2025 Agenda

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May 20th

4:30 pm

Registration

5:00 pm - 6:00 pm WELCOME DAY SPECIAL CONTENT

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

Vaishali Shukla

Vice President CGT & API Global Expansion

Eli Lilly

Dorothy Barr

Senior Vice President Manufacturing & Technical Operations

Lantheus

Vijay Raju

VP CMC

Pioneering Medicines / Flagship Pioneering

Christine Goldschneider

Head of Alliances, Manufacturing & Supply - Specialty Care

Sanofi

Moderator

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?

May 21st

Stream 1 Chair

Charles L. Cooney

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

MIT

Stream 2 Co-Chair

Neil Fausz

Managing Director

Accenture

Stream 3 Co-Chair

Austin Caudle

Project Farma

7:30 am - 8:15 am

registration & breakfast

Breakfast Brought To You By

8:15 am - 8:30 am

Opening Remarks, Important Announcements & 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

8:30 am - 9:05 am KEYNOTE

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

9:05 am - 9:40 am KEYNOTE

Supporting AZ's Bold Ambition: Scaling Advanced Therapies for Success

Sheena Behn

Vice President Vaccine & Immune Therapies Supply Chain & Vice President for Oncology Supply

AstraZeneca

Session Details

AstraZeneca’s bold ambition to deliver 20 new medicines by the close of the decade
How AstraZeneca is adopting innovative manufacturing strategies to harness the potential of advanced therapies and modalities
Exploring the unique challenges and opportunities of new modalities while meeting the growing demand for targeted therapies
The role of smart factories and flexible, modular and continuous manufacturing processes in accelerating and scaling supply
AstraZeneca’s commitment to reducing its environmental impact through sustainable practices and energy-efficient operation

9:45 am - 10:20 am Workshops

Stream One

Panel: Technical Operations Challenges: Manufacturing in Shifting Market Conditions

Jacob Greenwood

Vice President

Project Farma

Scott Hamm

VP, Strategic Operations

Project Farma

Dottie Barr

Senior Vice President Manufacturing & Technical Operations

Lantheus

Lindsey Daniel

Head of Global Operational Excellence for Takeda’s Biologics Operating Unit

Takeda

Session Details

Current trends and considerations across cGMP manufacturing
Optimizing production while navigating uncertain supply chain variables
Short-term and long-term planning for effective Technical Operations

Stream Two

Maximizing Return on Automation – Benchmarking Digitization ROI

Katherine Farley

Vice President of Product

MasterControl, Inc.

Session Details

The Value of Digitization in Manufacturing – Automating manual tasks in manufacturing significantly reduces errors, improves efficiency, and accelerates production processes. Digital execution eliminates GDP (Good Documentation Practice) errors, reduces review and release time, and allows operators to focus on value-added tasks
Compounding Impact of Automation – The benefits of automation are cumulative, similar to compound interest. Transitioning from paper-based processes to digital systems can eliminate or automate up to 81% of manual data entries, leading to faster decision-making, fewer errors, and continuous process improvement

Stream Three

Power of Partnership in Advancing Innovation

Dr. Michael Kraich

Head of Global Project & Product Management BioXcellence

Boehringer Ingelheim Biopharmaceuticals GmbH

Venkatesh Srinivasan

Chief Technical Operations Officer

Sutro Biopharma, Inc.

Session Details

Boehringer Ingelheim BioXcellence™ and Sutro Biopharma demonstrate how a purposeful collaboration and partnership through contract manufacturing can expedite the delivery of innovative medicines and enable a new platform for biologics manufacturing
Learn how upscaling of the production process leveraged Boehringer’s expertise in biopharmaceuticals’ development and manufacturing with existing infrastructure for cell-based operations
Find out how Sutro’s novel proprietary cell-free expression platform has been successfully implemented on a commercial scale
The session will include dual viewpoints from both CMO and partner and will underscore the transformative power of collaboration and innovation in the biopharmaceutical industry

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

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

12:10 pm - 12:45 pm Case Studies

Stream One - Strategic Manufacturing

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

Joanne Beck

Former 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

Stream Two - Quality

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

Stream Three - Supply Chain & Innovation

Fireside Chat: Advanced Scenario Planning

Judy Yeh

Vice President, Global Clinical 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

12:45 pm - 1:45 pm

General 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.

Product Stewardship Best Practices that Drive Performance and Improve Patient Outcomes in the Age of New Modalities

Vinod Bulusu

Executive Director, Biologics Product Leadership

AstraZeneca

Strategies for Rapidly Building a Manufacturing Network for New Modalities and New Capabilities

Cliff Carroll

Executive Director, New Modalities and Platform Technology, Global Technical Operations

AstraZeneca

Scaling Digital: Overcoming Common Transformation Hurdles

Rohan Mehta

GPS Digital Transformation Lead

Bristol Myers Squibb

Best Practices in Pharmaceutical Quality Systems – Clinical vs. Commercial and the Lifecycle Approach

Jennifer Martinez

Director of Business Strategy and Operations

Gilead

Small Molecule Process Optimization: What Can We Learn from Other Industries' Cultures of Continuous Improvement?

Cedric Dubois

AVP Small Molecule Manufacturing

Merck

Think Fast: How Modular Construction is Revolutionizing Speed to Market for cGMP Manufacturers

David Frank

Chief Commercial Officer

Modular Devices Cleanrooms

AI-Enabled Biopharma Operations: Innovation vs. Compliance in Complex Regulated Industries

Rohit Harve

Partner

PA Consulting

Abhi Naravane

Partner

PA Consulting

Project Artemis: Pre-Competitive Industry Collaboration to Build a Sustainable Digital Ecosystem for CMC

Vijay Raju

VP CMC

Pioneering Medicines / Flagship Pioneering

Resilient and Efficient: Future-Proofing Pharma Infrastructure

Ian Larson

SVP Solutions

Redaptive

From Smart Factory to Smart Network: Reaching Best in Class Performance via Digital Capabilities and AI at Scale

Inna Ben-Anat

AVP, Global Head Connected Smart Factories, Manufacturing & Supply

Sanofi

1:45 pm - 2:20 pm KEYNOTE

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.

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

2:25 pm - 3:00 pm Workshops

Stream One

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

Joe Goodman

GM Americas

Honeywell Life Sciences

Session Details

As the number of drug approvals increases year on year, in parallel with the market share of large molecules, we will discuss how drug manufacturers can now start their journey to achieving:

Faster scale-up & transfer from development to manufacturing
Faster batch release with reduction in cycle time through review by exception
Proactive quality response with reduction in defects per million opportunities
Quality By Design through continuous process verification, process characterization & ultimate achievement of ‘golden batch’ conditions

Stream Two

CDMO/Biopharma Parnerships: What [Additional] Traits Biopharma Companies Should Look for When Partnering with Drug Substance CDMOs

Arul Ramadurai

Chief Commercial Officer

Axplora

Jin Seok Hur

Director, ADC Platform Management

Axplora

Session Details

Contract manufacturing is becoming increasingly critical in the development of new and innovative therapeutics. As such, ensuring that the right CDMO is selected to work with is of the utmost importance
Working with a CDMO should not be transactional; it should be a partnership
Due diligence from both sides should be done to determine project and partnership fit. This not only involves technical expertise, but goal alignment and prioritization and a commitment to service, efficiency, & quality
A presentation of case studies will also be used to highlight what a true Biopharma/CDMO partnership looks like.

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

3:05pm – 3:25pm: 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 KEYNOTE

Managing Pharma Supply Chains to Navigate Tariffs

Allyson Nicholson

Vice President Global Supply Chain

BioMarin

Session Details

Frontline insights: a real-world perspective on building a resilient supply chain amid unprecedented tariff and geopolitical challenges in 2025
Trapped by global dependencies: lessons from an industry heavily reliant on globally concentrated products and trade between geopolitically distant economies
Redemption approaches explained: leveraging Digital Twins for scenario planning, embracing cooperation with partners to shift production locations and end markets, enhancing flexibility to reallocate orders globally, and embedding supply chain resilience through product design
Recent breaking news & the road ahead: forward-looking strategies to navigate the evolving supply chain challenges

4:55 pm - 5:30 pm KEYNOTE

Transforming Global Operations: Accelerating Production and Innovation at BMS

Catalina Vargas

Senior Vice President, Global Supply Chain

Bristol Myers Squibb

Session Details

Overview of leading a global supply chain through rapid transformation while integrating cutting-edge technology
Building a command center using analytics-driven decision engine to provide actionable insights
Making informed strategic network and supply decisions across the enterprise
Establishing Global Product Development and Supply organization as a competitive advantage

5:30 pm - 5:35 pm

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

5:35 pm

Drinks Reception

6:05 pm

Executive Dinner

(By Invite Only)

May 22nd

Stream 1 Chair

Charles L. Cooney

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

MIT

Stream 2 Co-Chair

Neil Fausz

Managing Director

Accenture

7:30 am - 8:20 am

registration & breakfast

Breakfast Brought To You By

8:25 am - 8:35 am

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

8:35 am - 9:10 am KEYNOTE

Resilient Operations in a Changing World: Innovation with Purpose

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

9:10 am - 9:45 am KEYNOTE

From Platform Excellence to Personalized Oncology: Shaping the Next Era of mRNA Science and Manufacturing 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

9:50 am - 10:25 am Case Studies

Stream One - Strategic Manufacturing

Are We There Yet? – A Maturity Model for Enabling Process Monitoring and Learning in Biologics Manufacturing

Jack Prior

Head of Process Monitoring & Data Science/AI Strategy

Sanofi

Session Details

Discover why biopharma organizations use as little as 1% of their process data despite increased digitization, and how a structured 6×6 assessment can quantify as-is state
Learn how to balance competing data priorities with a scoring system that aligns objectives across Quality, Digital, Manufacturing, and MSAT teams
Explore how a process monitoring maturity model can drive AI-ready data foundations that enable organizations to understand and reduce process variability

Stream Two - Quality

AI as an Enabler for a Sustainable Quality Transformation

Magaly Aham

Senior Vice President, Head Global Quality Compliance & Systems

Takeda

Session Details

Global Quality Takeda is reimagining their quality commitments across the value chain. By harnessing data, digital, and emerging technologies like AI, they aim to accelerate product delivery, foster a culture of learning and innovation, and ensure environmental sustainability. They are simplifying, standardizing, and digitalizing quality processes with increased automation and AI, demonstrated through case studies such as one-day batch release, investigation reports, and APQRs. These examples highlight how AI can enable sustainable quality transformation.

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

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

11:20 am - 11:55 am Workshops

Stream One

Building Audit-Ready Facilities: Quality Leadership from Design to Commercial Launch

LeeAnn Chrisco

Director of Quality Assurance

INCOG BioPharma Services, Inc.

Session Details

Learn how to integrate audit readiness into facility design and startup activities
Understand critical quality system elements that support regulatory success
Explore leadership strategies for cross-functional alignment and compliance culture
Review case studies from greenfield and clinical facility launches

Stream Two

Overcoming the Challenges of a Global Next Gen CPV Program at BMS

Vishal Prasad

Co-Founder and CPO

Mareana

Ganesh Subramanian

Director of CPV

BMS

Session Details

CPV challenges at BMS
The solution provided by Mareana
The business outcome

12:00 pm - 12:35 pm KEYNOTE

Regulatory Instability's Impact on Drug and Biologics Manufacturing

Alexander Gaffney

Vice President, Regulatory Policy and Intelligence

POLITICO / AgencyIQ

12:35 pm - 1:35 pm

General 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.

Balancing the Promise of Data-Driven Operations With the Reality of Regulatory Compliance and Data Integrity

Linda Lai

Associate Vice President

Amgen

Sharing What Works to Optimize Costs and Productivity in Manufacturing Operations

Regis Gautier

Executive Director, Technical Operations

AstraZeneca

End-to-End Integrated Control Strategy for Biologics Products: Ensuring Quality, Supply Stabilization, and Robustness

Uday Aich

Director, Analytical Sciences and CMC Strategy

Bristol Myers Squibb

Fit-for-Purpose Assays: Are We Keeping Pace with Gene Therapy Innovation?

Vaishali Shukla

Vice President CGT & API Global Expansion

Eli Lilly

Navigating the Challenges in AAV Process Development and Manufacturing

Ganesh Krishnamoorthy

Director of Downstream Process Development

Forge Biologics

Strategic Supplier Partnerships: Aligning Business & Quality Goals

Sunny Patel

Director, Global Supplier Quality Management

Gilead

Overcoming Challenges with Accelerating Technology Transfer to get Capacity Online

Thomas Hilfer

Associate Director MSAT

Lonza

Seamless Execution: Harnessing the Synergy Between Project Management and Quality

Celia Baula

Executive Director, R&D Operations and Quality

Neuraly

1:35 pm - 2:20 pm PANEL

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

MODERATOR

Charles L. Cooney

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

MIT

Vinod Bulusu

Executive Director, Biologics Product Leadership

AstraZeneca

Steven Wesel

Director Upstream Process Development

Forge Biologics

Jack Prior

Head of Process Monitoring & Data Science/AI Strategy

Sanofi

Session Details

Evaluating which production platforms will be most effective for emerging modalities, such as rAAV gene therapies
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
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

2:20 pm - 2:30 pm

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

Sessions From Previous Years

Transforming Global Operations: Accelerating Production and Innovation at BMS

Jun 2, 2025

Managing Pharma Supply Chains to Navigate Tariffs

Jun 2, 2025

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

May 29, 2025

Are We There Yet? – A Maturity Model for Enabling Process Monitoring and Learning in Biologics Manufacturing

May 29, 2025

Panel: Technical Operations Challenges: Manufacturing in Shifting Market Conditions

May 29, 2025

Regulatory Instability's Impact on Drug and Biologics Manufacturing

May 29, 2025

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

May 29, 2025

From Platform Excellence to Personalized Oncology: Shaping the Next Era of mRNA Science and Manufacturing at Moderna

May 29, 2025

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

May 29, 2025

Transformation in Quality to Meet the Needs of Our Customers

May 29, 2025

Supporting AZ's Bold Ambition: Scaling Advanced Therapies for Success

May 29, 2025

Resilient Operations in a Changing World: Innovation with Purpose

May 29, 2025

Fireside Chat: Accelerating Innovation and Manufacturing Excellence: Leveraging Over 30 Years of Biotech Leadership

May 29, 2025

Panel: Looking Backwards, Looking Forwards: Maximizing Our Impact on the Future of Medicine

May 31, 2024

Maximizing Quality and Compliance: A Strategic Approach for Pharmaceutical Manufacturing

May 30, 2024

The CDMO of the Future

May 20, 2024

Real-Time Release, a Distant Dream or Reality?

May 20, 2024

Fireside Chat: Navigating Technological Advancements, Global Operations, and Supply Chain Innovation

May 20, 2024

Sanofi Manufacturing Transformation: Turning Science into Reality for Patients

May 17, 2024

Becoming a “Best in Class” Supply Chain Network to Deliver More Medicines to More Patients, Faster

May 17, 2024

Manufacturing as a Strategic Enabler for Serial Innovation

May 16, 2024

Accelerate Your Bench to Production Timeline by Collocating Research with Process Development and Pilot Scale Production

May 16, 2024

Panel: Optimizing Technical Operations: Best Practices for Manufacturing Next-Gen Medicines

May 16, 2024