May 18th

3:30 pm

Registration

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

Panel: Delivering Tomorrow's Medicines Today: Real-World Lessons from Pharma Leaders

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  • Navigating Change: How are organizations managing the transition from legacy processes to the next generation of manufacturing technologies?
  • Cross-Functional Collaboration: How are leaders aligning Manufacturing, Quality, and Supply Chain to ensure seamless execution and faster speed-to-patient?
  • Managing Risk & Resilience: What practical lessons have been learned from navigating recent global disruptions, and how is that experience shaping future strategy?
  • Scaling for Success: Beyond the technical challenges, what are the primary organizational hurdles to successfully scaling new products and expanding facility footprints?
5:00 pm - 5:55 pm WELCOME DAY SPECIAL CONTENT

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

Moderator

Joanne Beck

Chief Operating Officer

Elektrofi

Glenn A. Gerecke

Chief Manufacturing and Supply Officer

Sandoz

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

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

  • Workforce & Talent: With billions invested in 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

7:00 pm

Executive dinner

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 KEYNOTE

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

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

Leading Technical Operations in an Era of Complexity

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  • Navigating growing complexity across quality, supply, and technical decision-making

  • Aligning cross-functional teams to drive consistent execution and accountability

  • Lessons learned in balancing speed, compliance, and long-term operational priorities

Stream Two - Quality

Turning Quality into an Operational Enabler

Anthony Mire-Sluis

Senior Vice President, Global Quality

Gilead Sciences

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  • Integrating quality early into process development and operations

  • Using data and insights to inform faster, smarter decisions

  • Shifting from reactive oversight to proactive, risk-driven quality management

Stream Three - Supply Chain & Innovation

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
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

Content to be Announced

Kathleen Van Citters

Sr Director, Advanced Therapies MSAT

Johnson & Johnson

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 Case Studies
Stream One

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

Stream Two - Quality

Risk-Based Quality Strategies for Next-Generation Therapies

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  • Prioritizing deviations, investigations, and inspections with predictive risk models

  • Balancing speed to market and regulatory rigor for cell, gene, and novel biologics

  • Integrating digital tools for real-time oversight and early detection of quality issues

  • Case studies on managing uncertainty in untested modalities

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

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  • Embedding patient perspective into biologics innovation—from design to delivery
  • Aligning scientific excellence with human impact to drive the next wave of transformative therapies

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

Translating Manufacturing Strategy into Operational Reality: Lessons from Large-Scale Pharmaceutical Operations

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

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

Eamonn Warren

Group Vice President, Global API & Dry Products Manufacturing

Eli Lilly

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  • 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

Harish Santhanam

Vice President Cell Therapy Technical Operations

Bristol Myers Squibb

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  • 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

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  • 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

The Resilient Supply Chain: Lessons in Agility

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  • 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
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 Pharma Manufacturing

Executive to be Announced

Fabriq

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  • 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

Driving Operational Excellence Through Digital Transformation and Quality Leadership

Executive to be Announced

Accenture

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  • How integrated digital tools and data-driven approaches strengthen quality and compliance

  • Lessons learned in building resilient, scalable manufacturing and supply networks

  • Practical insights on aligning people, processes, and technology for consistent execution

Stream Three

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

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  • 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 - 12:45 pm PANEL

Charting the Course - Past Progress and Future Potential in Pharma

Moderator

Vikki Sluzky

Chief Technology Officer

Elektrofi

Kevin Trivett

Senior Vice President Manufacturing Operations

Eli Lilly

Elizabeth Hewitt

VP, Head of Pharmaceutical Sciences Program Leadership

Takeda

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  • 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
12:45 pm - 1:45 pm

Executive 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.

Content to be Announced

Michel Russell

Executive Director, Intercompany Operations, (GLS)  (GSC) (GPS)

Bristol Myers Squibb

Content to be Announced

Pontaah Arbtan

Director, Enterprise Quality Training & Documentation

CSL (Seqirus)

Content to be Announced

Steve Lexa

Site Quality Lead

Eli Lilly

Content to be Announced

Diana Aberion

Sr. Director, Corporate QA Audit Program and Inspection Management

Gilead

Content to be Announced

Stephen Mahoney

Executive Director, Head of Quality Policy & Advocacy

Gilead

Content to be Announced

Katelyn Hahn

Director, Biotherapeutics Site & External Planning

Johnson & Johnson

Supplier Risk Management: Strategies for Identifying and Managing Highest-Risk Outsourcing Partners Across R&D and the Supply Chain

Joseph Pollarine

Sr Director, Supplier & Vendor Quality

Johnson & Johnson

Content to be Announced

Amanda Lewis

Sr. Director of DNA Operations & Manufacturing Support

Moderna

Content to be Announced

Joseph Neal

VP, Supply Chain

Moderna

Content to be Announced

Meg Gao

Senior Director, Manufacturing Sciences and Technology

Moderna

Content to be Announced

Katie Masterson

Sr. Director Manufacturing Operations

Regenxbio

Content to be Announced

Kumar Namdev

Global Head, CMC Product development and industrialization, mRNA Center of Excellence

Sanofi

Content to be Announced

Christoph Pistek

SVP, Head of Sustainability and Technology, R&D

Takeda

Sessions From Previous Years

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