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2026 Agenda

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May 18th

3:00 pm

Registration

3:30 pm - 4:20 pm WELCOME DAY SPECIAL CONTENT

Panel: Next-Generation Modalities in Action - Operational Insights

Moderator

Jason Martin

SVP, Head of Technical Operations, Hypercon

Halozyme

Kanti Thirumoorthy

Vice President, Cell Therapy Development and Operations

AstraZeneca

Carlos Candido

Vice President, External Manufacturing, MSAT & Supply Chain

Be Biopharma

Scott May

VP, Chemistry

Eli Lilly and Company

Amanda Ashcraft

Site Head, VP Norwood Drug Substance Operations

Moderna

Session Details Arrow Icon

  • Next-Gen Modalities Manufacturing: How organizations are overcoming challenges in cell, gene, and mRNA therapy production

  • Execution in Action: Real-world strategies for aligning Manufacturing, Quality, and Supply Chain to move therapies faster to patients

  • Operational Resilience: Lessons learned from recent global disruptions and how teams are building more robust systems

  • Scaling and Capability Building: Tackling both technical and organizational hurdles to expand capacity and deliver innovative medicines

4:25 pm - 5:00 pm KEYNOTE

The New Entry‑Level MES from the Makers of PAS-X MES

Andrew Jacon

Head of Sales & Marketing

Körber Pharma Software

Pierrick Lebigre

Vice President Product Management

Körber Pharma Software

Session Details Arrow Icon

In this session, Körber introduces its new Entry-Level MES product, purpose-built for focused shopfloor use cases, fast deployment, and GMP compliance.

Explore a new approach to MES that brings the trusted quality of Körber PAS‑X into a right-sized, cloud native foundation designed to help manufacturers take their first step toward digitalization.

5:10 pm - 6:00 pm WELCOME DAY SPECIAL CONTENT

Panel: The Five Big Questions Defining the Future of Pharmaceutical Manufacturing

Moderator

Joanne Beck

Chief Operating Officer, Hypercon

Halozyme

Vinod Bulusu

Executive Director, Product Stewardship Lead

AstraZeneca

Vaishali Shukla

VP, CGT & API Global Expansion Quality

Eli Lilly

Hilary Marston

Principal, Drug & Biological Therapies | Former Chief Medical Officer

Canal Row Advisors | Former FDA

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 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

6:30 pm

Executive dinner

May 19th

Stream 1 Chair

Joanne Beck

Chief Operating Officer, Hypercon

Halozyme

Stream 2 Co-Chair

Allison Cacciatore

Vice President of Technical Operations

Project Farma

Stream 3 Co-Chair

Sanjay Srivastava

Managing Director, Cell & Gene Therapy CoE Lead

Accenture

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, Hypercon

Halozyme

8:30 am - 9:05 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

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

9:10 am - 9:45 am Case Studies
Stream One - Strategic Manufacturing

Built for Any Modality: Future Proofing Manufacturing for a Fast-Shifting Pipeline

Anne Kantardjieff

VP, Head of CMC Development and Regulatory for Biologics and ATMPs

Biogen

Session Details Arrow Icon
  • The “modality agnostic” playbook: launch-at-scale readiness across CMC and manufacturing—supporting a broadening pipeline and evolving product presentations
  • Investments that matter most: balancing capital, technology, and people investments to reduce risk and accelerate readiness
  • Enabling differentiated product delivery (devices/combination products) while balancing build vs. partner decisions and strengthening supply continuity
Stream Two - Quality

Turning Quality into an Operational Enabler

Anthony Mire-Sluis

Senior Vice President, Global Quality

Gilead Sciences

Session Details Arrow Icon

  • 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

Autologous Cell Therapy Manufacturing – A Core Competency

Harish Santhanam

Vice President Cell Therapy Technical 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
9:50 am - 10:25 am Workshops
Stream One

Smarter Facilities, Faster Delivery: The Future of Pharma Manufacturing

Jacob Greenwood

Vice President

Project Farma

Kerri Edwards

Associate Director, MSAT

Lonza

Session Details Arrow Icon
  • Address the unique industry challenges from evolving regulatory landscapes and complex supply chains to scaling production efficiently
  • Highlight technical operations best practices to optimize manufacturing from facility planning to operational readiness and product delivery
  • Explore how agile models enable flexibility and resilience in rapidly evolving manufacturing environments
  • Identify risk-based approaches for various phases including design, construction, CQV and quality
  • Share real world examples of adaptive and agile facility design that support accelerated manufacturing
  • Discuss strategies for integrating digital transformation, automation and data analytics to drive efficiency and scalability across sites
Stream Two

Unlocking Manufacturing Intelligence: The AI Advantage in Regulated Environments

Brian Curran

SVP Manufacturing Excellence Success

MasterControl

Session Details Arrow Icon
  • Tips for identifying high-value AI opportunities in pharma and biotech manufacturing, particularly around batch record management
  • Recommendations for building a “Return on Automation” business case that justifies digitization investments
  • Strategies for implementing “human-in-the-loop” AI systems that maintain regulatory compliance while delivering operational improvements
  • Methods to keep sensitive manufacturing data secure while leveraging AI insights
  • Opportunities to envision transformative applications of AI across production processes
Stream Three

Throughput Is the Strategy in Cell & Gene Therapy Manufacturing

Ignacio Nunez

Former Chief Operations Officer at CellReady

ScaleReady LLC

Session Details Arrow Icon
  • Why most platforms fail at scale, and how to choose without over-capitalizing
  • Fix the operation first: automation doesn’t solve broken processes
  • Doing more with less is not optional, it’s the only path to viability
10:30 am - 12:05 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
12:10 pm - 12:45 pm Case Studies
Stream One - Strategic Manufacturing

Scaling Continuous Manufacturing for Small-Molecule APIs

Marian Gindy

Vice President, Small Molecule Science and Technology

Merck

Session Details Arrow Icon
  • 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

From Static Policies to Dynamic Quality Systems: Managing Complexity in a Global Network

Rae Ann Cook

VP, Global Quality

Otsuka Pharmaceuticals

Stream Three - Supply Chain & Innovation

The Product Lifecycle Spine - A Living Digital Thread: Submission-Ready, Transfer-Smooth, Launch-Fast, Always-in-Control

Christoph Pistek

VP, Head of Sustainability and Technology, R&D

Takeda

Session Details Arrow Icon

  • Establishing a connected, structured product knowledge model from Discovery (TCP → TPP → QTPP) through submission, tech transfer, launch, post-approval lifecycle management, and retirement

  • Designing the digital and business architecture required to enable an end-to-end “living” product lifecycle spine

  • Enabling closed-loop, contextual, and fully traceable data flow across the value stream to reduce handoffs and rework

  • Driving improved submission and inspection transparency, faster tech transfer and time-to-market, and sustained lifecycle state-of-control

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.

Navigating Global Regulatory Divergence: How to Stay Compliant Without Slowing Down

Yolanda McClean

Senior Director, Quality Strategy & Operations

Alnylam

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

Regis Gautier

Executive Director, Product Development & Sustainability Lead

AstraZeneca

Regulatory Challenges with Accelerated Global Launches and Product Maximisation, Strategies to Mitigate the Complexity

Frank Montgomery

Vice President, CMC Regulatory Affairs

AstraZeneca

Speed vs. Control: Are We Breaking Our Own Systems?

Steve Lexa

Site Quality Lead

Eli Lilly

New ICH Q9 Training Materials on Quality Risk Management (QRM) from PhRMA Topic Lead

Stephen Mahoney

Executive Director, Head of Quality Policy & Advocacy

Gilead

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

Kevin Kerls

Executive Site Director

Lonza

Challenges and Solutions for Upstream Scale Up and Down Across Facilities

Sandra Bennun

Director Biologics Drug Substance Process Development

Merck

Next-Gen Operations: Talent & Organization Design at the Intersection of AI, Automation, and Digital Manufacturing

Brendan Walker

Sr. Director, DS Network Smart Factory Lead

Moderna

Next-Gen Operations: Talent at the Intersection of AI, GMP, and Process Science

Amanda Lewis

Sr. Director of DNA Operations & Manufacturing Support

Moderna

Accelerating Modernization and Digital Transformation Initiatives in Existing Manufacturing Facilities

James Flacke

Senior Director, Biotech Production

Regeneron

Gene Therapy Manufacturing at Scale: Operational Challenges and Solutions for AAV Production

Katie Masterson

Sr. Director Manufacturing Operations

Regenxbio

1:50 pm - 2:25 pm Case Studies
Stream One - Strategic Manufacturing

Democratising Data to Unlock Manufacturing Agility: Sterile manufacturing in a smarter, faster, more connected operating model

Cormac Dalton

Vice President Sterile Manufacturing

AbbVie

Stream Two - Quality

Quality Business Leadership - Redesigning Quality

Anders Vinther

Former Chief Quality Officer, Founder & CEO

Quality Business Administration

Session Details Arrow Icon
  • Exploring how quality leaders evolve from compliance gatekeepers to strategic partners shaping portfolio, supply, and financial decisions
  • Demonstrating the link between quality leadership and business outcomes: product availability, risk reduction, and financial performance
  • Sharing key leadership traits that enable quality teams to drive value beyond compliance and influence executive decisions
Stream Three - Supply Chain & Innovation

Driving Operational Excellence Through Site Transformation

Odile Smith

Vice President, Devens Site Head

Bristol Myers Squibb

2:30 pm - 3:05 pm Workshops
Stream One

Facilities of the Future: Building AI‑Driven, Connected Systems Across Quality, Manufacturing, and Facilities

Bart Reitter

VP Sales

Honeywell Life Sciences

Session Details Arrow Icon
  • Life sciences manufacturers are facing unprecedented demands to boost speed, enhance quality, and ensure supply chain resilience, all while adhering to strict regulatory compliance in increasingly complex operational landscapes.
  • Discover the potential of a unified digital platform that integrates quality, manufacturing, cybersecurity, and building operations. Explore how forward-thinking organizations leverage AI to create a cohesive, data-driven ecosystem, paving the way for the future of connected compliance and operational excellence.
  • Learn how adopting a validated, single-vendor approach can simplify processes, accelerate time-to-value, and enhance patient safety, supply continuity, and regulatory assurance
Stream Two

Powering Production Performance: How a Global Biopharmaceutical Network Drives Flexibility and Resilience

Rainer Haemmerle

Executive Director Manufacturing, Fremont

Boehringer Ingelheim

Session Details Arrow Icon
  • You will learn how a globally connected production network enhances flexibility, supports rapid scale‑up, and strengthens supply resilience across markets
  • You will explore how harmonized technologies, shared platforms, and site‑to‑site collaboration reduce variability and accelerate operational readiness
  • You will see how a machine learning approach – initially designed to uncover the root causes of parameter variability during process transfers – has matured into a predictive toolset that supports anticipating outcomes, guiding decisions, and streamlining transfer execution
  • You will understand how digitalization and AI can be embedded into the broader biopharma production ecosystem to create smarter, more adaptive manufacturing strategies
Stream Three

Balancing Speed, Quality, and Cost in Global Manufacturing Networks

Nida Sayed

Senior Manager of Upstream Process Development

Boston Institute of Biotechnology, LLC

Session Details Arrow Icon
  • 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
3:10 pm - 4:20 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.

  • 3:10 pm – 3:30 pm: Meeting Slot 5/Networking
  • 3:35 pm – 3:55 pm: Meeting Slot 6/Networking
  • 4:00 pm – 4:20 pm: Meeting Slot 7/Networking
4:25 pm - 5:00 pm KEYNOTE

Navigating the Evolving Regulatory Environment: A Fireside Conversation

Michael Rogers

Principal, Quality and Compliance | Former Associate Commissioner

Canal Row Advisors | Former FDA

Moderator: Kim Wolfram

Head of Global Regulatory CMC Biologics & ATMP

Biogen

Session Details Arrow Icon
  • Examining the latest trends in FDA inspections including the use of generalist inspectors and the expansion of unannounced foreign facility inspections
  • Discussing how recent regulatory shifts are reshaping compliance strategies and what manufacturing leaders should be doing differently today
  • Exploring the future direction of pharma regulation and how industry can best engage with regulators to drive better outcomes for patients and manufacturers alike
5:00 pm - 5:05 pm

Chair’s Closing Remarks

Joanne Beck

Chief Operating Officer, Hypercon

Halozyme

5:05 pm

Drinks Reception

5:40 pm

Executive dinner

(By Invite Only)

May 20th

Stream 1 Chair

Joanne Beck

Chief Operating Officer, Hypercon

Halozyme

Stream 2 Co-Chair

Allison Cacciatore

Vice President of Technical Operations

Project Farma

Stream 3 Co-Chair

Sanjay Srivastava

Managing Director, Cell & Gene Therapy CoE Lead

Accenture

7:30 am - 8:45 am

registration & breakfast

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

From CMC Strategy to Execution: Delivering Results Across Pharma Manufacturing

Executive to be Announced

McKinsey & Co

8:45 am - 8:55 am

Chair’s Opening Remarks

Joanne Beck

Chief Operating Officer, Hypercon

Halozyme

9:00 am - 9:35 am KEYNOTE

From Smart Factory to Autonomous Factory: Building the Next Generation of Pharma Manufacturing

Jim Fox

SVP, Americas Supply Operations

AstraZeneca

Session Details Arrow Icon
  • How autonomous manufacturing is moving beyond machine automation to self-optimizing, data-driven operations
  • The role of AI, advanced analytics, robotics, and connected systems in reducing variability and improving reliability
  • Practical lessons from integrating manufacturing execution systems, quality systems, and supply networks into a single digital backbone
  • How autonomous operations can improve speed, resilience, compliance, and patient supply
  • What leaders should prioritize now to move from pilot programs to enterprise scale
9:40 am - 10:15 am Case Studies
Stream One - Strategic Manufacturing

Manufacturing as a Competitive Advantage: Driving Growth, Agility, and Innovation

Michelle LaFond

Vice President, Preclinical Manufacturing & Process Development

Regeneron Pharmaceuticals

Benjamin Parkhurst

Senior Director, CMC Lead

Flagship Pioneering

Session Details Arrow Icon

  • Leveraging operational excellence to accelerate launches and improve portfolio flexibility

  • Lessons from biologics and advanced therapy programs: overcoming technical, regulatory and organizational challenges

  • Elevating manufacturing leaders as strategic partners in R&D, pipeline, and business decisions

  • Turning technical and operational capabilities into measurable competitive advantage

Stream Two - Quality

Bridging the Gap: Practical Insights for Effective Quality Collaboration

Jasmine Riley

Head of Global Quality, Pharma Service Group

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

From Infusion to Injection: Developing Subcutaneous Drug-Device Combinations for Rare Disease Therapies

Justin Burt

Executive Director, Synthetic Product Development

Alexion Pharmaceuticals

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
10:25 am - 11:00 am FOCUS GROUP

Executive focus groups are informal moderated discussions among peers, held during networking breaks outside the summit agenda. No sign-up is required; delegates and speakers can join any group of interest.

TOPIC one

Quality at Scale: Navigating CMC, Regulatory Complexity, and Global Expansion in Advanced Therapeutics

Lyndsey Young

Executive Director, Head of Quality

Tr1X, Inc.

Paresma (Pinky) Patel

Director, Regulatory CMC Policy and Advocacy

Gilead Sciences

Vaishali Shukla

VP, CGT & API Global Expansion Quality

Eli Lilly

11:20 am - 11:55 am Workshops
Stream One

Takeda Case Study: Scaling Digital Tier Boards to Standardize Operations and Accelerate Decision-Making

Lindsey Daniel

P.E Global Operational Excellence Network Lead, Biologics

Takeda

Fabriq

Session Details Arrow Icon
  • Scaling a standardized, digital tiered management system across multiple biologics sites to strengthen operational control while enabling local flexibility through clearly defined governance principles
  • Connecting enterprise value drivers—capacity, quality, and service—to daily execution, ensuring alignment from leadership to shop floor
  • Leveraging real-time visibility to accelerate deviation management, reduce capacity losses, and improve lead times and inventory performance
  • Driving adoption across sites with varying maturity levels, balancing standardization with user engagement and ease of use
Stream Two

Reinventing BioPharma from Lab to Line

Anne Marie O’Halloran

Life Sciences Supply Chain & Operations, Americas Lead

Accenture

Session Details Arrow Icon

In this session we explore how discovery, development, quality, and manufacturing can operate as one connected lifecycle. Moving beyond siloed “futures,” this workshop examines how intelligent technologies enable seamless collaboration from lab to line—and back again—to accelerate delivery, scale innovation and drive competitive advantage.

Stream Three

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

Executive to be Announced

eschbach North America, Inc.

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 - 1:00 pm

Executive Lunch Seating

12:00 pm - 1:00 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.

Standardizing Manufacturing Technology in a Global Commercial Manufacturing Supply Network – Benefits vs Cost and Effort

Julie Ennis

Vice President, Technical Operations Science & Innovation

AstraZeneca

Different Uniform, Same Mission. Leading in Life Sciences After Military Service: Navigating Transition, Leading with Confidence, and Delivering Results

Michel Russell

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

Bristol Myers Squibb

Building Scalable Quality Training Programs: Ensuring Competency Across Global Operations

Pontaah Arbtan

Director, Enterprise Quality Training & Documentation

CSL (Seqirus)

From Gatekeeper to Enabler: Using AI‑Enabled Quality Systems to Move Faster and Stay Inspection‑Ready

Cory Johnson

Director of Quality Assurance

Eli Lilly and Company

Building Inspection Readiness Across a Global Manufacturing Network

Jonathan Chapman

Executive Director, Global Head of Quality Compliance & Audits

Gilead

Strategic Capacity Planning: Balancing Internal Manufacturing with External Partnerships for Biologics

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

Industrializing mRNA Manufacturing: From Platform Development to Commercial Scale Production

Mark Keegan

Global Head of Drug Substance Development, mRNA Center of Excellence

Sanofi

1:05 pm - 1:55 pm PANEL

Charting the Course - Past Progress and Future Potential in Pharma

Moderator

Joanne Beck

Chief Operating Officer, Hypercon

Halozyme

Kevin Trivett

Senior Vice President Manufacturing Operations

Eli Lilly

David Geer

Vice President, CMC

Replimune

Elizabeth Hewitt

VP, Head of Pharmaceutical Sciences Program Leadership

Takeda

Sue Marrichi

Vice President and Site Head, Gene Therapy Manufacturing Facility

Ultragenyx Pharmaceuticals, Inc.

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
1:55 pm - 2:00 pm

Closing Remarks

Joanne Beck

Chief Operating Officer, Hypercon

Halozyme