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2026 Agenda

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May 18th

4:30 pm

Registration

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

Panel: Planning for Pharma Manufacturing of the Future: The Five Big Questions

Moderator

Joanne Beck

Chief Operating Officer

Elektrofi

Kanti Thirumoorthy

Vice President, Cell Therapy Development and Operations

AstraZeneca

Jason Martin

SVP, Head of Technical Operations

Elektrofi

Jens Vogel

SVP & Head of Global Biologics Operating Unit

Merck

Session Details Arrow Icon

  • Production & Operations: What are the key challenges affecting production speed, scalability, and operational efficiency today?

  • Workforce & Talent: With billions invested in U.S. manufacturing, how is the workforce evolving, and what strategies ensure facilities are properly staffed with trained talent?

  • Technology & Innovation: Which cutting-edge technologies are having the greatest impact on modern pharmaceutical manufacturing?

  • Regulatory Landscape: What recent regulatory advancements have been made, and how can approvals be further streamlined?

  • Global Access: How can the industry enhance access to innovative medicines across global markets while balancing speed, quality, and compliance?

6:00 pm - 7:00 pm

Drinks Reception

May 19th

7:30 am - 8:15 am

registration & breakfast

8:15 am - 8:30 am

Opening Remarks, Important Announcements & Chair’s Welcome Address

Joanne Beck

Chief Operating Officer

Elektrofi

8:30 am - 9:05 am KEYNOTE

Operational Excellence: From Continuous Improvement to Continuous Innovation

Matt Schwartz

SVP Global Manufacturing Operations

Bristol Myers Squibb

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  • Exploring how to evolve traditional continuous improvement into a culture of ongoing innovation
  • Discussing tools and methodologies that enable rapid identification and implementation of process enhancements
  • Highlighting how operational excellence drives both efficiency and breakthrough performance
9:10 am - 9:45 am Case Studies
Stream One - Strategic Manufacturing

Future-Ready CMC: From Lab Concept to Continuous, Sustainable Manufacture

Kripa Ram

Senior VP, Global Head of CMC Development

Sanofi

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  • Transitioning from batch to continuous manufacturing

  • Connecting development to scalable, real-world production

  • Driving efficiency and sustainability in CMC operations

Stream Two - Quality

Integrating GMP and GCP in a Converging Compliance Environment

Anthony Mire-Sluis

Senior Vice President, Global Quality

Gilead Sciences

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  • Examining the evolving regulatory landscape where Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) intersect
  • Addressing challenges in aligning manufacturing and clinical trial operations to ensure compliance and data integrity
  • Highlighting strategies for harmonizing quality systems and workflows across clinical and commercial stages
Stream Three - Supply Chain & Innovation

Direct-to-Patient Supply Chain Models: Operational and Regulatory Implications

Jim Fox

SVP, Americas Supply Operations

AstraZeneca

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  • Exploring the operational shifts required to support direct-to-patient distribution channels in pharma
  • Evaluating regulatory challenges and compliance considerations unique to patient-centric supply models
  • Discussing how data transparency and cold chain management impact patient safety and product integrity
9:50 am - 10:25 am Workshops
Stream One

Navigating Early-Phase Manufacturing with CDMO Partnerships

Executive to be Announced

Project Farma

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  • Demonstrating how CDMOs accelerate early development through streamlined tech transfer, rapid scale-up, and regulatory expertise
  • Outlining collaboration models that reduce risk and improve speed-to-clinic for emerging programs
  • Showcasing how early-phase partnerships lay the foundation for seamless late-stage and commercial success
Stream Two

Managing Quality in Rapid-Scale Launch Environments

Executive to be Announced

MasterControl

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  • Illustrating how to maintain rigorous quality standards while rapidly scaling production for accelerated launches
  • Highlighting systems and expertise that enable speed without compromising compliance or product integrity
  • Sharing partnership models that help pharma companies navigate scale-up challenges with confidence
Stream Three

Harnessing PAT Tools to Enable Real-Time Release Testing in CDMO Operations

Executive to be Announced

Scale Ready LLC

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  • Showcasing how to leverage Process Analytical Technology (PAT) to accelerate product release and reduce cycle times
  • Demonstrating the role of real-time data and automation in enhancing quality and regulatory confidence
  • Highlighting case studies where PAT-driven strategies improved flexibility and responsiveness for pharma partners
10:30 am - 12:10 pm Pre-Arranged One-To-One Meetings Arrow Icon

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
12:15 pm - 12:50 pm Case Studies
Stream One - Strategic Manufacturing

Scaling Continuous Manufacturing for Small-Molecule APIs

Marian Gindy

Vice President, Small Molecule Science and Technology

Merck

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  • Analyzing best practices for transitioning from batch to continuous manufacturing at commercial scale
  • Exploring technical and regulatory considerations unique to small-molecule API production
  • Demonstrating how continuous processes improve efficiency, quality, and supply chain agility
Stream Two - Quality

Redefining Quality in an Era of Rapid Innovation

Executive to be Announced

Johnson & Johnson Innovative Medicine

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  • Examining how quality frameworks are adapting to support fast-paced product development and emerging therapies
  • Evaluating risk-based strategies and real-time data integration to uphold compliance while fostering innovation
  • Emphasizing the need for collaborative approaches that align speed, quality, and regulatory demands across teams
Stream Three - Supply Chain & Innovation

Advancing In Vivo CAR-T Therapeutics: Clinical Progress and Manufacturing Challenges

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  • Latest developments in in vivo CAR-T therapies and pipeline highlights.
  • Key scientific, regulatory, and manufacturing hurdles for commercialization.
  • Strategies for scaling production while maintaining safety and efficacy.
  • Emerging collaborations between biotech and pharma to accelerate development.
12:50 pm - 1:50 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 Global Regulatory Divergence: How to Stay Compliant Without Slowing Down

Yolanda McClean

Senior Director, Quality Strategy & Operations

Alnylam

Best Practices for Scaling Emerging Modalities (Cell, Gene, mRNA) in Commercial Settings

Julie Ennis

Vice President, Technical Operations Science & Innovation

AstraZeneca

Tackling Talent Shortages: Attracting and Retaining the Next Generation of Operators and Engineers

Regis Gautier

Executive Director, Product Development & Sustainability Lead

AstraZeneca

Lessons Learned from Accelerated Launch Timelines

Frank Montgomery

Vice President, CMC Regulatory Affairs

AstraZeneca

Breaking Down Silos: Improving Collaboration Between Manufacturing, Quality, and Supply Teams

Kevin Kerls

Executive Site Director

Lonza

The True ROI of Digital Transformation Initiatives — What’s Worth the Investment?

Brendan Walker

Sr. Director, DS Network Smart Factory Lead

Moderna

Embedding Sustainability into Supply Chain and Plant Strategy Without Sacrificing Speed

James Flacke

Senior Director, Biotech Production

Regeneron

Designing Flexible Facilities: Is Modular Really the Future?

Heather Schmidt

Associate Vice President, Industrial Franchise Leader, Rare Disease

Sanofi

1:55 pm - 2:30 pm KEYNOTE

The Resilient Supply Chain: Lessons in Agility

Session Details Arrow Icon
  • Reflecting on recent disruptions and how agility has become a critical success factor in supply chain resilience
  • Identifying key strategies that enable rapid response to market volatility and global uncertainties
  • Highlighting the role of collaboration, diversification, and risk management in building adaptable supply networks
2:25 pm - 3:00 pm Workshops
Stream One

Managing Complexity: High-Mix, Low-Volume Manufacturing at Commercial Scale

Executive to be Announced

Honeywell Life Sciences

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  • Showcasing how CDMOs optimize processes and capacity to handle diverse product portfolios efficiently
  • Highlighting digital tools, flexible facilities, and expertise that enable cost-effective, compliant operations
  • Demonstrating how strategic partnerships help pharma companies meet niche and orphan product demands at scale
Stream Two

Quality Agreements in a Digital World: Standardization and Automation

Executive to be Announced

Boehringer Ingelheim

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  • Demonstrating how CDMOs use digital platforms to streamline quality agreements and ensure compliance at scale
  • Exploring standardization practices that reduce negotiation time and improve operational transparency
  • Showcasing how automation drives efficiency and strengthens trust between CDMOs and pharma partners
Stream Three

Balancing Speed, Quality, and Cost in Global Manufacturing Networks

Executive to be Announced

Boston Institute of Biotechnology, LLC

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  • Addressing how leaders are meeting aggressive launch timelines without ballooning cost structures
  • Exploring strategies for optimizing capacity, labor, and sourcing decisions globally
  • Highlighting where partnerships add leverage without eroding margins
3:05 pm - 4:15 pm Pre-Arranged One-To-One Meetings Arrow Icon

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.

  • 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 KEYNOTE

Leading Through Change: Organizational Agility in a Rapidly Evolving Pharma Landscape

Executive to be Announced

Amgen

4:55 pm - 5:05 pm

Chair’s Closing Remarks

Joanne Beck

Chief Operating Officer

Elektrofi

5:10 pm

Drinks Reception

5:40 pm

Executive dinner

(By Invite Only)

May 20th

7:30 am - 8:45 am

registration & breakfast

8:00 am - 8:35 am breakfast workshops
Stream Two

From Validation Bottleneck to Velocity: Leveraging Digital Twins for GxP-Compliant Equipment Commissioning and Lifecycle Management

Executive to be Announced

Körber Pharma Software

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  • Highlighting how Digital Twins accelerate GxP equipment commissioning and validation time.
  • Discussing how to drive faster facility readiness and speed-to-market without compromising regulatory compliance.
  • Looking at ensuring lifecycle compliance and establishing a dynamic, single source of truth for ongoing change management and operational excellence.
8:45 am - 8:55 am

Chair’s Opening Remarks

Vikki Sluzky

Chief Technology Officer

Elektrofi

9:00 am - 9:35 am KEYNOTE

From Expansion to Excellence: Leveraging Advanced Technologies in Global Operations

Eamonn Warren

Group Vice President, Global API & Dry Products Manufacturing

Eli Lilly

Session Details Arrow Icon

  • Exploring how Lilly’s rapid capacity expansion balances growth, reliability, and operational excellence across global manufacturing networks

  • Identifying advanced technologies, including large-scale single-use systems and digital tools, that drive modernization and efficiency

  • Highlighting real-world examples of integrating innovation, quality, and compliance to build resilient, future-ready production capabilities

9:40 am - 10:15 am Case Studies
Stream One - Strategic Manufacturing

Manufacturing for the Patient: Delivering Speed, Safety, and Accessibility

Thomas Potgieter

Senior Vice President of Cell Therapy Development and Operations

Bristol Myers Squibb

Session Details Arrow Icon
  • Focusing on strategies to accelerate time-to-market without compromising product quality and safety
  • Discussing approaches to ensure manufacturing processes prioritize patient access and equitable distribution
  • Exploring how patient-centric manufacturing drives innovation in packaging, dosing, and delivery methods
Stream Two - Quality

Bridging the Gap: Practical Insights for Effective Quality Collaboration

Robin Kumoluyi

Global Vice President, Quality, Regulatory and EH&S

Thermo Fisher Scientific

Session Details Arrow Icon

  • Why many quality agreements fail in practice — and how to make them effective.

  • Moving beyond compliance to true end-to-end collaboration.

Stream Three - Supply Chain & Innovation

Purpose-Driven Science: Connecting the Patient Experience to Next-Generation Biologics

Yatin Gokarn

SVP, Head of Product Development & Clinical Supply

Alexion Pharmaceuticals

Session Details Arrow Icon
  • Embedding patient perspective into biologics innovation—from design to delivery

  • Aligning scientific excellence with human impact to drive the next wave of transformative therapies

10:20 am - 11:15 am Pre-Arranged One-To-One Meetings Arrow Icon

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.

  • 10:25 am – 10:45 am: Meeting Slot 8/Networking
  • 10:50 am – 11:10 am: Meeting Slot 9/Networking
11:20 am - 11:55 am Workshops
Stream One

From Innovator to Industry Impact: Accelerating Technology Development in Biomanufacturing

Session Details Arrow Icon

  • Looking at the benefits of prioritizing R&D to develop GMP-ready technologies for biologics and cell & gene therapies.

  • Strategies to adopt advanced, cost-intensive equipment and processes.

  • Discussing opportunities to improve collaboration, data sharing, and process standardization across the industry.

  • Driving faster, more cost-efficient development through innovation and strategic investment.

Stream Two

Building Robust Quality Systems and Avoiding CMC Pitfalls

Session Details Arrow Icon
  • A look into the approach to establish commercial-ready quality systems
  • Lessons learned from common CMC pitfalls and how they were addressed.
  • Insights on fostering a quality-driven culture across teams and sites.
  • Practical takeaways on strengthening quality practices.
Stream Three

Advanced Therapy Production: Keys to GMP-GCP Alignment & CDMO Partnerships

Session Details Arrow Icon
  • Exploring how CDMOs help emerging therapies navigate the intersection of GMP manufacturing and GCP clinical requirements
  • Highlighting best practices to ensure seamless handoffs between manufacturing and clinical operations
  • Showcasing partnership models that accelerate timelines while ensuring regulatory and quality alignment
12:00 pm - 12:35 pm PANEL

Charting the Course - Past Progress and Future Potential in Pharma

Moderator

Vikki Sluzky

Chief Technology Officer

Elektrofi

Elizabeth Hewitt

VP, Head of Pharmaceutical Sciences Program Leadership

Takeda

Session Details Arrow Icon
  • Reflecting on key milestones that are shaping the modern pharmaceutical industry
  • Assessing the evolving role of pharma manufacturing leaders in a complex global environment
  • Identifying critical capabilities needed to sustain growth and resilience
  • Discussing lessons learned over the past year
  • Outlining priorities for future-proofing pharma manufacturing through agility, alignment, and innovation
12:35 pm - 12:45 pm

Chair’s Closing Address

Vikki Sluzky

Chief Technology Officer

Elektrofi

12:45 pm - 1:45 pm

Executive Lunch Seating

Sessions From Previous Years

Transforming Global Operations: Accelerating Production and Innovation at BMS

Transforming Global Operations: Accelerating Production and Innovation at BMS

Jun 2, 2025
Managing Pharma Supply Chains to Navigate Tariffs

Managing Pharma Supply Chains to Navigate Tariffs

Jun 2, 2025
Using Innovation to Accelerate & Optimize Your Drug Manufacturing Scale-Up Strategy

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

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

Panel: Technical Operations Challenges: Manufacturing in Shifting Market Conditions

May 29, 2025
Regulatory Instability's Impact on Drug and Biologics Manufacturing

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

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

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

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

Transformation in Quality to Meet the Needs of Our Customers

May 29, 2025
Supporting AZ's Bold Ambition: Scaling Advanced Therapies for Success

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

May 29, 2025
Resilient Operations in a Changing World: Innovation with Purpose

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

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

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

Maximizing Quality and Compliance: A Strategic Approach for Pharmaceutical Manufacturing

May 30, 2024
The CDMO of the Future

The CDMO of the Future

May 20, 2024
Real-Time Release, a Distant Dream or Reality?

Real-Time Release, a Distant Dream or Reality?

May 20, 2024
Fireside Chat: Navigating Technological Advancements, Global Operations, and Supply Chain Innovation

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

May 20, 2024
Sanofi Manufacturing Transformation: Turning Science into Reality for Patients

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

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

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

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

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

May 16, 2024
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