion on navigating regulatory requirements and ensuring compliance while prioritizing patient needs
Strategies for fostering collaboration between manufacturers, distributors, and healthcare providers to create a more responsive and patient-focused supply chain

12:45pm - 1:45pm

Executive Lunch Seating

12:45pm - 1:45pm

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 Practices for Integrated Business Planning in Pharma: Leveraging Connected Planning to Drive Growth

Industry Trends, Challenges, and Opportunities in Process and Technology Platforms for the Commercialization of Gene Therapy Products

Supply Chain Revolution: Prioritizing Patients in Pharmaceutical Logistics

1:45pm - 2:20pm

Sanofi’s Manufacturing Transformation: Bringing Scientific Innovation to Patients

Brendan O’Callaghan

Executive Vice President, Head of Manufacturing & Supply

Sanofi

Session Details

Assessing global biopharmaceutical trends and disruptions to navigate industry changes and capitalize on new opportunities
Developing strategic initiatives to drive continuous improvement and achieve operational excellence
Identifying key transformation drivers and evaluating their impact on modernization efforts
Building agile, cross-functional teams to implement transformative strategies
Managing change effectively while addressing risks and utilizing digital technologies and data analytics to optimize efficiency and maintain a competitive edge

2:25pm - 3:00pm

Supply Chain Digital Transformation with Business Impacts for Pharmaceutical Manufacturers

Session Details

Proving that the most valuable data in supply chain/manufacturing is from production itself
Choosing the right goals and outcomes to make a difference
Connecting disparate IT systems together into a unified whole
Building a scalable approach for the enterprise, step-by-step: Start small to go big
Understanding why data lakes and bespoke projects do not scale
Illustrating successful projects with concrete examples

2:25pm - 3:00pm

What Traits Should Biopharma Companies Look for When Partnering with Drug Substance CDMOs?

Executive to be Announced

Axplora

Session Details

Best traits to look for when partnering with a CDMO, besides just capabilities and capacity
Best practices for discerning which CDMO’s are best for biopharma companies to partner with
Key steps for helping biopharma companies navigate complex sales processes with CDMOs

2:25pm - 3:00pm

Global Talent Trends in Pharma and Biotech Technical Operations: A Perfect Storm

Session Details

The great reckoning – single-asset company valuation recalibrations reverse top talent trend and lead to unprecedented layoffs in the industry
The generational gap continues to progress – leading only becomes more challenging
Leaders in the healthcare industry indicate the greatest drop in leadership confidence across industries

3:05pm - 4:15pm

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

4:20pm - 4:55pm

Regulatory Update: Advanced Manufacturing and Complex Biologic Products

Ingrid Markovic

Senior Science Advisor/CMC Lead

FDA

Session Details

Grasping the significance of FDA-CBER’s oversight in pharma manufacturing, ensuring adherence to strict quality standards, safety measures, and ethical guidelines for global health and patient well-being
Discuss efforts to expedite development of products for small populations through increased use of accelerated approval
Review efforts toward global regulatory convergence
Summarize internal changes and external initiatives at FDA in support of expeditious product development

4:55pm - 5:30pm

Innovations in Personalized Medicine Manufacturing: A Glimpse into the Future

Nicole Murphy

Executive Vice President, Head of Pharmaceutical Operations & Technology

Biogen

Session Details

The growth of biologics and precision and personalized medicine is driving the need for new types of solutions across automation, manufacturing, and quality and compliance
Learn how to modernize your operations and achieve manufacturing excellence using a future forward, agile, integrated, manufacturing solution that supports compliance and real-time quality management
Take an industry standard approach to reach new levels of maturity in your digital transformation journey
A look ahead at the expanding role of personalized medicine in pharma and overcoming hurdles in personalized medicine production and scalability

5:30pm - 5:35pm

Chair’s Closing Remarks

Charles L. Cooney

Robert T. Haslam Professor of Chemical Engineering, Emeritus, and Faculty Director, Emeritus Deshpande Center for Technological Innovation

MIT

5:35pm

7:30am - 8:20am

7:45am - 8:20am

Pioneering Manufacturing Automation Innovation with AI

Session Details

Leveraging lessons learned from the semiconductor industry for tech-first companies
The journey of defining the high value problems and opportunities for personalized medicine
Optimizing productivity and quality for manufacturing resilience and sustainability
Speed to insights for “Right First Time”
Innovation enabling improvements in key achievement drivers

8:25am - 8:35am

Chair’s Opening Remarks

Charles L. Cooney

Robert T. Haslam Professor of Chemical Engineering, Emeritus, and Faculty Director, Emeritus Deshpande Center for Technological Innovation

MIT

8:35am - 9:10am

The Things We Can Achieve and Our Shared Journey Along the Way

Arleen Paulino

Senior Vice President Global Manufacturing

Amgen

Session Details

The current landscape on digital innovation, technology, people and our ways of working and thinking
Understanding current capabilities and where we need to be collectively headed as a community of pharmaceutical manufacturers
Strategies that compel and empower us to move beyond past constraints and set new, ambitious goals for the future
Thinking beyond the data to find purpose and meaningful connections for people

9:10am - 9:45am

Pushing Boundaries: The Future of Pharmaceutical Manufacturing and Innovation at Moderna

Jerh Collins

Chief Technical Operations & Quality Officer

Moderna

Session Details

Expanding manufacturing capabilities, including new sites and innovative technologies, to support an exciting pipeline of products, especially in cancer vaccines
How nurturing bold and curious talent fosters a mindset where taking risks is encouraged and failure is seen as a learning opportunity
The integration of human capital, business processes, and emerging technologies to enhance operational efficiency
Exploring how to work more effectively with regulatory bodies to ensure innovation isn’t stifled, while also holding them accountable
The role of robotics and manufacturing advancements in Europe and how these innovations shape Moderna’s global strategy

9:50am - 10:25am

Advancing Gene Therapy Manufacturing: Technical Excellence and Innovation at Sarepta Therapeutics

Bilal Arif

Executive Vice President, Chief Technical Operations Officer

Sarepta Therapeutics

Session Details

Pioneering Gene Therapy Manufacturing: Sarepta’s approach to scaling production and overcoming technical challenges in gene therapy
Innovative Technologies in Rare Disease Treatment: How cutting-edge tools and platforms are driving the development of treatments for rare diseases
Optimizing Supply Chain for Precision Medicine: Strategies for ensuring a reliable and efficient supply chain for complex, high-value therapies
Regulatory Compliance and Quality Assurance: Maintaining compliance and quality in a rapidly evolving regulatory landscape for gene therapies
Expanding Manufacturing Capabilities: Sarepta’s initiatives to grow manufacturing capacity while maintaining agility and innovation
Workforce Development in Advanced Therapies: Empowering technical teams to support complex manufacturing processes through specialized training and talent retention Bottom of Form

9:50am - 10:25am

Bold and Unafraid: Lessons in Leadership and the Value of Manufacturing in Building the Next Great Biotech

Timothy Maines

Chief Technical Operations & Quality Officer

Alnylam Pharmaceuticals

Session Details

When all others said ‘impossible’, Alnylam turned the promise of RNAi into a proven new class of medicines and is at an inflection point to launch a blockbuster medicine. Alnylam has ambitions to address some of the world’s most prevalent diseases. Success is dependent upon fueling the potential of a deep pipeline of clinical and commercial-stage assets. The problem is, How? The answer goes beyond R&D and Commercial capabilities. As Chief of Technical Operational and Quality, Tim Maines has the experience and mindset to scale for the opportunities ahead for siRNA-based medicines and beyond. This session will discuss how to elevate manufacturing innovation as instrumental for helping the most patients by enabling companies to be big and small at the same time.

Case study: Delivering a new class of medicines and the role of manufacturing, supply chain and quality
From underappreciated to instrumental – importance of executive leadership for technical, operations and quality capabilities
Truths in leadership: authentic, nimble, bold, and unafraid

9:50am - 10:25am

Shaping the Future: Leading a Culture of Collaboration and Growth

Chris Stevens

Chief Patient Supply Officer

Spark Therapeutics

Session Details

Identifying key drivers of change in the pharmaceutical industry, with a focus on workforce engagement and development
Strategies for building an organizational culture that prioritizes talent retention, continuous learning, and employee development
Analyzing whether industry changes will lead to dramatic shifts in workforce dynamics or more incremental adaptations
Proactive approaches to equipping teams for future uncertainties and maintaining operational resilience in a fast-changing environment
How the interaction between advanced technologies and human talent will redefine processes and productivity in the next decade
Ensuring long-term sustainability by focusing on employee well-being, skill development, and leadership empowerment

10:25am - 11:15am

Pre-Arranged One-to-One Meetings

10:30 am – 10:50am: Meeting Slot 8/Networking
10:55am – 11:15am: Meeting Slot 9/Networking

11:20am - 11:55am

Why Your Digital Strategy May Be Incomplete: How Legacy Models Prevent End-To-End Digital Manufacturing

Session Details

Why pharma organizations must diversify their digitization strategy, looking beyond legacy models that prevent complete, end-to-end digital manufacturing
How a light, configurable MES can remove paper from production entirely and enable any-sized pharma company to fully utilize their MES across all lines and sites
How a modern MES can digitally connect different data sources to close offline data gaps, improve data integrity and visibility, and unlock critical business intelligence

11:20am - 11:55am

The CDMO of the Future

Executive to be Announced

INCOG BioPharma Services, Inc.

Session Details

Learn how a CDMO can be a Customer-Driven Manufacturing Organization
How CDMOs can use digital infrastructure to make the experience from technology transfer all the way through lifecycle management more customer-focused
How CDMOs can partner to integrate the supply chain to simplify processes and increase reliability
How strategic investments by customers with CDMOs can create value for both customer and CDMO

11:20am - 11:55am

The Value of a Unified Life Sciences Solution in Pharma 4.0

Session Details

Manage the production process and quality in real time from order to batch release in one browser-based user interface visualizing real-time and historical data
Streamline collaboration between manufacturing and quality people and processes to maximize throughput and accelerate batch release
Digitize all direct batch execution (EBR) and execution related activities (Logbooks and Digital Procedures) to eliminate paper or unstructured electronic records where data is trapped
Take advantage of configurable functionality
Analyze and report on operational data in one place for a single source of the truth
Achieve measurable results in cost reduction, risk mitigation, and revenue opportunities

12:00pm - 12:35pm

Transforming Global Operations: Accelerating Production and Innovation at Bristol Myers Squibb

Catalina Vargas

Senior Vice President, Global Supply Chain

Bristol Myers Squibb

Session Details

Overview of leading one of the world’s largest manufacturing operations through rapid transformation while integrating cutting edge technology
How GPS delivers value to the enterprise through the Product Development and R&D interface
The integration of Cell Therapy into GPS and how the company is working to improve predictability long-term
Establishing a competitive advantage for BMS from within GPS – an operational model built to last
Examples of GPS’s evolution to support the New Product Pipeline

12:00pm - 12:35pm

Building a Leading Quality Management Framework

Allyson Nicholson

Vice President Global Supply Chain

BioMarin

Session Details

Recognizing the pivotal role of quality assurance and quality control in driving key business objectives, ensuring they are strategically aligned
Upholding adherence to cGMPs, established policies, procedures, and industry standards to maintain regulatory compliance
Investing in personnel capabilities and knowledge to strengthen the effectiveness of the quality management system
Ensuring the efficiency and efficacy of global quality management systems across varied operational landscapes
Deploying advanced tools and techniques to enhance quality assurance and control practices

12:00pm - 12:35pm

How to Enable the Digital Pharmaceutical Supply Chain of the Future Now

Paul Testa

Executive Vice President Supply Chain & Operations

Kyowa Kirin

Session Details

Exploring how advanced data analytics and real-time monitoring can improve supply chain visibility, forecasting, and decision-making
Utilizing digital twin technology to create virtual models of supply chains for better simulation, optimization, and real-time problem-solving
Adopting digital tools to streamline compliance with regulatory requirements, ensuring product quality, safety, and adherence to evolving industry standards
The role of AI and machine learning in predictive maintenance, inventory management, and risk mitigation across the pharmaceutical supply chain

12:35pm - 1:35pm

Executive Lunch Seating

12:35pm - 1:35pm

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.

Realtime Manufacturing While Stabilizing the Workforce

Culture Transformation: from Compliance to Performance

Pharma 4.0: Unlocking Rapid Tech Transfer

1:35pm - 2:10pm

Advancing Quality Standards: A Strategic Approach

Magaly Aham

Senior Vice President, Head Global Quality Compliance & Systems

Takeda

Session Details

Developing a forward-thinking strategy that emphasizes problem-solving, regular self-evaluations, and adherence to regulatory standards to ensure smooth production
Encouraging a mindset of ongoing improvement and accountability, with an emphasis on continuous learning and process refinement
Harnessing cutting-edge digital solutions to refine workflows, streamline quality management systems, and boost operational excellence
Utilizing risk assessment techniques to pinpoint and address potential challenges early, ensuring key processes remain compliant and secure

2:15pm - 2:50pm

Panel: Reflecting on the Past and Shaping the Future: Enhancing Our Influence on Medicine

Session Details

Examining the changes within the CMC ecosystem and assessing whether we are once again overextending our capacity.
Addressing the risks of fragmentation: How can we improve communication, collaboration, and the consolidation of our best ideas to ensure collective success?
Discussing the motivations for launching new companies today and envisioning the future growth and evolution of our business ecosystem.
Evaluating which production platforms will be most effective for emerging modalities.
Considering the next steps for established platforms like mAbs, ADCs, and mRNA: How can we efficiently address significant markets, such as treatments for Alzheimer’s

2:50pm - 3:00pm

Chair’s Closing Remarks

Charles L. Cooney

Robert T. Haslam Professor of Chemical Engineering, Emeritus, and Faculty Director, Emeritus Deshpande Center for Technological Innovation

MIT

2025 Agenda

Welcome Day Panel: Planning for Pharmaceutical Manufacturing of the Future: What are the Five Big Things We Need to Talk About?

Charles L. Cooney

Opening Remarks and Important Announcements

Chair’s Welcome Address

Charles L. Cooney

Driving Innovation and Operational Excellence: AstraZeneca’s Approach to Digital Transformation

Pam Cheng

Transformation in Quality to Meet the Needs of Our Customers

Melissa Seymour

Technical Operations Strategies for Transformative Medicines

Executive to be Announced

Data Doesn’t Lie – Digital Marketing ROI

Executive to be Announced

From “Impossible” to Commercialization

Executive to be Announced

Accelerating Innovation and Manufacturing Excellence: Leveraging Over 30 Years of Biotech Leadership and Cell Therapy Success

Joanne Beck

Proactive Quality Management for the Future

Steve Johnson

Supply Chain Revolution: Prioritizing Patients in Pharmaceutical Logistics

Erica Olson

Executive Lunch Seating

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 Practices for Integrated Business Planning in Pharma: Leveraging Connected Planning to Drive Growth

Industry Trends, Challenges, and Opportunities in Process and Technology Platforms for the Commercialization of Gene Therapy Products

Supply Chain Revolution: Prioritizing Patients in Pharmaceutical Logistics

Sanofi’s Manufacturing Transformation: Bringing Scientific Innovation to Patients

Brendan O’Callaghan

Supply Chain Digital Transformation with Business Impacts for Pharmaceutical Manufacturers

What Traits Should Biopharma Companies Look for When Partnering with Drug Substance CDMOs?

Executive to be Announced

Global Talent Trends in Pharma and Biotech Technical Operations: A Perfect Storm

Regulatory Update: Advanced Manufacturing and Complex Biologic Products

Ingrid Markovic

Innovations in Personalized Medicine Manufacturing: A Glimpse into the Future

Nicole Murphy

Chair’s Closing Remarks

Charles L. Cooney

Pioneering Manufacturing Automation Innovation with AI

Chair’s Opening Remarks

Charles L. Cooney

The Things We Can Achieve and Our Shared Journey Along the Way

Arleen Paulino

Pushing Boundaries: The Future of Pharmaceutical Manufacturing and Innovation at Moderna

Jerh Collins

Advancing Gene Therapy Manufacturing: Technical Excellence and Innovation at Sarepta Therapeutics

Bilal Arif

Bold and Unafraid: Lessons in Leadership and the Value of Manufacturing in Building the Next Great Biotech

Timothy Maines

Shaping the Future: Leading a Culture of Collaboration and Growth

Chris Stevens

Why Your Digital Strategy May Be Incomplete: How Legacy Models Prevent End-To-End Digital Manufacturing

The CDMO of the Future

Executive to be Announced

The Value of a Unified Life Sciences Solution in Pharma 4.0

Transforming Global Operations: Accelerating Production and Innovation at Bristol Myers Squibb

Catalina Vargas

Building a Leading Quality Management Framework

Allyson Nicholson

How to Enable the Digital Pharmaceutical Supply Chain of the Future Now

Paul Testa

Executive Lunch Seating

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.

Realtime Manufacturing While Stabilizing the Workforce

Culture Transformation: from Compliance to Performance

Pharma 4.0: Unlocking Rapid Tech Transfer

Advancing Quality Standards: A Strategic Approach

Magaly Aham

Panel: Reflecting on the Past and Shaping the Future: Enhancing Our Influence on Medicine

Chair’s Closing Remarks

Charles L. Cooney

Sessions From Previous Years

Download The Agenda PDF

Summit Floorplan

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